![](media/image1.png){width="5.886111111111111in"
height="2.3854166666666665in"}

**U.S. Department of Health and Human Services**

**Public Health Service**

**Grant Application (PHS 398)**

Instructions for PHS 398 Form Approved Through 11/30/2010\
Rev. 11/2007 OMB No. 0925-0001

Table of Contents

[Part I. Instructions for Preparing and Submitting an
Application](#PartI)

[1. Foreword I-1](#__RefHeading___Toc186425112)

[1.1 Application Guide Format I-5](#application-guide-format)

[1.2 NIH Extramural Research and Research Training Programs
I-6](#nih-extramural-research-and-research-training-programs)

[1.3 Research Grant Mechanisms and Program Guidelines
I-6](#research-grant-mechanisms-and-program-guidelines)

[1.4 Interactions with PHS Staff I-6](#interactions-with-phs-staff)

[1.5 Grants Policy Statements I-9](#grants-policy-statements)

[1.6 References I-10](#references)

[1.7 Authorization I-11](#authorization)

[1.8 Paperwork Burden I-11](#paperwork-burden)

[2. General Instructions I-12](#general-instructions)

[2.1 Introduction I-12](#introduction)

[2.2 Registration Processes I-12](#registration-processes)

[2.2.1 (Reserved) I-12](#reserved)

[2.2.2 DUNS Registration for the Applicant Organization & Subaward/\
Consortium Organizations
I-12](#duns-registration-for-the-applicant-organization-subawardconsortium-organizations)

[2.2.3 Central Contractor Registration (CCR) for the Applicant
Organization
I-13](#central-contractor-registration-ccr-for-the-applicant-organization)

[2.2.4 eRA Commons Registration I-13](#era-commons-registration)

[2.3 (Reserved) I-14](#reserved-1)

[2.4 Funding Opportunities I-14](#funding-opportunities)

[2.4.1 NIH Guide for Grants and Contracts
I-15](#nih-guide-for-grants-and-contracts)

[2.4.2 Funding Opportunity Announcements (FOAs)
I-15](#funding-opportunity-announcements-foas)

[2.5 (Reserved) I-16](#reserved-2)

[2.6 Format Specifications I-16](#format-specifications)

[2.7 Resubmission Applications I-17](#__RefHeading___Toc186425134)

[2.8 Revision Application I-19](#revision-application)

[2.9 Similar, Essentially Identical, or Identical Applications
I-19](#similar-essentially-identical-or-identical-applications)

[2.10 (Reserved) I-20](#reserved-3)

[2.11 (Reserved) I-20](#reserved-4)

[2.12 (Reserved) I-20](#reserved-5)

[2.13 Submission of Supplementary or Corrective Information
I-20](#submission-of-supplementary-or-corrective-information)

[2.14 Application Submission Dates I-20](#application-submission-dates)

[2.15 Submission, Review and Award Cycles
I-21](#submission-review-and-award-cycles)

[2.16 Resources for Finding Help I-21](#resources-for-finding-help)

[2.16.1 (Reserved) I-21](#reserved-6)

[2.16.2 Finding Help for the eRA Commons Registration
I-21](#finding-help-for-the-era-commons-registration)

[2.16.3 Finding Help for Application Preparation
I-22](#finding-help-for-application-preparation)

[3. Submission of the Grant Application
I-22](#submission-of-the-grant-application)

[3.1 Cover Letter I-22](#cover-letter)

[3.2 Number of Copies I-23](#number-of-copies)

[3.3 Bindings and Packaging I-23](#bindings-and-packaging)

[3.4 Application Mailing Address I-24](#application-mailing-address)

[4. Completing the PHS 398 Forms and Format Pages
I-24](#completing-the-phs-398-forms-and-format-pages)

[4.1 Face Page I-25](#face-page)

[4.2 Description, Project/Performance Sites, Senior/key Personnel, Other
Significant Contributors, and Human Embryonic Stem Cells
I-33](#description-projectperformance-sites-seniorkey-personnel-other-significant-contributors-and-human-embryonic-stem-cells)

[4.2.1 Description: Project Summary and Relevance
I-33](#description-project-summary-and-relevance)

[4.2.2 Project/Performance Site(s) I-33](#projectperformance-sites)

[4.2.3 Senior/key Personnel I-34](#seniorkey-personnel)

[4.2.4 Other Significant Contributors
I-34](#other-significant-contributors)

[4.2.5 Human Embryonic Stem Cells I-34](#human-embryonic-stem-cells)

[4.3 Research Grant Table of Contents
I-34](#research-grant-table-of-contents)

[4.4 Budget Instructions I-35](#budget-instructions)

[4.5 Budget for Entire Proposed Period of Support
I-38](#budget-for-entire-proposed-period-of-support)

[4.6 Biographical Sketch I-38](#biographical-sketch)

[4.6.1 Other Support Information I-39](#other-support-information)

[4.7 Resources I-40](#resources)

[4.8 Personal Data I-40](#personal-data)

[4.9 Senior/key Personnel Report I-40](#seniorkey-personnel-report)

[5. Preparing the Research Plan, the Checklist, and the Appendix
I-41](#preparing-the-research-plan-the-checklist-and-the-appendix)

[5.1 (Reserved) I-41](#reserved-7)

[5.2 (Reserved) I-41](#reserved-8)

[5.3 (Reserved) I-41](#reserved-9)

[5.4 Research Plan Format and Notice of Proprietary Information
I-41](#research-plan-format-and-notice-of-proprietary-information)

[5.4.1 Research Plan Format I-41](#research-plan-format)

[5.4.2 Notice of Proprietary Information
I-42](#notice-of-proprietary-information)

[5.5 Content of Research Plan I-42](#content-of-research-plan)

[5.6 Checklist I-47](#checklist)

[5.7 Appendix I-48](#appendix)

[6. The Peer Review Process I-49](#the-peer-review-process)

[7. Instructions for Preparing an Individual Research Career Development
Award\
(CDA) Application -- "K" Series
I-53](#instructions-for-preparing-an-individual-research-career-development-award-cda-application-k-series)

[7.1 Introduction I-53](#introduction-1)

[7.2 Individual Career Development Award Mechanism
I-53](#individual-career-development-award-mechanism)

[7.3 Letters of Reference I-54](#letters-of-reference)

[7.4 Basic Administrative Data I-54](#basic-administrative-data)

[7.4.1 Form Page 1 I-54](#form-page-1)

[7.4.2 Description, Project/Performance Sites, Senior/key Personnel,
Other\
Significant Contributors, and Human Embryonic Stem Cells
I-55](#description-projectperformance-sites-seniorkey-personnel-other-significant-contributors-and-human-embryonic-stem-cells-1)

[7.4.3 Table of Contents I-56](#table-of-contents)

[7.4.4 Detailed Budget for Initial Budget Period
I-56](#detailed-budget-for-initial-budget-period-1)

[7.4.5 Budget for Entire Proposed Period of Support
I-56](#budget-for-entire-proposed-period-of-support-1)

[7.4.6 Biographical Sketch I-57](#biographical-sketch-1)

[7.4.7 Other Support Format Page I-58](#other-support-format-page)

[7.4.8 Resources I-58](#resources-1)

[7.5 Career Development Plan I-59](#career-development-plan)

[7.5.1 The Candidate I-59](#the-candidate)

[7.5.2 Statements by Mentor, Co-mentor(s), Consultant(s), and
Contributor(s)
I-59](#statements-by-mentor-co-mentors-consultants-and-contributors)

[7.5.3 Environment and Institutional Commitment to the Candidate
I-61](#environment-and-institutional-commitment-to-the-candidate)

[7.5.4 Research Plan I-62](#research-plan)

[7.5.5 Checklist I-63](#checklist-1)

[7.5.6 Appendix I-64](#appendix-1)

[8. Instructions for Preparing an Institutional Research Training
Application\
Including Ruth L. Kirschstein-NRSA Applications
I-65](#instructions-for-preparing-an-institutional-research-training-application-including-ruth-l.-kirschstein-nrsa-applications)

[8.1. Introduction I-65](#introduction-3)

[8.2 Specific Instructions I-66](#specific-instructions)

[8.2.1 Face Page I-66](#face-page-1)

[8.3 Description, Project/Performance Sites, Senior/key Personnel, Other
Significant Contributors, and Human Embryonic Stem Cells
I-68](#description-projectperformance-sites-seniorkey-personnel-other-significant-contributors-and-human-embryonic-stem-cells-2)

[8.4 Table of Contents I-69](#table-of-contents-1)

[8.5 Detailed Budget for Initial Budget Period
I-69](#detailed-budget-for-initial-budget-period-2)

[8.6 Budget for Entire Proposed Period of Support
I-70](#budget-for-entire-proposed-period-of-support-2)

[8.7 Biographical Sketch I-70](#biographical-sketch-2)

[8.8 Resources I-70](#resources-2)

[8.9 Research Training Program Plan
I-70](#research-training-program-plan)

[8.9.1 Introduction (Resubmission or Revision Applications Only)
I-71](#introduction-resubmission-or-revision-applications-only-1)

[8.9.2 Background I-71](#background)

[8.9.3 Program Plan I-71](#program-plan)

[8.9.4 Recruitment and Retention Plan to Enhance Diversity
I-73](#recruitment-and-retention-plan-to-enhance-diversity)

[8.9.5 Plan for Instruction in the Responsible Conduct of Research
I-75](#plan-for-instruction-in-the-responsible-conduct-of-research)

[8.9.6 Progress Report (Renewal Applications Only)
I-75](#progress-report-renewal-applications-only)

[8.9.7 Human Subjects I-76](#human-subjects)

[8.9.8 Vertebrate Animals I-76](#vertebrate-animals-1)

[8.9.9 Select Agent Research I-76](#select-agent-research-1)

[8.9.10 Literature Cited I-77](#literature-cited)

[8.9.11 Multiple PD Leadership Plan I-77](#multiple-pd-leadership-plan)

[8.9.12 Consortium/Contractual Arrangements
I-77](#consortiumcontractual-arrangements-1)

[8.9.13 Participating Faculty Biosketches
I-77](#participating-faculty-biosketches)

[8.9.14 Data Tables I-77](#data-tables)

[8.9.15 Letters of Support I-77](#letters-of-support)

[8.10 Checklist I-78](#checklist-2)

[8.11 Appendix I-78](#appendix-2)

[Part II. Supplemental Instructions for Preparing the Protection\
of Human Subjects Section of the Research Plan](#Human_Subjects_PartII)

[1. Introduction II-1](#introduction-4)

[2. Scenarios II-1](#scenarios)

[3. Instructions for Preparing the Section on Protection of Human
Subjects
II-3](#instructions-for-preparing-the-section-on-protection-of-human-subjects)

[4. Instructions Pertaining to Non-Exempt Human Subjects Research
II-7](#instructions-pertaining-to-non-exempt-human-subjects-research)

[4.1 Protection of Human Subjects II-7](#protection-of-human-subjects-1)

[4.1.1 Risks to Human Subjects II-7](#risks-to-human-subjects)

[4.1.2 Adequacy of Protection Against Risks
II-8](#adequacy-of-protection-against-risks)

[4.1.3 Potential Benefits of the Proposed Research to Human Subjects
and\
Others
II-8](#potential-benefits-of-the-proposed-research-to-human-subjects-and-others)

[4.1.4 Importance of the Knowledge to be Gained
II-9](#importance-of-the-knowledge-to-be-gained)

[4.1.5 Data and Safety Monitoring Plan
II-9](#data-and-safety-monitoring-plan)

[4.1.6 ClinicalTrials.gov Requirements
II-10](#clinicaltrials.gov-requirements)

[4.2 Inclusion of Women and Minorities
II-10](#inclusion-of-women-and-minorities-1)

[4.2.1 Additional Instructions and Requirements When NIH-Defined Phase
III\
Clinical Trials Are Proposed
II-12](#additional-instructions-and-requirements-when-nih-defined-phase-iii-clinical-trials-are-proposed)

[4.3 Instructions for Completing the Targeted/Planned Enrollment Tables
for\
Reporting Race and Ethnicity Data for Subjects in Clinical Research
II-12](#instructions-for-completing-the-targetedplanned-enrollment-tables-for-reporting-race-and-ethnicity-data-for-subjects-in-clinical-research)

[4.4 Inclusion of Children II-14](#inclusion-of-children-1)

[5. Human Subjects Research Policy
II-15](#human-subjects-research-policy)

[5.1 Protection of Human Subjects
II-15](#protection-of-human-subjects-2)

[5.2 Vulnerable Populations II-16](#vulnerable-populations)

[5.3 Data and Safety Monitoring Plans for Clinical Trials
II-17](#data-and-safety-monitoring-plans-for-clinical-trials)

[5.4 IRB Approval II-17](#irb-approval)

[5.5 Required Education in the Protection of Human Research Participants
II-18](#required-education-in-the-protection-of-human-research-participants)

[5.6 NIH Policy on the Inclusion of Women and Minorities in Clinical
Research
II-18](#nih-policy-on-the-inclusion-of-women-and-minorities-in-clinical-research)

[5.7 NIH Policy on Inclusion of Children
II-18](#nih-policy-on-inclusion-of-children)

[5.8 NIH Policy on Reporting Race and Ethnicity Data: Subjects in
Clinical Research
II-19](#nih-policy-on-reporting-race-and-ethnicity-data-subjects-in-clinical-research)

[5.9 Research on Transplantation of Human Fetal Tissue
II-20](#research-on-transplantation-of-human-fetal-tissue)

[5.10 Research Using Human Embryonic Stem Cells
II-20](#research-using-human-embryonic-stem-cells)

[5.11 ClinicalTrials.gov Requirements
II-20](#clinicaltrials.gov-requirements-1)

[Part III. Policies, Assurances, Definitions, and Other
Information](#Policy_PartIII)

[1. Policy III-1](#policy)

[1.1 Applications That Include Consortium/Contractual Facilities and
Administrative\
Costs
III-1](#applications-that-include-consortiumcontractual-facilities-and-administrative-costs)

[1.2 Resubmission of Unpaid RFA Applications and Resubmission of
Applications with\
a Changed Grant Activity Code
III-1](#resubmission-of-unpaid-rfa-applications-and-resubmission-of-applications-with-a-changed-grant-activity-code)

[1.3 NIH Policy on Resubmission Applications
III-2](#nih-policy-on-resubmission-applications)

[1.4 Policy on the Acceptance for Review of Unsolicited Applications
That Request\
\$500,000 or More in Direct Costs
III-3](#policy-on-the-acceptance-for-review-of-unsolicited-applications-that-request-500000-or-more-in-direct-costs)

[1.5 Sharing Research Resources III-4](#sharing-research-resources)

[1.5.1 Data Sharing Policy III-4](#data-sharing-policy)

[1.5.2 Sharing Model Organism Policy
III-5](#sharing-model-organism-policy)

[1.5.3 Policy for Genome-Wide Association Studies (GWAS)
III-5](#policy-for-genome-wide-association-studies-gwas)

[1.6 Inventions and Patents III-5](#inventions-and-patents)

[1.7 Just-In-Time Policy III-6](#just-in-time-policy)

[1.8 Other Support III-6](#other-support)

[1.9 Graduate Student Compensation
III-7](#graduate-student-compensation)

[1.10 DUNS Number III-8](#duns-number)

[1.11 Public Access Policy III-8](#public-access-policy)

[1.12 PHS Metric Program III-9](#phs-metric-program)

[1.13 Transition to the SF424 (R&R) Application and Electronic
Submission through\
Grants.gov
III-9](#transition-to-the-sf424-rr-application-and-electronic-submission-through-grants.gov)

[2. Assurances and Certifications
III-9](#assurances-and-certifications-1)

[2.1 Human Subjects Research III-10](#human-subjects-research)

[2.1.1 Research on Transplantation of Human Fetal Tissue
III-12](#research-on-transplantation-of-human-fetal-tissue-1)

[2.1.2 Research Using Human Embryonic Stem Cells
III-12](#research-using-human-embryonic-stem-cells-1)

[2.1.3 NIH Policy on the Inclusion of Women and Minorities as Subjects
in\
Clinical Research
III-12](#nih-policy-on-the-inclusion-of-women-and-minorities-as-subjects-in-clinical-research)

[2.1.4 NIH Policy on Reporting Race and Ethnicity Data: Subjects in
Clinical\
Research
III-13](#nih-policy-on-reporting-race-and-ethnicity-data-subjects-in-clinical-research-1)

[2.1.5 NIH Policy on Inclusion of Children
III-13](#nih-policy-on-inclusion-of-children-1)

[2.1.6 ClinicalTrials.gov III-13](#clinicaltrials.gov)

[2.2 Vertebrate Animals III-14](#vertebrate-animals-2)

[2.3 Debarment and Suspension III-15](#debarment-and-suspension)

[2.4 Drug-Free Workplace III-15](#drug-free-workplace)

[2.5 Lobbying III-15](#lobbying)

[2.6 Non-Delinquency on Federal Debt
III-16](#non-delinquency-on-federal-debt)

[2.7 Research Misconduct III-16](#research-misconduct)

[2.8 Assurance of Compliance (Civil Rights, Handicapped Individuals,
Sex\
Discrimination, Age Discrimination)
III-17](#assurance-of-compliance-civil-rights-handicapped-individuals-sex-discrimination-age-discrimination)

[2.9 Research Involving Recombinant DNA, including Human Gene Transfer\
Research
III-17](#research-involving-recombinant-dna-including-human-gene-transfer-research)

[2.10 Financial Conflict of Interest
III-18](#financial-conflict-of-interest)

[2.11 Smoke-Free Workplace III-19](#smoke-free-workplace)

[2.12 Prohibited Research III-19](#prohibited-research)

[2.13 Select Agent Research III-19](#select-agent-research-2)

[2.14 Program Director/Principal Investigator Assurance
III-20](#program-directorprincipal-investigator-assurance)

[2.15 Impact of Grant Activities on the Environment and Historic
Properties
III-20](#impact-of-grant-activities-on-the-environment-and-historic-properties)

[3. Definitions III-22](#definitions)

[4. General Information III-31](#general-information)

[4.1 Research Grant Mechanisms III-31](#research-grant-mechanisms)

[4.2 Mail Addressed to the National Institutes of Health
III-33](#mail-addressed-to-the-national-institutes-of-health)

[4.3 Government Use of Information Under Privacy Act
III-34](#government-use-of-information-under-privacy-act)

[4.4 Information Available to the Program Director(s)/Principal
Investigator(s)
III-35](#information-available-to-the-program-directorsprincipal-investigators)

[4.5 Information Available to the General Public
III-35](#information-available-to-the-general-public)

[4.6 Access to Research Data III-35](#access-to-research-data)

[]{#PartI .anchor}PART I\
\
Instructions for Preparing and Submitting\
an Application

# 1. Foreword

The PHS 398 instructions contain information for preparing grant
applications to the National Institutes of Health (NIH) and other Public
Health Service agencies for:

-   *Public Health Service (PHS) Research Grants*

-   *Career Development Awards (K-awards)*

-   *Institutional Research Training including Ruth L. Kirschstein
    National Research Service Awards (NRSA) (Training Grants)*

Applicants to PHS agencies other than NIH should contact the agency
using the PHS Agency Contacts Table in 1.4 below because some awarding
components have application requirements that differ from those for NIH.

NIH continues to transition grant mechanisms from the PHS 398 to the
SF424 (R&R) and electronic submission through Grants.gov. This PHS 398
is required for all grant mechanisms that have not transitioned to the
SF424 (R&R), including Resubmission, Renewal, Revision, and research
training grants, changes of grantee institution, and cooperative
agreement applications. Once a mechanism has transitioned to electronic
submission the applicant must apply through Grants.gov using the SF424
(R&R) and electronic PHS 398 components that are provided as part of the
electronic application forms.

For more information on NIH\'s transition plans, including a timeline
for the transition of various mechanisms, see the website for Electronic
Submission of Grant Applications:
<http://era.nih.gov/ElectronicReceipt>/.

Bookmark this website
(<http://grants.nih.gov/grants/funding/phs398/phs398.html>) for easy
electronic access to this document.

#### Summary of Changes

These instructions include numerous clarifications and updates. The
following table is a summary of policy changes and notifications
implemented since the 04/2006 interim revision of the PHS 398
application.

+-------------------------------+--------------------------------------+
| title                         | nih guide link                       |
+===============================+======================================+
| NIH Announces Plans to        | NOTICE: NOT-OD-06-066                |
| Eliminate Mailing of Paper    |                                      |
| Assignment and Change of      | <http://grants.nih.gov/grants/gu     |
| Assignment Letters            | ide/notice-files/NOT-OD-06-066.html> |
+-------------------------------+--------------------------------------+
| NIH Policy on Late Submission | NOTICE: NOT-OD-06-086                |
| of Grant Applications         |                                      |
|                               | <http://grants.nih.gov/grants/gu     |
|                               | ide/notice-files/NOT-OD-06-086.html> |
+-------------------------------+--------------------------------------+
| Notice of New NIH Policy for  | Notice: NOT-OD-06-090                |
| Funding of Tuition, Fees, and |                                      |
| Health Insurance on Ruth L.   | <http://grants.nih.gov/grants/gu     |
| Kirschstein National Research | ide/notice-files/NOT-OD-06-090.html> |
| Service Awards                |                                      |
+-------------------------------+--------------------------------------+
| Revision: Notice of New NIH   | NOTICE: NOT-OD-06-093                |
| Policy for Funding of         |                                      |
| Tuition, Fees, and Health     | <http://grants.nih.gov/grants/gu     |
| Insurance on Ruth L.          | ide/notice-files/NOT-OD-06-093.html> |
| Kirschstein National Research |                                      |
| Service Awards                |                                      |
+-------------------------------+--------------------------------------+
| NIH Announces Requirement for | NOTICE: NOT-OD-06-096                |
| Detailed (Non-Modular) Budget |                                      |
| Submissions for All Competing | <http://grants.nih.gov/grants/gu     |
| Grant Applications from       | ide/notice-files/NOT-OD-06-096.html> |
| Foreign (Non-U.S.)            |                                      |
| Institutions                  |                                      |
+-------------------------------+--------------------------------------+
| Change in Standing Receipt    | NOTICE: NOT-OD-07-001                |
| Dates for NIH/AHRQ/NIOSH      |                                      |
| Beginning in January 2007     | <http://grants.nih.gov/grants/gu     |
|                               | ide/notice-files/NOT-OD-07-001.html> |
+-------------------------------+--------------------------------------+
| Guidance to Applicant         | NOTICE: NOT-OD-07-003                |
| Organizations about           |                                      |
| Registering Research Fellows  | <http://grants.nih.gov/grants/gu     |
| in the eRA Commons            | ide/notice-files/NOT-OD-07-003.html> |
+-------------------------------+--------------------------------------+
| Limits on Resubmission of an  | NOTICE: NOT-OD-07-015                |
| Application: Clarification of |                                      |
| NIH Policy                    | <http://grants.nih.gov/grants/gu     |
|                               | ide/notice-files/NOT-OD-07-015.html> |
+-------------------------------+--------------------------------------+
| Establishment of Multiple PI  | NOTICE: NOT-OD-07-017                |
| Awards for the Support of     |                                      |
| Team Science Projects         | <http://grants.nih.gov/grants/gu     |
|                               | ide/notice-files/NOT-OD-07-017.html> |
+-------------------------------+--------------------------------------+
| New Limits on Appendix        | NOTICE-OD-07-018                     |
| Materials for All             |                                      |
| NIH/AHRQ/NIOSH Grant          | <http://grants.nih.gov/grants/gu     |
| Applications Beginning with   | ide/notice-files/NOT-OD-07-018.html> |
| Receipt Dates on or After     |                                      |
| January 3, 2007               |                                      |
+-------------------------------+--------------------------------------+
| NIH Policy on Late Submission | NOTICE-OD-07-026                     |
| of Grant Applications -       |                                      |
| Clarification for Multiple PI | <http://grants.nih.gov/grants/gu     |
| Applications and New          | ide/notice-files/NOT-OD-07-026.html> |
| Submission/Receipt Dates      |                                      |
+-------------------------------+--------------------------------------+
| Change in Standing Receipt    | NOTICE OD-07-053                     |
| Dates for AIDS and            |                                      |
| AIDS-related applications for | <http://grants.nih.gov/grants/gu     |
| NIH/AHRQ Beginning in May     | ide/notice-files/NOT-OD-07-053.html> |
| 2007                          |                                      |
+-------------------------------+--------------------------------------+
| Policy for Sharing of Data    | NOTICE OD-07-088                     |
| Obtained in NIH Supported or  |                                      |
| Conducted Genome-Wide         | <http://grants.nih.gov/grants/gu     |
| Association Studies (GWAS)    | ide/notice-files/NOT-OD-07-088.html> |
+-------------------------------+--------------------------------------+
| Implementation Guidance and   | NOTICE OD-08-013                     |
| Instructions for Applicants:  |                                      |
| Policy for Sharing of Data    | <http://grants.nih.gov/grants/gu     |
| Obtained in NIH-Supported or  | ide/notice-files/NOT-OD-08-013.html> |
| Conducted Genome-Wide         |                                      |
| Association Studies (GWAS)    |                                      |
+-------------------------------+--------------------------------------+
| Clinical Trials Registration  | NOTICE OD-08-023                     |
| in ClincialTrials.gov (Public |                                      |
| Law 110-85): Competing        | <http://grants.nih.gov/grants/gu     |
| Applications and              | ide/notice-files/NOT-OD-08-023.html> |
| Non-Competing Progress        |                                      |
| Reports                       |                                      |
+-------------------------------+--------------------------------------+

**Changes to instructions are highlighted as follows:**

Implementation of Grants.Gov Terminology

-   As part of the ongoing effort to keep the PHS 398 and the SF424
    (R&R) synchronized, new terminology is implemented throughout this
    document. For reference, the following table is provided:

  -----------------------------------------------------------------------
  old term                      new term
  ----------------------------- -----------------------------------------
  Competing continuation        Renewal application
  application                   

  Revision or amendment \[to    Resubmission application
  application\]                 

  Competing supplement          Revision application

  Principal Investigator        Program Director/Principal Investigator

  Key Personnel                 Senior/key Personnel

  Performance site              Project/performance site

  Duly authorized               Authorized Organizational Representative
  representative                
  -----------------------------------------------------------------------

Definition of new investigator

-   Revised to provide clarity.

Structure of Document

-   Instructions are reorganized for greater consistency with the SF424
    (R&R) and PHS 398 Component Instructions used for electronic
    submission. A numerical reference system is incorporated in order to
    more closely parallel the SF424 (R&R) instructions. As a result
    there are some blank sections in this document labeled \"Reserved.\"

-   In Part I, the Research Plan is reorganized for consistency with the
    SF424 (R&R) instructions, with one exception: The section titled
    "Bibliography and References Cited" in the PHS 398 is requested in
    Section 5.5 Content of Research Plan, item 7.a; in the SF424 (R&R)
    this information is located in 4.4 Other Project Information
    component, as item 8.

-   Part II is revised for purposes of clarity and ease of reference,
    and the definitions related to human subjects research are moved to
    Part III.

Suggested Cover Letter Format

-   A suggested cover letter format is provided for greater consistency
    and to facilitate the use of requests for specific Institutes or
    Centers (ICs) or Scientific Review Groups.

Budget Justification

-   The instructions for justification of a foreign applicant or foreign
    component are reworded for consistency with NIH criteria for funding
    a foreign project (i.e., the project must present special
    opportunities for furthering research programs through the use of
    unusual talents, resources, populations, or environmental
    characteristics that augment existing U.S. resources) (see Part I,
    4.5).

Indefinite Plans for Involvement of Human Subjects or Use of Vertebrate
Animals

-   Instructions for the Research Plan sections addressing human
    subjects and vertebrate animals are modified to provide guidance to
    applicants when plans are indefinite at the time of application.

Instructions for Career Development Award Applications

-   Term *mentor* is used in place of *sponsor*.

-   Numerous instructional clarifications.

Institutional Research Training Application Including Ruth L.
Kirschstein-NRSA Applications

-   Instructions and forms are renamed to acknowledge that there are
    institutional training programs that are not Ruth L. Kirschstein
    National Research Service Awards.

-   Integration of the NIH diversity recruitment and retention policy
    described in institutional Kirschstein-NRSA training grant,
    institutional career development, and research education Funding
    Opportunity Announcements (e.g.,
    [PA-06-468](http://grants.nih.gov/grants/guide/pa-files/PA-06-468.html)).

-   Narrative instructions for training data tables are replaced with
    fillable format tables and examples of completed tables (see Form
    and Format changes below).

-   Provision for multiple PD/PIs is included for institutional training
    grants.

Appendix Format

-   Appendix material is to be submitted on CDs in PDF format, and will
    no longer be accepted on paper.

Part II, Instructions for Preparing the Protection of Human Subjects
Section of the Research Plan

-   All exemptions appear in one scenario (Scenario C).

-   A scenario for \"Delayed Onset of Human Subjects Research\" is
    incorporated.

**Changes to specific form and format pages are noted below:**

398 Face Page

-   Item 3 changed from PI/PD to PD/PI to be consistent with SF
    424(R&R).

-   IACUC approval date (formerly item 5a) deleted since information is
    collected only as Just-in-Time; Item 5b renumbered 5a.

398 Form Page 2 and Project/Performance Site Format Page

-   Form page 2 is revised, and the Project/Performance Site Format Page
    created to collect information for each project/performance site as
    required by the Federal Financial Accountability and Transparency
    Act.

Modular Budget Form Page

-   Form page is no longer included since mechanisms using modular
    budgets have transitioned to SF424 (R&R) and do not use the PHS 398
    paper application. Modular budget form pages still exist as part of
    electronic submission.

Checklist Form Page

-   A Disclosure Permission Statement checkbox is added to allow
    disclosure of certain information to organizations that may be
    interested in possible collaboration, investment, etc.

Institutional Training Grant Data Tables

-   Fillable format pages and samples of completed tables provided to
    afford structure for and promote consistency in data.

#### Important Reminders for all Applicants

Font and margin specifications must be followed; if not, application
processing may be delayed or the application may be returned to the
applicant without review. NIH requires the use of one of four approved
fonts and a font size of 11 points or larger. The approved font options
include two serif fonts (Palatino and Georgia) and two sans serif fonts
(Arial and Helvetica). A symbol font may be used to insert Greek letters
or special characters; the font size requirement still applies. A
smaller font size may be used for figures, graphs, diagrams, charts,
tables, figure legends, and footnotes, but this type must follow the
font typeface requirement and be readily legible.

Prepare a *succinct* Research Plan. There is no requirement for
applicants to use the maximum allowable pages allotted to the Research
Plan (Part I, 5.5, Items 2-5). The remaining sections of the Research
Plan (6-17) have no maximum allowable pages, but should also be
succinct.

Several elements of an application are not required at the time the
application is submitted. This information is requested later in the
review cycle (i.e., just-in-time) to ensure that it is current. See
[Just-In-Time Policy](#just-in-time-policy) in Part III. 1.7.

## 1.1 Application Guide Format

This edition of the PHS 398 is organized into three parts, and is
available in two different formats: MS Word and PDF. Within each Part
are links to pertinent sections of the application, other documents, or
NIH web pages. To use these links in the MS Word version effectively,
you must enable the \"web\" tool bar in order to have a "back button" to
return to a page after using a link. The three parts of the 398 are
described below:

#### Part I: Instructions for Preparing and Submitting an Application  {#part-i-instructions-for-preparing-and-submitting-an-application .Subhead---No-TOC}

Part I includes instructions on submitting a grant application,
completing the PHS 398 forms and format pages, preparing the cover
letter, Research Plan, and checklist, and information on the peer review
process. Section 7 of Part I provides instructions to prepare an
individual Career Development Award application. Section 8 consists of
instructions to prepare an institutional research training (including
Ruth L. Kirschstein National Research Service Award) application.

#### Part II: Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan  {#part-ii-supplemental-instructions-for-preparing-the-protection-of-human-subjects-section-of-the-research-plan .Subhead---No-TOC}

Part II includes instructions for research that proposes to involve
[human subjects](#Human_Subjects_Defs_Human), including scenarios and
detailed instructions to complete [Items 8-11 of the Research Plan
(Human Subjects Research)](#protection-of-human-subjects).

#### Part III: Policies, Assurances, Definitions and Other Information  {#part-iii-policies-assurances-definitions-and-other-information .Subhead---No-TOC}

Part III includes information on policies, assurances, definitions, and
other information relating to submitting applications to the PHS.
Applicants should refer to this document as well as the PHS 398
instructional materials, [Grants Information](#grants-information)
(GrantsInfo), and the relevant Grants Policy Statement for additional
sources of information. The [NIH Grants Policy
Statement](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm)
applies to all NIH awardees; other PHS agencies use the [HHS Grants
Policy Statement](http://www.hhs.gov/grantsnet/).

Form pages are available *separately* on the NIH website
(<http://grants.nih.gov/grants/funding/phs398/phs398.html#forms>).

**THESE INSTRUCTIONS AND APPLICATION FORMS (Revised 11/2007) SUPERSEDE
ALL PREVIOUS EDITIONS.** Carefully read the instructions. Submission of
an application that fails to meet the PHS requirements will be grounds
for the PHS to delay the review or to return the application without
peer review. A properly prepared application will facilitate the
administrative processing and peer review that must occur before an
award can be made.

While the instructions are generally applicable, grant programs of PHS
agencies other than NIH may have additional specific instructions.
Applicants should contact an official listed in the
[table](#phs-agency-contacts) of PHS agencies to obtain the most current
information and instructions.

## 1.2 NIH Extramural Research and Research Training Programs

The NIH Office of Extramural Research is the focal point for policies
and guidelines for extramural research grants administration
(<http://grants.nih.gov/grants/oer.htm>).

The Division of Extramural Outreach and Information Resources (DEOIR) is
the central source for general information about NIH extramural research
and research training programs, funding mechanisms, the peer review
system, and application procedures. Grants Information (GrantsInfo) may
be contacted by e-mailing
[[GrantsInfo@nih.gov]{.underline}](mailto:GrantsInfo@nih.gov), or
calling (301) 435-0714.

## 1.3 Research Grant Mechanisms and Program Guidelines

A partial list of research grant mechanisms that use the paper PHS 398
Grant Application is provided below, however, not all awarding
components use all programs. For a complete listing of program
guidelines, visit the OER Grants website
<http://grants.nih.gov/grants/funding/funding_program.htm>. As grant
mechanisms transition to electronic submission through Grants.gov using
the SF 424 (R&R) they will no longer use this paper PHS 398 application.
See <http://era.nih.gov/ElectronicReceipt/strategy_timeline.htm> for the
latest information on the transition to electronic submission.

#### Research Program Projects and Centers:

-   [Program Project Grant (P01)](#P01)

-   Exploratory Grants (P20)

-   Center Core Grants (P30)

-   Biotechnology Resource Grants (P41)

-   [Research Center Grant (P50)](#P50)

-   Comprehensive Center (P60)

#### Training, Fellowships and Career Development Programs

-   [NIH Institutional Ruth L. Kirschstein National Research Service
    Award (T32)](#T32)

-   [Individual Ruth L. Kirschstein National Research Service Award
    Fellowships (NRSA) (F31, F32, F33, F34, etc.)](#NRSA)

-   [Research Career Development Award (K Award)](#KAward)

#### Other Grant Mechanisms

-   International Training Grants (D43, D71)

-   Research Centers in Minority Institutions (G12)

-   Resource-Related Research Projects (R24, U24)

## 1.4 Interactions with PHS Staff

The PHS agencies encourage applicants to communicate with staff
throughout the entire application, review and award process. Web site
addresses and phone numbers of relevant NIH awarding components and
other PHS agencies are listed in the table below. The non-NIH agencies
listed below use this application form, but some have application
requirements that differ from NIH. For specific instructions for AHRQ,
CDC, FDA and IHS, refer to the links provided below and the terms and
conditions of the Notice of Award.

All inquiries regarding the assignment, review, or recommendation on
funding of applications are to be made only to PHS officials.

#### PHS Agency Contacts

  -----------------------------------------------------------------------------------------------------------------------------
  phs agency\                                    awarding component\                                             telephone
  (link to web site)                             (link to web site)                                              number 
  ---------------------------------------------- --------------------------------------------------------------- --------------
  [NATIONAL INSTITUTES OF HEALTH                 [*Eunice Kennedy Shriver* National Institute of Child Health    301-496-0104
  (NIH)](http://www.nih.gov/)                    and Human Development](http://www.nichd.nih.gov/)               

  NIH                                            [Fogarty International Center](http://www.fic.nih.gov/)         301-496-1653

  NIH                                            [National Cancer Institute](http://www.nci.nih.gov/)            301-496-3428

  NIH                                            [National Center for Complementary and Alternative              301-496-4792
                                                 Medicine](http://nccam.nih.gov/)                                

  NIH                                            [National Center on Minority Health and Health                  301-402-1366
                                                 Disparities](http://ncmhd.nih.gov/)                             

  NIH                                            [National Center for Research                                   301-496-6023
                                                 Resources](http://www.ncrr.nih.gov/)                            

  NIH                                            [National Eye Institute](http://www.nei.nih.gov/)               301-451-2020

  NIH                                            [National Heart, Lung, and Blood                                301-435-0260
                                                 Institute](http://www.nhlbi.nih.gov/index.htm)                  

  NIH                                            [National Human Genome Research                                 301-496-7531
                                                 Institute](http://www.nhgri.nih.gov/)                           

  NIH                                            [National Institute on Aging](http://www.nih.gov/nia/)          301-496-9322

  NIH                                            [National Institute on Alcohol Abuse and                        301-443-4375
                                                 Alcoholism](http://www.niaaa.nih.gov/)                          

  NIH                                            [National Institute of Allergy and Infectious                   301-496-7291
                                                 Diseases](http://www.niaid.nih.gov/default.htm)                 

  NIH                                            [National Institute of Arthritis and Musculoskeletal and Skin   301-594-2463
                                                 Diseases](http://www.nih.gov/niams/)                            

  NIH                                            [National Institute of Biomedical Imaging and                   301-451-4792
                                                 Bioengineering](http://www.nibib.nih.gov/)                      

  NIH                                            [National Institute on Deafness and Other Communication         301-496-1804
                                                 Disorders](http://www.nidcd.nih.gov/)                           

  NIH                                            [National Institute of Dental and Craniofacial                  301-594-4800
                                                 Research](http://www.nidr.nih.gov/)                             

  NIH                                            [National Institute of Diabetes and Digestive and Kidney        301-594-8834
                                                 Diseases](http://www.niddk.nih.gov/)                            

  NIH                                            [National Institute on Drug Abuse](http://www.nida.nih.gov/)    301-443-2755

  NIH                                            [National Institute of Environmental Health                     919-541-7723
                                                 Sciences](http://www.niehs.nih.gov/)                            

  NIH                                            [National Institute of General Medical                          301-594-4499
                                                 Sciences](http://www.nigms.nih.gov/)                            

  NIH                                            [National Institute of Mental Health](http://www.nimh.nih.gov/) 301-443-3367

  NIH                                            [National Institute of Neurological Disorders and               301-496-9248
                                                 Stroke](http://www.ninds.nih.gov/)                              

  NIH                                            [National Institute of Nursing                                  301-594-6906
                                                 Research](http://www.nih.gov/ninr/)                             

  NIH                                            [National Library of Medicine](http://www.nlm.nih.gov/)         301-496-4621

  NIH                                            [Center For Scientific Review](http://www.csr.nih.gov/)         301-435-0715

  [AGENCY FOR HEALTHCARE RESEARCH AND            [Agency for Healthcare Research and                             301-427-1447
  QUALITY](http://www.ahrq.gov/)                 Quality](http://www.ahrq.gov/)                                  

  [CENTERS FOR DISEASE CONTROL AND PREVENTION    [Coordinating Center for Health Information and                 404-498-1186
  (CDC)](http://www.cdc.gov/)                    Services](http://www.cdc.gov/about/organization/cchis.htm)      

  CDC                                            [Coordinating Center for Infectious                             404-639-3770
                                                 Disease](http://www.cdc.gov/about/organization/ccid.htm)        

  CDC                                            [Coordinating Center for Environmental Health & Injury          770-488-4668
                                                 Prevention](http://www.cdc.gov/about/organization/ccehip.htm)   

  CDC                                            [Coordinating Center for Health                                 770-488-8390
                                                 Promotion](http://www.cdc.gov/about/organization/cchp.htm)      

  CDC                                            [Office of Public Health                                        404-639-4621
                                                 Research](http://www.cdc.gov/od/science/PHResearch/)            

  CDC                                            [National Institute for Occupational Safety and                 404-498-2530
                                                 Health](http://www.cdc.gov/niosh/homepage.html)                 

  CDC                                            [Procurement and Grants                                         770-488-2700
                                                 Office](http://www.cdc.gov/about/business/funding.htm)          

  [FOOD AND DRUG                                 [Food and Drug Administration](http://www.fda.gov/)             301-827-7185
  ADMINISTRATION](http://www.fda.gov/)                                                                           

  [INDIAN HEALTH SERVICE](http://www.ihs.gov/)   [Indian Health Service](http://www.ihs.gov/)                    301-443-0578

  [AGENCY FOR TOXIC SUBSTANCES AND DISEASE       [Agency for Toxic Substances and Disease                        404-842-6630
  REGISTRY](http://www.atsdr.cdc.gov/)           Registry](http://www.atsdr.cdc.gov/)                            

  [OFFICE OF PUBLIC HEALTH AND                   [Office of Population                                           301-594-4004
  SCIENCE](http://www.hhs.gov/ophs/index.html)   Affairs](http://www.hhs.gov/opa/familylife/)                    

  [OFFICE OF PUBLIC HEALTH AND                   [Office of Family                                               301-594-4008
  SCIENCE](http://www.hhs.gov/ophs/index.html)   Planning](http://www.hhs.gov/opa/familyplanning/index.html)     
  -----------------------------------------------------------------------------------------------------------------------------

#### Before Submission

Applicants may contact NIH staff with a variety of questions before
submitting an application.

-   Contact GrantsInfo at (301) 435-0714 or email GrantsInfo@nih.gov,
    and/or the Division of Receipt and Referral in the Center for
    Scientific Review (CSR) at (301) 435-0715:

```{=html}
<!-- -->
```
-   To identify Institutes/Centers (ICs) at NIH or other non-NIH
    agencies, and/or a Scientific Review Group (SRG), that might be
    appropriate for the application. Note that requests for assignment
    to an IC and/or a SRG may be made in a [cover letter](#Cover_Letter)
    at the time of application submission.

-   To learn about [grant mechanisms](#research-grant-mechanisms).

-   To receive advice on preparing and submitting an application (e.g.,
    format, structure).

```{=html}
<!-- -->
```
-   Contact program staff in the relevant awarding component:

```{=html}
<!-- -->
```
-   To determine whether a proposed application topic would fit into the
    NIH IC or other non-NIH agency\'s programmatic area.

-   To learn about programmatic areas of interest to the IC or other
    non-NIH agencies.

-   To find out about requesting an assignment to an IC.

-   To discuss responding to a Request for Applications.

```{=html}
<!-- -->
```
-   Contact Scientific Review Officers (SRO) in the Center for
    Scientific Review to discuss requesting assignment to a SRG.

#### After Submission

If the initial assignment to an IC or SRO seems inappropriate, the
Program Director/Principal Investigator (PD/PI) may request
reassignment. Such requests should be made in writing to:

Division of Receipt and Referral

Center for Scientific Review

National Institutes of Health

6701 Rockledge Drive, Suite 2030, MSC 7720

Bethesda, MD 20892-7720

Fax requests (301-480-1987) are also acceptable.

Although these requests will be carefully considered, the final
determination will be made by the PHS agency.

Applicants must never contact reviewers regarding their applications
because discussion of the scientific content of an application or an
attempt to influence review outcome will constitute a conflict of
interest in the review process. Reviewers are required to notify the
Scientific Review Officer if they are contacted by an applicant.
Communication by the applicant to a reviewer may delay the review or
result in the return of the application without review.

#### After Assignment

Contact the SRO to discuss the review assignment, to request permission
to send additional/corrective materials, and/or to discuss any review
concerns (e.g., expertise needed on the study section, conflicts,
reviewers that may have bias).

#### After Peer Review

Feedback to applicants is very important. Once the PD/PI reviews the
Summary Statement in the eRA Commons, the appropriate awarding component
program official (noted in the Summary Statement) may be contacted:

-   To discuss the review outcome of the application and obtain
    guidance.

-   To get feedback and answers to any questions about the Summary
    Statement.

-   To find out the meaning of a numerical designation pertaining to
    human subjects or vertebrate animals on the Summary Statement.

-   To find out the funding status of an application.

The Peer Review Outcome Letter and Summary Statement will not be mailed
to the PD/PI and may only be accessed through the eRA Commons.

## 1.5 Grants Policy Statements

The [*NIH Grants Policy
Statement*](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm)
serves as a term and condition of award and is a compilation of the
salient features of policies and various policy issues regarding the
administration of NIH awards.

The [*HHS Grants Policy
Statement*](http://www.hhs.gov/grantsnet/adminis/gpd/index.htm) serves
as a term and condition of award and is a compilation of the salient
features of policies and various policy issues regarding the
administration of grant awards from other PHS agencies, excluding NIH
awards.

## 1.6 References

#### Applicants New to NIH: Getting Started {#applicants-new-to-nih-getting-started .Subhead---No-TOC}

<http://grants.nih.gov/grants/useful_links.htm>

#### Award Data {#award-data .Subhead---No-TOC}

<http://grants.nih.gov/grants/award/award.htm>

([CRISP](http://crisp.cit.nih.gov/), [extramural research
grants](http://grants.nih.gov/grants/award/resgr.htm), [award
trends](http://grants.nih.gov/grants/award/awardtr.htm), [training and
career awards](http://grants.nih.gov/grants/award/granfell.htm))

#### Contact Information for an NIH Staff Person {#contact-information-for-an-nih-staff-person .Subhead---No-TOC}

[http://ned.nih.gov](http://ned.nih.gov/)\
NIH locator: (301) 496-4000

#### eRA Commons {#era-commons .Subhead---No-TOC}

<https://commons.era.nih.gov/commons/index.jsp>

Institutions and Program Directors/Principal Investigators (PD/PIs) are
required to register with the eRA Commons. Registered PD/PIs can check
assignment/contact information, review outcome, and other important
information.

Email the Commons Help Desk at
[commons@od.nih.gov](mailto:commo9ns@od.nih.gov).

Call the Commons Help Desk at 1-800-504-9552 (toll-free) or
301-402-7469; 301-451-5939 (TTY). Business hours are M-F 7am-8pm Eastern
Time.

#### Grant Writing Tips and Sample Applications  {#grant-writing-tips-and-sample-applications .Subhead---No-TOC}

<http://grants.nih.gov/grants/grant_tips.htm>

#### Grants Information {#grants-information .Subhead---No-TOC}

<http://grants.nih.gov/grants/giwelcome.htm>\
E-mail: [GrantsInfo@nih.gov](mailto:grantsinfo@nih.gov)\
Telephone: (301) 435-0714

#### NIH Office of Extramural Research Human Subjects Website {#nih-office-of-extramural-research-human-subjects-website .Subhead---No-TOC}

<http://grants.nih.gov/grants/policy/hs/index.htm>

This site provides DHHS and NIH requirements and resources for the
extramural community involved in human subjects research.

#### Office of Biotechnology Activities (OBA) {#office-of-biotechnology-activities-oba .Subhead---No-TOC}

<http://www4.od.nih.gov/oba>

NIH Guidelines for Research Involving Recombinant DNA Molecules and
Institutional Biosafety Committee Registration\
Telephone: (301) 496-9838

#### Office of Human Research Protections (Department of Health and Human Services) {#office-of-human-research-protections-department-of-health-and-human-services .Subhead---No-TOC}

<http://www.hhs.gov/ohrp>

Information about human subject protections, Institutional Review
Boards, and Federal Wide Assurances.\
Telephone: 1-866-447-4777 or (301) 496-7005

#### Office of Laboratory Animal Welfare (OLAW)  {#office-of-laboratory-animal-welfare-olaw .Subhead---No-TOC}

<http://grants.nih.gov/grants/olaw/olaw.htm>

Information about animal welfare policy requirements, Institutional
Animal Care and Use Committees (IACUC), and Animal Welfare Assurances.\
Telephone: (301) 496-7163

#### Receipt/Referral of an Application {#receiptreferral-of-an-application .Subhead---No-TOC}

<http://www.csr.nih.gov/EVENTS/AssignmentProcess.htm>

Division of Receipt and Referral\
Center for Scientific Review\
Telephone: (301) 435-0715\
Fax: (301) 480-1987

#### Specific Application: Before Review  {#specific-application-before-review .Subhead---No-TOC}

Telephone or e-mail the Scientific Review Officer identified for the
application in the eRA Commons.

#### Specific Application: Post Review  {#specific-application-post-review .Subhead---No-TOC}

Telephone or e-mail the NIH Program Official named in the Summary
Statement for the application.

## 1.7 Authorization

The PHS requests the information described in these instructions
pursuant to its statutory authorities for awarding grants, contained in
Sections 301 (a) and 487 of the PHS Act, as amended (42 USC 241a and 42
USC 288). Therefore, such information must be submitted if an
application is to receive due consideration for an award. Lack of
sufficient information may hinder the ability of the PHS to review an
application and to monitor the grantee's performance.

## 1.8 Paperwork Burden

The PHS estimates that it will take approximately 40 hours to complete
this form. This estimate excludes time for development of the scientific
plan. Other items such as human subjects are cleared and accounted for
separately, and therefore are not part of the time estimate. An agency
may not conduct or sponsor the collection of information unless it
displays a currently valid OMB control number. Nor is a person required
to respond to requests for the collection of information without this
control number. Send comments regarding this burden estimate or any
other aspect of this collection of information, including suggestions
for reducing this burden, to: NIH, Project Clearance Office, 6705
Rockledge Drive MSC 7974, Bethesda, MD 20892-7974, ATT: PRA (0925-0001).
Do not send applications or any materials related to training or career
award applications to this address.

# 2. General Instructions

## 2.1 Introduction

Read all of the instructions thoroughly prior to application
preparation.

These instructions pertain to applications for research project grants
that have not transitioned to electronic submission using the SF424
(R&R). Use the additional instructions and sample pages included in
[Section
7](#instructions-for-preparing-an-individual-research-career-development-award-cda-application-k-series)
of this Part when applying for Career Development Awards, and [Section
8](#instructions-for-preparing-an-institutional-research-training-application-including-ruth-l.-kirschstein-nrsa-applications)
of this Part when applying for an Institutional Research Training grant
(including Ruth L. Kirschstein National Research Service Awards).

For other specialized grants or cooperative agreements, request
additional instructions from the appropriate NIH awarding component or
other PHS agency. Phone numbers for contacting the appropriate staff are
listed in the [Agency Contact Table.](#phs-agency-contacts) For further
assistance, contact:

GrantsInfo

National Institutes of Health (NIH)

E-mail: [GrantsInfo@nih.gov](mailto:grantsinfo@nih.gov)

Phone: (301) 435-0714

Read and follow the instructions carefully to avoid delays,
misunderstandings and possible return of the application. Adherence to
font and margin requirements is necessary for several reasons. No
applicant should have an advantage over other applicants by providing
more content using smaller, denser type. Small type sizes may also make
it difficult for reviewers to read the application.

The NIH Center for Scientific Review (CSR), Division of Receipt and
Referral, has the responsibility to make the final determination of
legibility and the authority to return applications. This decision is
final and not subject to appeal. Inquiries should be directed to the:

CSR, Division of Receipt and Referral\
Phone: 301-435-0715; TTY 301-451-0088; Fax: 301- 480-1987

## 2.2 Registration Processes

### 2.2.1 (Reserved)

### 2.2.2 DUNS Registration for the Applicant Organization & Subaward/Consortium Organizations

A Data Universal Numbering System (DUNS) number is required for all
applications (paper and electronic) and must be obtained by the
organization prior to submission. For organizations that already have
multiple DUNS numbers, one DUNS number should be selected by an
authorized organizational representative and used consistently for all
application submissions. The authorized organizational representative
should be consulted to determine the appropriate number to use for
applications.

The DUNS number is considered the Federally-recognized unique identifier
and is used for reporting purposes, particular those associated with the
*Federal Financial Assistance Transparency Act (FFATA) of 2006* (P.L.
109-282).

FFATA also includes a requirement for reporting on subaward information.
Therefore accurate DUNS for each subaward/consortium organization must
also be provided as part of the Project/Performance Site information.

Additional information on DUNS registration is found at:
<http://fedgov.dnb.com/webform/displayHomePage.do>

A DUNS number is required for Central Contractor Registration (see
2.2.3. below).

### 2.2.3 Central Contractor Registration (CCR) for the Applicant Organization

Prior to submission of all applications (paper and electronic),
applicant organizations are required to be registered in the Central
Contractor Registration (CCR). Organizations must maintain the currency
of the information in the registry and renew the registration annually.
A DUNS number is required for CCR registration.

CCR is a government-wide registry for organizations doing business with
the U.S. Government. The registry collects, validates, stores, and
disseminates data in support of agency acquisition missions, including
Federal agency contract and assistance awards. The CCR registry will be
used by Federal agencies to validate the DUNS number provided as part of
the application process. Validation of the DUNS number will be critical
for agencies to comply with the requirements of the *Federal Financial
Assistance Transparency Act (FFATA) of 2006* (P.L. 109-282).

Organizational information entered into the CCR must match that in the
eRA Commons. Since CCR Registration can take several days to complete,
the process should be started well in advance of a submission date to
avoid potential delays. An authorized organizational representative
should be consulted to determine if the organization has properly
completed and maintained CCR registration. Additional information on CCR
registration is found at: <http://www.ccr.gov/>.

### 2.2.4 eRA Commons Registration

The applicant organization and the PD/PI must also complete a
**one-time** registration in the eRA Commons. Access to the Commons is
vital for all steps in the process after application submission. An
organization and PD/PIs must be registered in the Commons for purposes
of retrieval of grant information, institute/center assignments, review
outcomes, and Summary Statements. Institutional/organizational officials
are responsible for registering PD/PIs in the eRA Commons. PD/PIs should
work with their authorized organizational official (also known as the
Signing Official in the eRA Commons) to determine their
institutional/organizational process for registration.

IMPORTANT: The eRA Commons registration process should be started at
least **two (2) weeks** prior to submission. A valid PD/PI Commons user
name ID must be entered in item 3.h of the Face Page.

#### 2.2.4.1 Commons Registration for the Organization

Organizations may verify their current registration status by accessing
the "List of Grantee Organizations Registered in NIH eRA Commons"
(<http://era.nih.gov/userreports/ipf_com_org_list.cfm>).

To register an Organization in the eRA Commons:

1\. Open the eRA Commons homepage
(<https://commons.era.nih.gov/commons/>).

2\. Click Grantee Organization Registration (found in "About the
Commons" links on the right side of the screen).

3\. Follow the step-by-step instructions. Remember to fax in the
registration signature page to eRA.

4\. Click Submit. The organization is registered when the NIH confirms
the information and sends an email notification of registered Signing
Official (SO) account (userid/password).

Organizational data elements, such as Institutional Profile Number
(IPF), Entity Identification Number (e.g., 5555555555A5) and DUNS Number
must be accurately identified. **Note the DUNS number must be included
in the Institutional Profile, and must match the number on the
application.**

Since eRA has not required a DUNS number during eRA Commons
registration, there are many accounts that do not contain valid
information in this field. Prior to submission, the Authorized
Organizational Representative/SO should verify that their organization's
eRA Commons profile contains the valid DUNS number that will be used for
the submission process. The SO has the ability to edit this field in the
organization profile in Commons.

To confirm that the organization has a DUNS number or to find out if the
DUNS number you have matches the one in the Commons, access the List of
Grantee Organizations Registered in NIH eRA Commons
(<http://era.nih.gov/userreports/ipf_com_org_list.cfm>). This listing of
grantee organizations registered in Commons and their DUNS numbers can
be accessed without logging into Commons.

#### 2.2.4.2 Commons Registration for the Project Director/Principal Investigator (PD/PI)

The individual designated as the PD/PI on the application must also be
registered in the Commons. The PD/PI must hold a PI account **and** be
affiliated with the applicant organization. **This registration must be
done by an organizational official (or delegate) who is already
registered in the Commons.** To register PD/PIs in the Commons, refer to
the NIH eRA Commons System Users Guide
(<http://era.nih.gov/Docs/COM_UGV2630.pdf>).

Once the PD/PI has received email confirming his/her registration within
the Commons, the PD/PI must verify that all Personal Information located
within the Personal Profile tab in the eRA Commons System is accurate.
Please have the PD/PI review and update, as needed, data elements such
as first name, middle initial, last name, prefix and/or suffix to PD/PI
name (including all embedded punctuation), email, phone, fax, street
address, city, state, country, zip and degrees earned. These data must
contain the most recent information in order for the application to be
processed accurately.

Both PD/PI and SO need separate accounts in Commons since both must
verify the application. If you are the SO for your organization as well
as a PI of the grant, you will need two separate accounts with different
user names -- one with SO authority and one with PI authority. When an
organization is registered, an SO account is created. Log on to the
account with the SO authority role and create another account with PI
authority.

It is important to note that if a PD/PI is also an NIH peer-reviewer
with an Individual DUNS and CCR registration, that particular DUNS
number and CCR registration are for the individual reviewer only. These
are different than any DUNS number and CCR registration used by an
applicant organization. Individual DUNS and CCR registration should be
used only for the purposes of personal reimbursement and should not be
used on any grant applications submitted to the Federal Government.

## 2.3 (Reserved)

## 2.4 Funding Opportunities

Grants for health-related research and research training projects or
activities make up the largest category of funding provided by the NIH
Institutes/Centers (ICs) and other non-NIH agencies. Most applications
for support are **unsolicited** and originate with individual
investigators who develop proposed plans for research or research
training within an area that is relevant to the NIH. Research project
grants are awarded to organizations/institutions on behalf of PD/PIs to
facilitate the pursuit of a scientific objective when the idea for the
research is initiated by the investigator. If the funding agency
anticipates substantial program involvement during the conduct of the
research, a cooperative agreement will be awarded, rather than a grant.
The NIH awards grants and cooperative agreements for terms ranging from
one to five years. Organizational/institutional sponsorship assures that
the awardee organization will provide the facilities and the financial
stability necessary to conduct the research, and be accountable for the
funds. For a list and brief description of grant mechanisms, [see Part
III, 4.1.](#research-grant-mechanisms)

### 2.4.1 NIH Guide for Grants and Contracts

The [*NIH Guide for Grants and
Contracts*](http://grants.nih.gov/grants/guide), a weekly electronic
publication (<http://grants.nih.gov/grants/guide>), contains
announcements about funding opportunities, such as Requests for
Applications (RFAs) and Program Announcements (PAs), including Parent
Announcements, from NIH and other PHS agencies. The *NIH Guide* also
contains vital information about policies and procedures. To subscribe
to the *NIH Guide*, visit
<http://grants.nih.gov/grants/guide/listserv.htm>.

### 2.4.2 Funding Opportunity Announcements (FOAs)

To hasten the development of a program or to stimulate submission of
applications in an area of high priority or special concern, an awarding
component will encourage applications through the issuance of a PA to
describe new, continuing, or expanded program interests, or issuance of
an RFA inviting applications in a well-defined scientific area to
accomplish a scientific purpose.

Definitions are as follows:

**Parent Announcements**: Electronic grant applications must be
submitted in response to a Funding Opportunity Announcement (FOA). For
applicants who wish to submit what were formerly termed
"investigator-initiated" or "unsolicited" applications, NIH and other
PHS agencies have developed Parent Announcements. Responding to such an
omnibus or umbrella Parent FOA ensures that the correct application
package is used and enables NIH to receive the application from
[Grants.gov](http://www.grants.gov/). Additional information about, as
well as links to published Parent Announcements, can be found at:
<http://grants.nih.gov/grants/guide/parent_announcements.htm>.

**Program Announcement (PA):** A formal statement about a new or ongoing
extramural activity or mechanism. It may serve as a reminder of
continuing interest in a research area, describe modification in an
activity or mechanism, and/or invite applications for grant support.
Most applications in response to PAs may be submitted to a standing
submission date and are reviewed with all other applications received at
that time.

**Request for Applications (RFA):** A formal statement that solicits
grant or cooperative agreement applications in a well-defined scientific
area to accomplish specific program objectives. An RFA indicates the
estimated amount of funds set aside for the competition, the estimated
number of awards to be made, and the application submission date(s).
Applications submitted in response to an RFA are usually reviewed by a
Scientific Review Group (SRG) specially convened by the awarding
component that issued the RFA.

PAs (including Parent Announcements) and RFAs are published in the [*NIH
Guide for Grants and Contracts*](http://www.nih.gov/grants/guide)
(<http://grants.nih.gov/grants/guide>), the [*Federal
Register*](http://www.gpoaccess.gov/nara/index.html)
(<http://www.gpoaccess.gov/nara/index.html>), and on Grants.gov under
Find Grant Opportunities
(<http://www.grants.gov/applicants/find_grant_opportunities.jsp>). Read
the announcement carefully for special instructions. The instructions in
the announcement may differ from these general instructions, and the
instructions in the announcement **always** supersede these general
instructions. Each announcement published in the [*NIH Guide for Grants
and Contracts*](http://grants.nih.gov/grants/guide), the [*Federal
Register*](http://www.gpoaccess.gov/nara/index.html), [Grants.gov
Find](http://www.grants.gov/applicants/find_grant_opportunities.jsp), or
other public document contains contact information under *Inquiries* in
addition to information specific to the announcement.

While individual announcements will continue to carry an announcement
number reference to "PA" or "RFA", all announcements are "Funding
Opportunity Announcements (FOAs)." This general term will be used to
reference any type of funding announcement. NIH will continue to use the
PA and RFA references in the actual announcement number to distinguish
between the various types of announcements.

## 2.5 (Reserved)

## 2.6 Format Specifications

Follow font and format specifications. Otherwise, application processing
may be delayed, or the application may be returned to the applicant
without review.

#### Font

-   Use an *Arial, Helvetica, Palatino Linotype or Georgia typeface, a
    black font color, and a font size of 11 points or larger*. A symbol
    font may be used to insert Greek letters or special characters; the
    font size requirement still applies.

-   Type density, including characters and spaces, must be no more than
    15 characters per inch.

-   Type may be no more than six lines per inch.

-   Use black ink that can be clearly copied.

-   Print must be clear and legible.

#### Paper Size and Page Margins

-   Use *standard size (8 ½\" x 11\")* sheets of paper.

-   Use at least one-half inch margins (top, bottom, left, and right)
    for all pages, including continuation pages. No information should
    appear in the margins, including the PD/PI\'s name and page numbers.

#### Page Formatting

-   Since a number of reviewers will be reviewing applications as an
    electronic document and not a paper version, applicants are strongly
    encouraged to use only a standard, single-column format for the
    text. Avoid using a two-column format since it can cause
    difficulties when reviewing the document electronically.

-   The application must be single-sided and single-spaced.

-   Consecutively number pages throughout the application. Do not use
    suffixes (e.g., 5a, 5b).

-   Do not include additional pages between the face page and page 2.

-   Do not include unnumbered pages.

#### Figures, Graphs, Diagrams, Charts, Tables, Figure Legends, and Footnotes

-   A smaller type size is acceptable, but it must be in black ink,
    readily legible, and follow the font typeface requirement.

#### Grantsmanship

-   Use English and avoid jargon.

-   If terms are not universally known, spell out the term the first
    time it is used and note the appropriate abbreviation in
    parentheses. The abbreviation may be used thereafter.

#### Photographs and Images

-   Do not include photographs or other materials that are not printed
    directly on an application page in the body of the application.
    Pictures or other materials that are glued or taped onto application
    pages are incompatible with the current duplication/scanning
    process.

-   You may include black-and-white or color images in the six (6)
    submitted copies provided such images are printed directly on the
    application page and are critical to the content of the application.

#### Copies

-   Send the original application (signed by an authorized
    organizational official) and five identical, legible, single-sided
    photocopies.

-   Do not use photo reduction.

-   The application must contain only material that reproduces well when
    photocopied in black and white. Glossy photographs or other
    materials that cannot be photocopied must be submitted in the
    appendix (see [Section 5.7](#appendix)). *Note:* Photographs may be
    included in the appendix; however, a photo copy of each must also be
    included within the page limitations of the Research Plan.

#### Page Limitations and Content Requirements

All applications and proposals for NIH funding must be self-contained
within specified page limitations.

Observe the page number limitations given in the
[table](#page_limitations_table) below. Only in cases involving
interdependent multiple subprojects (e.g., Program Projects and
Multi-Center Clinical Trials) will the PHS accept applications that
exceed the page number limitations. However, specific page number limits
may apply to each subproject. For information pertaining to page number
limits for such projects, contact the awarding component to which the
application may be assigned. (See [Agency Contact
Table](#phs-agency-contacts).) The page number limitations may also be
different for other specialized grant applications; consult and follow
the additional instructions for those applications.

  ----------------------------------------------------------------------------------
  []{#page_limitations_table   page limit **^1^**          content
  .anchor}section                                          
  ---------------------------- --------------------------- -------------------------
  Biographical Sketches        4 pages per person.         No more than 4 pages for
                                                           each Senior/Key Personnel
                                                           and each Other
                                                           Significant Contributor.

  Research Plan ^2^\           New application - not       See Instructions.
  Section 1                    allowed.\                   
                               Resubmission application -  
                               3 pages.\                   
                               Revision application - 1    
                               page.                       

  Research Plan\               25 pages.                   Limit includes text, and
  Sections 2 -- 5                                          all figures, tables and
                                                           diagrams.

  Research Plan\               None.                       See Instructions.
  Sections 6 -- 17                                         

  Appendix                     No page limitations, but    See Instructions. Limited
                               limit on number of items    publications allowed.
                               (no more than 3             Photographs and other
                               publications).              images must also be
                                                           included in the Research
                                                           Plan.
  ----------------------------------------------------------------------------------

> []{#__RefHeading___Toc186425134 .anchor}^1^ Page limitations specified
> in the Funding Opportunity Announcements (FOAs) published in the Guide
> always supersede these instructions.
>
> ^2^ See Section 5.5 for more information on the content of the
> Research Plan.

## 2.7 Resubmission Applications

For all original new (i.e., never submitted) and competing renewal
applications submitted for the January 25, 2009 due date and beyond, NIH
will accept only a single amendment (A1) to the original application
(called a resubmission application).There is no time limit for a
resubmission application. Any second resubmission will be
administratively withdrawn and not accepted for review. For original new
and competing applications submitted prior to January 25, 2009,
applicants are permitted two resubmissions (A1 and A2). For these
"grandfathered" applications, any second resubmission (A2) must be
submitted no later than January 7, 2011, and NIH will not accept any A2
resubmissions after that date. See [NIH Policy on Resubmission
Applications](#nih-policy-on-resubmission-applications) in Part III,
1.3.

NIH has established policies for application resubmissions of certain
categories. See [Resubmission of Unpaid RFA Applications and
Resubmission of Applications with a Changed Grant Activity
Code](#resubmission-of-unpaid-rfa-applications-and-resubmission-of-applications-with-a-changed-grant-activity-code)
in Part III, 1.2.

There are four requirements for a Resubmission application:

-   The Summary Statement must be available in the eRA Commons
    (<http://commons.era.nih.gov/commons/>).

-   The PD/PI(s) must make significant changes to the application.

-   An Introduction must be included that summarizes the substantial
    additions, deletions and changes to the application. The
    Introduction must also include a response to the issues and
    criticism raised in the Summary Statement. The Introduction is
    separate from the Cover Letter and should be placed immediately
    before item 2. of the Research Plan. Page limits for the
    Introduction should not exceed three pages unless the FOA specifies
    otherwise.

-   The substantial scientific changes must be marked in the text of the
    application by bracketing, indenting, or change of typography. Do
    not underline or shade the changes. Deleted sections should be
    described but not marked as deletions. If the changes are so
    extensive that essentially all of the text would be marked, explain
    this in the Introduction. The Preliminary Studies/Progress Report
    section (see 5.5, item 4) should incorporate work completed since
    the prior version of the application was submitted.

See
[NOT-OD-07-083](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-083.html)
for special conditions and due dates for new investigator resubmission
applications submitted for consecutive review cycles. Note this applies
only to new investigator R01s submitted for standard receipt dates and
reviewed in recurring study sections in CSR.

Acceptance of a resubmission application will not automatically withdraw
the prior version. eRA keeps all versions (e.g., 01, A1) of a grant
application active and provides an internal Multiple Active Applications
(MAA) flag for each application in an active cluster. The cluster allows
applicants to identify quickly all versions of one application. If any
version in a cluster is awarded, all other applications within the
cluster will be automatically withdrawn without any additional action by
applicants or staff.

Investigators who have submitted three versions of an application and
have not been successful often ask NIH what constitutes a "new
application." It is recognized that investigators are trained in a
particular field of science and are not likely to make drastic changes
in their research interests. However, a new application following three
reviews is expected to be substantially different in content and scope
with more significant differences than are normally encountered in a
Resubmission application. Simply rewording the title and Specific Aims
or incorporating minor changes in response to comments in the previous
Summary Statement does not constitute a substantial change in scope or
content. Changes to the Research Plan should produce a significant
change in direction and approach for the research project. Thus, a new
application would include substantial changes in all sections of the
Research Plan, particularly the Specific Aims and the Research Design
and Methods sections. Requests for review by a different review
committee or funding consideration by a different NIH IC are not
sufficient reasons to consider an application as new.

In the referral process, NIH staff look at all aspects of the
application, not just the title and Description (abstract). Requesting
review by a different review committee does not affect the
implementation of this policy. When necessary, previous applications are
analyzed for similarities to the present one. Thus, identical
applications or those with only minor changes will not be accepted for
review. If identified after assignment or review, identical applications
will be withdrawn.

## 2.8 Revision Application

A Revision application (formerly called a competing supplement) may be
submitted to request support for a significant expansion of a project's
scope or research protocol. Revision applications are not appropriate
when the sole purpose is to restore awards to the full SRG-recommended
level if they were administratively reduced by the funding agency. **A
Revision application must not be submitted until after the original
application has been awarded and may not extend beyond the term of the
current award period.**

**Introduction:** Provide a one-page introduction at the beginning of
the Research Plan that describes the nature of the revision and how it
will influence the Specific Aims, Research Design, and Methods of the
current grant. Any budgetary changes for the remainder of the project
period of the current grant should be discussed under the budget
justification. The body of the application should contain sufficient
information from the original grant application to allow evaluation of
the proposed revision in relation to the goals of the original
application.

If the Revision application relates to a specific line of investigation
presented in the original application that was not recommended for
approval by the SRG, then the applicant must respond to the criticisms
in the prior Summary Statement, and substantial changes must be clearly
evident and summarized in the Introduction.

#### Administrative Supplements 

An administrative supplement provides additional funding to meet
increased costs that are within the scope of an approved application,
but that were unforeseen when the new or competing Renewal application
was submitted. If considering administrative supplemental funding,
consult in advance with the designated Grants Management Officer and
Program Official. It is important to submit a request before the grant
expires. To be considered for an administrative supplement, submit a
request in writing to the Institute/Center, **not** to the Division of
Receipt and Referral, Center for Scientific Review. The request must be
signed by the authorized Business Official and describe the need for
additional funding and the categorical costs. In the letter, point out
what will NOT be accomplished if such a request is denied.
Administrative supplements are **not** submitted using the 398
Application.

## 2.9 Similar, Essentially Identical, or Identical Applications

Submissions of identical applications to one or more components of the
PHS are not allowed, and the NIH will **not** accept similar grant
applications with essentially the same research focus from the same
applicant organization. This includes derivative or multiple
applications that propose to develop a single product, process or
service that, with non-substantive modifications, can be applied to a
variety of purposes. Likewise, identical or essentially identical grant
applications submitted by different applicant organizations will not be
accepted. Applicant organizations should ascertain and assure that the
materials they are submitting on behalf of the PD/PI are the original
work of the PD/PI and have not been used elsewhere in the preparation
and submission of a similar grant application. Applications to the NIH
are grouped by scientific discipline for review by individual Scientific
Review Groups and not by disease or disease state. The reviewers can
thus easily identify multiple grant applications for essentially the
same project. In these cases, application processing may be delayed or
the application(s) may be returned to the applicant without review.

Essentially identical applications will only be reviewed in the
following circumstances: 1) an application for an Independent Scientist
Award (K02) proposing essentially identical research in an application
for a research project; and 2) an application for a research project
identical to a subproject of a program project or center grant
application.

## 2.10 (Reserved)

## 2.11 (Reserved)

## 2.12 (Reserved)

## 2.13 Submission of Supplementary or Corrective Information

Unless specifically required by these instructions, do not send
supplementary or corrective material after the submission date unless
the Scientific Review Officer of the Scientific Review Group solicits or
agrees to accept this information.

## 2.14 Application Submission Dates

Paper application submission dates fall under two different
categories: 1) Standard Postmark/Submission Dates (also known as "send
by" dates) and 2) Special Receipt Dates (also known as "arrive by"
dates) which are specified in RFAs and PAs.

Applications submitted for the standard submission dates listed at
<http://grants.nih.gov/grants/dates.htm> are considered on time if they
are sent on or before the appropriate date listed and a proof of mailing
is provided. The critical determination is when the application is sent,
not when it arrives at NIH. Proof of timely mailing consists of one of
the following: a legibly dated U.S. Postal Service postmark, or a dated
receipt from a commercial carrier or the U.S. Postal Service. Private
metered postmarks are not acceptable.

**Weekend/Federal holiday submission dates.** If a submission date falls
on a weekend, it will be extended to the following Monday; any time the
date falls on a Federal holiday the submission date will be extended to
the following business day. The application will be on time if it is
sent on or before the following business day.

**Funding Opportunity Announcements (RFAs and PARs). Applications in
response to announcements with special receipt dates must be received at
NIH by the specified date.** However, an application received after the
deadline may be acceptable if it carries a legible proof-of-mailing date
assigned by the carrier not later than 1 week prior to the deadline
date. Note that this differs from the procedures for submitting
applications for the standard due dates, which are considered submission
or "send by" dates.

[]{#Late_applications .anchor}**Late applications.** Permission is
**not** granted in advance for submission of a late application. Late
applications are accepted only in extenuating circumstances. If an
application is submitted late, a cover letter explaining the reasons for
the delay **must** be included with the signed, completed application.
Late applications are evaluated on an individual basis considering the
reasons provided. Contacting the Division of Receipt and Referral in
advance will not influence the acceptance of a late application. For
additional information on late applications, see NIH Guide Notices
[OD-06-086](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-086.html)
and
[OD-07-026](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-026.html).

## 2.15 Submission, Review and Award Cycles

The PHS submission, review, and award schedule is provided at this
website: <http://grants.nih.gov/grants/dates.htm>. Note that many
funding mechanisms have transitioned to electronic submission and the
SF424 (R&R) application and instructions. The PHS 398 should only be
used for those mechanisms where the Application Form is identified as
PHS 398. Applicants should refer to the OER Electronic Submission of
Grant Applications website, <http://era.nih.gov/ElectronicReceipt/> for
details on the transition to electronic submission.

For specialized grant applications, consult with the appropriate PHS
agency prior to the preparation of an application.

#### Application Assignment Information

Competing grant applications submitted to the PHS agencies will be
processed through the Division of Receipt and Referral, CSR, unless
otherwise stated. Administrative information about the application is
entered into a computer system. The application will be assigned to an
appropriate Scientific Review Group and awarding component. Assignment
is based on the scientific content of the application using established
referral guidelines.

After the submission date, usually within 2 weeks, the following
information regarding the grant application will be available in the NIH
eRA Commons for viewing by the PD/PI(s) and an authorized organizational
official:

-   application assignment number;

-   name, address, and telephone number of the Scientific Review Officer
    of the Scientific Review Group to which the application has been
    assigned for peer review; and

-   assigned Institute/Center information.

If assignment information is not available in the eRA Commons within two
weeks of the submission date, contact the Division of Receipt and
Referral, Center for Scientific Review (CSR), National Institutes of
Health, Bethesda, MD 20892-7720, (301) 435-0715. If there is a change in
assignment, you will receive a notification and the change will be
reflected in the eRA Commons.

Applicants must **not** communicate directly with any review group
member about an application either before or after the review. Failure
to strictly observe this policy will create serious breaches of
confidentiality and conflicts-of-interest in the peer review process.
From the time of assignment to the time the review of the application is
complete, applicant investigators must direct all questions to the
Scientific Review Officer. This individual is in charge of the review
group and is identified in the eRA Commons.

## 2.16 Resources for Finding Help

### 2.16.1 (Reserved)

### 2.16.2 Finding Help for the eRA Commons Registration

If help is needed with the eRA Commons registration process for the
applicant organization and PD/PIs, contact the eRA Commons Helpdesk:

eRA Commons Helpdesk:
[[http://ithelpdesk.nih.gov/eRA/]{.underline}](http://ithelpdesk.nih.gov/eRA/)

eRA Commons Helpdesk Email:
[[commons@od.nih.gov]{.underline}](mailto:commons@od.nih.gov)

eRA Commons Phone: 301-402-7469\
866-504-9552 (Toll Free)\
301-451-5939 (TTY)

The eRA Commons Helpdesk hours of operation are Monday-Friday from 7:00
a.m. to 8:00 p.m. Eastern Time.

### 2.16.3 Finding Help for Application Preparation

If after reviewing these application instructions, help is needed in
preparing the application, contact GrantsInfo:

GrantsInfo Phone: 301-435-0714\
301-451-0088 (TTY)

GrantsInfo Email: <GrantsInfo@nih.gov>

# 3. Submission of the Grant Application

**Submit a complete application.** Incomplete applications will be
grounds for the PHS to return the application without peer review. An
application will be returned if it is illegible, if the instructions
were not followed, or if the material presented is insufficient to
permit an adequate review.

The application must be complete and accurate at the time of submission.
There is no guarantee that the Scientific Review Officer will accept or
the peer reviewers will consider late material.

## 3.1 Cover Letter

Applicants are encouraged to include a cover letter with the
application. The letter is only for internal agency use and will not be
shared with peer reviewers. Place the letter at the beginning of the
original application; do not copy it.

-   Application title.

-   Funding Opportunity Announcement (PA, RFA or Parent Announcement
    title, if applicable).

-   Request of an assignment (referral) to a particular IC or
    [Scientific Review Group
    (SRG)](http://www.csr.nih.gov/review/irgdesc.htm). While requests
    are given careful consideration, the PHS makes the final
    determination for assignments. (See suggested format below.)

-   List of individuals (e.g., competitors) who should not review the
    application and why.

-   Disciplines involved, if multidisciplinary.

-   Statement that any required NIH approval documentation for the type
    of application submitted is enclosed. This may include approval for
    applications requesting \$500,000 or more, approval for Conference
    Grant, Cooperative Agreement, etc.

-   For late applications (see [Late Application
    Policy](#Late_applications)), include an explanation of the delay as
    part of the cover letter.

#### Suggested Cover Letter Format

The Division of Receipt and Referral (DRR), Center for Scientific Review
(CSR) is responsible for assigning applications to ICs and to scientific
review groups (SRGs). DRR will be utilizing knowledge management
approaches as an adjunct to the work of referral experts as part of an
overall plan to shorten the time from submission to review. Analysis has
shown that requests made by investigators are a valuable source of
information in this process. In order to facilitate the use of these
requests in conjunction with knowledge management analysis of the
content of the application, applicants are requested to use the
following format when assignment requests are contained in a cover
letter.

-   List one request per line.

-   Place institute/center (IC) and SRG review requests (if both are
    made) on separate lines.

-   Place positive and negative requests (if both are made) on separate
    lines.

-   Include name of IC or SRG, followed by a dash and the acronym. Do
    not use parentheses.

-   Provide explanations for each request in a separate paragraph.

Examples:

Please assign this application to the following:

Institutes/Centers

National Cancer Institute - NCI

National Institute for Dental and Craniofacial Research -- NIDCR

Scientific Review Groups

Molecular Oncogenesis Study Section -- MONC

Cancer Etiology Study Section -- CE

Please do not assign this application to the following:

Scientific Review Groups

Cancer Genetics Study Section -- CG

The reasons for this request are \[provide a narrative explanation for
the request(s)\].

## 3.2 Number of Copies

Submit the **original and five** identical, legible, single-sided
photocopies of each application. The **original must be signed** by an
authorized organizational official.

## 3.3 Bindings and Packaging

Submit the following materials in *one* package:

-   cover letter (original only);

-   original application, including the Personal Data page at the end of
    the application;

-   five copies of the application, made after the original has been
    signed and **not** including the Personal Data Page;

-   Appendix materials -- five identical CDs of all appendix material in
    PDF format.

Do not include more than one application (original plus 5 copies and
appendices) in each mailing envelope.

**Cover letter.** Place the original cover letter at the beginning of
the original application. It should not be duplicated.

**The original application.** The original application must be
single-sided, with the required signature on the Face Page. Do **not**
staple or otherwise bind the original application. Rubber bands or clips
are acceptable. Assemble the pages in the order specified in the table
of contents. Place the Personal Data page at the end of the application;
it is **not** to be duplicated.

**Five identical, single-sided copies of the original application.**
Make the copies **after** an authorized organizational official has
signed the Face Page so that the official's signature is present on the
copies. Do **not** include the cover letter or the Personal Data Page in
the copies. Do not staple or otherwise bind the five copies of the
original application. Rubber bands or clips are acceptable.

**Five identical CDs containing all appendix material.** When preparing
CDs:

-   Use PDF format.

-   Label each disk with the PD/PI name and application title.

-   If burning CD-ROM disks on a Mac, select the ISO 9660 format.

-   Do not use compression techniques for the electronic files.

-   Do not use password protection, encryption, digital signature and/or
    digital certification in the PDF files.

## 3.4 Application Mailing Address

For applications to NIH, use the mailing labels provided at the end of
the forms.

Send the application to the following address, making sure to use the
correct ZIP code:

Center for Scientific Review

National Institutes of Health

6701 Rockledge Drive, Suite 1040

MSC 7710

Bethesda, MD 20892-7710

**(United States Postal Service (USPS) Express or Regular mail)**

> or

Bethesda, MD 20817 **(Express/Courier Non-USPS Service)**

**C.O.D. applications will not be accepted.**

All applications and other deliveries to the Center for Scientific
Review must come either via courier delivery (e.g., Federal Express,
DHL, UPS) or via the USPS. Applications delivered by individuals to the
Center for Scientific Review will not be accepted. For additional
information, see [http://grants.nih.gov/grants/
guide/notice-files/NOT-OD-03-040.html](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

There may be additional instructions for submission of responses to
RFAs; check the FOA for details.

For applications to other (non-NIH) PHS agencies, refer to the FOA for
submission instructions and mailing addresses.

# 4. Completing the PHS 398 Forms and Format Pages

Prepare the application using the PHS 398 MS WORD or PDF form pages and
format pages as provided at
<http://grants.nih.gov/grants/funding/phs398/phs398.html>.

-   *Form pages* must be identical to those provided. You may substitute
    computer-generated facsimiles for government-provided forms;
    however, they must maintain the exact wording and format of the
    government forms, including all captions and spacing.

-   *Format pages* are intended to assist you in the development of
    specific sections of the application. Alternatively, you may create
    a page similar to any format provided as long as all the requisite
    information is included.

-   Shading/colors may not be used in any text portions, including the
    face page.

-   Font sizes on some PHS 398 form pages vary due to field or space
    limitations. The PHS 398 Microsoft Word (MS Word) and Portable
    Document File (PDF) Form Pages as provided are acceptable to NIH.
    All other sections of the application (e.g., Biographical Sketch;
    Introduction, if necessary; and the Research Plan) must conform to
    the font requirements stated below.

-   Some fields on the PDF Form Pages are pre-set to auto calculate. In
    these cases, a zero will appear until actual data are entered.

## 4.1 Face Page

The first part of the Face Page ([Form Page
1](http://grants.nih.gov/grants/funding/phs398/phs398.html#fp1)) must be
printed on a single page. The Face Page must not have any shading or
colors. Form Page 1-continued is only for multi-PD/PI applications; if
used, it should be printed as a separate page.

The information provided on the Face Page of the application and the
fiscal information, including the calculation of F&A costs, must be
verified by the official signing for the applicant organization.

#### Item 1. Title of Project 

**Do not exceed 81 characters, including the spaces between words and
punctuation.** Choose a descriptive title that is specifically
appropriate. A new application must have a different title from any
other PHS project with the same PD/PI. A Renewal or Resubmission
application should normally have the same title as the previous grant or
application. If the specific aims of the project have significantly
changed, choose a new title. A Revision application **must** have the
same title as the currently funded grant.

#### Item 2. Response to Specific Request for Applications (RFA) or Program Announcement (PA)

Check "Yes" and insert the appropriate announcement number (e.g.,
PA-06-512) and title of the announcement if the application is submitted
in response to an RFA or a PA issued through the NIH Guide for Grants
and Contracts.

#### Item 3. Program Director(s)/Principal Investigator(s) (PD/PI) 

**New Investigator.** Check "Yes" in the "New Investigator" box only if
the PD/PI has not previously competed successfully as PD/PI for a
significant NIH independent research award.  Specifically, a PD/PI is
identified as a New Investigator if he/she has not previously competed
successfully for an NIH-supported research project **other than** the
following small or early stage research awards:

-   Pathway to Independence Award-Research Phase (R00)

-   Small Grant (R03)

-   Academic Research Enhancement Award (R15)

-   Exploratory/Developmental Grant (R21)

-   Clinical Trial Planning Grant (R34)

-   Dissertation Award (R36)

-   Small Business Technology Transfer Grant-Phase I (R41)

-   Small Business Innovation Research Grant-Phase I (R43)

-   Shannon Award (R55)

-   NIH High Priority, Short-Term Project Award (R56)

-   Competitive Research Pilot Projects (SC2, SC3)

Additionally, the PD/PI is not excluded from consideration as a "New
Investigator" if he/she has received an award from any of the following
classes of awards:

**Training-Related and Mentored Career Awards**

-   All Fellowships (F awards)

-   All career awards (K awards)

-   Loan repayment contracts (L30, L32, L40, L50, L60)

**Instrumentation, Construction, Education, Health Disparity Endowment
Grants, or Meeting Awards**

-   G07, G08, G11, G13, G20

-   S10, S15, S21, S22

**Note regarding grants with Multiple PD/PIs:** In the case of a grant
application that involves more than one PI, all PD/PIs must meet the
definition of New Investigator to check "Yes" in the "New Investigator"
box.

#### Item 3a. Name of Program Director/Principal Investigator (PD/PI) 

***[Name of Program Director/Principal Investigator]{.underline}***.
Name the one person responsible to the applicant organization for the
scientific and technical direction of the project. **PHS staff conduct
official business only with the named PD/PI and institutional
officials.** A Revision application **must** have the same PD/PI as the
currently funded grant.

When multiple PD/PIs are proposed, use the Face Page-Continued page to
provide items 3a -- 3h for all PD/PIs. NIH requires one PD/PI be
designated as the "contact PD/PI" for all communications between the
PD/PIs and the agency. The contact PD/PI must meet all eligibility
requirements for PD/PI status in the same way as other PD/PIs, but has
no special roles or responsibilities within the project team beyond
those mentioned above. The contact PD/PI may be changed during the
project period. The contact PD/PI should be listed in block 3 of Form
Page 1 (the Face Page), with all additional PD/PIs listed on Form Page
1-Continued. When inserting the name of the PD/PI in the header of each
application page, use the name of the "Contact PD/PI, et. al." The
contact PD/PI must be from the applicant organization if PD/PIs are from
more than one institution.

All individuals designated as PD/PI must be registered in the eRA
Commons and must be assigned the PD/PI role in that system (other roles
such as SO or IAR will not give the PD/PI the appropriate access to the
application records). Each PD/PI must include their respective eRA
Commons ID in the eRA Commons User Name field.

#### Item 3b. Degree(s) 

Indicate up to three academic and professional degrees or other
credentials, such as licenses (e.g., R.N.).

#### Item 3c. Position Title 

Provide the academic or professional title of the PD/PI. If more than
one title, indicate the one most relevant to the proposed project (e.g.,
Professor of Biochemistry, Chief of Surgical Service, or Group Leader).

#### Item 3d. Mailing Address 

Provide complete information (including room number, building, and
street address) necessary for postal delivery. All written
communications with the PD/PI will use this address. For electronic
mail, enter the appropriate e-mail address (not a website URL).

#### Item 3e. Department, Service, Laboratory, or Equivalent 

Indicate organizational affiliation, such as Department of Medicine,
Materials Research Laboratory, or Social Sciences Institute.

#### Item 3f. Major Subdivision 

Indicate school, college, or other major subdivision, such as medical,
dental, engineering, graduate, nursing, or public health. If there is no
such subdivision, enter "None."

#### Item 3g. Telephone and Fax Numbers 

Provide a daytime telephone number and, if available, a fax number.

#### Item 3h. eRA Commons User Name

The Commons User Name is the ID assigned to and used by the individual
to access the [eRA Commons](https://commons.era.nih.gov/commons/).
**All** PD/PIs are required to be registered in the eRA Commons and
**must** provide their Commons User Name.

#### Item 4. Human Subjects Research

#### No Human Subjects Involved

Check "No" if activities involving human subjects are not planned at any
time during the proposed project period. The remaining parts of Item 4
are then not applicable.

#### Human Subjects Involved 

Check "Yes" if activities involving human subjects are planned at any
time during the proposed project period, either at the applicant
organization or at any other Project/Performance Site or collaborating
institution. Check "Yes" if the research is exempt from DHHS regulatory
requirements for the protection of human subjects (see [Exemption
Categories](#Human_Subjects_Exemption_Cat)).

If you plan to conduct research involving human subjects, but do not
have definite plans at the time of application, you will need to include
item 8 of the Research Plan. Certification of IRB review and approval
must be provided and accepted by the awarding component before the
research may occur.

NIH does not require certification of review and IRB approval of
proposed research prior to NIH peer review of an application (see
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-031.html> and
Part II, [Human Subjects Research](#Human_Subjects_NoIRBApproval)
supplemental instructions). However, any modification of the Research
Plan section of the application required by the IRB or to address human
subjects concerns raised during review, must be submitted for approval
before award. See also the [Just-In-Time Policy](#just-in-time-policy)
and [IRB Approval](#Human_Subjects_NoIRBApproval).

The DHHS regulations \"Protection of Human Subjects\" ([45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm),
administered by OHRP) define a [human
subject](#Human_Subjects_Defs_Human) as "a living individual about whom
an investigator conducting research obtains: data through *intervention*
or *interaction* with the individual or *identifiable private
information*." See Part III.3 for the definitions of italicized terms
used in the definition of human subject.

Regulatory requirements (Federal and state) to protect human subjects
may apply to research using human specimens and/or data, such as use of:

-   Bodily materials, such as cells, blood or urine, tissues, organs,
    hair or nail clippings, from living individuals who are individually
    identifiable to the investigator(s), even if these materials were
    collected by others;

-   Residual diagnostic specimens from living individuals that are
    individually identifiable to the investigator(s), including
    specimens obtained for routine patient care that would have been
    discarded if not used for research;

-   Private information, such as medical information, about living
    individuals that is individually identifiable to the
    investigator(s), even if the information was not specifically
    collected for the study in question. This includes research on
    genetic information that can be readily associated by the
    investigator(s) with identifiable living individuals.

Research that involves only *coded* private information/data or *coded*
human biological specimens may not constitute human subjects research
under the DHHS human subjects regulations (45 CFR Part 46) if:

-   the specimens and/or private information were not collected
    specifically for the currently proposed research project through an
    interaction/intervention with living individuals AND

-   the investigator(s) (including collaborators) on the proposed
    research cannot readily ascertain the identity of the individual(s)
    to whom the coded private information or specimens pertain (e.g.,
    the researcher's access to subject identities is prohibited by
    written repository procedures and policies and/or through a written
    agreement signed by the investigator and the repository providing
    the specimens and/or data).

See definition of [*coded*](#Human_Subjects_Defs_Coded) in Part III.3
under Human Subjects definitions, and the following guidance from the
Office for Human Research Protections (OHRP) for additional information
and examples:
<http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf>.

Individuals who provide *coded* information or specimens for proposed
research and who also collaborate on the research involving such
information or specimens are considered to be involved in the conduct of
human subjects research as investigators (see definition of [human
subjects](#Human_Subjects_Defs_Human)).

Additional information is available at:

-   OHRP Decision Charts:
    <http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm>

-   OHRP Guidance on Repositories:
    <http://www.hhs.gov/ohrp/humansubjects/guidance/reposit.htm>;
    <http://www.hhs.gov/ohrp/humansubjects/guidance/guid1223.pdf>

-   OHRP Memo on Engagement:
    <http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm>

-   NIH Office of Extramural Research Human Subjects website:
    <http://grants.nih.gov/grants/policy/hs/index.htm>.

#### Item 4a. Exemptions from Department of Health and Human Services (DHHS) Human Subjects Regulations 

Check "Yes" if the activities proposed are exempt from the regulations
at [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). Insert
the exemption number(s) corresponding to one or more of the [six
exemption categories](#Human_Subjects_Exemption_Cat) listed in Part III
under Human Subjects Research Definitions and Terms.

OHRP guidance states that appropriate use of Exemptions described in 45
CFR 46 should be determined by an authority independent from the
investigators
(<http://www.hhs.gov/ohrp/humansubjects/guidance/irb71102.pdf>).
Institutions often designate their IRB to make this determination.
Because NIH does not require IRB approval at the time of application,
the exemptions designated in item 4a often represent the opinion of the
PD/PI, and the justification provided for the exemption by the PD/PI is
evaluated during peer review.

Proposed research may include more than one research project; thus the
application may include individual projects that meet the requirements
for non-exempt or exempt human subjects research, or are not defined as
human subjects research. Human subjects research should be designated as
exempt if **all** of the proposed research meets the criteria for one or
more of the six exemptions.

Check "No" if any of the planned activities involving human subjects are
not exempt, and complete the remaining parts of Item 4.

#### Item 4b. Human Subjects Assurance Number 

If the applicant organization has a current approved Federal Wide
Assurance (FWA) on file with the OHRP (<http://www.hhs.gov/ohrp/>),
enter the number in the space provided.

Enter "None" in Item 4b if the applicant organization does not have an
approved FWA on file with OHRP. In this case, the signature on the Face
Page is a declaration that the applicant organization will comply with
[45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm) and
proceed to obtain a FWA (see
[http://www.hss.gov/ohrp](http://www.hhs.gov/ohrp/)).

**Do not enter the human subjects assurance number of any
Project/Performance Site or collaborating institution in the space
provided.**

#### Item 4c. Clinical Trial

Check "Yes" or "No" to indicate whether the project includes a clinical
trial. Refer to the definition of "[clinical
trial](#Human_Subjects_Defs_ClinicalTrial)" in Part III.3, under Human
Subjects Research Definitions and Terms.

Note that Public Law 110-85, enacted 09/27/2007, mandates registration
and results reporting of applicable clinical trials in
ClinicalTrials.gov (see [Part II,
4.1.6](#clinicaltrials.gov-requirements) and [Part III,
2.1.6](#clinicaltrials.gov)).

#### Item 4d. NIH-Defined Phase III Clinical Trial

Check "Yes" or "No" to indicate whether the project is an NIH-Defined
Phase III Clinical Trial. Refer to the definition of [\"NIH-Defined
Phase III Clinical Trial\"](#Human_Subjects_Defs_NIH_PhaseIIIl) in Part
III.3, under Human Subjects Research Definitions and Terms.

#### Item 5. Vertebrate Animals 

Check "No" if activities involving vertebrate animals are not planned at
any time during the proposed project period, and leave item 5a blank.
Note that generation of custom antibodies constitutes an activity
involving vertebrate animals.

Check "Yes" if activities involving vertebrate animals are anticipated
or planned at any time during the proposed project period, either at the
applicant organization or at any other Project/Performance Site or
collaborating institution. If animal involvement is anticipated within
the period of award but plans are indefinite and it is not possible to
describe the use of animals, check \"Yes\" and in the Research Plan,
item 12, provide an explanation and indicate when it is anticipated that
animals will be used. Before activities with animals begin, the
applicant must provide all of the information required by 5.5, Research
Plan, item 12, Vertebrate Animals, with verification of current IACUC
approval, to the awarding component for prior approval. IACUC approval
must have occurred within the past three years to be considered current.

NIH does not require verification of review and approval of the proposed
research by the Institutional Animal Care and Use Committee (IACUC)
before peer review of the application. However, this information is
required under [Just-In-Time Policy](#just-in-time-policy).

#### Item 5a. Animal Welfare Assurance

If the applicant organization has a current approved Animal Welfare
Assurance on file with the Office of Laboratory Animal Welfare (OLAW),
enter the Assurance number of the applicant organization in Item 5a. To
determine whether the organization holds an Animal Welfare Assurance,
contact the IACUC or see
<http://grants.nih.gov/grants/olaw/olaw.htm#assur>.

Enter "None" in Item 5a if the applicant organization does not have an
Animal Welfare Assurance on file with OLAW. **Do not enter the Animal
Welfare Assurance number of any Project/Performance Site or
collaborating institution.** The signature on the Face Page constitutes
declaration that the applicant organization will comply with [PHS Policy
on Humane Care and Use of Laboratory
Animals](http://grants.nih.gov/grants/olaw/references/phspol.htm) by
submitting an Animal Welfare Assurance when requested by OLAW and
providing verification of IACUC approval when requested by the PHS
awarding component.

#### Item 6. Dates of Proposed Period of Support 

Request no more than 5 years of support, unless specifically authorized
in the FOA. Note that some mechanisms specify fewer years.

***[New application.]{.underline}*** Consult the schedule at
<http://grants.nih.gov/grants/dates.htm> for an appropriate beginning
date. Refer to the FOA for beginning dates for PHS agencies other than
NIH.

***[Renewal application.]{.underline}*** Choose a beginning date
immediately following the termination date of the current period of
support.

***[Revision application.]{.underline}*** **Submit a Revision
application only for a period within the current period of the active
grant.** At the time of submission, the Revision request must be within
the time period of the original (parent) award period, and any extension
must be done **before** submission. Make the ending date of the
Revision's first budget period coincide with the ending date of the
budget period that is to be supplemented, regardless of the Revision's
beginning date. If requesting supplemental funds for the future years of
a currently funded grant, make the future years' budget periods coincide
with those of the currently funded grant.

#### Budget Request

All amounts requested in Items 7 and 8 and on the budget pages must be
in U.S. dollars.

#### Item 7. Costs Requested for Initial Budget Period

#### Item 7a. Direct Costs 

From Form Page 4, enter the \"Subtotal Direct Costs for Initial Budget
Period.\"

#### Item 7b. Total Costs 

Enter the sum of: 1) the \"Total Direct Costs for Initial Budget
Period\" from Form Page 4 and 2) the Facilities and Administrative costs
for the initial budget period, as calculated on the Checklist Form Page.

Note the \"Total Direct Costs\" used to calculate Item 7b includes any
consortium F&A costs.

#### Item 8. Costs Requested for Proposed Period of Support 

#### Item 8a. Direct Costs 

From Form Page 5, enter the sum of \"Subtotal Direct Costs\" for all
years.

#### Item 8b. Total Costs 

Enter the sum of: 1) \"Total Direct Costs for Entire Proposed Project
Period\" from Form Page 5; and, 2) the total Facilities and
Administrative costs for all years calculated on the Checklist Form
Page.

Note the \"Total Direct Costs\" used to calculate Item 8b includes any
consortium F&A costs.

#### Item 9. Applicant Organization 

Name the one organization that will be legally and financially
responsible for the conduct of activities supported by the award.

#### Item 10. Type of Organization 

Check the appropriate box. See definitions of [Applicant Organization
Types](#applicant-organization-types.) definitions in Part III, 3.

#### Item 11. Entity Identification Number, DUNS Number, Congressional District 

***[Entity Identification Number.]{.underline}*** Enter the 12-digit
Entity Identification Number (EIN) assigned to the applicant
organization by the Department of Health and Human Services Payment
Management System for payment and accounting purposes. This number is an
expansion of the 9-digit EIN assigned by the IRS. If the institution has
not yet been assigned a number, enter either (1) the organization's
Internal Revenue Service employer identification number (nine digits) or
(2) the words "Applied for" to indicate that the organization does not
have an EIN but has applied to the local office of the IRS for one. **Do
not enter the PD/PI\'s social security number**; it is not appropriate
for this item.

***[Data Universal Numbering System (DUNS) number.]{.underline}*** Enter
the DUNS number. Applicant organizations must provide a DUNS number when
applying for Federal grants or cooperative agreements. The DUNS, a
Universal Identifier number, is a nine-digit number assigned by Dun and
Bradstreet Information Services. An authorized organizational official
should be consulted to determine the appropriate number to enter. If the
organization does not have a DUNS number, an authorized organizational
official should complete the electronic [US D&B D-U-N-S Number Request
Form](https://eupdate.dnb.com/requestoptions.html) or contact Dun and
Bradstreet by telephone directly at **1-866-705-5711 (toll-free)** to
obtain one. A DUNS number will be provided immediately by telephone at
no charge. Note this is an organizational number. Individual PD/PIs do
not need to register for a DUNS number.

***[Congressional District.]{.underline}*** Enter the number of the
Congressional District of the applicant organization. To locate the
appropriate district see
<http://congress.org/congressorg/dbq/officials/?lvl=L>.

#### Item 12. Administrative Official to be Notified if Award is Made 

Name the applicant organization administrative official to be notified
if an award is made. Provide a complete address for postal delivery and
the telephone, fax, and e-mail address for the administrative official.

#### Item 13. Official Signing for Applicant Organization 

Name an individual authorized to act for the applicant organization and
to assume the obligations imposed by the Federal laws, requirements, and
conditions for a grant or grant application, including the applicable
Federal regulations. Provide a complete address for postal delivery and
the telephone, fax, and e-mail address for the signing official.

#### Item 14. Applicant Organization Certification and Acceptance 

An original signature, in ink, is required. Only an institutional
official with formal designated or delegated authority to sign on behalf
of the organization may sign the form. The signature must be dated. *In
signing the application Face Page, the Authorized Organizational
Representative of the applicant organization certifies that the
applicant organization will comply with all applicable [policies,
assurances and/or
certifications](../PolAssurDef.doc#Policy_Assurances_Definitions)
referenced in the application.*

The applicant organization is responsible for verifying its eligibility
and the accuracy, validity, and conformity with the most current
institutional guidelines of all the administrative, fiscal, and
scientific information in the application, including the Facilities and
Administrative rate. Deliberate withholding, falsification, or
misrepresentation of information could result in administrative actions,
such as withdrawal of an application, suspension and/or termination of
an award, debarment of individuals, as well as possible criminal
penalties. The signer further certifies that the applicant organization
will be accountable both for the appropriate use of any funds awarded
and for the performance of the grant-supported project or activities
resulting from this application. The grantee institution may be liable
for the reimbursement of funds associated with any inappropriate or
fraudulent conduct of the project activity.

#### Assurances and Certifications

Each application to the PHS requires that the following policies,
assurances and/or certifications be verified by the signature of the
Official Signing for Applicant Organization on the Face Page of the
application. These assurances are explained in [Part III: Policies,
Assurances, Definitions, and Other
Information.](#assurances-and-certifications-1) Applicants and grantees
must comply with a number of additional public policy requirements.
Refer to the institution's research grant administrative office or the
[*NIH Grants Policy
Statement*](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm)
(<http://grants.nih.gov/grants/policy/policy.htm>) for additional
information.

The policies, assurances and certifications listed below may or may not
be applicable to the project, program, or type of applicant
organization:

[Human Subjects Research](#human-subjects-research)

[Research on Transplantation of Human Fetal
Tissue](#research-on-transplantation-of-human-fetal-tissue-1)

[Research Using Human Embryonic Stem Cells](#Section_7_4_7)

[Women and Minority Inclusion Policy](#Section_7_4_7)

[Inclusion of Children Policy](#Section_7_4_7)

[ClinicalTrials.gov Requirements](#clinicaltrials.gov)

[Vertebrate Animals](#vertebrate-animals-2)

[Debarment and Suspension](#debarment-and-suspension)

[Drug-Free Workplace](#drug-free-workplace)

[Lobbying](#Section_7_4_7)

[Non-Delinquency on Federal Debt](#Section_7_4_7)

[Research Misconduct](#Section_7_4_7)

[Civil Rights](#Section_7_4_7)

[Handicapped Individuals](#Section_7_4_7)

[Sex Discrimination](#Section_7_4_7)

[Age Discrimination](#Section_7_4_7)

[Recombinant DNA, including Human Gene Transfer
Research](#Section_7_4_7)

[Financial Conflict of Interest](#financial-conflict-of-interest)

[Smoke-Free Workplace](#Section_7_4_7)

[Prohibited Research](#Section_7_4_7)

[Select Agent Research](#select-agent-research-2)

[Program Director/Principal Investigator(s)
Assurance](#program-directorprincipal-investigator-assurance)

[Impact of Grant Activities on the Environment and Historic
Properties](#impact-of-grant-activities-on-the-environment-and-historic-properties)

## 4.2 Description, Project/Performance Sites, Senior/key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells

[FORM PAGE
2](http://grants.nih.gov/grants/funding/phs398/phs398.html#fp2) and
2-continued

Do NOT insert additional pages between Form Page 1 and Form Page 2.

### 4.2.1 Description: Project Summary and Relevance

The first and major component of the Description is a **Project
Summary**. It is meant to serve as a succinct and accurate description
of the proposed work when separated from the application. State the
application\'s broad, long-term objectives and specific aims, making
reference to the health relatedness of the project (i.e., relevance to
the mission of the agency). Describe concisely the research design and
rationale and techniques for achieving the stated goals. This section
should be informative to other persons working in the same or related
fields and insofar as possible understandable to a scientifically or
technically literate reader. Avoid describing past accomplishments and
the use of the first person.

The second component of the Description is **Relevance**. Using no more
than two or three sentences, describe the relevance of this research to
public health. In this section, be succinct and use plain language that
can be understood by a general, lay audience.

**DO NOT EXCEED THE SPACE PROVIDED.**

Do not include proprietary, confidential information or trade secrets in
the description section. If the application is funded, the project
description will be entered into an NIH database (Computer Retrieval of
Information on Scientific Projects - CRISP) and will become public
information.

### 4.2.2 Project/Performance Site(s)

Indicate where the work described in the Research Plan will be
conducted. If there are more than two Project/Performance Sites, use the
Project/Performance Site Format Page to list all the sites, including
Department of Veterans Affairs (VA) facilities and foreign sites.
Provide an explanation on the Resources Format Page of the application,
and state whether a consortium/contractual arrangement is involved with
one or more collaborating organizations for the conduct of a portion of
the work described in the Research Plan. One of the sites indicated must
be the applicant organization or be identified as off-site in accordance
with the conditions of the applicant organization's negotiated
Facilities and Administrative (F&A) agreement. This information must
agree with the F&A information on the Checklist Form Page of the
application.

If a Project/Performance Site is engaged in research involving human
subjects, the applicant organization is responsible for ensuring that
the Project/Performance Site operates under an appropriate Federal Wide
Assurance for the protection of human subjects and complies with [45 CFR
Part 46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm) and
other NIH human subject related policies described in the PHS 398 and
[GPS](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).

For research involving live vertebrate animals, the applicant
organization must ensure that all Project/Performance Sites hold
OLAW-approved Assurances. If the applicant organization does not have an
animal program or facilities and the animal work will be conducted at an
institution with an Assurance, the applicant must obtain an Assurance
from OLAW prior to an award.

### 4.2.3 Senior/key Personnel 

In addition to the PD/PI, Senior/key Personnel are defined as
individuals who contribute to the scientific development or execution of
the project in a substantive, measurable way, whether or not salaries
are requested.

Typically, these individuals have doctoral or other professional
degrees, although individuals at the masters or baccalaureate level
should be included if their involvement meets the definition of
Senior/key Personnel. **Consultants should also be included if they meet
the same definition.**

Senior/key Personnel must devote measurable effort (described in person
months) to the project, whether or not salaries are requested. \"Effort
of zero person months" or "as needed" are not acceptable levels of
involvement for those designated as Senior/key Personnel.

**Start with the PD/PI(s).** List the PD/PI's last name first. When
multiple PIs are proposed, list the contact PI first, then all
additional PIs in alphabetical order. Then list all other Senior/key
Personnel in alphabetical order, last name first. For each individual
provide name, eRA Commons User Name (if known), organization name (their
institutional affiliation), and role on the project. Under role on the
project, indicate how the individual will function on the proposed
project. *Use additional consecutively numbered pages as necessary.*

### 4.2.4 Other Significant Contributors

This category identifies individuals who have committed to contribute to
the scientific development or execution of the project, but are not
committing any specified measurable effort (i.e., person months) to the
project. These individuals are typically presented at \"effort of zero
person months" or \"as needed.\" Individuals with measurable effort may
**not** be listed as Other Significant Contributors (OSCs). Consultants
should be included if they meet this definition. This is also an
appropriate designation for mentors on Career awards.

A biosketch, including Research Support information, will be required
for Senior/key Personnel and OSCs, as this highlights their relevant
accomplishments. Reviewers use these pages to address the
\"investigator\" review criterion (see Research Project Evaluation
Criteria in Section 6. The Peer Review Process).

However, if an award is to be made, Other Support information will not
be required or accepted for OSCs since considerations of overlap do not
apply to these individuals.

Should the level of involvement for an individual listed as an OSC
increase to measurable effort, they must be redesignated as Senior/key
Personnel. This change must be made before any compensation is charged
to the project.

### 4.2.5 Human Embryonic Stem Cells

If the proposed project involves human embryonic stem cells, in this
section list the registration number of the specific cell line(s) from
the stem cell registry found at:
<http://stemcells.nih.gov/research/registry/>. Use continuation pages as
needed. If a specific line cannot be referenced at the time of
application submission, include a statement that one from the registry
will be used.

## 4.3 Research Grant Table of Contents 

[FORM PAGE
3](http://grants.nih.gov/grants/funding/phs398/phs398.html#fp3)

Provide the page number for each category listed on the Table of
Contents. Place page numbers at the bottom of each page, and
consecutively number pages throughout the application. **Do not include
unnumbered pages, and do not use suffixes, such as 5a, 5b.**

## 4.4 Budget Instructions 

[FORM PAGE
4](http://grants.nih.gov/grants/funding/phs398/phs398.html#fp4)

#### DETAILED BUDGET FOR INITIAL BUDGET PERIOD

Each item listed on Form Page 4 must be clearly justified on Form Page
5. List only the direct costs requested in this application. Do not
include any items that are treated by the applicant organization as
Facilities and Administrative (F&A) costs according to a Federal rate
negotiation agreement, except for those F&A costs included in
consortium/contractual costs.

**Note: If you are requesting a budget of \$500,000 direct costs or more
for any year, you must obtain prior approval from Institute/Center
staff. This limit is exclusive of any consortium F&A costs. If the
subtotal Direct Costs on Form Page 5 equals or exceeds \$500,000 in any
year, prior approval is required. (See** [Policy on the Acceptance for
Review of Unsolicited Applications That Request \$500,000 or More in
Direct
Costs](#policy-on-the-acceptance-for-review-of-unsolicited-applications-that-request-500000-or-more-in-direct-costs)**.)**
The following items pertain individually to the completion of Form Page
4 (Detailed Budget for Initial Budget Period -- Direct Costs Only).

#### Personnel

***[Name]{.underline}***. Starting with the PD/PI(s), list the names of
all applicant organization employees who are involved on the project
during the initial budget period, regardless of whether a salary is
requested. Include all collaborating investigators, individuals in
training, and support staff.

***[Role on Project.]{.underline}*** Identify the role of each
individual listed on the project. Describe their specific functions
under Justification on Form Page 5. Provide budget narrative for ALL
personnel by position, role, and level of effort using person months
(calendar, academic and/or summer). This includes any "to-be-appointed"
positions.

***[Months Devoted to Project]{.underline}***. Enter the number of
months devoted to the project. Three columns are provided depending on
the type of appointment being reflected: academic, calendar, and/or
summer months. Individuals may have consecutive appointments within a
calendar year, for example for an academic period and a summer period.
In this case, each appointment should be identified separately using the
corresponding column.

If effort does not change throughout the year, use only the calendar
months column. If effort varies between academic and summer months,
leave the calendar months column blank and use only the academic and
summer months columns. In cases where no contractual appointment exists
with the applicant organization and salary is requested, enter the
number of months for the requested period.

***[Institutional Base Salary]{.underline}***. An applicant organization
may choose to leave this column blank. However, PHS staff will require
this information prior to award. See [Definitions in Part
III.3](#Definitions_Salary).

***[Salary Requested.]{.underline}*** Regardless of the number of months
being devoted to the project, indicate only the amount of salary being
requested for this budget period for each individual listed.

Some PHS grant programs are currently subject to a legislatively imposed
salary limitation. Any adjustment for salary limits will be made at the
time of award. For guidance on current salary limitations see the
[*Salary Cap
Summary*](http://grants.nih.gov/grants/policy/salcap_summary.htm) on the
NIH grants Web site or contact the organization's office of sponsored
programs.

NIH grants also limit the compensation for graduate students.
Compensation includes salary or wages, fringe benefits and tuition
remission. While actual institutional-based compensation should be
requested and justified, this may be adjusted at the time of the award.
For more guidance on this policy, see: [http://grants.nih.gov/grants/
guide/notice-files/NOT-OD-02-017.html](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-017.html).

***[Fringe Benefits]{.underline}***. Fringe benefits may be requested in
accordance with institutional guidelines for each position, provided the
costs are treated consistently by the applicant organization as a direct
cost to all sponsors.

***[Totals.]{.underline}*** Calculate the totals for each position and
enter the subtotals in each column where indicated.

The applicant organization and its consortium/contractor(s) may omit
salaries and fringe benefits for individuals from copies of the
application that are available to non-Federal reviewers. In such cases,
replace the numbers with asterisks. You must show the subtotals. Provide
one copy, for use only by PHS staff, with the asterisks replaced by the
salaries and fringe benefits.

#### Special Instructions for Joint University and Department of Veterans Affairs (VA) Appointments 

Individuals with joint university and VA appointments may request the
university's share of their salary in proportion to the effort devoted
to the research project. The individual's salary with the university
determines the base for computing that request. Signature by the
institutional official on the application certifies that: (1) the
individual is applying as part of a joint appointment specified by a
formal Memorandum of Understanding between the university and the VA;
and (2) there is no possibility of dual compensation for the same work,
or of an actual or apparent conflict of interest regarding such work.
Additional information may be requested by the awarding components.

#### Consultant Costs 

Whether or not costs are involved, provide the names and organizational
affiliations of all [consultants](#Definitions_Consultant), other than
those involved in consortium/contractual arrangements. Include
consultant physicians in connection with patient care and persons who
are confirmed to serve on external monitoring or advisory committees.
Describe the services to be performed on Form Page 5 under
"Justification." Include the number of days of anticipated consultation,
the expected rate of compensation, travel, per diem, and other related
costs.

#### Equipment 

List each item of [equipment](#Definitions_Equipment) with amount
requested separately and justify each purchase on Form Page 5.

#### Supplies 

Itemize supplies in separate categories, such as glassware, chemicals,
radioisotopes, etc. Categories in amounts less than \$1,000 do not have
to be itemized. If animals are to be purchased, state the species and
the number to be used.

#### Travel 

Itemize travel requests and justify on Form Page 5. Provide the purpose
and destination of each trip and the number of individuals for whom
funds are requested.

#### Patient Care Costs

If inpatient and/or outpatient costs are requested for research with
human subjects, provide the names of any hospitals and/or clinics and
the amounts requested for each on Form Page 5.

State whether each hospital or clinic has a currently effective
DHHS-negotiated research patient care rate agreement and, if not, what
basis is used for calculating costs. If an applicant does not have a
DHHS-negotiated rate, the PHS awarding component can approve a
provisional rate. Indicate, in detail, the basis for estimating costs in
this category, including the number of patient days, estimated cost per
day, and cost per test or treatment. If both inpatient and outpatient
costs are requested, provide information for each separately. If
multiple sites are to be used, provide detailed information by site.

Include information regarding projected patient accrual for the
project/budget periods and relate this information to the budget request
for patient care costs. If patient accrual is anticipated to be lower at
the start or during the course of the project, plan budget(s)
accordingly.

Provide specific information regarding anticipated sources of Other
Support for patient care costs, e.g., third party recovery or
pharmaceutical companies. Include any potential or expected utilization
of General Clinical Research Centers/Clinical Translation Science
Awards.

#### Alterations and Renovations 

Itemize by category and justify on Form Page 5 the costs of essential
alterations and renovations including repairs, painting, removal or
installation of partitions, shielding, or air conditioning. Where
applicable, provide the square footage and costs. Note, costs for any
Alterations and Renovations (A&R) were previously unallowable from
foreign institutions, international organizations and domestic
applications with foreign subawards. However an HHS policy change now
allows for minor A&R (\<\$500,000) on these applications. When
requesting minor A&R costs under this policy, provide detailed
information on the planned A&R in the budget justification.

#### Other Expenses 

Itemize any other expenses by category and unit cost. These might
include animal maintenance (unit care costs and number of care days),
patient travel, patient participation incentives, donor fees,
publication costs, computer charges, rentals and leases, equipment
maintenance, service contracts, and tuition remission when budgeted
separately from salary/fringe benefits. **Justify costs on Form Page
5.**

#### Consortium/Contractual Costs 

Each participating consortium/contractual organization must submit a
separate detailed budget for both the initial budget period (Form Page
4) and the entire proposed project period (Form Page 5).

Consortium arrangements may involve personnel costs, supplies, and other
allowable costs, including Facilities and Administrative (F&A) costs.
Contractual costs for support services, such as the laboratory testing
of biological materials, clinical services, or data processing, are
occasionally sufficiently high to warrant a similar categorical
breakdown of costs.

For each budget from a participating consortium/contractual
organization, leave the \"Consortium/Contractual Direct Costs\" category
blank and use the \"Subtotal Direct Costs\" category to total the
consortium direct costs. When F&A costs are requested by a consortium
organization, enter those costs in the \"Consortium/Contractual F&A
Costs\" category for each supplementary budget. Provide the F&A cost
base and rate information in the budget justification section. The
\"Total Direct Costs for Initial Budget Period\" category can be used
for the consortium/contractual Total Costs (Direct Costs plus F&A).

For the applicant organization budget, list the sum of all
consortium/contractual costs (direct and F&A). Insert additional budget
page(s) after Form Page 5, numbering them sequentially. (Do not use 5a,
5b, 5c, etc.)

#### Budget Totals for Applicant Organization

For Face Page Item 7a, use the "Subtotal Direct Costs for Initial Budget
Period" on Form Page 4.

For Face Page Item 7b, add together the "Total Direct Costs for Initial
Budget Period" from Form Page 4 and the F&A costs calculated for the
initial budget period on the Checklist Form Page.

For Face Page Item 8a, total the "Subtotal Direct Costs" for all years
on Form Page 5 (see 4.5 below).

For Face Page Item 8b, add together the "Total Direct Costs for Entire
Proposed Project Period" on Form Page 5 and the Total F&A costs for all
years calculated on the Checklist Form Page.

#### Revision Application

For a Revision application, show only those items for which additional
funds are requested. If the initial budget period of the Revision
application is less than 12 months, prorate the personnel costs and
other appropriate items of the detailed budget.

## 4.5 Budget for Entire Proposed Period of Support

[FORM PAGE
5](http://grants.nih.gov/grants/funding/phs398/phs398.html#fp5)

In the first column enter the budget category totals of the initial
budget period costs from Form Page 4.

Enter the totals under each budget category for all additional years of
support requested. Identify with an asterisk (\*), and justify any
significant increases or decreases from the initial year budget. Also,
justify budgets with more than a standard escalation from the initial to
the future year(s) of support.

#### Justification for Foreign Application or Component

If the applicant organization is a foreign institution, or if the
project includes a foreign component, provide a justification on Form
Page 5. Describe special opportunities for furthering research programs
through the use of unusual talents, resources, populations, or
environmental characteristics that augment existing U.S. resources.
Indicate whether similar research is being done in the United States.
For a definition of [foreign component](#Definitions_Foreign), see
Definitions in Part III.3.

## 4.6 Biographical Sketch

[BIOGRAPHICAL SKETCH FORMAT
PAGE](http://grants.nih.gov/grants/funding/phs398/phs398.html#biosketch)

Follow the instructions on the Biographical Sketch Format Page. This
section must contain the biographical sketches of all individuals listed
as **Senior/key Personnel and Other Significant Contributors**,
including consultants, following the order as listed on Form Page 2.

All individuals who have the PD/PI role **must** be registered in the
eRA Commons, and **must** include the assigned Commons User Name. This
information is required, and is equivalent to the "Credential, e.g.,
agency login" in the federal-wide SF 424 (R&R) Senior/Key Person
Profile. For information on the eRA Commons, see
[https://commons.era.nih.gov/commons/index.jsp.](https://commons.era.nih.gov/commons/index.jsp)

Use the sample format on the Biographical Sketch Format Page to prepare
this section for **all** grant applications. The Biographical Sketch may
not exceed 4 pages. This 4-page limit includes the table at the top of
the first page. (See sample of a completed Biographical Sketch:
<http://grants.nih.gov/grants/funding/phs398/phs398.html#biosample>.)

Complete the educational block at the top of the format page, and
complete sections A, B, and C:

A. Positions and Honors. List in chronological order previous positions,
concluding with the present position. List any honors. Include present
membership on any Federal Government public advisory committee.

B. Selected peer-reviewed publications or manuscripts in press (in
chronological order). Do not include manuscripts submitted or in
preparation. When citing articles that fall under the Public Access
Policy, were authored or co-authored by the applicant and arose from NIH
support, provide the NIH Manuscript Submission reference number (e.g.,
NIHMS97531) or the PubMed Central (PMC) reference number (e.g.,
PMCID234567) for each article. If the PMCID is not yet available because
the Journal submits articles directly to PMC on behalf of their authors,
indicate \"PMC Journal - In Process.\" A list of these Journals is
posted at: <http://publicaccess.nih.gov/submit_process_journals.htm>.
Citations that are not covered by the Public Access Policy, but are
publicly available in a free, online format may include URLs or PMCID
numbers along with the full reference (note that copies of publicly
available publications are **not** accepted as appendix material.)

C. Research Support. List both selected ongoing and completed research
projects for the past three years (Federal or non-Federally-supported).
*Begin with the projects that are most relevant to the research proposed
in the application.* Briefly indicate the overall goals of the projects
and responsibilities of the key person identified on the Biographical
Sketch. Do not include number of person months or direct costs.

Do not confuse \"Research Support\" with \"Other Support.\" Though they
sound similar, these parts of the application are distinctly different.
As part of the biosketch section of the application, \"Research
Support\" highlights your accomplishments, and those of your colleagues,
as scientists. This information will be used by the reviewers in the
assessment of each individual\'s qualifications for a specific role in
the proposed project, as well as to evaluate the overall qualifications
of the research team. In contrast, \"Other Support\" information is
required for all applications that are selected to receive grant awards
and includes detailed financial information (see Part I, 4.6.1). NIH
staff will request complete and up-to-date \"Other Support\" information
*after* peer review. This information will be used to check that the
proposed research is not already funded through other sources.

Information on Other Support beyond that required in the biographical
sketch should NOT be submitted with the application.

### 4.6.1 Other Support Information

[OTHER SUPPORT FORMAT
PAGE](http://grants.nih.gov/grants/funding/phs398/phs398.html#othersupport)

Do not submit unless requested by the NIH Institute/Center (IC).

There is no form page for Other Support. Follow the sample format on the
Other Support Format Page. The sample is intended to provide guidance
regarding the type and extent of information requested.

The following instructions should be followed in completing the
information:

-   Information on active and pending Other Support is required for
    Senior/key Personnel, excluding consultants. For individuals with no
    active or pending support, indicate "None." Neither the application
    under consideration nor the current PHS award for this project
    should be listed as Other Support. Do not include Other Support for
    individuals listed as \"Other Significant Contributors\" unless
    their involvement has changed so that they now meet the definition
    of \"Senior/key Personnel.\"

-   If the support is provided under a consortium/subcontract
    arrangement or is part of a multiproject award, indicate the project
    number, PD/PI, and source for the overall project, and provide all
    other information for the subproject only.

#### Instructions for Selected Items {#instructions-for-selected-items .Subhead---No-TOC}

Project Number: If applicable, include a code or identifier for the
project.

Source: Identify the agency, institute, foundation, or other
organization that is providing the support. Include institutional,
federal, public and private sources of support.

Major Goals: Provide a brief statement of the overall objectives of the
project, subproject, or subcontract.

Dates of Approved/Proposed Project: Indicate the inclusive dates of the
project as approved/proposed. For example, in the case of NIH support,
provide the dates of the approved/proposed competitive segment.

Annual Direct Costs: In the case of an active project, provide the
current year's direct cost budget. For a pending project, provide the
proposed direct cost budget for the initial budget period.

Percent Effort/Person Months: For an active project, provide the level
of actual effort in person months (even if unsalaried) for the current
budget period. Person months should be classified as academic, calendar
and/or summer. For a pending project, indicate the level of effort in
person months as proposed for the initial budget period. In cases where
an individual's appointment is divided into academic and summer
segments, indicate the proportion of each devoted to the project.

Overlap: After listing all support, summarize for each individual any
potential overlap with the active or pending projects and this
application in terms of the science, budget, or an individual's
committed effort.

#### Special Instructions for Individuals with Multiple Research Appointments (e.g., dual university/Department of Veterans Affairs appointments)  {#special-instructions-for-individuals-with-multiple-research-appointments-e.g.-dual-universitydepartment-of-veterans-affairs-appointments .Subhead---No-TOC}

When an individual holds multiple appointments involving support for
research activities, information from each appointment must be included
separately in the Other Support documentation. The support from each
funding source should be clearly and separately delineated so that the
separate appointments can be considered independently when determining
any potential overlap.

List each appointment separately and include enough information on the
type of appointment; (e.g., full time academic or 6/8 VA) so that an
assessment of an individual's commitment can be made. Within each
appointment, include appropriate sources of research support providing
the standard detailed information cited above.

Note that when an individual has multiple appointments it is possible
that the combined effort can result in excess of 12 calendar months (not
from any one institution, but a combination of multiple appointments).
In all cases, an individual's combined total professional effort must
meet a test of reasonableness.

## 4.7 Resources 

[RESOURCES FORMAT
PAGE](http://grants.nih.gov/grants/funding/phs398/phs398.html#resources)

Follow the sample format and instructions on the Resources Format Page
when completing information on resources available for the project. If
there are multiple Project/Performance Sites the resources available at
each site should be described. In describing the scientific environment
in which the work will be done, discuss ways in which the proposed
studies will benefit from unique features of the scientific environment
or subject populations, or employ useful collaborative arrangements. If
research involving Select Agent(s) will occur at any Project/Performance
Site(s), the biocontainment resources available at each site should be
described.

## 4.8 Personal Data 

[PERSONAL DATA FORM
PAGE](http://grants.nih.gov/grants/funding/phs398/phs398.html#personaldata)

Follow instructions on the form. When multiple PD/PIs are proposed, this
form is applicable to all PD/PIs. Place the form(s) at the end of the
original application. **Do not copy.**

## 4.9 Senior/key Personnel Report 

[SENIOR/KEY PERSONNEL REPORT FORMAT
PAGE](http://grants.nih.gov/grants/funding/phs398/phs398.html#keypersonnel) -
Renewal Applications Only

Use **only** when requested by the awarding component.

List all [Senior/key Personnel](#Definitions_KeyPersonnel), salaried and
unsalaried, at the applicant organization or elsewhere, who participated
in the project during the current budget period. Include all degrees,
role on project, date of birth, number of person months devoted to the
project (indicate academic, calendar, and/or summer) and the last four
digits of the Social Security number. When requesting this portion of
the Social Security numbers from personnel, explain that provision of
the Social Security number is voluntary, and the information will be
used only for program management purposes.

Individuals designated as Other Significant Contributors, e.g. those
that may contribute to the scientific development or execution of the
project, but are not committing any specified measurable effort to the
project, should **not** be included in this report unless their
involvement has changed so that they now meet the definition of
\"Senior/key Personnel.\"

# 5. Preparing the Research Plan, the Checklist, and the Appendix

## 5.1 (Reserved)

## 5.2 (Reserved)

## 5.3 (Reserved)

## 5.4 Research Plan Format and Notice of Proprietary Information

### 5.4.1 Research Plan Format

No Specific Form Page - Use [CONTINUATION
PAGE](http://grants.nih.gov/grants/funding/phs398/phs398.html#continuation)

The Research Plan consists of items 1-17 in Section 5.5 below, as
applicable. It should be self-contained and include sufficient
information to evaluate the project, independent of any other document
(e.g., previous application). Be specific and informative, and avoid
redundancies. For grant writing tips, see
<http://grants.nih.gov/grants/grant_tips.htm>. Carefully follow all
instructions.

#### Page Limitations

**Do not exceed 25 pages for Items 2-5.** All tables, graphs, figures,
diagrams, and charts must be included within the 25-page limit. Be
succinct and remember that there is no requirement to use all 25-pages
allotted to Items 2-5. Recommended page numbers for items 2-4 are
included in the instructions below. If PAs or RFAs contain specific page
limitations, those instructions supersede these PHS 398 instructions.

#### Use of URLs

Unless otherwise specified in a solicitation, do not use Internet
website addresses (URLs) to provide information because reviewers are
not obligated to view the Internet sites. Moreover, reviewers are
cautioned that they should not directly access an internet site (except
to review publications cited in the Biographical Sketch or Progress
Report Publication List) because this may compromise their anonymity.

#### Other Materials

Do not include photographs or other materials that are not printed
directly on the application page in the body of the application.
Pictures or other materials glued or taped into the application pages
are incompatible with the duplication/scanning process.

PDF images of material such as electron micrographs or gels may be
included in the Appendix; however, a photocopy of each must also be
included within the page limitations of the Research Plan (see [Section
5.7](#appendix)).

### 5.4.2 Notice of Proprietary Information

Applicants are discouraged from submitting information considered
proprietary unless it is deemed essential for proper evaluation of the
application. However, when the application contains information that
constitutes trade secrets, or information that is commercial or
financial, or information that is confidential or privileged, identify
the pages in the application that contain this information by marking
those paragraphs or lines with an asterisk (\*) at the beginning of the
paragraph. Indicate at the beginning of the Research Plan which pages
contain asterisks and a note stating: *\"The following sections marked
with an asterisk contain proprietary/privileged information that \[name
of applicant\] requests not be released to persons outside the
Government, except for purposes of review and evaluation.\"*

When information in the application constitutes trade secrets or
information that is commercial or financial, or information that is
confidential or privileged, it is furnished to the Government in
confidence with the understanding that the information shall be used or
disclosed only for evaluation of this application. If a grant is awarded
as a result of or in connection with the submission of this application,
the Government shall have the right to use or disclose the information
to the extent authorized by law. This restriction does not limit the
Government's right to use the information if it is obtained without
restriction from another source.

## 5.5 Content of Research Plan 

The Research Plan consists of the following items, as applicable. Begin
each section of the Research Plan with a section header (e.g.,
Introduction, Specific Aims, etc.). Organize Items 2-5 of the Research
Plan to answer these questions: *What do you intend to do? Why is the
work important? What has already been done? How are you going to do the
work?* Remember that Items 2-5 may not exceed 25 pages, including all
tables and figures.

1\. Introduction to Application (Resubmission or Revision Applications
only)

2\. Specific Aims

3\. Background and Significance

4\. Preliminary Studies/Progress Report

5\. Research Design and Methods

6\. Inclusion Enrollment Report (Renewal or Revision Applications only)

7\. Bibliography and References Cited/Progress Report Publication List

8\. Protection of Human Subjects

9\. Inclusion of Women and Minorities

10\. Targeted/Planned Enrollment Table

11\. Inclusion of Children

12\. Vertebrate Animals

13\. Select Agent Research

14\. Multiple PD/PI Leadership Plan

15\. Consortium/Contractual Arrangements

16\. Letters of Support (e.g., Consultants)

17\. Resource Sharing Plan(s)

#### 1. Introduction (Resubmission or Revision Applications only)

All Resubmission and Revision applications must include an Introduction.
The Introduction may not exceed three pages for Resubmission
applications, or one page for Revision applications. See specific
instructions in [2.7 Resubmission
Applications](#resubmission-applications) and [2.8 Revision
Applications](#revision-application) on the content of the Introduction.
Place the Introduction at the very beginning of the Research Plan.

#### 2. Specific Aims

List the broad, long-term objectives and the goal of the specific
research proposed, e.g., to test a stated hypothesis, create a novel
design, solve a specific problem, challenge an existing paradigm or
clinical practice, address a critical barrier to progress in the field,
or develop new technology. **One page is recommended.**

#### 3. Background and Significance

Briefly sketch the background leading to the present application,
critically evaluate existing knowledge, and specifically identify the
gaps that the project is intended to fill. State concisely the
importance and health relevance of the research described in this
application by relating the specific aims to the broad, long-term
objectives. If the aims of the application are achieved, state how
scientific knowledge or clinical practice will be advanced. Describe the
effect of these studies on the concepts, methods, technologies,
treatments, services or preventative interventions that drive this
field. **Two to three pages are recommended.**

#### 4. Preliminary Studies/Progress Report

***[(a) Preliminary Studies.]{.underline}*** For new applications, use
this section to provide an account of the PD/PI\'s preliminary studies
pertinent to this application, including preliminary experience with and
outreach to the proposed racial/ethnic group members. This information
will also help to establish the experience and competence of the
investigator to pursue the proposed project.

Peer review committees generally view preliminary data as an essential
part of a research grant application. Preliminary data often aid the
reviewers in assessing the likelihood of the success of the proposed
project.

***[(b) Progress Report for Renewal and Revision
Applications.]{.underline}*** A Progress Report must be provided for
Renewal and Revision applications. Provide the beginning and ending
dates for the period covered since the project was last reviewed
competitively. Summarize the previous application's specific aims and
the importance of the findings. Provide a succinct account of published
and unpublished results, indicating progress toward their achievement.
Discuss any changes in the specific aims as a result of budget
reductions.

A list of publications, manuscripts accepted for publication, patents,
and other printed materials will be included in Item 7.b; do not include
that information here.

**Six to eight pages are recommended.**

#### 5. Research Design and Methods

Describe the research design conceptual or clinical framework,
procedures, and analyses to be used to accomplish the specific aims of
the project. Unless addressed separately in Item 17, include how the
data will be collected, analyzed, and interpreted as well as the
data-sharing plan as appropriate. Describe any new methodology and its
advantage over existing methodologies. Describe any novel concepts,
approaches, tools, or technologies for the proposed studies. Discuss the
potential difficulties and limitations of the proposed procedures and
alternative approaches to achieve the aims. As part of this section,
provide a tentative sequence or timetable for the project. Point out any
procedures, situations, or materials that may be hazardous to personnel
and the precautions to be exercised.

**Although no specific number of pages is recommended for the Research
Design and Methods section, be as succinct as possible. There is no
requirement that all 25 total pages allotted for items 2-5 be used.**

#### 6. Inclusion Enrollment Report (Renewal or Revision Applications only)

If the Renewal or Revision application involves clinical research, then
you must report on the enrollment of research subjects and their
distribution by ethnicity/race and sex/gender using the Inclusion
Enrollment Report for each protocol.

#### 7. Bibliography and References Cited/Progress Report Publication List 

When citing articles in (a) or (b) below that fall under the Public
Access Policy, were authored or co-authored by the applicant and arose
from NIH support, provide the NIH Manuscript Submission reference number
(e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g.,
PMCID234567) for each article. If the PMCID is not yet available because
the Journal submits articles directly to PMC on behalf of their authors,
indicate \"PMC Journal - In Process.\" A list of these Journals is
posted at: <http://publicaccess.nih.gov/submit_process_journals.htm>.
Citations that are not covered by the Public Access Policy, but are
publicly available in a free, online format may include URLs or PMCID
numbers along with the full reference (note that copies of these
publications are not accepted as appendix material, see [Section
5.7](#appendix)).

***[(a) Bibliography and References Cited]{.underline}*** - Provide a
bibliography of any references cited in the description of the Project
Summary and Relevance (Form Page 2). Each reference must include names
of all authors (in the same sequence in which they appear in the
publication), the article and journal title, book title, volume number,
page numbers, and year of publication. Include only bibliographic
citations. Follow scholarly practices in providing citations for source
materials relied upon in preparing any section of the application.

*The references should be limited to relevant and current literature.*
While there is not a page limitation, it is important to be concise and
to select only those literature references pertinent to the proposed
research.

***[(b) Progress Report Publication List]{.underline}*** - For Renewal
applications list the title and complete references to all appropriate
publications, manuscripts accepted for publication, patents, and other
printed materials that have resulted from the project since it was last
reviewed competitively.

#### 8. Protection of Human Subjects

Refer to Part II of the PHS 398: [Supplemental Instructions for
Preparing the Protection of Human Subjects Section of the Research
Plan](#Human_Subjects_PartII) if the proposed research will involve
[human subjects](../HumanSubjects.doc#Human_Subjects_Defs_Human).

#### 9. Inclusion of Women and Minorities

To determine if Inclusion of Women and Minorities applies to the
application, see Part II Supplemental Instructions for Preparing the
Protection of Human Subjects Section of the Research Plan, Sections
[4.2](#inclusion-of-women-and-minorities-1) and
[5.6](#nih-policy-on-the-inclusion-of-women-and-minorities-in-clinical-research).

#### 10. Targeted/Planned Enrollment Table

If this application involves the Inclusion of Women and Minorities,
complete the Targeted/Planned Enrollment Table for each protocol; see
Part II Supplemental Instructions for Preparing the Protection of Human
Subjects Section of the Research Plan, [Section 4.3](#Section_7_4_7).

#### 11. Inclusion of Children

To determine if Inclusion of Children applied to this application, see
Part II Supplemental Instructions for Preparing the Protection of Human
Subjects Section of the Research Plan, Sections
[4.4](#inclusion-of-children-1) and
[5.7](#nih-policy-on-inclusion-of-children).

#### 12. Vertebrate Animals 

If vertebrate animals are involved in the project, address each of the
five points below.

If all or part of the proposed research involving vertebrate animals
will take place at alternate sites (such as project/performance or
collaborating sites), identify those sites and describe the activities
at those locations.

Although no specific page limitation applies to this section of the
application, be succinct. Failure to address the following five points
will result in the application being designated as incomplete and will
be grounds for the PHS to defer the application from the peer review
round. Alternatively, the application\'s priority score may be
negatively affected.

The five points are as follows:

1\. Provide a detailed description of the proposed use of the animals
for the work outlined in the Research Design and Methods section.
Identify the species, strains, ages, sex, and numbers of animals to be
used in the proposed work.

2\. Justify the use of animals, the choice of species, and the numbers
to be used. If animals are in short supply, costly, or to be used in
large numbers, provide an additional rationale for their selection and
numbers.

3\. Provide information on the veterinary care of the animals involved.

4\. Describe the procedures for ensuring that discomfort, distress,
pain, and injury will be limited to that which is unavoidable in the
conduct of scientifically sound research. Describe the use of analgesic,
anesthetic, and tranquilizing drugs and/or comfortable restraining
devices, where appropriate, to minimize discomfort, distress, pain, and
injury.

5\. Describe any method of euthanasia to be used and the reason(s) for
its selection. State whether this method is consistent with the
recommendations of the American Veterinary Medical Association (AVMA)
Guidelines on Euthanasia. If not, include a scientific justification for
not following the recommendations.

If the involvement of animals is indefinite, provide an explanation and
indicate when it is anticipated that animals will be used.

#### 13. Select Agent Research

Select Agents are hazardous biological agents and toxins that have been
identified by DHHS or USDA as having the potential to pose a severe
threat to public health and safety, to animal and plant health, or to
animal and plant products. CDC maintains a list of these agents; see
<http://www.cdc.gov/od/sap/docs/salist.pdf>.

If the activities proposed in the application involve only the use of a
strain(s) of Select Agents which has been excluded from the list of
select agents and toxins as per 42 CFR 73.4(f)(5), the Select Agent
requirements do not apply. Use this section to identify the strain(s) of
the Select Agent that will be used and note that it has been excluded
from this list. The CDC maintains a list of exclusions at
<http://www.cdc.gov/od/sap/sap/exclusion.htm>.

If the strain(s) is not currently excluded from the list of select
agents and toxins but you have applied or intend to apply to DHHS for an
exclusion from the list, use this section to indicate the status of the
request or the intent to apply for an exclusion and provide a brief
justification for the exclusion.

If any of the activities proposed in the application involve the use of
Select Agents at any time during the proposed project period, either at
the applicant organization or at any other Project/Performance Site,
address the following three points for each site at which Select Agent
research will take place. Although no specific page limitation applies
to this section, be succinct.

1\. Identify the Select Agent(s) to be used in the proposed research.

2\. Provide the registration status of all entities\* where Select
Agent(s) will be used.

-   If the Project/Performance Site(s) is a foreign institution, provide
    the name(s) of the country or countries where Select Agent research
    will be performed.

\*An "entity" is defined in 42 CFR 73.1 as "any government agency
(Federal, State, or local), academic institution, corporation, company,
partnership, society, association, firm, sole proprietorship, or other
legal entity."

3\. Provide a description of all facilities where the Select Agent(s)
will be used.

-   Describe the procedures that will be used to monitor possession, use
    and transfer of Select Agent(s).

-   Describe plans for appropriate biosafety, biocontainment, and
    security of the Select Agent(s).

If you are responding to a specific Funding Opportunity Announcement
(e.g., PA or RFA), address any requirements specified by the
solicitation.

Reviewers will assess the information provided in this section, and any
questions associated with Select Agent research will need to be
addressed prior to award.

#### 14. Multiple Project Director/Principal Investigator (PD/PI) Leadership Plan

For applications designating multiple PD/PIs, a leadership plan must be
included. A rationale for choosing a multiple PD/PI approach should be
described. The governance and organizational structure of the leadership
team and the research project should be described, including
communication plans, process for making decisions on scientific
direction, and procedures for resolving conflicts. The roles and
administrative, technical, and scientific responsibilities for the
project or program should be delineated for the PD/PIs, including
responsibilities for human or live vertebrate animal subject studies as
appropriate.

If budget allocation is planned, the distribution of resources to
specific components of the project or the individual PD/PIs should be
delineated in the Leadership Plan. In the event of an award, the
requested allocations may be reflected in a footnote on the Notice of
Award.

#### 15. Consortium/Contractual Arrangements 

Explain the programmatic, fiscal, and administrative arrangements to be
made between the applicant organization and the consortium
organization(s). For applications including multiple PD/PIs, this
information may be included as part of the Leadership Plan above. If
consortium/contractual activities represent a significant portion of the
overall project, explain why the applicant organization, rather than the
ultimate performer of the activities, should be the grantee.

The signature of the authorized organizational official on the Face Page
signifies that the applicant and all proposed consortium participants
understand and agree to the following statement: *The appropriate
programmatic and administrative personnel of each organization involved
in this grant application are aware of the agency's consortium agreement
policy and are prepared to establish the necessary inter-organizational
agreement(s) consistent with that policy.*

#### 16. Letters of Support (e.g., Consultants)

Attach all appropriate letters of support, including any letters
necessary to demonstrate the support of consortium participants and
collaborators such as Senior/Key Personnel and Other Significant
Contributors included in the grant application. Letters are not required
for personnel (such as research assistants) not contributing in a
substantive, measurable way to the scientific development or execution
of the project. For consultants, letters should include rate/charge for
consulting services. Do **not** place these letters in the Appendix.
Consultant biographical sketches should be in the Biographical Sketch
section.

#### 17. Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through
NIH-sponsored research an important means to enhance the value and
further the advancement of the research. When resources have been
developed with NIH funds and the associated research findings published
or provided to NIH, it is important that they be made readily available
for research purposes to qualified individuals within the scientific
community.

\(a\) *Data Sharing Plan*: Investigators seeking \$500,000 or more in
direct costs in any year are expected to include a brief 1-paragraph
description of how final research data will be shared, or explain why
data-sharing is not possible. Specific FOAs may require that all
applications include this information regardless of the dollar level.
Applicants are encouraged to read the specific opportunity carefully and
discuss data-sharing plans with their program contact at the time they
negotiate an agreement with the Institute/Center (IC) staff to accept
assignment of their application. See [Data-Sharing
Policy](#Policy_DataSharing) or
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html>.

\(b\) *Sharing Model Organisms*: Regardless of the amount requested, all
applications where the development of model organisms is anticipated are
expected to include a description of a specific plan for sharing and
distributing unique model organisms or state appropriate reasons why
such sharing is restricted or not possible. See [Sharing Model Organisms
Policy](#sharing-model-organism-policy), and [NIH Guide
NOT-OD-04-042](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html).

\(c\) *Genome-Wide Association Studies (GWAS):* Regardless of the amount
requested, applicants seeking funding for a genome-wide association
study are expected to provide a plan for submission of GWAS data to the
NIH-designated GWAS data repository, or provide an appropriate
explanation why submission to the repository is not possible. GWAS is
defined as any study of genetic variation across the entire genome that
is designed to identify genetic associations with observable traits
(such as blood pressure or weight) or the presence or absence of a
disease or condition. For further information see Policy for Sharing of
Data Obtained in NIH Supported or Conducted Genome-Wide Association
Studies, [NIH Guide
NOT-OD-07-088](http://www.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html),
and <http://grants.nih.gov/grants/gwas/>.

## 5.6 Checklist

[CHECKLIST FORM
PAGE](http://grants.nih.gov/grants/funding/phs398/phs398.html#checklist)

#### Type of Application

Check all that apply.

#### Inventions and Patents (Renewal Applications Only) 

If no inventions were conceived or reduced to practice during the course
of work under this project, check "No." The remaining parts of the item
are then not applicable.

If any inventions were conceived or reduced to practice during the
previous period of support, check "Yes." Also indicate whether this
information has been reported previously to the PHS or to the applicant
organization official responsible for patent matters.

Note: NIH recipient organizations must promptly report inventions to the
Extramural Inventions and Technology Resources Branch of the Office of
Policy for Extramural Research Administration, OER, NIH, Bethesda, MD
20892-2750, (301) 435-1986. Invention reporting compliance according to
regulations at 37 CFR 401.14 is described at
[http://www.iedison.gov](http://www.iedison.gov/). The grantee is
encouraged to submit reports electronically using Interagency Edison
([http://www.iedison.gov](http://www.iedison.gov/)). See also
"[Inventions and Patents"](#Section_7_4_7) in Part III, 1.6.

#### 1. Program Income 

If no [program income](#Definitions_ProgramIncome) is anticipated during
the period(s) for which grant support is requested, so state.

If program income is anticipated, use the format provided. If the
application is funded, the Notice of Award will provide specific
instructions regarding the use of such income.

#### 2. Assurances/Certifications 

Each application to the PHS requires that the policies, assurances, and
certifications provided in Part III and listed in Part 1, 4.1 under Item
14, be verified by the signature of the official signing for the
applicant organization on the Face Page of the application.

#### 3. Facilities and Administrative (F&A) Costs 

Indicate the applicant organization's most recent F&A cost rate
established with the appropriate DHHS Regional Office, or, in the case
of for-profit organizations, the rate established with the Division of
Financial Advisory Services (DFAS), NIH. If the applicant organization
does not have a current negotiated rate, it should develop a provisional
rate for application purposes, and immediately upon notification that an
award will be made, it should submit the provisional F&A cost rate
proposal to the appropriation negotiation office. This proposal is to be
based on the organization's most recently completed fiscal year in
accordance with the principles set forth in the pertinent DHHS guidance
for establishing indirect cost rates, and submitted to the appropriate
DHHS Regional Office or the DFAS, NIH. If the applicant organization has
a current negotiated rate with another Federal agency, the negotiated
rate must be adjusted to treat any independent research and development
(IR&D) costs in accordance with DHHS policy. F&A costs will NOT be paid
on construction grants, grants to Federal organizations, grants to
individuals, and conference grants. Follow any additional instructions
provided for [Career Development
Awards](#instructions-for-preparing-an-individual-research-career-development-award-cda-application-k-series),
[Institutional Training, including Ruth L. Kirschstein National Research
Service
Awards](#instructions-for-preparing-an-institutional-research-training-application-including-ruth-l.-kirschstein-nrsa-applications),
foreign grants, and specialized grant applications.

#### 4. Disclosure Permission Statement

In the case this application does not result in an award, check "yes" to
provide permission for the Government to disclose the title of the
proposed project, and the name, address, telephone number and email
address of the official signing for the applicant organization, to
organizations that may be interested in contacting you for further
information (e.g., possible collaborations, investment). Check "no" if
you do not provide this permission. Your response will not affect any
peer review or funding decisions.

## 5.7 Appendix

Do not use the appendix to circumvent the page limitations of the
Research Plan. Graphs, diagrams, tables, and charts should be included
in the body of the Research Plan unless a PDF file is necessary to show
detail. Not all grant mechanisms allow publications to be included in
the appendix. When publications are allowed, a limit of 3 publications,
which are not publicly available, will be considered in the initial peer
review (see below for further details and check the FOA for any specific
instructions). A summary listing all of the items included in the
appendix is encouraged, but not required. When including a summary, it
should be the first file on the CD. Applications that do not follow the
appendix requirements may be delayed in the review process.

Five identical CDs containing all appendix material must be submitted in
the same package with the application. When preparing CDs:

-   Use PDF format. Where possible, applicants should avoid creating PDF
    files from scanned documents. NIH recommends producing the documents
    electronically using text or work-processing software and then
    converting to PDF. Scanned documents are generally of poor quality
    and difficult to read.

-   Label each disk with the PD/PI name and application title.

-   If burning CD-ROM disks on a Mac, select the ISO 9660 format.

-   Do not use compression techniques for the electronic files.

-   Do not use password protection, encryption, digital signature and/or
    digital certification in the PDF files.

The following materials may be included in the appendix to New,
Revision, Renewal and Resubmission applications:

-   Up to 3 publications of the following types. In each case include
    the entire document:

```{=html}
<!-- -->
```
-   Manuscripts and/or abstracts accepted for publication but not yet
    published.

-   Published manuscripts and/or abstracts where a free, online,
    publicly available journal link is not available.

-   Patents directly relevant to the project.

Do not include unpublished theses or abstracts/manuscripts submitted,
but not yet accepted, for publication.

-   Surveys, questionnaires, and other data collection instruments,
    clinical protocols, and informed consent documents.

-   Color images of gels, micrographs, etc., provided that a photocopy
    (may be reduced in size) is also included within the 25-page limit
    of Items 2-5 of the Research Plan. No images may be included in the
    appendix that are not also represented within the Research Plan.

-   For materials that cannot be submitted on CD (e.g., medical devices,
    prototypes), applicants should contact the Scientific Review Officer
    for instructions following notification of assignment of the
    application to a study section. Applicants are encouraged to be as
    concise as possible and submit only information essential for the
    review of the application.

Publications that are publicly accessible must not be included in the
appendix. For such publications, the URL or PMC submission
identification numbers along with the full reference should be included
as appropriate in the Bibliography and References Cited/Progress Report
Publication List section of the Research Plan, and/or in the
Biographical Sketch.

# 6. The Peer Review Process

#### Overview

NIH policy is intended to ensure that applications for funding submitted
to the NIH are evaluated on the basis of a process that is fair,
equitable, timely, and conducted in a manner free of bias. The NIH dual
peer review system is mandated by statute in accordance with section 492
of the Public Health Service Act and federal regulations governing
\"Scientific Peer Review of Research Grant Applications and Research and
Development Contract Proposals\" ([42 CFR Part
52h](http://www.access.gpo.gov/nara/cfr/waisidx_07/42cfr52h_07.html)).

The first level of review is carried out by a Scientific Review Group
(SRG) composed primarily of non-federal scientists who have expertise in
relevant scientific disciplines and current research areas. The second
level of review is performed by Institute and Center (IC) National
Advisory Councils or Boards. Councils are composed of both scientific
and lay members chosen for their expertise, interest, or activity in
matters related to health and disease. Only applications that are
favorably recommended by both the SRG and the Advisory Council may be
recommended for funding. Only the NIH Institute or Center may make
actual funding decisions.

A detailed description of what happens to a research project grant
application after it is received for peer review can be found at the
following location:
<http://grants.nih.gov/grants/peer_review_process.htm>. Additional
information about charters and membership of SRGs, Councils, and Boards
can be obtained from the appropriate agency. Information on CDC review
procedures is located at
<http://www.cdc.gov/od/science/PHResearch/peerreview.htm>.

Note: Applications received for potential FY2009 funding will be
evaluated using the review criteria adopted October 12, 2004 (see
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-002.html>)
and modified May 11, 2006 (see
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-069.html>).
The enhanced review criteria and scoring procedures below have been
issued for the evaluation of research applications received for
potential FY2010 funding and thereafter.

#### Streamlining

The initial scientific peer review of most applications will also
include a process in which only those applications deemed by the
reviewers to have the highest scientific merit, generally the better
half of the applications under review, will be discussed at the SRG
meeting, assigned an impact score, and receive a second level review.
Applications in the lower half are reviewed by SRG members but they are
not discussed or scored at the SRG meeting. This process allows the
reviewers to focus their discussion on the most meritorious
applications.

Before the review meeting, each reviewer and discussant assigned to an
application will give a separate score for each of the five core review
criteria and a preliminary impact score for that application (see
below). The preliminary impact scores will be used to determine which
applications will be discussed.

#### Scoring

SRG members are instructed to evaluate research applications by
addressing the five core review criteria (see below) and additional
review criteria as applicable for the application. However, Requests for
Applications (RFAs) and other types of funding opportunities (e.g.,
construction grants and fellowship applications) may list different
and/or additional review criteria and considerations.

For each application that is discussed, a final impact score will be
given by each eligible committee member (without conflicts of interest)
following the panel discussion. Each member's impact score will reflect
his/her evaluation of the overall impact of the project in its entirety,
rather than an arithmetic formula applied to the reviewer's scores given
to each criterion. The final impact score for each discussed application
will be determined by calculating the arithmetic average of all the
eligible members' impact scores, and multiplying the average by 10.

As part of the initial merit review, and regardless of whether an
application is discussed or not discussed (streamlined), all applicants
will receive a written critique, called a Summary Statement, unless
stated otherwise in the FOA. The Summary Statement represents a
combination of the reviewers\' written comments and scores for
individual criteria. The Summary Statement for discussed applications
includes the Scientific Review Officer\'s summary of the members\'
discussion during the study section meeting; the final impact score; the
recommendations of the study section, including budget recommendations;
and administrative notes of special considerations. For applications
that are not discussed by the full committee, the scores of the assigned
reviewers and discussants for the five core criteria will be reported
individually on the Summary Statement. Final impact scores are not given
for applications that are not discussed.

#### Research Project Evaluation Criteria

**Overall Impact.** Reviewers will provide an overall impact score to
reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following five core review criteria, and additional
review criteria (as applicable for the project proposed).

**Core Review Criteria.** Reviewers will consider each of the five
review criteria below in the determination of scientific and technical
merit, and give a separate score for each. An application does not need
to be strong in all categories to be judged likely to have major
scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

> ***Significance.*** Does the project address an important problem or a
> critical barrier to progress in the field? If the aims of the project
> are achieved, how will scientific knowledge, technical capability,
> and/or clinical practice be improved? How will successful completion
> of the aims change the concepts, methods, technologies, treatments,
> services, or preventative interventions that drive this field?
>
> ***Investigator(s).*** Are the PD/PIs, collaborators, and other
> researchers well suited to the project? If Early Stage Investigators
> or New Investigators, do they have appropriate experience and
> training? If established, have they demonstrated an ongoing record of
> accomplishments that have advanced their field(s)? If the project is
> collaborative or multi-PD/PI, do the investigators have complementary
> and integrated expertise; are their leadership approach, governance
> and organizational structure appropriate for the project?
>
> ***Innovation.*** Does the application challenge and seek to shift
> current research or clinical practice paradigms by utilizing novel
> theoretical concepts, approaches or methodologies, instrumentation, or
> interventions? Are the concepts, approaches or methodologies,
> instrumentation, or interventions novel to one field of research or
> novel in a broad sense? Is a refinement, improvement, or new
> application of theoretical concepts, approaches or methodologies,
> instrumentation, or interventions proposed?
>
> ***Approach.*** Are the overall strategy, methodology, and analyses
> well-reasoned and appropriate to accomplish the specific aims of the
> project? Are potential problems, alternative strategies, and
> benchmarks for success presented? If the project is in the early
> stages of development, will the strategy establish feasibility and
> will particularly risky aspects be managed?
>
> If the project involves clinical research, are the plans for 1)
> protection of human subjects from research risks, and 2) inclusion of
> minorities and members of both sexes/genders, as well as the inclusion
> of children, justified in terms of the scientific goals and research
> strategy proposed?
>
> ***Environment.*** Will the scientific environment in which the work
> will be done contribute to the probability of success? Are the
> institutional support, equipment and other physical resources
> available to the investigators adequate for the project proposed? Will
> the project benefit from unique features of the scientific
> environment, subject populations, or collaborative arrangements?

**Additional Review Criteria.** As applicable for the project proposed,
reviewers will consider the following additional items in the
determination of scientific and technical merit, but will not give
separate scores for these items.

> ***Protections for Human Subjects.*** For research that involves human
> subjects but does not involve one of the six categories of research
> that are exempt under 45 CFR Part 46, the committee will evaluate the
> justification for involvement of human subjects and the proposed
> protections from research risk relating to their participation
> according to the following five review criteria: 1) risk to subjects,
> 2) adequacy of protection against risks, 3) potential benefits to the
> subjects and others, 4) importance of the knowledge to be gained, and
> 5) data and safety monitoring for clinical trials.
>
> For research that involves human subjects and meets the criteria for
> one or more of the six categories of research that are exempt under 45
> CFR Part 46, the committee will evaluate: 1) the justification for the
> exemption, 2) human subjects involvement and characteristics, and 3)
> sources of materials.
>
> ***Inclusion of Women, Minorities, and Children.*** When the proposed
> project involves clinical research, the committee will evaluate the
> proposed plans for inclusion of minorities and members of both
> genders, as well as the inclusion of children.
>
> ***Vertebrate Animals.*** The committee will evaluate the involvement
> of live vertebrate animals as part of the scientific assessment
> according to the following five points: 1) proposed use of the
> animals, and species, strains, ages, sex, and numbers to be used; 2)
> justifications for the use of animals and for the appropriateness of
> the species and numbers proposed; 3) adequacy of veterinary care; 4)
> procedures for limiting discomfort, distress, pain and injury to that
> which is unavoidable in the conduct of scientifically sound research
> including the use of analgesic, anesthetic, and tranquilizing drugs
> and/or comfortable restraining devices; and 5) methods of euthanasia
> and reason for selection if not consistent with the AVMA Guidelines on
> Euthanasia.
>
> ***Biohazards.*** Reviewers will assess whether materials or
> procedures proposed are potentially hazardous to research personnel
> and/or the environment, and if needed, determine whether adequate
> protection is proposed.

**Additional Review Considerations.** As applicable for the project
proposed, reviewers will address each of the following items, but will
not give scores for these items and should not consider them in
providing an overall impact score.

> ***Budget and Period Support.*** Reviewers will consider whether the
> budget and the requested period of support are fully justified and
> reasonable in relation to the proposed research.
>
> ***Select Agent Research.*** Reviewers will assess the information
> provided in this section of the application, including 1) the Select
> Agent(s) to be used in the proposed research, 2) the registration
> status of all entities where Select Agent(s) will be used, 3) the
> procedures that will be used to monitor possession use and transfer of
> Select Agent(s), and 4) plans for appropriate biosafety,
> biocontainment, and security of the Select Agent(s).
>
> ***Applications from Foreign Organizations.*** Reviewers will assess
> whether the project presents special opportunities for furthering
> research programs through the use of unusual talent, resources,
> populations, or environmental conditions that exist in other countries
> and either are not readily available in the United States or augment
> existing U.S. resources.
>
> ***Resource Sharing Plans.*** Reviewers will comment on whether the
> following Resource Sharing Plans, or the rationale for not sharing the
> following types of resources, are reasonable: 1) Data Sharing Plan
> (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm);
> 2) Sharing Model Organisms
> (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html);
> and 3) Genome Wide Association Studies (GWAS)
> (<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html>).

#### Dual-Level Peer Review

The second level of review will usually be performed by the Advisory
Council or Board of the potential awarding component (Institute, Center,
or other unit). Council or Board recommendations are based not only on
considerations of scientific merit, as judged by the SRGs, but also on
the relevance of the proposed study to an Institute/Center's mission,
programs and priorities.

# 7. Instructions for Preparing an Individual Research Career Development Award (CDA) Application -- "K" Series

## 7.1 Introduction

This section includes additional instructions to be used when applying
for an individual Research Career Development Award (CDA): a substitute
Table of Contents (CDA Substitute Form Page 3), a summary of current CDA
mechanisms, and guidelines for letters of reference. The instructions in
this section of the PHS 398 application should be used along with the
instructions in the preceding sections.

These instructions do not cover applications for K12 and other
institutional career development programs. Institutions planning such
applications should contact the potential awarding component concerning
eligibility, award criteria, and application procedures. Some K-series
funded through Requests for Applications (RFAs) may have special
instructions.

#### Summary of Research Career Development Award Mechanisms

  ------------------------------------------------------------------------------------------
  []{#SummaryCDAMechs   description                                     mentor   reference
  .anchor}program                                                                letters
  --------------------- ----------------------------------------------- -------- -----------
  K01                   Mentored Research Scientist Development Award   Yes      Yes

  K02                   Independent Scientist Award                     No       No

  K05                   Senior Scientist Award                          No       No

  K07                   Academic Career Award                           \*       \*

  K08                   Mentored Clinical Scientist Development Award   Yes      Yes

  K18                   Career Enhancement Award (see specific IC)      Yes      Yes

  K22                   Career Transition Award (see specific IC)       \*       Yes

  K23                   K23 Mentored Patient-Oriented Research Career   Yes      Yes
                        Development Award                                        

  K24                   Mid-Career Investigator Award in Patient        No       No
                        Oriented Research                                        

  K25                   Mentored Quantitative Research Career           Yes      Yes
                        Development Award                                        

  K26                   Midcareer Investigator Award in Mouse           No       No
                        Pathobiology Research                                    

  K99/R00               NIH Pathway to Independence (PI) Award          Yes      Yes
                        (K99/R00)                                                
  ------------------------------------------------------------------------------------------

> \* Varies with career status and source of award. Check the program
> announcement (PA).

## 7.2 Individual Career Development Award Mechanism

Before applying for a CDA, applicants should carefully review the
guidelines in the NIH or other PHS agency Funding Opportunity
Announcement (FOA) including Program Announcement (PA) or Request for
Application (RFA) for the specific career award(s) of interest, noting
especially the eligibility requirements, award provisions, requirements
for a mentor, and review criteria. NIH and other agency program
announcements and requests for applications for career awards are issued
periodically in the [*NIH Guide for Grants and
Contracts*](http://grants.nih.gov/grants/guide). The PAs and other
guidelines are available on the NIH website
[http://grants.nih.gov/training/
careerdevelopmentawards.htm](http://grants.nih.gov/training/careerdevelopmentawards.htm).

The eligibility criteria, support levels, and other important aspects of
specific career awards, including availability, may vary among NIH
Institutes or Centers and other PHS agencies. For this reason, it is
strongly recommended that applicants consult with the NIH
Scientific/Research contact of the appropriate awarding component prior
to the preparation of an application. For NIH career awards, the program
contacts are listed in the individual FOA for each CDA (see K Kiosk:
[http://grants.nih.gov/training/
careerdevelopmentawards.htm](http://grants.nih.gov/training/careerdevelopmentawards.htm)).
For non-NIH career awards, applicants should read the instructions of
the appropriate FOA carefully or contact an official. (See [Agency
Contact table](#phs-agency-contacts).)

Note: A few individual K-series programs supported by the NIH include a
delayed award activation and/or two award phases (e.g., K22, K99/R00).
NIH intramural researchers may be eligible to apply for these
mechanisms. The FOA will include any additional and/or specific
instructions that must be followed when applying for such support.

## 7.3 Letters of Reference

Three letters are required for all new and resubmission mentored CDA
applications (see table of [Career Development Award
Mechanisms](#SummaryCDAMechs), Section 7.1). **Applications with fewer
than three reference letters may be delayed or may be returned without
review**. These letters should be from individuals not directly involved
in the application, but who are familiar with your qualifications,
training, and interests. A letter of reference may be submitted by an
individual not directly involved in the proposed research project; e.g.,
advisory committee members (if applicable). However, **the mentor(s) of
this application must not submit a letter of reference because a
mentor's statement is required as part of the application (Section
7.6.2).**

The letters are critically important and should address the candidate\'s
competence and potential to develop into an independent biomedical or
behavioral investigator. Only those individuals who can make the most
meaningful comments about the candidate\'s professional training and
qualifications for a research career should be used as referees. Where
possible, some referees who are not from the candidate\'s current
department or organization, but are knowledgeable about their
qualifications, should be selected.

Request reference letters only from individuals who are able to return
them to you in time for submission with the application.

Complete the upper section of the CDA Reference Guidelines Format Page
including the application submission deadline. Then send copies of the
CDA Reference Guidelines Format Page to those who have agreed to serve
as referees. Referees should be provided with postage-paid return
envelopes addressed to the candidate with the following words in the
front bottom left corner \"DO NOT OPEN PHS USE ONLY.\" **Attach unopened
envelopes to the Face Page of the original application and submit the
entire package by the submission deadline**. **Resubmission applications
must include a complete set of three reference letters.**

## 7.4 Basic Administrative Data

### 7.4.1 Form Page 1

Complete as directed in the previous [Section 4. Completing the PHS 398
Forms and Format Pages](#completing-the-phs-398-forms-and-format-pages),
except items 2, 3, and 6, which are to be completed in accordance with
the following instructions:

#### Item 2. Response to Specific Program Announcement (PA) or Request for Applications (RFA)

Check \"Yes.\" Provide appropriate K Award PA or RFA number ([see
previous section](#SummaryCDAMechs)) and title for the specific type of
CDA requested.

#### Item 3. Program Director/Principal Investigator (PD/PI)

Provide the name of the candidate who is the PD/PI. Indicate the
doctoral degree(s) in 3b. If the candidate is not located at the
applicant organization at the time the application is submitted, the
mailing and e-mail addresses (Item 3d) and telephone (Item 3g) should
indicate where the applicant can be reached prior to the requested award
date; items 3c, 3 e, and 3f should reflect the candidate\'s projected
position at the applicant organization. Multiple PD/PI applications are
not accepted for CDAs.

#### Item 6. Dates of Proposed Period of Support

The period of support must be within specified limits for the type of
CDA requested. If the application involves a change of applicant
organization for an active CDA awardee, indicate the time remaining in
the original award.

### 7.4.2 Description, Project/Performance Sites, Senior/key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells 

[FORM PAGE
2](http://grants.nih.gov/grants/funding/phs398/phs398.html#fp2)

#### Description: Project Summary and Relevance 

The first major component of the Description is a **Project Summary**.
Provide an abstract of the entire application. Include the candidate\'s
immediate and long-term career goals, research project and career
development plan, and the research environment.

The second component of the Description is **Relevance**. Using no more
than two or three sentences, describe the relevance of this research to
public health. In this section, be succinct and use plain language that
can be understood by a general, lay audience.

#### Project/Performance Site(s)

Indicate where the work described in the Research and Career Development
Plans will be conducted. If there is more than one Project/Performance
Site, list all the sites, including Department of Veterans Affairs (VA)
facilities and foreign sites.

If research involving human subjects is planned, whether at the grantee
institution or at a Project/Performance Site, the grantee is responsible
for safeguarding the rights and welfare of human subjects in
DHHS-supported research activities. The grantee must assure that
Project/Performance Sites comply with requirements set forth in the DHHS
regulations ([45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm)) to
protect human subjects and NIH policies that apply to clinical research
described in the PHS 398, Part II. For research involving vertebrate
animals, the applicant organization must ensure that all
Project/Performance Sites have an assurance approved by the NIH Office
of Laboratory Animal Welfare (OLAW).

#### Senior/key Personnel and Other Significant Contributors

**Note:** For the purposes of the CDA, the candidate is generally listed
as Senior/key Personnel, and all other individuals are listed as Other
Significant Contributors.

Name the candidate and, if applicable, the mentor(s), co-mentor(s),
consultants, advisory committee members (if applicable), and
contributors as Senior/key Personnel or as Other Significant
Contributors as described in [Section 4.2.3, and Section 4.2.4,
respectively](#seniorkey-personnel). Individuals identified as
Senior/key Personnel must devote measurable effort (described in person
months) to the proposed project whether or not salaries are requested.
Individuals who have committed to contribute to the scientific
development and execution of the project, but are not committing any
specified measurable effort to the proposed project should be identified
as Other Significant Contributors. Please note that for Mentored Career
Development Awards, Other Support Pages must be submitted for mentor(s)
and co-mentor(s) even though they are designated as other significant
contributors (see [Section 7.4.7](#Section_7_4_7) below).

For non-mentored CDAs, provide the name of the candidate\'s department
head or other senior staff member who is responsible for ensuring that
the candidate\'s time is protected for the expressed goals of the award.

#### Human Embryonic Stem Cells

If the Research Plan involves the use of human embryonic stem cells,
read and follow the instructions in [Section
4.2.5](#human-embryonic-stem-cells).

### 7.4.3 Table of Contents

[CDA SUBSTITUTE FORM PAGE
3](http://grants.nih.gov/grants/funding/phs398/phs398.html#cdafp3)

Use the **substitute** Table of Contents for CDAs.

***[Citizenship]{.underline}***

All applicants must provide information regarding citizenship at the
bottom of the substitute Table of Contents. For Career awards other than
the K99 program, the Candidate must be a citizen or non-citizen national
of the United States or its possessions and territories, or must have
been lawfully admitted to the United States for permanent residence by
the time of the award. The option of selecting "Non-citizen with
temporary visa" is applicable to K99 candidates only.

### 7.4.4 Detailed Budget for Initial Budget Period

[FORM PAGE
4](http://grants.nih.gov/grants/funding/phs398/phs398.html#fp4)

**Do not include Form Page 4 at the time of application unless it is
specifically requested in the FOA to which you are responding.** Should
Form Page 4 be requested prior to award, specific instructions will be
provided.

If you are submitting an application to an agency other than NIH, be
sure to read the instructions in the funding announcement to determine
whether the application should be submitted in the modular format; or
contact an appropriate official. (See [PHS Agency Contact
Table](#phs-agency-contacts).)

### 7.4.5 Budget for Entire Proposed Period of Support

[FORM PAGE
5](http://grants.nih.gov/grants/funding/phs398/phs398.html#fp5)

Do not fill in the budget table on Form Page 5. Provide only the total
direct costs requested for each year and total direct costs for the
entire proposed period of support. **Consult the relevant PA or RFA for
guidelines on allowable costs and budget limitations.** Begin the budget
justification in the space provided; use continuation pages as needed.

#### Budget Justification

List the name, role on project, and number of person months to be
devoted to the project (indicate academic, calendar, and/or summer) for
all project personnel (salaried or unsalaried) and provide a narrative
justification for each person based on his/her role on the project and
proposed level of effort.

All individual "K" awards require a minimum percent of full-time
professional effort to be devoted to the career development program
which is specified in each FOA. For information about "Determining
Full-Time Professional Effort for Career Awards" see NIH Notice,
[NOT-OD-04-056](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html)
released August 3, 2004.

Identify all consultants by name and organizational affiliation, and
describe the services to be performed.

Provide a narrative justification for any major budget items, other than
personnel, that are requested for the conduct of the project that would
be considered unusual for the scope of research. **No specific costs for
items** **or categories should be shown.**

### 7.4.6 Biographical Sketch 

[BIOGRAPHICAL SKETCH FORMAT
PAGE](http://grants.nih.gov/grants/funding/phs398/phs398.html#biosketch)

A biographical sketch **(limited to four pages for each person)** is
required for the candidate, mentor(s), co-mentor(s), and Senior/key
Personnel and Other Significant Contributors included on Form Page
2-continued. Biographical sketches for individuals other than the
candidate should follow the Biographical Sketch Format Page, and appear
in the order listed on Form Page 2-continued.

**The biographical sketch for the candidate should follow the
instructions below:**

#### Education 

Provide the month and year for each degree conferred. For non-degree
education, indicate the time period covered. List professional
certifications received within the last 10 years.

#### Research and/or Professional Experience 

Use the headings given below instead of the instructions on the
Biographical Sketch Format Page. Identify each heading.

**Employment**

Start with the first position held following the baccalaureate and give
a consecutive record to date. Indicate the department and organization,
department head or supervisor, rank, tenured or non-tenured, status
(full- or part-time), and inclusive dates. Where applicable, include
information on military service, internships, residencies, research
assistantships, fellowships, etc.

**Honors**

List academic and professional honors chronologically, including
research grants and fellowships awarded to the candidate.

**Professional Societies and Public Advisory Committees**

Identify professional societies and related organizations in which
membership has been held within the last 10 years, giving dates. Include
present membership on any Federal Government public advisory committee.

**Publications**

List all publications (chronologically), divided into the following
groups:

-   Original research and theoretical treatises;

-   Non-experimental articles, e.g., review of literature in field, book
    chapters, etc.;

-   Books, pamphlets, etc.

-   The list should include the title and complete references. If the
    list of publications cannot be accommodated within the four-page
    limit, select the most pertinent publications. If a copy of a
    publication is being submitted with the application, indicate with
    an asterisk and footnote \"copies sent.\" For Renewal applications
    (when applicable), also identify with a double asterisk and
    appropriately footnote all papers published during the previous
    period of support.

    When citing articles that fall under the Public Access Policy, were
    authored or co-authored by the applicant and arose from NIH support,
    provide the NIH Manuscript Submission reference number (e.g.,
    NIHMS97531) or the PubMed Central (PMC) reference number (e.g.,
    PMCID234567) for each article. If the PMCID is not yet available
    because the Journal submits articles directly to PMC on behalf of
    their authors, indicate \"PMC Journal - In Process.\" A list of
    these Journals is posted at:
    <http://publicaccess.nih.gov/submit_process_journals.htm>. Citations
    that are not covered by the Public Access Policy, but are publicly
    available in a free, online format may include URLs or PMCID numbers
    along with the full reference (note that copies of publicly
    available publications are not accepted as appendix material.)

### 7.4.7 Other Support Format Page

[OTHER SUPPORT FORMAT
PAGE](http://grants.nih.gov/grants/funding/phs398/phs398.html#othersupport)

**For mentored CDAs** (see [Summary of Award Mechanisms
table](#SummaryCDAMechs))**:** Submit modified Other Support Page(s)
(omitting details of scientific overlap and level of effort) for the
mentor(s) and co-mentor(s), but not for the candidate. Provide
information on the following selected items for the mentor's and
co-mentor's current and pending research support relevant to the
candidate's Research Plan.

#### Instructions for Selected Items

*Project Number*: If applicable, include a code or identifier for the
project.

*Source:* Identify the agency, institute, foundation, or other
organization that is providing the support.

*Major Goals:* Provide a brief statement of the overall objectives of
the project, subproject, or subcontract.

*Dates of Approved/Proposed Project*: Indicate the inclusive dates of
the project as approved/proposed. For example, in the case of NIH
support, provide the dates of the approved/proposed competitive segment.

*Annual Direct Costs:* In the case of an active project, provide the
current year's direct cost budget. For a pending project, provide the
proposed direct cost budget for the initial budget period.

Do not include information on overlap and level of effort.

**For non-mentored CDAs (e.g. K24):** Candidates for non-mentored CDAs
should not submit Other Support Pages at the time of application unless
specified to do so in the applicable FOA.

Updated information on all active support for the candidate, mentor(s),
co-mentor(s), and Senior/key Personnel may be requested by the awarding
component prior to award.

### 7.4.8 Resources

[RESOURCES FORMAT
PAGE](http://grants.nih.gov/grants/funding/phs398/phs398.html#resources)

For each Project/Performance Site listed on page 2, provide a detailed
description of the career development program related activities and
institutional resources available to you, following instructions on the
Resources Format Page. The information provided is of major importance
in establishing the feasibility of the goals of the career development
plan.

## 7.5 Career Development Plan

Use [CONTINUATION FORMAT
PAGES](http://grants.nih.gov/grants/funding/phs398/phs398.html#continuation)
to complete the sections below.

**Note: The total number of pages for Section 7.5.1 (The Candidate) and
Section 7.5.4 (Research Plan) combined may not exceed 25 pages.** In
many cases, CDA applications will be shorter than the limit.

### 7.5.1 The Candidate

Note: The total number of pages for Section 7.5.1 (The Candidate) and
items 2-5 of Section 7.5.4 (Research Plan: this Section) combined may
not exceed 25 pages. In many cases, CDA applications will be shorter
than the limit.

#### Candidate\'s Background

Use this section to provide any additional information not described in
the Biographical Sketch Format Page such as research and/or clinical
training experience.

#### Career Goals and Objectives: Scientific Biography

Describe your past scientific history, indicating how the award fits
into past and future research career development. If there are
consistent themes or issues that have guided previous work, these should
be made clear; if your work has changed direction, the reasons for the
change should be indicated. It is important to justify the award and how
it will enable you to develop or expand your research career. You may
include a timeline, including plans to apply for subsequent grant
support.

#### Career Development/Training Activities During Award Period

Stress the new enhanced research skills and knowledge you will acquire
as a result of the proposed award. If you have considerable research
experience in the same areas as the proposed research, reviewers may
determine that the application lacks potential to enhance your research
career. For mentored awards, describe structured activities, such as
course work or technique workshops, which are part of the developmental
plan. If course work is included, provide course numbers and descriptive
titles. Briefly discuss each of the activities, except research, in
which you expect to participate. Include a percentage of time
involvement for each activity by year, and explain how the activity is
related to the proposed research and the career development plan.

Note that recipients of mentored "K" awards may receive concurrent
support from an NIH research grant award or cooperative agreement only
under certain conditions (see NIH Notice
[NOT-OD-04-007](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html)
released November 14, 2003).

#### Training in the Responsible Conduct of Research

**All CDA applications must describe a plan to** **acquire training (or
provide training in the case of independent awards, e.g., K05, K24) in
the responsible conduct of research.** There are no specific curriculum
or formal requirements for this instruction; however, conflict of
interest, responsible authorship, policies for handling misconduct,
policies regarding the use of human and animal subjects, data
management, and data-sharing are areas that are strongly suggested for
consideration. Applicants may wish to consult the NIH web site
(<http://www.nih.gov/sigs/bioethics/researchethics.html>) for additional
guidance.

### 7.5.2 Statements by Mentor, Co-mentor(s), Consultant(s), and Contributor(s)

This section is to be completed by the mentor, co-mentor(s),
consultant(s), and contributor(s), as appropriate.

For mentored awards (see [Summary of Career Development Award Mechanisms
table](#SummaryCDAMechs)), the mentor must explain how they will
contribute to the development of the candidate\'s research career. This
explanation should include all of the following:

1\. The plan for the candidate\'s training and research career
development. This description must include not only research, but also
other developmental activities, such as seminars, scientific meetings,
training in the responsible conduct of research, and presentations. It
should discuss expectations for publications over the entire period of
the proposed project.

2\. The source of anticipated support for the candidate's research
project for each year of the award period.

3\. The nature and extent of supervision and mentoring of the candidate,
and commitment to the candidate\'s development that will occur during
the award period.

4\. The candidate\'s anticipated teaching load for the period of the
award (number and types of courses or seminars), clinical
responsibilities, committee and administrative assignments, and the
portion of time available for research.

5\. A plan for transitioning the candidate from the mentored stage of
his/her career to the independent investigator stage by the end of the
project period of the award. The mentor should describe previous
experience as a mentor, including type of mentoring (e.g., graduate
students, career development awardees, postdoctoral students), number of
persons mentored, and career outcomes.

All mentored career development applications should identify all
co-mentors, consultants and collaborators involved with the proposed
research and career development program. Briefly describe their roles
and anticipated contributions. A co-mentor must specifically address the
nature of his/her role in the career development plan and how the
responsibility for the candidate's development is shared with the
mentor. Describe respective areas of expertise and how they will be
combined to enhance the candidate's development. Also describe the
nature of any resources that will be committed to this CDA. Letters from
the mentor(s), co-mentor(s), consultant(s), advisory committee members
(if applicable), and contributor(s) documenting their role and
willingness to participate in the project must be included in this
section of the application. Do not place these letters in the Appendix.

**Non-mentored career development award applications** should list any
contributors or consultants. Briefly describe research materials, data,
guidance, or advice they will provide. Letters from consultant(s) and
contributor(s), documenting their willingness to participate in the
project and describing their roles, must be included in this section of
the application.

**Plan to Provide Mentoring, if required by FOA (e.g., K05, K24):** The
plan should provide information about the candidate's commitment to
serve as a mentor to other investigators, and describe previous
mentoring activities. The plan should describe the setting and provide
information about the available pool of mentees with appropriate
backgrounds and interests in the same field of science. It should also
include information on the candidate's past and proposed mentees
sufficient to evaluate the quality of prior mentoring experiences,
including the professional levels of mentees, and the frequency and
kinds of mentoring interactions between the candidate and the mentees.
Describe the productivity of the mentoring relationship for the
scientific development of the new scientists as judged by their
publications and current research activities. Senior level (K05)
candidates should describe any financial and material support from their
own funded research and research resources that will be available to
their mentees. The candidate's proposed percent effort commitment to the
mentoring plan should also be stated.

### 7.5.3 Environment and Institutional Commitment to the Candidate

#### Description of Institutional Environment

The sponsoring institution must document a strong, well-established
research program related to the candidate\'s area of interest, including
the names of key faculty members relevant to the candidate\'s proposed
developmental plan. Referring to the [resources](#Section_7_4_7)
description (Resources Format Page), indicate how the necessary
facilities and other resources will be made available for career
enhancement as well as the research proposed in this application.
Describe opportunities for intellectual interactions with other
investigators, including courses offered, journal clubs, seminars, and
presentations.

#### Institutional Commitment to the Candidate\'s Research Career Development

#### Introduction

The institution should provide a document on institutional letterhead
that describes its commitment to the candidate and the candidate's
career development, independent of the receipt of the CDA. The document
should include the institution's agreement to provide adequate time and
support for the candidate to devote the proposed protected time to
research and career development for the entire period of the proposed
award. The institution should provide the equipment, facilities, and
resources necessary for a structured research career development
experience. It is essential to document the institution\'s commitment to
the retention, development and advancement of the candidate during the
period of the award.

Because of the diverse types of K awards, applicants should contact the
appropriate awarding component Scientific/Research contact listed in the
specific PA or RFA to determine the level of commitment required for
this application.

#### Agreement

The applicant organization must:

a\. Agree to release the candidate from other duties and activities to
devote the required percentage of time for development of a research
career. For most K awards, commitment of at least 75 percent of time is
required. Describe actions that will be taken to ensure this; e.g.,
reduction of the candidate\'s teaching load, committee and
administrative assignments, and clinical or other professional
activities for the current academic year. (For example, describe the
actions that will be taken to compensate for the reduction in clinic
responsibilities of the candidate, e.g., hiring of additional staff).
Describe the candidate\'s academic appointment, bearing in mind that it
must be full-time, and that the appointment (including all rights and
privileges pertaining to full faculty status if in an academic setting)
and the continuation of salary should not be contingent upon the receipt
of this award. Describe the proportion of time currently available for
the candidate\'s research experience and what the candidate\'s
institutional responsibilities will be if an award is made.

b\. Provide the candidate with appropriate office and laboratory space,
equipment, and other resources and facilities (including access to
clinical and/or other research populations) to carry out the proposed
Research Plan.

c\. Provide appropriate time and support for any proposed mentor(s)
and/or other staff consistent with the career development plan.

#### Signatures

The institutional commitment must be dated and signed by the person who
is authorized to commit the institution to the agreements and assurances
listed above. In most cases, this will be the dean or the chairman of
the department. The signature must appear over the signer\'s name and
title at the end of the statement. If the candidate will be working away
from the home institution, signatures from both the home and the host
institution are required.

The sponsoring institution, through its signatures on the Face Page and
in the institutional commitment section, certifies that all items
outlined above will be provided and that the institution will abide by
the applicable assurances and PHS policies.

### 7.5.4 Research Plan

A Research Plan is required for all types of individual K awards. The
Research Plan is a major component of the research career development
plan. It is important to relate the research to the candidate\'s
scientific career goals. Describe how the research, coupled with other
developmental activities, will provide the experience, knowledge, and
skills necessary to achieve the objectives of the career development
plan and launch and conduct an independent research career, or enhance
an established research career. For mentored K awards, explain the
relationship between the candidate's research on the CDA and the
mentor's ongoing research program.

For most types of research, the plan should include: a specific
hypothesis; a list of the specific aims and objectives that will be used
to examine the hypothesis; a description of the
methods/approaches/techniques to be used in each aim; a discussion of
possible problems and how they will be managed; and, when appropriate,
alternative approaches that might be tried if the initial approaches do
not work.

The Research Plan should be appropriate for, and tailored to the
experience level of the candidate, and allow him/her to develop the
necessary skills needed for further career advancement. The plan should
be achievable within the requested time period. Pilot or preliminary
studies and routine data gathering are usually not appropriate for the
purposes of a CDA. Although candidates for mentored K awards are
expected to write the Research Plan, the mentor should review a draft of
the plan and discuss it in detail with the candidate. Review by other
knowledgeable colleagues is also helpful.

**Note: Follow the Research Plan format and instructions described in
[Section 5.5. Content of Research Plan](#content-of-research-plan)
except as noted below.**

**1. Introduction to Resubmission Application**

There *is no time limit for the submission of the first and second
resubmissions (A1 and A2). See NIH Notice*
[NOT-OD-07-015](http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-07-015.html)
for additional information/clarification of NIH policy.

Resubmission applications must include an Introduction to Resubmission
Application, not to exceed three pages. The Introduction must include
responses to the criticisms and issues raised in the Summary Statement.
Summarize the substantial additions, deletions, and changes. In the body
of the application, highlight paragraphs with significant changes by
bracketing and changing typography.

**2. Specific Aims**

**3. Background and Significance**

**4. Preliminary Studies/Progress Report**

**5. Research Design and Methods**

**Note: The total number of pages for Section 7.5.1 (The Candidate) and
items 2-5 of Section 7.5.4 (Research Plan: this Section) combined may
not exceed 25 pages. In many cases, CDA applications will be shorter
than the limit.**

Although it is understood that CDA applications do not require the
extensive detail usually incorporated into regular research
applications, a fundamentally sound Research Plan and a reasonably
detailed methods section should be provided.

In general, less detail will be expected in descriptions of research
planned for the future years of the proposed CDA. However, there should
be sufficient detail to enable the peer reviewers to determine that the
plans for those years, including the methods to be used, are appropriate
and are likely to enable the candidate to achieve the objectives of the
Research Plan.

**6. Inclusion Enrollment Report (Renewal Applications only)**

**7. Bibliography and References Cited/Progress Report Publication
List**

**8. Protection of Human Subjects**

**9. Inclusion of Women and Minorities**

**10. Targeted/Planned Enrollment Table**

**11. Inclusion of Children**

**12. Vertebrate Animals**

**13. Select Agents**

**14. Multiple PD/PI Leadership Plan (Not applicable to CDAs)**

**15. Consortium/Contractual Arrangements**

**16. Letters of Support/Consultants** (Not applicable to CDAs, see
[Part I, 7.5.2](#Section_7_4_7))

**17. Resource Sharing Plan(s)**

### 7.5.5 Checklist

[CHECKLIST FORM
PAGE](http://grants.nih.gov/grants/funding/phs398/phs398.html#checklist)

**Submit the Checklist Page with the application.**

#### Type of Application

Check all that apply.

#### Inventions and Patents (Renewal Applications Only) 

If no inventions were conceived or reduced to practice during the course
of work under this project, check "No." The remaining parts of the item
are then not applicable.

If any inventions were conceived or reduced to practice during the
previous period of support, check "Yes." Also indicate whether this
information has been reported previously to the PHS or to the applicant
organization official responsible for patent matters.

**Note:** NIH recipient organizations must promptly report inventions to
the Extramural Inventions and Technology Resources Branch of the Office
of Policy for Extramural Research Administration, OER, NIH, Bethesda, MD
20892-2750, (301) 435-1986. Invention reporting compliance according to
regulations at 37 CFR 401.14 is described at
[http://www.iedison.gov](http://www.iedison.gov/). The grantee is
encouraged to submit reports electronically using Interagency Edison
([http://www.iedison.gov](http://www.iedison.gov/)). See also
"[Inventions and Patents"](#Section_7_4_7) in the *Policies, Assurances
and Definitions and Other Information*.

#### [Program Income](#Definitions_ProgramIncome) 

If no program income is anticipated during the period(s) for which grant
support is requested, so state.

If program income is anticipated, use the format provided. If the
application is funded, the Notice of Award will provide specific
instructions regarding the use of such income.

#### [Assurances/Certifications](#assurances-and-certifications-1) 

Each application to the PHS requires that the policies, assurances, and
certifications listed on the Checklist be verified by the signature of
the official signing for the applicant organization on the Face Page of
the application.

#### Facilities and Administrative (F&A) Costs 

For career awards other than the R00 phase of the K99/R00, these costs
will be reimbursed at 8 percent of modified total direct costs.

### 7.5.6 Appendix

Follow the instructions in [Section 5.7](#appendix).

# 8. Instructions for Preparing an Institutional Research Training Application Including Ruth L. Kirschstein-NRSA Applications

**Sequential Guide for Preparing an Institutional Training Grant
Application\
Including Ruth L. Kirschstein-NRSA Applications** (Requires use of Part
I, Sections 4 and 8)

+---------------------------------------------------------+------------+
| web document links                                      | part i     |
+=========================================================+============+
| **Form Page 1**, Item 1. PHS 398 Instructions           | [4         |
|                                                         | .1](#item- |
|                                                         | 1.-title-o |
|                                                         | f-project) |
+---------------------------------------------------------+------------+
| **Form Page 1**, Item 2. Institutional Training Grant   | [          |
| Instructions and PHS 398 Instructions                   | 8.2](#comp |
|                                                         | lete-as-di |
|                                                         | rected-in- |
|                                                         | the-previo |
|                                                         | us-section |
|                                                         | -4-except- |
|                                                         | items-2-4- |
|                                                         | 5-and-6-wh |
|                                                         | ich-are-to |
|                                                         | -be-comple |
|                                                         | ted-in-acc |
|                                                         | ordance-wi |
|                                                         | th-the-fol |
|                                                         | lowing-ins |
|                                                         | tructions) |
|                                                         |            |
|                                                         | [4         |
|                                                         | .1](#item- |
|                                                         | 2.-respons |
|                                                         | e-to-speci |
|                                                         | fic-reques |
|                                                         | t-for-appl |
|                                                         | ications-r |
|                                                         | fa-or-prog |
|                                                         | ram-announ |
|                                                         | cement-pa) |
+---------------------------------------------------------+------------+
| **Form Page 1**, Item 3. PHS 398 Instructions           | [          |
|                                                         | 4.1](#item |
|                                                         | -3.-progra |
|                                                         | m-director |
|                                                         | sprincipal |
|                                                         | -investiga |
|                                                         | tors-pdpi) |
+---------------------------------------------------------+------------+
| **Form Page 1**, Item 4. Institutional Training Grant   | [          |
| Instructions                                            | 8.2](#item |
|                                                         | -4.-human- |
|                                                         | subjects-r |
|                                                         | esearch-1) |
+---------------------------------------------------------+------------+
| **Form Page 1**, Item 5. Institutional Training Grant   | [          |
| Instructions                                            | 8.2](#comp |
|                                                         | lete-as-di |
|                                                         | rected-in- |
|                                                         | the-previo |
|                                                         | us-section |
|                                                         | -4-except- |
|                                                         | items-2-4- |
|                                                         | 5-and-6-wh |
|                                                         | ich-are-to |
|                                                         | -be-comple |
|                                                         | ted-in-acc |
|                                                         | ordance-wi |
|                                                         | th-the-fol |
|                                                         | lowing-ins |
|                                                         | tructions) |
+---------------------------------------------------------+------------+
| **Form Page 1**, Item 6. Institutional Training Grant   | [          |
| Instructions and PHS 398 Instructions                   | 8.2](#item |
|                                                         | -4.-human- |
|                                                         | subjects-r |
|                                                         | esearch-1) |
|                                                         | and        |
|                                                         | [          |
|                                                         | 4.1](#item |
|                                                         | -6.-dates- |
|                                                         | of-propose |
|                                                         | d-period-o |
|                                                         | f-support) |
+---------------------------------------------------------+------------+
| **Form Page 1**, Item 7. PHS 398 Instructions           | [4.1](#    |
|                                                         | item-7.-co |
|                                                         | sts-reques |
|                                                         | ted-for-in |
|                                                         | itial-budg |
|                                                         | et-period) |
+---------------------------------------------------------+------------+
| **Form Page 2 and Institutional Training Substitute     | [          |
| Form Page 3:**\                                         | 8.3](#Sect |
| Institutional Training Grant Instructions (Form Page 2  | ion_7_4_7) |
| and\                                                    | and        |
| Substitute Form Page 3)                                 | [8.4](#    |
|                                                         | table-of-c |
|                                                         | ontents-1) |
+---------------------------------------------------------+------------+
| **Institutional Training Substitute Form Page 4:**\     | [          |
| Institutional Training Grant Instructions and Stipends  | 8.5](#deta |
|                                                         | iled-budge |
|                                                         | t-for-init |
|                                                         | ial-budget |
|                                                         | -period-2) |
+---------------------------------------------------------+------------+
| **Institutional Training Substitute Form Page 5:**\     | [8.6       |
| Institutional Training Grant Instructions               | ](#budget- |
|                                                         | for-entire |
|                                                         | -proposed- |
|                                                         | period-of- |
|                                                         | support-2) |
+---------------------------------------------------------+------------+
| **Biographical Sketch Format Page:** Institutional      | [8.7](#bi  |
| Training Grant Instructions                             | ographical |
|                                                         | -sketch-2) |
+---------------------------------------------------------+------------+
| **Resources Format Page:** Institutional Training Grant | [8.8](#re  |
| Instructions                                            | sources-2) |
+---------------------------------------------------------+------------+
| **Research Training Program Plan:** Institutional       | [8.9](#r   |
| Training Grant Instructions                             | esearch-tr |
|                                                         | aining-pro |
|                                                         | gram-plan) |
+---------------------------------------------------------+------------+

## 8.1. Introduction

This section includes instructions to be used when applying for
competing (New, Renewal, Resubmission or Revision) institutional
training grants, including both PHS Institutional Ruth L. Kirschstein
National Research Service Awards (Kirschstein-NRSA) and non-NRSA awards.
The contents include substitute form pages for the Table of Contents and
both budget pages, and instructions for the Research Training Program
Plan. Begin by reading the previous Sections 4 and 5, and then follow
both sets of instructions using the Sequential Guide for Preparing an
Institutional Training Grant Application (see table above).

Prior to preparing an application, review the Funding Opportunity
Announcement (FOA) to which you are responding and consult with the
appropriate [PHS awarding component](#phs-agency-contacts) identified in
the FOA. Current NIH-wide T32, T34 or T35 Kirschstein-NRSA Program
Announcements (PA) are available at
(<http://grants.nih.gov/training/nrsa.htm>). Note especially the
eligibility requirements, submission dates, award provisions, payback
provisions, and review criteria. PAs are also issued periodically by the
individual NIH Institutes or Centers in the [*NIH Guide for Grants and
Contracts*](http://grants.nih.gov/grants/guide). These training programs
may or may not be Kirschstein-NRSA award programs. Non-NRSA programs may
have different eligibility requirements, submission dates, award
provisions, and review criteria. This information is available from the
appropriate PHS agency, from grantee offices of sponsored programs, or
equivalent offices.

**Please note that for Kirschstein-NRSA programs that include
postdoctoral trainees, the Program Director must explain the terms of
the payback service requirement to all prospective postdoctoral training
candidates. A complete description of the service payback obligation is
available in the relevant NRSA Program Announcement or the** [NIH Grants
Policy
Statement](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm)**.**

## 8.2 Specific Instructions

### 8.2.1 Face Page 

#### Complete as directed in the previous Section 4, except items 2, 4, 5, and 6, which are to be completed in accordance with the following instructions:

#### Item 2. Response to Specific Request for Applications (RFA) or Program Announcement (PA)

Enter the specific FOA number and title, such as PA-06-468 \"Ruth L.
Kirschstein NRSA Institutional Research Training Grant."

#### Item 4. Human Subjects Research

Check "Yes" if training plans include or potentially will include
trainee participation in projects involving human subjects as defined by
45 CFR 46 (see Part III, Human Subjects Research Definitions and Terms,
and Part I, 4.1, Item 4 for additional guidance concerning the
involvement of human subjects). If training plans are not anticipated to
involve human subjects, check "No" and leave the remaining items 4a-4d
blank. If plans for research involving human subjects are indefinite at
the time of application, check \"yes\" and provide an explanation in the
Research Training Program Plan at 8.9.7.

**4a.** If human subjects will be involved, but the proposed research
meets the criteria for one or more exempt categories described in the
DHHS regulations for the protection of human subjects (45 CFR 46); check
\"yes\" and enter the exemption number(s) corresponding to one or more
of the six exemption categories listed in Part III.3 under Human
Subjects Research Definitions and Terms (See [Exemption
Categories](#Human_Subjects_Exemption_Cat)). Check \"no\" if activities
will, or potentially will, involve human subjects and are *not*
anticipated to meet the criteria for research that is exempt from
regulatory requirements, and complete the remaining parts of Item 4.

The institution must ensure that trainees who will be involved in the
design or conduct of research involving human subjects receive training
in human subjects protections. It is the institution's responsibility to
ensure that trainees are properly supervised when working with human
subjects.

**4b.** If the applicant organization has a current approved Federal
Wide Assurance (FWA) on file with the Office for Human Research
Protections (OHRP), enter the number in Item 4b. Enter \"none\" if the
applicant organization does not have an approved assurance on file with
OHRP. Do not enter the FWA number of any institution other than the
applicant organization.

In many instances, trainees supported by institutional training grants
will be participating in research supported by research project grants
for which the IRB approval or a determination of exemption exists.
Existing IRB approval is sufficient for trainees, provided that the IRB
determines the research would not be substantially modified by the
participation of a trainee. The appropriate grants must be identified
along with their IRB approval dates or exemption designation in Section
8.9.7 of the Research Training Program Plan.

If an award is made and the research is not exempt from requirements
stipulated in 45 CFR 46, and trainees will participate in research for
which IRB review and approval does not otherwise exist, human subjects
may **not** be involved and trainees may **not** participate in research
involving human subjects unless the engaged institution has an approved
FWA on file with OHRP, certification of the date of IRB approval has
been submitted to and accepted by the PHS agency, and NIH requirements
for human subjects protections have been addressed (see instructions in
[Part II, Preparing the Protection of Human Subjects Section of the
Research Plan](#Section_7_4_7), and in the Research Training Program
Plan at 8.9.7).

**4c.** If training plans include, or potentially will include, trainee
participation in a project defined as a Clinical Trial, answer "Yes" to
question 4c.

**4d.** If training plans include or potentially will include trainee
participation in projects that are NIH-Defined Phase III Clinical
Trials, answer "Yes" to question 4d.

Inclusion and Population Tracking reporting requirements do not apply to
training grants.

These policies apply to all Project/Performance Sites.

#### Item 5. Vertebrate Animals 

Check "Yes" if training plans include or potentially will include
trainees in projects involving the use of live vertebrate animals at any
time during the proposed project period, either at the applicant
organization or at any other training site or collaborating institution.
If training plans are not anticipated to involve vertebrate animals,
check \"No\" and leave item 5a blank. Note that generation of custom
antibodies constitutes an activity involving vertebrate animals. If
plans to include trainees in vertebrate animal activities are indefinite
at the time of application, check "Yes," provide an explanation in the
Research Training Program Plan at Section 8.9.8, and indicate when it is
anticipated that animals will be used.

The institution must ensure that trainees are enrolled in the
institution's animal welfare training and occupational health and safety
programs for personnel who will have contact with animals. It is the
institution's responsibility to ensure that trainees are properly
supervised when working with live vertebrate animals.

These policies apply to all training sites.

**5a.** If the applicant organization has a current approved Animal
Welfare Assurance (Assurance) on file with the Office of Laboratory
Animal Welfare (OLAW), enter the number in Item 5a. Contact the IACUC to
determine whether the organization currently has an approved Assurance.
Alternatively, this information may be obtained at the following
website: <http://grants.nih.gov/grants/olaw/olaw.htm#assur>. Enter
"none" if the applicant organization does not have an approved Assurance
on file with OLAW. Do not enter the Assurance number of any institution
other than the applicant organization. Submission of the application
constitutes declaration that the applicant organization will comply with
the [PHS Policy on Humane Care and Use of Laboratory
Animals](http://grants.nih.gov/grants/olaw/references/phspol.htm) by
submitting an Assurance when request by OLAW and providing verification
of IACUC approval when requested by the PHS awarding component.

In many instances, trainees supported by institutional training grants
will be participating in research supported by research project grants
for which the IACUC review and approval exists. This existing IACUC
approval is sufficient for trainees, provided that the research would
not be substantially modified by the participation of a trainee. The
appropriate grants must be identified along with their IACUC approval
dates in Section 8.9.8 of the Research Training Program Plan.

If an award is made and trainees will participate in research for which
IAUC approval does not otherwise exist, vertebrate animals may **not**
be involved and trainees may **not** participate in research utilizing
vertebrate animals unless the institution has an approved Assurance on
file with OLAW, certification of the date of IACUC approval has been
submitted to and accepted by the PHS agency, and NIH requirements for
the use of vertebrate animals have been addressed (see instructions at
5.5 item 12).

#### Item 6. Dates of Entire Proposed Period of Support 

The usual starting date for an institutional Kirschstein-NRSA is July 1,
but there are other possible starting dates. Consult the webpage of
Standard Due Dates for Competing Applications
(<http://grants.nih.gov/grants/funding/submissionschedule.htm>). Many
PHS awarding components restrict submission and review dates to once a
year. Applicants are strongly encouraged to contact the appropriate
awarding component staff before submitting an application.

## 8.3 Description, Project/Performance Sites, Senior/key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells 

[FORM PAGE
2](http://grants.nih.gov/grants/funding/phs398/phs398.html#fp2)

#### Description: Project Summary and Relevance

The first and major component of the Description is a **Project
Summary**. Summarize the objectives, rationale and design of the
research training program. Provide information regarding the research
areas and scientific disciplines encompassed by the program. Include a
brief description of the level(s) and duration of the proposed training,
the projected number of participating trainees and their anticipated
levels of experience.

The second component of the Description is **Relevance**. Using no more
than two or three sentences, describe the relevance of this research to
public health. In this section, be succinct and use plain language that
can be understood by a general, lay audience.

**Project/Performance Sites.**

List all of the locations where training, program management, and the
research experiences described in the Research Training Program Plan
(8.9) will be performed. If a Project/Performance Site will be engaged
in research involving human subjects, it is the responsibility of the
applicant organization to assure that all Project/Performance Sites
comply with the human subject protection regulations in [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm) and NIH
policies for the protection of human subjects. For research involving
live vertebrate animals, the applicant organization must supply
information for all training sites where animals will be used by
trainees. The applicant organization is responsible for assuring that
all Project/Performance Sites have a current Animal Welfare Assurance
and comply with the PHS Policy on Humane Care and Use of Laboratory
Animals.

**Senior/key Personnel and Other Significant Contributors.**

The Program Director, training faculty and any other individuals whose
contributions are critical to the development, management and execution
of the Research Training Program Plan in a substantive, measurable way
(whether or not salaries are reimbursed) should be identified as
Senior/key Personnel. Since these efforts are not project related
research endeavors, they should not be identified in Other Support
information. The Other Significant Contributors section is not relevant
for institutional training grant and NRSA applications.

**Human Embryonic Stem Cells (HESC).** For each trainee utilizing HESC
in a research project, list project title, mentor, and specific cell
line(s) from the
[registry](http://stemcells.nih.gov/research/registry/).

## 8.4 Table of Contents

[INSTITUTIONAL TRAINING GRANT SUBSTITUTE FORM PAGE
3](http://grants.nih.gov/grants/funding/phs398/phs398.html#nrsafp3)

Use the substitute Table of Contents for all Kirschstein-NRSA training
grant applications. See instructions in the FOA to which you are
responding for which form to use for non-NRSA applications.

Provide the page number for each category listed on the Table of
Contents. Place page numbers at the bottom of each page, and
consecutively number pages throughout the application. Do not include
unnumbered pages, and do not use suffixes, such as 5a, 5b.

## 8.5 Detailed Budget for Initial Budget Period

[INSTITUTIONAL TRAINING GRANT SUBSTITUTE FORM PAGE
4](http://grants.nih.gov/grants/funding/phs398/phs398.html#nrsafp4)

If you are requesting a budget of \$500,000 directs costs or more for
any year, contact the awarding component to determine whether you must
obtain prior approval before submitting the application. (See [Policy on
the Acceptance for Review of Unsolicited Applications That Request
\$500,000 or More in Direct
Costs.](#policy-on-the-acceptance-for-review-of-unsolicited-applications-that-request-500000-or-more-in-direct-costs))

Complete the Institutional Training Grant Substitute Form Page 4
following the instructions below. Refer to the relevant PA or consult
the PHS awarding component for current allowable costs and stipend
levels. Additional details will be provided on Institutional Training
Grant Substitute Form Page 5. For non-NRSA training grant programs refer
to the FOA for instructions regarding which Budget Form pages to use and
how to complete them.

**Stipends**

Enter the number of trainees and total stipend amount for each trainee
category as appropriate. For Kirschstein-NRSA applications, use the
current Institutional [Kirschstein-NRSA Stipends
Notice](http://grants.nih.gov/training/nrsa.htm), published in the NIH
Guide and listed under NRSA Policy Issues at
<http://grants.nih.gov/training/nrsa.htm>. If a category contains
different stipend levels, e.g., for varying levels of postdoctoral
experience and/or varying appointment periods, itemize. Enter the total
stipends for all categories In the Dollar Total column.

**Tuition and Fees**

Institutions are referred to the policy for funding of tuition, fees,
and health insurance,
[NOT-OD-06-093](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html).
Note that health insurance is not included as part of this budget
category. See the Training Related Expenses category below.

Explain, in detail, the composition of tuition and fees and itemize them
individually. If tuition varies, (e.g., in-state, out-of-state, student
status) identify these separately. Tuition at the postdoctoral level is
limited to that required for specified courses. Tuition and fees may be
requested only to the extent that the same resident or nonresident
tuition and fees are charged to non-Federally supported students and
postdoctorate fellows. Applicants should request full needs. Enter the
total requested in the Dollar Total Column. A formula will be applied by
the NIH awarding component at the time an award is calculated.

**Trainee Travel**

State the purpose of any travel, giving the number of trips involved,
the destinations, and the number of trainees for whom funds are
requested. PHS policy requires coach class air travel be used. Justify
foreign travel in detail, describing its importance to the training
experience. Enter the total requested in the Dollar Total Column.

**Training Related Expenses (including Health Insurance)**

Funds to defray other costs of training, such as health insurance
(self-only or family), staff salaries, consultant costs, equipment,
research supplies, staff travel, etc., are requested as a lump sum based
on the amounts for each predoctoral and postdoctoral trainee specified
in the relevant FOA. Enter the number of positions requested
(predoctoral, postdoctoral, short-term), multiply each by the relevant
Training Related Expenses level in the [NRSA Stipends
Notice](http://grants.nih.gov/training/nrsa.htm#policy), and enter the
sum under Dollar Total.

Health insurance (self-only or family, as applicable) is an allowable
expense that may be charged to the Training Related Expenses budget
category but only to the extent that the same health insurance fees are
charged to non-Federally-supported students and postdoctoral fellows.
See
[NOT-OD-06-093](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html)
for details.

No further itemization or explanation of the Training Related Expenses
budget category is required.

The awarding Institute/Center will apply the Training Related Expenses
level established in the [NRSA Stipends
Notice](http://grants.nih.gov/training/nrsa.htm#policy) for the relevant
fiscal year at the time of award.

## 8.6 Budget for Entire Proposed Period of Support

[INSTITUTIONAL TRAINING GRANT SUBSTITUTE FORM PAGE
5](http://grants.nih.gov/grants/funding/phs398/phs398.html#nrsafp5)

Use the Institutional Training Grant Substitute Form Page 5.

## 8.7 Biographical Sketch

[BIOGRAPHICAL SKETCH FORMAT
PAGE](http://grants.nih.gov/grants/funding/phs398/phs398.html#biosketch)

There is no Form Page for biographical sketches. Follow the format on
the Biographical Sketch Format Page. Include biographical sketches, not
to exceed four pages each, for the Program Director and Other Senior/key
Personnel contributing to the training program. Assemble sketches with
the Program Director first and others following in alphabetical order.
See instructions in 4.6. Biographical sketches for mentors will be
provided in 8.9.13 below.

The Program Director must be registered in the eRA Commons and must
include the assigned Commons User ID.

## 8.8 Resources

[RESOURCES FORMAT
PAGE](http://grants.nih.gov/grants/funding/phs398/phs398.html#resources)

Follow the format and instructions on the Resources Format Page.
Describe the facilities and resources that will be used in the proposed
training program. Indicate in what ways the applicant organization will
support the program (e.g., supplementation of stipends, protected time
for mentoring, support for student activities).

## 8.9 Research Training Program Plan

**Before preparing the training plan, be sure to check the specific
instructions in the Funding Opportunity Announcement (FOA) to which you
are responding. Contact the appropriate PHS awarding component, which
may have further advice or suggestions on completing your application,
including the data tables mentioned below.**

Note that there are page limits for certain sections. Sections
8.9.2-8.9.5, collectively, may **not** exceed 25 pages. Sections
8.9.6-8.9.15 are not part of the 25 page limitation. The information
provided in required data tables (see below) will not be counted toward
the page limitation. These tables should be numbered consecutively and
titled as shown, even if some are not required by the PHS awarding
component to which you are applying or in the FOA to which you are
responding. Indicate by table number and title, those tables that are
intentionally omitted. Additional tables that are not required may be
included in the Research Training Program Plan, however, these tables
will count as part of the 25 page limit. Additional tables not specified
in these instructions should be identified by letter, rather than number
to avoid confusion with the sequentially numbered required tables.

The instructions for Data Tables 1-12 are located on the OER website at
[http://grants.nih.gov/
grants/funding/phs398/phs398.html#DataTableInstruct](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTableInstruct).
Please read the [Introduction to the Data Tables](#data-tables) in
Section 8.9.14 before beginning to prepare your application. This
section includes important definitions that should be used consistently
both in the Data Tables and in all other parts of the application. The
tables described in Section 8.9.14 should be included in the application
at the point indicated and should not be inserted in the narrative for
Sections 8.9.2-8.9.5.

### 8.9.1 Introduction (Resubmission or Revision Applications Only)

If you are preparing a Resubmission or Revision application, prepare an
Introduction section. The Introduction may not exceed three pages for
Resubmission applications or one page for Revision applications. See
specific instructions in Section 2.7 Resubmission Applications and 2.8
Revision Applications concerning the content of the Introduction.

### 8.9.2 Background

Provide the rationale for the proposed research training program,
relevant background history, and the need for the research training
proposed. Indicate how the proposed program relates to current training
activities at the applicant institution.

Summarize the research training activities of the major participating
unit(s) and department(s) represented in the proposed program. Complete
and refer to the data reported in Tables 1-3:

[Table
1](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable1).
Membership of Participating Departments/Programs

[Table
2](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable2).
Participating Faculty Members

[Table
3](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable3).
Institutional Training Grant Support Available to Participating Faculty
Members, Departments, or Programs

Use this data to document the environment in which the proposed training
program will take place.

### 8.9.3 Program Plan

**a. Program Administration**. Describe the Program Director\'s
qualifications for providing leadership of the program, including
relevant scientific background, current research areas, and experience
in research training. Indicate the Program Director\'s percent effort in
the proposed program.

Describe the administrative structure of the program and the
distribution of responsibilities within it, including the means by which
the program director will obtain continuing advice with respect to the
operation of the program.

Multiple Program Directors may be proposed **only** if the FOA to which
you are responding indicates that multi-PD applications will be
accepted. If multi-PDs are proposed, explain in this section your
rationale for how this will facilitate program administration. In
addition, you must complete Section 8.9.11 Multiple-PD Leadership Plan.

**b. Program Faculty**. Refer to the data presented in [Table 2.
Participating Faculty
Members](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable2)
and elaborate as necessary to describe each faculty member\'s research
that is relevant to the program and indicate how trainees will
participate in the research. Describe the extent to which participating
faculty members cooperated, interacted, and collaborated in the past,
including joint publications and joint sponsorship of student research.
Complete and refer to data in Tables 4-6:

[Table
4](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable4).
Grant and Contract Support of the Participating Faculty Members

[Table
5](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable5).
Pre and Postdoctoral Trainees of Participating Faculty Members

[Table
6](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable6)
Publications of Research Completed by Trainees (or Potential Trainees)

Use these tables to document the ability of the faculty to support the
research activities of the proposed trainees, the training record of the
faculty members, and the success of their trainees in generating
publishable research results.

For new applications, see the instructions for Table 6 in Section 8.9.14
and list publications for trainees who are representative of those who
would be appointed if the grant is awarded. For Renewal applications,
this data constitutes part of the Progress Report (see Section 8.9.6
Progress Report below).

**c. Proposed Training**. Describe the proposed training program. State
the training level and number of trainees. For postdoctoral trainees,
indicate the proposed distribution by degree (e.g., M.D., Ph.D.).
Describe course work and research opportunities, the extent to which
trainees will participate directly in research, and the duration of
training, i.e., usual period of time required to complete the training
offered.

Indicate how the individual disciplinary and/or departmental components
of the program are integrated and coordinated and how they will relate
to an individual trainee\'s experience.

For training programs that emphasize research training for clinicians,
describe the interactions with basic science departments and scientists.
Include plans for ensuring that the training of these individuals will
provide a substantive foundation for a competitive research career.
Generally, a minimum of 2 years of research training is required for all
postdoctoral trainees with health professional degrees. Describe fully
any trainee's access to and responsibility for patients, including time
commitment.

Provide representative examples of programs for individual trainees.
Include curricula, degree requirements, didactic courses, laboratory
experiences, qualifying examinations, and other training activities,
such as seminars, journal clubs, etc. Describe how the preceptor and
research problems are chosen, how each trainee\'s program will be
guided, and how the trainee\'s performance will be monitored and
evaluated. Include detailed mentoring plans as appropriate.

**d. Training Program Evaluation.** Program directors are encouraged to
develop methods for ongoing evaluation of the quality of the training
program. Describe any plans for such an evaluation, e.g., plans to
obtain feedback from current and former trainees to help identify
weaknesses in the training program and to provide suggestions for
program improvements.

**e. Trainee Candidates**. Describe recruitment plans, including the
sources and availability of trainees; the qualifications of prospective
trainees; and the criteria and procedures by which trainees will be
selected.

#### Admissions and Completion Records

For programs that request only predoctoral trainee support, complete
[Table
7A](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable7a).
Admissions and Completion Records for the Participating Departments and
Programs During the Past Five Years (Predoctoral Applicants).

For programs that request only postdoctoral trainee support, complete
[Table
7B](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable7b).
Admissions and Completion Records for the Participating Departments and
Programs During the Past Five Years (Postdoctoral Applicants).

Programs requesting support for both predoctoral and postdoctoral
trainees need to complete both [Table
7A](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable7a)
and [Table
7B](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable7b).

Use these tables to document the ability of the participating
departments/programs to recruit and retain predoctoral and/or
postdoctoral trainees through the completion of their training, the
selectivity of the admissions process, the success of the
departments/programs in recruitment and retention of trainees from
diverse backgrounds, and to defend the requested number of training
positions to be awarded.

#### Qualifications of Applicants

For programs that request only predoctoral trainee support, complete
[Table
8A](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable8a).
Qualifications of Recent Predoctoral Applicants.

For programs that request only postdoctoral trainee support, complete
[Table
8B](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable8b).
Qualifications of Recent Postdoctoral Applicants.

Programs requesting support for both predoctoral and postdoctoral
trainees need to complete both [Table
8A](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable8a)
and [Table
8B](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable8b).

Use these tables to document the quality and depth of the applicant
pools, including both Kirschstein-NRSA training grant eligible and
non-Kirschstein-NRSA eligible applicants; the selectivity of the
admissions process; the competitiveness of the program; and to justify
the number of number of training positions requested.

#### Current Trainee Qualifications

For programs that request only predoctoral trainee support, complete
[Table
9A](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable9a).
Qualifications of the Current Predoctoral Trainees Clearly Associated
with the Training Program.

For programs that request only postdoctoral trainee support, complete
[Table
9B](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable9b).
Qualifications of the Current Postdoctoral Trainees Clearly Associated
with the Training Program.

Programs that request both predoctoral and postdoctoral trainee support
need to complete both [Table
9A](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable9a)
and [Table
9B](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable9b).

Use these tables to document the number and quality of all trainees
currently enrolled in the program, and their distribution by department
and mentor; the selectivity of enrollment appointments to the training
grant over the time period represented by the current program
participants; and to defend the number of training positions to be
awarded.

### 8.9.4 Recruitment and Retention Plan to Enhance Diversity 

The NIH recognizes a unique and compelling need to promote diversity in
the biomedical, behavioral, clinical and social sciences workforce. The
NIH expects efforts to diversify the workforce to lead to the
recruitment of the most talented researchers from all groups; to improve
the quality of the educational and training environment; to balance and
broaden the perspective in setting research priorities; to improve the
ability to recruit subjects from diverse backgrounds into clinical
research protocols; and to improve the Nation's capacity to address and
eliminate health disparities.

Accordingly the NIH continues to encourage institutions to diversify
their student and faculty populations and thus to increase the
participation of individuals currently underrepresented in the
biomedical, clinical, behavioral, and social sciences such as:
individuals from underrepresented racial and ethnic groups, individuals
with disabilities, and individuals from socially, culturally,
economically, or educationally disadvantaged backgrounds that have
inhibited their ability to pursue a career in health-related research.
Institutions are encouraged to identify candidates who will increase
diversity on a national or institutional basis.

**Definition of Diversity Recruitment Groups**

The NIH is particularly interested in encouraging the recruitment and
retention of the following classes of candidates:

A. Individuals from racial and ethnic groups that have been shown by the
National Science Foundation to be underrepresented in health-related
sciences on a national basis (see data at
<http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27> and the
report Women, Minorities, and Persons with Disabilities in Science and
Engineering, 2007, p. 262). The following racial and ethnic groups have
been shown to be underrepresented in biomedical research: African
Americans, Hispanic Americas, Native Americans, Alaskan Natives,
Hawaiian Natives, and natives of the US Pacific Islands. In addition, it
is recognized that under-representation can vary from setting to setting
and individuals from racial or ethnic groups that can be convincingly
demonstrated to be underrepresented by the grantee institution should be
included in the recruitment and retention plan.

B. Individuals with disabilities, who are defined as those with a
physical or mental impairment that substantially limits one or more
major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1\. Individuals who come from a family with an annual income below
established low-income thresholds. These thresholds are based on family
size, published by the U.S. Bureau of the Census; adjusted annually for
changes in the Consumer Price Index; and adjusted by the Secretary for
use in all health professions programs. The Secretary periodically
publishes these income levels at
<http://aspe.hhs.gov/poverty/index.shtml>. For individuals from low
income backgrounds, the institution must be able to demonstrate that
such candidates (a) have qualified for Federal disadvantaged assistance;
or (b) have received any of the following student loans: Health
Professional Student Loans (HPSL), Loans for Disadvantaged Student
Program; or have received scholarships from the U.S. Department of
Health and Human Services under the Scholarship for Individuals with
Exceptional Financial Need.

2\. Individuals who come from a social, cultural, or educational
environment such as that found in certain rural or inner-city
environments that have demonstrably and recently directly inhibited the
individual from obtaining the knowledge, skills, and abilities necessary
to develop and participate in a research career. Recruitment and
retention plans related to a disadvantaged background are most
applicable to high school and perhaps undergraduate candidates, but
would be more difficult to justify for individuals beyond that level of
achievement.

**New applications** must include a description of plans to enhance
recruitment of a diverse trainee pool and may wish to include data in
support of past accomplishments. **Renewal applications** must include a
detailed account of experiences in recruiting individuals from
underrepresented groups during the previous funding period. Information
should be included on both successful and unsuccessful recruitment
strategies.

**History and Achievements.** Describe efforts to recruit trainees from
Diversity groups A, B, and C into the existing training program. For
competing continuation/renewal applications, also describe past efforts
to recruit and retain underrepresented minority students into training
grant funded positions. Refer to the data presented in [Table
1](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable1)
and [Tables
7A](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable7a)
and [Table
7B](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable7b)
that provided statistics on applications and admissions of these groups
in comparison to the overall trainee pool.

For Renewal applications, complete [Table
10](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable10)
Admissions and Completion Records for Underrepresented Minority (URM),
Trainees with Disabilities, and Trainees from Disadvantaged Backgrounds
Clearly Associated with the Training Program. New applicants may provide
this data if they wish; however, it is not required of new applicants.

Use this data to document the success of the program in recruiting and
retaining trainees who are under-represented minorities, provide
analysis of their support, and begin to establish a record of NIH
training of other Diversity Recruitment groups.

**Proposed plans.** Describe steps to be taken during the proposed award
period regarding the identification, recruitment, and retention of
graduate students and postdoctorates from underrepresented groups.
Consider the success and/or failures of recruitment strategies used in
the past. In particular, describe the specific efforts to be undertaken
by the training program and how these might relate to the recruitment
efforts of the medical school, graduate school, and/or the university at
large. In most cases, institutional efforts alone will not satisfy the
requirement to recruit individuals from underrepresented groups.

Applications without a description of diversity recruitment efforts will
be considered incomplete and may be delayed in the peer review process.

### 8.9.5 Plan for Instruction in the Responsible Conduct of Research

Every trainee **must** receive instruction in the responsible conduct of
research. Describe a plan to provide trainees with formal and informal
instruction on scientific integrity and ethical principles in research.
The plan must address the rationale for the instruction, the format and
subject matter, the degree of faculty participation, trainee attendance,
plans to assess the quality and the frequency of instruction. For
Renewal applications, describe the type of instruction provided in the
current project period, the degree of student participation, the results
of any assessments and other relevant information.

There are no specific curriculum or format requirements for this
instruction; however, it is strongly suggested that the instruction
include: conflict of interest, responsible authorship and publication,
peer review, policies for handling misconduct, policies regarding human
subjects and live vertebrate animal subjects in research, data
management, data-sharing, collaborative research and mentor-mentee
relationships. Applicants may wish to consult the NIH web site at
<http://grants.nih.gov/training/responsibleconduct.htm> and
[http://www.nih.gov/sigs/
bioethics/researchethics.html](http://www.nih.gov/sigs/bioethics/researchethics.html)
for additional guidance.

Applications lacking a plan for instruction in the responsible conduct
of research will be considered incomplete and will be returned to the
applicant without review.

Trainees who will participate in research involving human subjects must
meet the NIH policy requirement for education in human subjects
protections
(<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html>).
Trainees participating in research with live vertebrate animals must
also be enrolled in the institutional animal welfare training program
for personnel who have contact with animals. The requirements for
specific human subjects education and participation in the institutional
animal welfare training program may be included as elements of required
training in the Responsible Conduct of Research.

### 8.9.6 Progress Report (Renewal Applications Only)

State the period covered and briefly describe the accomplishments of the
training program. Describe any specific effects of this training program
on curriculum and/or research directions. Describe how the funds
provided under Training Related Expenses were used to benefit the
program. For each trainee supported during the period covered, indicate
their preceptor/mentor, and briefly summarize the research conducted by
the trainee. For previous trainees appointed to the training grant and
continuing in training, provide a brief statement of their status and
progress toward completion of their training program. Refer to data
presented in [Table
6](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable6)
Publications of Research Completed by Trainees (or Potential Trainees)
and include in the table publications of trainees through the time that
they complete their training for all trainees currently or previously
supported by the training grant program regardless of whether support
from this training grant is cited in the publication.

Complete [Table
11](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable11)
Appointments to the Training Grant For Each Year of the Past Award
(Renewal Applications Only).

Use this table to document the utilization of awarded training
positions. If any trainee positions were not filled, provide an
explanation.

For programs that request only predoctoral trainee support, complete
[Table
12A](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable12a)
Predoctoral Trainees Supported by this Training Grant (Renewal
Applications Only).

For programs that request only postdoctoral trainee support, complete
[Table
12B](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable12b)
Postdoctoral Trainees Supported by this Training Grant (Renewal
Applications Only).

Programs requesting support (or reporting on prior support) for both
predoctoral and postdoctoral trainees need to complete both [Table
12A](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable12a)
and [Table
12B](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTable12b).

Use these tables to document how predoctoral training positions are used
(i.e., distribution by mentor, year in program, years of support per
trainee) and the success of the program in achieving the training
objectives of the prior award period(s) for up to 10 years. Summarize
this data in the text.

If any postdoctoral trainee with a health professional degree appointed
to the grant during the most recent award period received less than 2
years of research training, explain why. Where possible for past
trainees, describe the extent of their current involvement in research,
including research grant support and representative recent publications.
Use the progress report narrative to provide information that is not
readily presented in the required tables.

### 8.9.7 Human Subjects

If trainee participation in research involving human subjects is solely
as part of other research projects that have received or will receive
IRB review and approval, and no portion of the Training Grant Award will
be used to support this research; provide a list of previously approved
research projects (grant number, PD/PI, and project title) and their IRB
approval dates or exemption designations. If plans are indefinite
provide an explanation and prior to trainee participation in other
research project grants, provide a list as indicated.

If the training program involves definite plans for the participation of
human subjects as defined in Part III.3, Human Subjects Research
Definitions and Terms, outside of research projects that have received
or will receive IRB review, follow the instructions in [Part II,
Supplemental Instructions for Preparing the Protection of Human Subjects
Section of the Research Plan](#Human_Subjects_PartII).

### 8.9.8 Vertebrate Animals

If the training program involves the use of live vertebrate animals
solely as part of other research project grants, and no portion of the
Training Grant Award will be used to support the purchase, use, or
husbandry of live vertebrate animals in this research; provide a list of
previously approved research projects (grant number, PD/PI, and project
title) and IACUC approval dates. If plans are indefinite provide an
explanation and prior to trainee participation in other research project
grants, provide a list as indicated.

If the training program involves definite plans to use live vertebrate
animals outside of research projects that have received or will receive
IACUC approval, follow the instructions in Part I, 5.5, Item 12.
[Vertebrate Animals](#vertebrate-animals).

### 8.9.9 Select Agent Research

If participating faculty proposed in the training program are conducting
or plan to conduct research involving select agents in which trainees
*may* participate, follow the instructions in Section 5.5, Item 13.
[Select Agents](#select-agent-research).

### 8.9.10 Literature Cited

Follow the instructions in Section 5.5, Item 7a, [Bibliography and
References
Cited](#bibliography-and-references-citedprogress-report-publication-list).
Include here references to literature cited in the Research Training
Plan, such as articles and reviews dealing with the scientific area of
training, pedagogical concepts, or evaluation methods. Do not include
here publications of the faculty or trainees that are not otherwise
cited in the text. These should be reported in the requested Data
Tables.

### 8.9.11 Multiple PD Leadership Plan

If the specific FOA to which you are responding indicates that
multi-Program Director applications will be accepted, and you wish to
submit a multi-PD application, you must provide a Leadership Plan. Refer
to the instructions in Section 5.5, item 14. Multiple PD/PI Leadership
Plan. However, the emphasis in a training grant multiple PD leadership
plan should be on how it will benefit the program and the trainees. A
single Contact PD must be designated for the purpose of communicating
with the NIH, although other individuals may contact the NIH on behalf
of the Contact PD when necessary. Because training programs are intended
to be coherent, NIH will not allocate the budget or training positions
between multiple PDs. A single award will be made. Multiple PD plans
should include reasonable numbers of PDs and each should be included for
a specific purpose. Multiple-PD applications should **not** include all
mentors of the training grant as PDs, except in unusual cases.

For background information on the Multi-PD/PI initiative, see:
<http://grants.nih.gov/grants/multi_pi/index.htm>.

### 8.9.12 Consortium/Contractual Arrangements

Describe any programmatic, fiscal, or administrative arrangements
between the applicant organization and other participating
organizations. See [Section 5.5, Item 15, Consortium/Contractual
Arrangements](#consortiumcontractual-arrangements) for additional
guidance

### 8.9.13 Participating Faculty Biosketches

Faculty Biosketches for all mentors involved in large programs may be
included at this point in the application. The Biosketches of the
Program Director and other Senior/key Personnel should be included after
the Budget Pages.

### 8.9.14 Data Tables

Instructions for Data Tables 1-12 mentioned above are located on the OER
website at the following URL
<http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTableInstruct>.
These instructions include an [Introduction to the Data
Tables](http://grants.nih.gov/grants/funding/phs398/phs398.html#DataTableIntro)
that provides instructions applicable to all tables, specific
instructions for each table, and [Sample Data
Tables](http://grants.nih.gov/grants/funding/phs398/phs398.html#SampleTables).
The Sample Data Tables illustrate the kind of data to include in each
table for Kirschstein-NRSA training grant applications. This webpage
also includes an explanation of how this information is used by
reviewers and NIH staff during peer review and in reaching funding
decisions. Blank Data Tables are available to download. Modification of
these instructions for use in non-Kirschstein-NRSA training grant
applications will be included in relevant FOAs.

### 8.9.15 Letters of Support

Letters documenting any agreements between the Program Director and
senior administration officials or other institutional officials are not
required but may be included at this point.

## 8.10 Checklist

CHECKLIST FORM PAGE

**Inventions and Patents**

Not applicable.

**Facilities and Administrative Costs**

Facilities and Administrative (F&A) costs under Institutional
Kirschstein-NRSAs, other than those issued to state or local government
agencies, will be awarded at 8 percent of total allowable direct costs
(exclusive of tuition and related fees). Equipment and consortium costs
are also excluded from the F&A costs on those training grants, where
Training Related Expenses are not calculated and awarded on a lump-sum
basis, such as the Minority Access to Research Careers Program (MARC) or
Career Opportunities in Research (COR) Undergraduate Research Training
Program. State and local government agencies will receive the full F&A
cost rate.

## 8.11 Appendix

Unless the FOA to which you are responding provides explicit
instructions about Appendix materials that will be accepted, follow the
instructions in [Section 5.7 Appendix](#appendix).

[]{#Human_Subjects_PartII .anchor}PART II\
\
Supplemental Instructions for Preparing the Protection of Human Subjects
Section of the Research Plan

# 1. Introduction

A Protection of Human Subjects section of the Research Plan is required
for all applications submitted using the PHS 398 instructions and forms.
The information provided in the section on Protection of Human Subjects
should be consistent with the information provided on the face page of
the application. []{.mark}

For all research involving human subjects, the Scientific Review Group
(SRG) will assess the adequacy of protections for research participants
against research risks, and the appropriate inclusion of women,
minorities, and children, based on the information provided in the
application.

To assist in preparing the section on Protection of Human Subjects, six
possible scenarios are provided in Section 2 below. All research
projects will fall into one of these six scenarios. Determine which
scenario the proposed research falls into, then go to the specific
instructions applicable to that scenario in [Section 3](#Section_7_4_7).
Where appropriate, Section 3 provides instructions on addressing the
Inclusion of Women and Minorities, the Targeted/Planned Enrollment
Table, and the Inclusion of Children (items 9, 10, and 11 of the
Research Plan). All definitions related to human subjects research are
linked to text found in Part III.3 under Human Subjects Research
Definitions and Terms. [Section 5](#Section_7_4_7) of this Part includes
descriptions of and links to the DHHS Human Subjects Protections
regulations and NIH policies that apply to clinical research.

# 2. Scenarios

#### Scenario A. No Human Subjects Research {#scenario-a.-no-human-subjects-research .Subhead---No-TOC}

If no human subjects research is proposed in the application, you will
have designated "No" in Item 4. on the PHS 398 face page, and you should
provide an explanation or statement to that effect in the Human Subjects
section.

See the [instructions for Scenario
A](#scenario-a.-no-human-subjects-research-proposed).

#### Scenario B. Non-Exempt Human Subjects Research {#scenario-b.-non-exempt-human-subjects-research .Subhead---No-TOC}

If research involving human subjects is anticipated to take place under
the award, you will have designated "Yes" in Item 4 on the PHS 398 face
page. In the Protection of Human Subjects section of the Research Plan,
you must provide sufficient information for reviewers to determine that
the proposed research meets (1) the requirements of the DHHS regulations
to protect human subjects from research risks ([45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm)), and
(2) the requirements of NIH policies on inclusion of women, minorities,
and children. Research involving a clinical trial will fall under either
Scenario E or F below.

See the [instructions for Scenario
B](#scenario-b.-non-exempt-human-subjects-research-1).

#### Scenario C. Exempt Human Subjects Research {#scenario-c.-exempt-human-subjects-research .Subhead---No-TOC}

If **all** of the proposed research meets the criteria for one or more
of the exemptions from the requirements in the DHHS regulations
(46.101(b)), "yes" should be designated in item 4 and in item 4a on the
PHS 398 face page. In the section on Protection of Human Subjects in the
Research Plan, provide a justification for the exemption(s) containing
sufficient information about the involvement of the human subjects to
allow a determination by peer reviewers and NIH staff that claimed
exemption(s) is/are appropriate.

The PHS will make a final determination as to whether the proposed
activities are covered by the regulations or are in an exempt category,
based on the information provided in the Research Plan. When in doubt,
consult with the Office for Human Research Protections (OHRP),
Department of Health and Human Services by accessing their website
<http://www.hhs.gov/ohrp/> for guidance and further information.

The exemptions appear in Part III under [Human Subjects Research
Definitions and Terms](#Human_Subjects_Exemption_Cat).

See the [instructions for Scenario C](#Section_7_4_7).

#### Scenario D. Delayed-Onset Human Subjects Research {#scenario-d.-delayed-onset-human-subjects-research .Subhead---No-TOC}

If human subjects research is anticipated within the period of the award
but plans for involvement of human subjects cannot be described in the
application as allowed by the DHHS regulations (45 CFR Part 46.118), you
will have designated "Yes" in Item 4. on the PHS 398 face page. In the
section on Protection of Human Subjects in the Research Plan, you should
either include an explanation of anticipated protections for human
subjects or an explanation of why protections cannot be described.

Examples of delayed-onset of human subjects research include:

-   Human subjects research is dependent upon the completion of animal
    or other studies; or

-   Human subjects research protocols to be included will undergo an
    independent decision-making process (often defined by a FOA).

See [instructions for Scenario D](#Section_7_4_7).

#### Scenario E. Human Subjects Research Involving a Clinical Trial {#scenario-e.-human-subjects-research-involving-a-clinical-trial .Subhead---No-TOC}

If research involving human subjects is anticipated to take place under
the award, and you intend to conduct a clinical trial during the project
period, you will have designated "Yes" in Item 4 on the PHS 398 face
page, "No" in Item 4a on the PHS 398 face page, and "Yes" in Item 4c on
the PHS 398 face page.

In the section on Protection of Human Subjects in the Research Plan, you
must provide sufficient information for reviewers to determine that the
proposed research meets:

1\) the requirements of the DHHS regulations to protect human subjects
from research risks ([45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm));

2\) NIH policy requirements for Data and Safety Monitoring for Clinical
Trials;

3\) the ClinicalTrials.gov requirements if applicable;

4\) the requirements of NIH policies on inclusion of women, minorities,
and children; and

5\) the requirements of NIH policy on reporting race and ethnicity data
for subjects in clinical research.

See [instructions for Scenario E](#Section_7_4_7).

#### Scenario F. Human Subjects Research Involving an NIH-Defined Phase III Clinical Trial {#scenario-f.-human-subjects-research-involving-an-nih-defined-phase-iii-clinical-trial .Subhead---No-TOC}

If research involving human subjects is anticipated to take place under
the award, and you intend to conduct an [NIH-defined Phase III clinical
trial](#Human_Subjects_Defs_NIH_PhaseIIIl) during the project period,
you will have designated "Yes" in Item 4 on the PHS 398 face page, "No"
in Item 4a on the PHS 398 face page, and "Yes" in Item 4d on the PHS 398
face page. In the section on Protection of Human Subjects in the
Research Plan, you must provide sufficient information for reviewers to
determine that the proposed research meets:

1\) the requirements of the DHHS regulations to protect human subjects
from research risks ([45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm));

2\) NIH policy requirements for Data and Safety Monitoring for Clinical
Trials;

3\) the ClinicalTrilas.gov requirements if applicable;

4\) the requirements of NIH policies on inclusion of women, minorities,
and children;

5\) additional Requirements for NIH-defined Phase III clinical trials;
and

6\) the requirements of NIH policy on reporting race and ethnicity data
for subjects in clinical research.

See [instructions for Scenario F](#Section_7_4_7).

# 3. Instructions for Preparing the Section on Protection of Human Subjects

#### Scenario A. No Human Subjects Research Proposed {#scenario-a.-no-human-subjects-research-proposed .Subhead---No-TOC}

## Criteria

[Human Subjects Research](#Human_Subjects_Defs_Human) No

[Exemption Claimed](#Human_Subjects_Exemption_Cat) No

[Clinical Trial](#Human_Subjects_Defs_ClinicalTrial) N/A

[NIH-Defined Phase III Clinical
Trial](#Human_Subjects_Defs_NIH_PhaseIIIl) N/A

## Instructions and Required Information

In the application narrative, create a heading labeled "Protection of
Human Subjects" and include the following statement below the heading:
"No Human Subjects Research is proposed in this application."

If proposed studies using coded human data or biospecimens do not
involve human subjects as described in the OHRP Guidance on Research
Involving Coded Private Information or Biological Specimens
(<http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.htm>), provide
an explanation of why the proposed studies do not constitute research
involving human subjects.

The explanation could include: a description of the source of the
data/biospecimens; the role(s) of providers of the data/biospecimens in
the proposed research; and the manner by which the privacy of research
participants and confidentiality of data will be ensured.

Research that does not involve intervention or interaction with living
individuals, or identifiable private information, is not human subjects
research (see Definitions in Part III.3).

Research that only proposes the use of cadaver specimens is not human
subjects research because human subjects are defined as "living
individuals." The use of cadaver specimens is not regulated by 45 CFR
Part 46, but may be governed by other Federal, State or local laws.

#### Scenario B. Non-Exempt Human Subjects Research {#scenario-b.-non-exempt-human-subjects-research-1 .Subhead---No-TOC}

## Criteria

[Human Subjects Research](#Human_Subjects_Defs_Human) Yes

[Exemption Claimed](#Human_Subjects_Exemption_Cat) No

[Clinical Trial](#Human_Subjects_Defs_ClinicalTrial) No

[NIH-Defined Phase III Clinical
Trial](#Human_Subjects_Defs_NIH_PhaseIIIl) No

## Instructions and Required Information 

Although no specific page limitation applies to this section of the
application, be succinct.

In the application narrative, create a section entitled "Protection of
Human Subjects" and create a subheading for each of the following items.

Follow the instructions that are identified for each of the following
topics and provide the information that is requested:

Protections for Human Subjects - [Section 4.1 -
4.1.4](#protection-of-human-subjects-1)

Inclusion of Women and Minorities - [Section
4.2](#inclusion-of-women-and-minorities-1)

Targeted/Planned Enrollment Table - [Section 4.3](#Section_7_4_7)

Inclusion of Children - [Section 4.4](#inclusion-of-children-1)

If the research involves collaborating sites, provide the information
identified above for each participating site.

#### Scenario C: Human Subjects Research Claiming Exemption 1, 2, 3, 4, 5, or 6 {#scenario-c-human-subjects-research-claiming-exemption-1-2-3-4-5-or-6 .Subhead---No-TOC}

## Criteria

[Human Subjects Research](#Human_Subjects_Defs_Human) Yes

[Exemption Claimed](#Human_Subjects_Exemption_Cat) 1, 2, 3, 4, 5, or 6

[Clinical Trial](#Human_Subjects_Defs_ClinicalTrial) Yes or No

[NIH-Defined Phase III Clinical
Trial](#Human_Subjects_Defs_NIH_PhaseIIIl) No

## Instructions and Required Information 

Although no specific page limitation applies to this section of the
application, be succinct. The exemptions appear in Part III under [Human
Subjects Research Definitions and Terms](#Human_Subjects_Exemption_Cat).

Although the research may be exempt from the DHHS regulatory
requirements, it is still research involving human subjects and the
application must follow the instructions that are identified for each of
the following topics and provide the information that is requested.

In the application narrative, create a heading entitled "Protection of
Human Subjects" and include the following statement below the heading:
"This Human Subjects Research falls under Exemption(s) ... ."

Follow the instructions that are identified for each of the following
topics and provide the information that is requested:

Justification for Claimed Exemption(s):

> In this section, identify which exemption(s) (1, 2, 3, 4\*, 5, or 6)
> you are claiming. Justify why the research meets the criteria for the
> exemption(s) that you have claimed.\
> \
> If the research will include a clinical trial, even if exempt, include
> a Data and Safety Monitoring Plan -- [Section
> 4.1.5](#data-and-safety-monitoring-plan), and address the
> ClinicalTrials.gov requirements if applicable -- [Section
> 4.1.6](#clinicaltrials.gov-requirements).

Inclusion of Women and Minorities - [Section
4.2](#inclusion-of-women-and-minorities-1)

Targeted/Planned Enrollment Table - [Section 4.3](#Section_7_4_7)

Inclusion of Children - [Section 4.4](#inclusion-of-children-1)\
\
\*NOTE: If all the proposed research meets the criteria for Exemption 4,
then the requirements for inclusion of women and minorities,
targeted/planned enrollment table, and inclusion of children, do not
need to be addressed.

#### Scenario D: Delayed-Onset Human Subjects Research {#scenario-d-delayed-onset-human-subjects-research .Subhead---No-TOC}

## Criteria

[Human Subjects Research](#Human_Subjects_Defs_Human) Yes

[Exemption](#Human_Subjects_Exemption_Cat) Yes or No

[Clinical Trial](#Human_Subjects_Defs_ClinicalTrial) Yes or No

[NIH-Defined Phase III Clinical
Trial](#Human_Subjects_Defs_NIH_PhaseIIIl) Yes or No

## Instructions and Required Information

In rare situations, applications are submitted with the knowledge that
human subjects will be involved during the period of support, but plans
are so indefinite that it is not possible to describe the involvement of
human subjects in the application. The kinds of activities that lack
definite plans are often institutional awards where the selection of
specific projects is the institution\'s responsibility, research
training grants, and projects in which the involvement of human subjects
depends upon completion of instruments, animal studies, or purification
of compounds.

If the involvement of human subjects is indefinite, create a heading
entitled "Protection of Human Subjects" and provide a detailed
explanation why it is not possible to develop definite plans at this
time. The explanation should be specific and directly related to the
Specific Aims in the application. If the involvement of human subjects
depends upon information that is not presently available (e.g.,
completion of instruments, animal studies, purification of compounds),
be explicit about the information and the factors affecting the
availability of the information. Describe the information that will be
necessary in order to develop definite plans for the involvement of
human subjects, why that information is not currently available, and
when the information is expected to become available during the course
of the project.

If an award is made, prior to the involvement of human subjects the
grantee must submit to the NIH awarding office for prior approval either
(1) detailed information as required in the Research Plan, Protection of
Human Subjects (addressing risks to the subjects, adequacy of protection
against risks, potential benefits of the proposed research, importance
of the knowledge to be gained, and data and safety monitoring plan if
applicable) and certification of IRB approval, OR (2) if all of the
research meets the criteria for one or more exemptions, identification
of which exemption(s) is/are applicable to the research, and a
justification for the exemption with sufficient information about the
involvement of human subjects to allow a determination that the claimed
exemption is appropriate. If the research is not exempt, the request for
prior approval must also address the inclusion of women and minorities,
the inclusion of children, and provide completed targeted/planned
enrollment tables as required in the Research Plan.

Under no circumstance may human subjects be involved in non-exempt
research until approval is granted by the awarding entity, and
certification of IRB approval has been accepted by the agency.

In the application narrative, create a section entitled Protection of
Human Subjects and a subheading for each of the following items. Follow
the instructions that are identified for each of the following topics
and EITHER provide as much of the information that is requested as
possible; OR describe why it is not possible to provide the information
due to delayed-onset of human subjects research:

Protection of Human Subjects - [Section 4.1 -
4.1.4](#protection-of-human-subjects-1)

If the research will include a clinical trial, include a Data and Safety
Monitoring Plan - [Section 4.1.5](#data-and-safety-monitoring-plan), and
address the ClinicalTrials.gov requirements if applicable -- [Section
4.1.6](#clinicaltrials.gov-requirements).

Inclusion of Women and Minorities - [Section
4.2](#inclusion-of-women-and-minorities-1)

Targeted/Planned Enrollment Table - [Section 4.3](#Section_7_4_7)

Inclusion of Children - [Section 4.4](#inclusion-of-children-1)

#### Scenario E: Clinical Trial {#scenario-e-clinical-trial .Subhead---No-TOC}

## Criteria

[Human Subjects Research](#Human_Subjects_Defs_Human) Yes

[Exemption](#Human_Subjects_Exemption_Cat) Yes or No

[Clinical Trial](#Human_Subjects_Defs_ClinicalTrial) Yes

[NIH-Defined Phase III Clinical
Trial](#Human_Subjects_Defs_NIH_PhaseIIIl) No

## Instructions and Required Information

In the application narrative, create a section entitled "Protection of
Human Subjects" and include the following statement below the heading:
"This Human Subjects Research meets the definition of a clinical trial."
(See definition of \"[clinical
trial](#Human_Subjects_Defs_ClinicalTrial)\" under Part III.3.) Create a
subheading for each of the following items. Follow the instructions that
are identified for each of the following topics and provide the
information that is requested:

Protection of Human Subjects - [Section 4.1 -
4.1.6](#protection-of-human-subjects-1)

Inclusion of Women and Minorities - [Section
4.2](#inclusion-of-women-and-minorities-1)

Targeted/Planned Enrollment Table - [Section 4.3](#Section_7_4_7)

Inclusion of Children - [Section 4.4](#inclusion-of-children-1)

If the research involves collaborating sites, provide the information
identified above for each participating site.

#### Scenario F: NIH Defined Phase III Clinical Trial {#scenario-f-nih-defined-phase-iii-clinical-trial .Subhead---No-TOC}

## Criteria

[Human Subjects Research](#Human_Subjects_Defs_Human): Yes

[Exempt](#Human_Subjects_Exemption_Cat): No

[Clinical Trial](#Human_Subjects_Defs_ClinicalTrial): Yes

[NIH-Defined Phase III Clinical
Trial](#Human_Subjects_Defs_NIH_PhaseIIIl): Yes

## Instructions and Required Information

In the application narrative, create a section entitled "Protection of
Human Subjects" and include the following statement below the heading:
"This Human Subjects Research involves an NIH-Defined Phase III Clinical
Trial." (See definition of \"[NIH defined Phase III Clinical
Trial](#Human_Subjects_Defs_NIH_PhaseIIIl)\" in Part III.3.)

Create a subheading for each of the following items. Follow the
instructions that are identified for each of the following topics and
provide the information that is requested:

Protection of Human Subjects - [Section 4.1 -
4.1.6](#protection-of-human-subjects-1)

Inclusion of Women and Minorities - [Section
4.2](#inclusion-of-women-and-minorities-1)

Additional Instructions and Requirements when NIH-Defined Phase III
Clinical Trials are Proposed - [Section 4.2.1](#Section_7_4_7)

Targeted/Planned Enrollment Table - [Section 4.3](#Section_7_4_7)

Inclusion of Children - [Section 4.4](#inclusion-of-children-1)

If the research involves collaborating sites, provide the information
identified above for each participating site.

# 4. Instructions Pertaining to Non-Exempt Human Subjects Research

In your application narrative, create a section entitled "Protection of
Human Subjects." Although no specific page limitation applies to this
section of the application, be succinct. Scientific Review Groups will
assess each application as being acceptable or unacceptable with regard
to the protection of human subjects. DHHS regulations and policies
governing human subjects research are described and referenced in
Section 5 below. Use subheadings to address the issues listed under
items 4.1-4.4 below. If your research includes a clinical trial, include
a subheading \"Data and Safety Monitoring Plan\" and follow the
instructions in 4.2 below. If your research includes an NIH-Defined
Phase III Clinical Trial, follow the additional instructions in 4.2.1
below.

## 4.1 Protection of Human Subjects

### 4.1.1 Risks to Human Subjects

a\. ***[Human Subjects Involvement and Characteristics]{.underline}***

-   Describe the proposed involvement of human subjects in the work
    outlined in the Research Design and Methods section.

-   Describe the characteristics of the subject population, including
    their anticipated number, age range, and health status.

-   Identify the criteria for inclusion or exclusion of any
    subpopulation.

-   Explain the rationale for the involvement of special classes of
    subjects, such as fetuses, neonates, pregnant women, children,
    prisoners, institutionalized individuals, or others who may be
    considered vulnerable populations. Note that \'prisoners\' includes
    all subjects involuntarily incarcerated (for example, in detention
    centers) as well as subjects who become incarcerated after the study
    begins.

-   List any collaborating sites where human subjects research will be
    performed, and describe the role of those sites and collaborating
    investigators in performing the proposed research.

b\. ***[Sources of Materials]{.underline}***

-   Describe the research material obtained from living individuals in
    the form of specimens, records, or data.

-   Describe any data that will be collected from human subjects for the
    project(s) described in the application.

-   Indicate who will have access to individually identifiable private
    information about human subjects.

-   Provide information about how the specimens, records, or data are
    collected and whether material or data will be collected
    specifically for the proposed research project.

c\. ***[Potential Risks]{.underline}***

-   Describe the potential risks to subjects (physical, psychological,
    financial, legal, or other), and assess their likelihood and
    seriousness to the subjects.

-   Where appropriate, describe alternative treatments and procedures,
    including the risks and potential benefits of the alternative
    treatments and procedures, to participants in the proposed research.

### 4.1.2 Adequacy of Protection Against Risks

a\. ***[Recruitment and Informed Consent]{.underline}***

-   Describe plans for the recruitment of subjects (where appropriate)
    and the process for obtaining informed consent. If the proposed
    studies will include children, describe the process for meeting
    requirements for parental permission and child assent.

-   Include a description of the circumstances under which consent will
    be sought and obtained, who will seek it, the nature of the
    information to be provided to prospective subjects, and the method
    of documenting consent. If a waiver of some or all of the elements
    of informed consent will be sought, provide justification for the
    waiver. Informed consent document(s) need not be submitted to the
    PHS agencies unless requested.

b\. ***[Protections Against Risk]{.underline}***

-   Describe planned procedures for protecting against or minimizing
    potential risks, including risks to privacy of individuals or
    confidentiality of data, and assess their likely effectiveness.

-   Research involving vulnerable populations, as described in the DHHS
    regulations, Subparts B-D must include additional protections. Refer
    to DHHS regulations, and OHRP guidance:

-   Additional Protections for Pregnant Women, Human Fetuses and
    Neonates:
    <http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartb>

-   Additional Protections for Prisoners:
    <http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartc>

    OHRP Subpart C Guidance:
    <http://www.hhs.gov/ohrp/policy/index.html#prisoners>

-   Additional Protections for Children:
    <http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd>

    OHRP Subpart D Guidance: <http://www.hhs.gov/ohrp/children/>

-   Where appropriate, discuss plans for ensuring necessary medical or
    professional intervention in the event of adverse effects to the
    subjects. Studies that involve clinical trials (biomedical and
    behavioral intervention studies) must include a general description
    of the plan for data and safety monitoring of the research and
    adverse event reporting to the IRB, the NIH and others, as
    appropriate, to ensure the safety of subjects.

### 4.1.3 Potential Benefits of the Proposed Research to Human Subjects and Others

-   Discuss the potential benefits of the research to research
    participants and others.

-   Discuss why the risks to subjects are reasonable in relation to the
    anticipated benefits to research participants and others.

### 4.1.4 Importance of the Knowledge to be Gained 

-   Discuss the importance of the knowledge gained or to be gained as a
    result of the proposed research.

-   Discuss why the risks to subjects are reasonable in relation to the
    importance of the knowledge that reasonably may be expected to
    result.

NOTE: Test articles (investigational new drugs, devices, or biologics)
including test articles that will be used for purposes or administered
by routes that have not been approved for general use by the Food and
Drug Administration (FDA) must be named. State whether the 30-day
interval between submission of applicant certification to the FDA and
its response has elapsed or has been waived and/or whether use of the
test article has been withheld or restricted by the FDA, and/or the
status of requests for an Investigational New Drug (IND) or
Investigational Device Exemption (IDE) covering the proposed use of the
test article in the Research Plan.

### 4.1.5 Data and Safety Monitoring Plan

The NIH Data and Safety Monitoring Plan Policy is described and
referenced in [Section
5.3](#data-and-safety-monitoring-plans-for-clinical-trials).

-   If the research includes a clinical trial, create a heading entitled
    \"Data and Safety Monitoring Plan.\"

-   Provide a general description of a monitoring plan that you plan to
    establish as the overall framework for data and safety monitoring.
    Describe the entity that will be responsible for monitoring and the
    process by which Adverse Events (AEs) will be reported to the
    Institutional Review Board (IRB), the funding I/C, the NIH Office of
    Biotechnology Activities (OBA), and the Food and Drug Administration
    (FDA) in accordance with Investigational New Drug (IND) or
    Investigational Device Exemption (IDE) regulations. Be succinct.
    Contact the FDA (<http://www.fda.gov/>) and also see the following
    websites for more information related to IND and IDE requirements:\
    <http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr312_01.html>
    (IND)\
    <http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr812_01.html>
    (IDE)

-   The frequency of monitoring will depend on potential risks,
    complexity, and the nature of the trial; therefore, a number of
    options for monitoring trials are available. These can include, but
    are not limited to, monitoring by a:

> a\. PD/PI (required)
>
> b\. Institutional Review Board (IRB) (required)
>
> c\. Independent individual/safety officer
>
> d\. Designated medical monitor
>
> e\. Internal Committee or Board with explicit guidelines
>
> f\. Data and Safety Monitoring Board (DSMB). NIH specifically requires
> the establishment of Data and Safety Monitoring Boards (DSMBs) for
> multi-site clinical trials involving interventions that entail
> potential risk to the participants, and generally for Phase III
> clinical trials. Although Phase I and Phase II clinical trials may
> also use DSMBs, smaller clinical trials may not require this oversight
> format, and alternative monitoring plans may be appropriate.

-   A detailed Data and Safety Monitoring Plan must be submitted to the
    applicant\'s IRB and subsequently to the funding IC for approval
    prior to the accrual of human subjects
    (<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html>).
    For additional guidance on creating this Plan, see the above
    reference.

### 4.1.6 ClinicalTrials.gov Requirements

Public Law 110-85 mandates registration and results reporting of
\"applicable clinical trials\" in ClinicalTrials.gov. Under the statute
these trials generally include: (1) [Trials of Drugs and
Biologics]{.underline}:  Controlled, clinical investigations, other than
Phase 1 investigations, of a product subject to FDA regulation; and (2)
[Trials of Devices]{.underline}: Controlled trials with health outcomes,
other than small feasibility studies, and pediatric postmarket
surveillance. Review the statutory definition of applicable clinical
trial to identify if registration is required to comply with the law
(See [PL
110-85](http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf),
Section 801(a), adding new 42 U.S.C. 282(j)(1)(A)).

NIH encourages registration of ALL trials whether required under the law
or not.

Registration is accomplished at the ClinicalTrials.gov Protocol
Registration System Information Website
(<http://prsinfo.clinicaltrials.gov/>). A unique identifier called an
NCT number will be generated during the registration process.

For new and renewal (competing) applications that include ongoing
clinical trials which require registration and results reporting,
provide the NCT number/s, Brief Title/s (as defined by
ClinicalTrials.gov, see <http://prsinfo.clinicaltrials.gov/>), and the
identity of the responsible party (or parties) in the human subjects
section of the Research Plan under a section heading entitled
ClinicalTrials.gov. The entity responsible for registering is the
"responsible party." The statute defines the responsible party as:

\(1\) the sponsor of the clinical trial (as defined in 21 C.F.R. 50.3)
(<http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/cfr_2003/aprqtr/pdf/21cfr50.3.pdf>),
or\
\
(2) the principal investigator of such clinical trial if so designated
by a sponsor, grantee, contractor, or awardee (provided that "the
principal investigator is responsible for conducting the trial, has
access to and control over the data from the clinical trial, has the
right to publish the results of the trial, and has the ability to meet
all of the requirements" for submitting information under the law)
(<http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf>).
See PL 110-85, Section 801(a), (adding new 42 U.S.C. 282(j)(1)(A)(ix)).

If a new applicable trial is proposed, under the heading
ClinicalTrials.gov include a statement that the application includes a
trial which requires registration in ClinicalTrials.gov. The signature
on the application of the Authorized Organizational Representative
assures compliance for the registration of any such trial.

## 4.2 Inclusion of Women and Minorities

Create a section heading entitled \"Inclusion of Women and Minorities\"
and place it immediately following the "Protection of Human Subjects\"
section. Although no specific page limitation applies to this section of
the application, be succinct. The NIH Policy on the Inclusion of Women
and Minorities in Clinical Research is described and referenced in
[Section
5.6](#nih-policy-on-the-inclusion-of-women-and-minorities-in-clinical-research).

Scientific Review Groups will assess each application as being
acceptable or unacceptable with regard to the protection of human
subjects.

In this section of the Research Plan, address, at a minimum, the
following four points:

1\. The targeted/planned distribution of subjects by sex/gender and
racial/ethnic groups for each proposed study or protocol using the
format in the Targeted/Planned Enrollment Table. (Instructions for
completing this table are provided below in 4.3.) If using existing
specimens and/or data without access to information on the distribution
of women and minorities, so state and explain the impact on the goals of
the research as part of the rationale that inclusion is inappropriate
(item 3 below). Alternatively, describe the women and minority
composition of the population base from whom the specimens and/or data
will be obtained. Include the Targeted/Planned Enrollment Table in this
section.

2\. A description of the subject selection criteria and rationale for
selection of sex/gender and racial/ethnic group members in terms of the
scientific objectives and proposed study design. The description may
include, but is not limited to, information on the population
characteristics of the disease or condition under study.

3\. A compelling rationale for proposed exclusion of any sex/gender or
racial/ethnic group (see examples below).

4\. A description of proposed outreach programs for recruiting
sex/gender and racial/ethnic group members as subjects.

Examples of acceptable justifications for exclusion of:

A. ***[One gender:]{.underline}***

1\. One gender is excluded from the study because:

-   inclusion of these individuals would be inappropriate with respect
    to their health;

-   the research question addressed is relevant to only one gender;

-   evidence from prior research strongly demonstrates no difference
    between genders; or

-   sufficient data already exist with regard to the outcome of
    comparable studies in the excluded gender, and duplication is not
    needed in this study.

2\. One gender is excluded or severely limited because the purpose of
the research constrains the applicant\'s selection of study subjects by
gender (e.g., uniquely valuable stored specimens or existing datasets
are single gender; very small numbers of subjects are involved; or
overriding factors dictate selection of subjects, such as matching of
transplant recipients, or availability of rare surgical specimens).

3\. Gender representation of specimens or existing datasets cannot be
accurately determined (e.g., pooled blood samples, stored specimens, or
data-sets with incomplete gender documentation are used), and this does
not compromise the scientific objectives of the research.

B. ***[Minority groups or subgroups:]{.underline}***

1\. Some or all minority groups or subgroups are excluded from the study
because:

-   inclusion of these individuals would be inappropriate with respect
    to their health;

-   the research question addressed is relevant to only one racial or
    ethnic group;

-   evidence from prior research strongly demonstrates no differences
    between racial or ethnic groups on the outcome variables;

-   a single minority group study is proposed to fill a research gap; or

-   sufficient data already exists with regard to the outcome of
    comparable studies in the excluded racial or ethnic groups and
    duplication is not needed in this study.

2\. Some minority groups or subgroups are excluded or poorly represented
because the geographical location of the study has only limited numbers
of these minority groups who would be eligible for the study, and the
investigator has satisfactorily addressed this issue in terms of:

-   the size of the study;

-   the relevant characteristics of the disease, disorder or condition;
    or

-   the feasibility of making a collaboration or consortium or other
    arrangements to include representation.

3\. Some minority groups or subgroups are excluded or poorly represented
because the purpose of the research constrains the applicant\'s
selection of study subjects by race or ethnicity (e.g., uniquely
valuable cohorts, stored specimens or existing datasets are of limited
minority representation, very small numbers of subjects are involved, or
overriding factors dictate selection of subjects, such as matching of
transplant recipients or availability of rare surgical specimens).

4\. Racial or ethnic origin of specimens or existing datasets cannot be
accurately determined (e.g., pooled blood samples, stored specimens or
data sets with incomplete racial or ethnic documentation are used) and
this does not compromise the scientific objectives of the research.

### 4.2.1 Additional Instructions and Requirements When NIH-Defined Phase III Clinical Trials Are Proposed

If the proposed research includes an [NIH-Defined Phase III Clinical
Trial](#Human_Subjects_Defs_NIH_PhaseIIIl), the section on Inclusion of
Women and Minorities also must address whether clinically important
sex/gender and/or race/ethnicity differences are expected from the
intervention effect. The discussion may include supporting evidence
and/or data derived from animal studies, clinical observations,
metabolic studies, genetic studies, pharmacology studies, and
observational, natural history, epidemiology and other relevant studies.
The discussion of expected sex/gender and/or race/ethnicity differences
in intervention effect must include selection and discussion of one of
the following analysis plans:

-   Plans to conduct valid analyses to detect significant differences in
    intervention effect among sex/gender and/or racial/ethnic subgroups
    when prior studies strongly support these significant differences
    among subgroups, *or*

-   Plans to include and analyze sex/gender and/or racial/ethnic
    subgroups when prior studies strongly support no significant
    differences in intervention effect between subgroups.
    (Representation of sex/gender and racial/ethnic groups is not
    required as subject selection criteria, but inclusion is
    encouraged.), *or*

-   Plans to conduct valid analyses of the intervention effect in
    sex/gender and/or racial/ethnic subgroups (without requiring high
    statistical power for each subgroup) when the prior studies neither
    support nor negate significant differences in intervention effect
    between subgroups.

## 4.3 Instructions for Completing the Targeted/Planned Enrollment Tables for Reporting Race and Ethnicity Data for Subjects in Clinical Research

The NIH Policy on Reporting Race and Ethnicity Data for Subjects in
Clinical Research is described and referenced in [Section
5.8](#nih-policy-on-reporting-race-and-ethnicity-data-subjects-in-clinical-research).

A. New Applications

All new clinical research studies should collect and report information
on participants with respect to two categories of ethnicity and five
categories of race. The Inclusion Enrollment Report
(<http://grants.nih.gov/grants/funding/phs398/phs398.html>) for
reporting summary data on participants to NIH includes two categories of
ethnicity and five categories of race and is based on the Office of
Management and Budget (OMB) reporting standards for data on race and
ethnicity. Investigators should review the instructions and Frequently
Asked Questions about using the Enrollment Table format at
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html>.

When reporting these data in the aggregate, investigators should report:
(a) the number of research participants in each ethnic category; (b) the
number of research participants who selected only one category for each
of the five racial categories; (c) the total number of research
participants who selected multiple racial categories reported as the
"number selecting more than one race," and (d) the number of research
participants in each racial category who are Hispanic or Latino.
Investigators may provide the detailed distributions, including all
possible combinations, of multiple responses to the racial designations
as additional information. However, more detailed data should be
compiled in a way that they can be reported using the required
categories.

**Instructions for Completing Targeted/Planned Enrollment Table**

Provide the study title.

The "Total Planned Enrollment" means the number of subjects that are
expected to be enrolled in the study, consistent with the definition in
ClinicalTrials.gov.

The "Total Planned Enrollment" will be reported in two ways in the
table: by "Ethnic Category" and by "Racial Categories."

"Ethnic Category": Provide the numeric distribution of the Total Planned
Enrollment according to ethnicity and sex/gender in the top part of the
table.

"Racial Categories": Provide the numeric distribution of the Total
Planned Enrollment, this time by racial categories and sex/gender, in
the bottom part of the table. Note that Hispanic is an ethnic, not a
racial, category.

If there is more than one study/protocol, provide a separate table for
each.

List any proposed racial/ethnic subpopulations below the table.

**Submitting Applications or Proposals Using Existing Data in Clinical
Research with No Plans for Collecting New/Additional Data:**

Investigators are instructed to provide plans for the total number of
subjects proposed for the study and to provide the distribution by
ethnic/racial categories and sex/gender using the Targeted/Planned
Enrollment Table. Under these circumstances, investigators are not
required to re-contact subjects solely to comply with the newly revised
categories.

**If Data Collection is Ongoing, Such that New Human Subjects Will be
Enrolled and/or Additional Data Will be Collected from Human Subjects:**

Investigators should report ethnicity/race and sex/gender sample
composition using the Inclusion Enrollment Report.

**If Data Collection is Complete, Such that No New/Additional Subject
Contact is Planned**:

Investigators should use the Inclusion Enrollment Report.

**Research Conducted at Foreign Sites:**

If proposed studies involve a foreign site, investigators are encouraged
to design culturally sensitive and appropriate data collection
instruments that allow research participants to self-identify their
racial and ethnic affiliation. However, these items should be designed
in a way that they can be aggregated into the OMB-required categories.
Also, the investigator can report on any racial/ethnic subpopulations by
listing this information in an attachment to the required table. This
may be particularly useful when distinctive subpopulations are relevant
to the scientific hypotheses being studied.

When completing the tables that describe research in foreign sites,
investigators should asterisk and footnote the table indicating that
data includes research participants in foreign sites. If the aggregated
data only includes participants in foreign research sites, the
investigator should provide information in one table with an asterisk
and footnote. However, if the study includes both domestic and foreign
sites, the investigator should complete two separate tables -- one for
domestic and another for foreign participants.

B. Renewal Application and Progress Reports

The Inclusion Enrollment Report
(<http://grants.nih.gov/grants/funding/phs398/phs398.html>) must be used
for reporting accrual data to the NIH. For Revision applications, any
proposed additions to the Targeted/Planned Enrollment Table should be
provided, in addition to the Inclusion Enrollment Report. In annual
progress reports, investigators conducting clinical research are
required to provide the cumulative total enrollment of subjects to-date,
showing the distribution by ethnic/racial categories and sex/gender on
the Inclusion Enrollment Report, and update the Targeted/Planned
Enrollment Table as needed.

## 4.4 Inclusion of Children

The NIH Policy on Inclusion of Children is referenced and described in
[Section 5.7](#nih-policy-on-inclusion-of-children). Instructions for
item 11 of the Research Plan are as follows:

-   Create a section entitled "Inclusion of Children" and place it
    immediately following the Targeted/Planned Enrollment Table.

-   For the purpose of implementing these guidelines, a *child* is
    defined as an individual under the age of 21 years (for additional
    information see
    <http://grants.nih.gov/grants/funding/children/children.htm> and
    <http://grants.nih.gov/grants/guide/notice-files/not98-024.html>).

-   Provide either a description of the plans to include children, or,
    if children will be excluded from the proposed research,
    application, or proposal, present an acceptable justification for
    the exclusion (see below).

-   If children are included, the description of the plan should include
    a rationale for selecting a specific age range of children. The plan
    also must include a description of the expertise of the
    investigative team for dealing with children at the ages included,
    of the appropriateness of the available facilities to accommodate
    the children, and the inclusion of a sufficient number of children
    to contribute to a meaningful analysis relative to the purpose of
    the study.

-   Scientific Review Groups will assess each application as being
    acceptable or unacceptable with regard to the age-appropriate
    inclusion or exclusion of children in the research project.

-   When children are involved in research, the Additional Protections
    for Children Involved as Subjects in Research ([45 CFR Part 46
    Subpart
    D](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd))
    apply and must be addressed under the Protections Against Risk
    subheading (4.1.2.b).

**Justifications for Exclusion of Children**

For the purposes of this policy, all individuals under 21 are considered
children; however, exclusion of any specific age group, such as
individuals under 18, should be justified in this section. It is
expected that children will be included in all clinical research unless
one or more of the following exclusionary circumstances can be fully
justified:

1\. The research topic to be studied is not relevant to children.

2\. There are laws or regulations barring the inclusion of children in
the research.

3\. The knowledge being sought in the research is already available for
children or will be obtained from another ongoing study, and an
additional study will be needlessly redundant. Documentation of other
studies justifying the exclusions should be provided. NIH program staff
can be contacted for guidance on this issue if the information is not
readily available.

4\. A separate, age-specific study in children is warranted and
preferable. Examples include:

a\. The condition is relatively rare in children, as compared to adults
(in that extraordinary effort would be needed to include children,
although in rare diseases or disorders where the applicant has made a
particular effort to assemble an adult population, the same effort would
be expected to assemble a similar child population with the rare
condition); or

b\. The number of children is limited because the majority are already
accessed by a nationwide pediatric disease research network; or

c\. Issues of study design preclude direct applicability of hypotheses
and/or interventions to both adults and children (including different
cognitive, developmental, or disease stages or different age-related
metabolic processes). While this situation may represent a justification
for excluding children in some instances, consideration should be given
to taking these differences into account in the study design and
expanding the hypotheses tested, or the interventions planned, to allow
inclusion of children rather than excluding them.

5\. Insufficient data are available in adults to judge potential risk in
children (in which case one of the research objectives could be to
obtain sufficient adult data to make this judgment). Although children
usually should not be the initial group to be involved in research
studies, in some instances, the nature and seriousness of the illness
may warrant their participation earlier based on careful risk and
benefit analysis.

6\. Study designs are aimed at collecting additional data on
pre-enrolled adult study subjects (e.g., longitudinal follow-up studies
that did not include data on children).

7\. Other special cases can be justified by the investigator and found
acceptable to the review group and the Institute Director.

# 5. Human Subjects Research Policy

Human Subjects Research Policy includes DHHS regulations for the
protection of human subjects and the following NIH policies related to
human subjects research.

## 5.1 Protection of Human Subjects

The Department of Health and Human Services (DHHS) regulations for the
protection of human subjects provide a systematic means, based on
established, internationally recognized ethical principles, to safeguard
the rights and welfare of individuals who participate as subjects in
research activities supported or conducted by the DHHS. The regulations
stipulate that the awardee organization, whether domestic or foreign,
bears responsibility for safeguarding the rights and welfare of human
subjects in DHHS-supported research activities. The regulations require
that applicant organizations proposing to involve human subjects in
nonexempt research hold a Federal-wide Assurance (FWA) with the Office
for Human Research Protections (OHRP), and establish appropriate
policies and procedures for the protection of human subjects. These
regulations, [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm),
Protection of Human Subjects, are available from OHRP, Department of
Health and Human Services, The Tower Building, 1101 Wootton Parkway,
Suite 200, Rockville, MD; telephone: 1-866-447-4777 (toll-free) or (240)
453-6900; email: <ohrp@osophs.dhhs.gov>.

Nonexempt research involving human subjects may only be conducted under
a DHHS award if the organization is operating in accord with an approved
FWA and provides verification that an Institutional Review Board (IRB)
that is registered under the specific FWA has reviewed and approved the
proposed activity in accordance with the DHHS regulations. No award to
an individual will be made unless that individual is affiliated with an
assured organization that accepts responsibility for compliance with the
DHHS regulations. Foreign applicant organizations must also comply with
the provisions of the regulations unless a determination of equivalent
protections is made in accord with 45 CFR 46.101(h).

Under DHHS regulations to protect human subjects, certain research areas
are [exempt](#Human_Subjects_Exemption_Cat). However, if an applicant
makes inappropriate designations of the noninvolvement of human subjects
or of exempt categories of research, this may result in delays in the
review of an application or the return of the application without
review. The PHS will make a final determination as to whether the
proposed activities are covered by the regulations or are in an exempt
category, based on the information provided in the Research Plan. With
the exception of research projects that meet the criteria for Exemption
4, studies that are exempt from the human subjects regulatory
requirements must still address the inclusion of women, minorities and
children in the study design.

Regulations of the Food and Drug Administration (21 CFR 50, 21 CFR 56)
generally apply to biomedical research involving an unapproved drug,
device or biologic and may apply to certain studies of approved
products. Additional information on FDA regulations is available at
<http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm>.
If work falls under FDA\'s regulatory requirements, the grantee must
follow both DHHS and FDA human subject protection regulations.

The *National Institutes of Health Guidelines for Research Involving
Recombinant DNA Molecules (NIH Guidelines)* apply to all projects
(NIH-funded and non NIH-funded) involving recombinant DNA molecules that
are conducted at or sponsored by an institution that receives NIH
support for recombinant DNA research. See Part III, 2.9. Research
Involving Recombinant DNA, including Human Gene Transfer Research.

Federal requirements to protect human subjects apply to most research on
human specimens (such as cells, blood, and urine), residual diagnostic
specimens, and medical information. Research involving the collection or
study of existing data, documents, records, pathological specimens,
diagnostic specimens, or tissues that are individually identifiable is
considered "research involving human subjects." The NIH Office of
Extramural Research Human Subjects website contains additional
information and Frequently Asked Questions to help investigators
understand how these federal requirements apply to their research. See
<http://grants.nih.gov/grants/policy/hs/index.htm>.

The DHHS regulations require the NIH to evaluate all applications and
proposals involving human subjects
(<http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.120>).
This independent evaluation is conducted at the NIH through the peer
review system and NIH staff review, and, as required, will take into
consideration the risks to the subjects, the adequacy of protection
against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to be
gained. On the basis of this evaluation, the NIH may approve or
disapprove the application or proposal, or enter into negotiations to
develop an approvable one.

## 5.2 Vulnerable Populations

Investigators who conduct research involving pregnant women, human
fetuses and neonates, prisoners, or children, must follow the provisions
of the regulations in Subparts
[B](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartb),
[C](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartc),
and
[D](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd)
of [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm),
respectively. The subparts describe the additional protections required
for conducting research involving these populations. Relevant
information may be obtained at the OHRP website
(<http://www.hhs.gov/ohrp/policy/index.html>).

REMINDER: DHHS regulations at [45 CFR Part 46, Subpart
C](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartc)
describe requirements for additional protections for research involving
prisoners as subjects *or* individuals who become prisoners after the
research has started. Refer to:
[[http://www.hhs.gov/ohrp/humansubjects/guidance/prisoner.htm]{.underline}](http://www.hhs.gov/ohrp/humansubjects/guidance/prisoner.htm)
for complete instructions.

[Exemptions 1-6](#Human_Subjects_Exemption_Cat) do **not** apply to
research involving prisoners or subjects who become prisoners (see
[Subpart
C](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartc)).
Although Exemptions 1 and 3-6 apply to research involving children (see
[Subpart
D](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd)),
[Exemption 2](#Human_Subjects_Exemption2) can only be used for research
involving educational testing or observations of public behavior when
the investigator(s) do not participate in the activities being observed.

## 5.3 Data and Safety Monitoring Plans for Clinical Trials 

For each proposed clinical trial, NIH requires a data and safety
monitoring plan that describes oversight and monitoring to ensure the
safety of participants and the validity and integrity of the data. The
level of monitoring should be commensurate with the risks and the size
and complexity of the clinical trial. Prior to the accrual of human
subjects, a detailed data and safety monitoring plan must be submitted
to the applicant's IRB and to the funding entity for approval. Adverse
Events must be reported to the IRB, the NIH funding Institute or Center,
and other appropriate offices or agencies. This policy requirement is in
addition to any monitoring requirements imposed by [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). NIH
policy specifically requires the establishment of a Data and Safety
Monitoring Board (DSMB) for multi-site clinical trials involving
interventions that entail potential risk to the participants, and
generally for Phase III clinical trials. See also Part III, 2.1 Human
Subjects Research.

## 5.4 IRB Approval

NIH does not require certification of IRB approval of the proposed
research prior to NIH peer review of an application. See
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-031.html>.

[]{#Human_Subjects_NoIRBApproval .anchor}Following NIH peer review,
applicants and their institutions will be notified of the need for
review and approval of the proposed research by an IRB that is
registered with OHRP. See <http://www.hhs.gov/ohrp/> to register an IRB.
Certification of IRB approval must be sent to the Grants Management
Office identified in the notice requesting documentation. Certification
of IRB review and approval must include: the PHS application number,
title of the project, name of the program director /principal
investigator, date of IRB approval, and appropriate signatures. Grantees
may also use the optional form "Protection of Human Subjects - Assurance
Identification/IRB Certification/Declaration of Exemption (Common Rule)"
(OMB Form No. 0990-0263
<http://www.hhs.gov/ohrp/humansubjects/assurance/OF310.rtf>) to meet
this requirement.

The OHRP has determined that an institution is automatically considered
to be engaged in human subjects research when it receives an NIH award
to support nonexempt human subjects research. See
<http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm>. All
institutions engaged in human subjects research must obtain a Federal
Wide Assurance (FWA) from OHRP. Instructions for applying for a Federal
Wide Assurance (FWA) are available from the OHRP website at
<http://www.hhs.gov/ohrp/assurances/assurances_index.html>.

HHS human subject regulations at 45CFR46.101(f) require that each
application for non-exempt HHS-supported human subject research be
reviewed and approved by an IRB (see also
<http://www.hhh.gov/ohrp/humansubjects/guidance/aplrev.htm>). Only the
date of approval of the application should be submitted to NIH. However,
the IRB must ensure that any corresponding protocol(s) are consistent
with the application, and must maintain documentation of IRB approval of
all corresponding protocols, including those reviewed by consortium
participants.

Any modifications to the Research Plan in the application, required by
either NIH or by the IRB, must be submitted with follow-up certification
of IRB approval to the NIH before the competing award is made. It is the
responsibility of the PD/PI and the applicant organization to submit the
follow-up documentation.

If more than a year will have elapsed between the initial IRB review
date and the anticipated award date, the awarding unit staff shall
require re-review by the IRB prior to award.

## 5.5 Required Education in the Protection of Human Research Participants

NIH requires education on the protection of human research participants
for all individuals identified in PHS applications as Senior/key
Personnel who will be involved in the design or conduct of human
subjects research, before funds are awarded for applications or contract
proposals involving human subjects. For information relating to this
requirement, see the following notices
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html> and
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-061.html>,
and Frequently Asked Questions at:
<http://grants.nih.gov/grants/policy/hs_educ_faq.htm>. Prior to award,
applicants will be required to provide a description of education
completed in the protection of human subjects for all Senior/key
Personnel involved in the design or conduct of human subjects research.
Although NIH does not endorse specific programs, there are curricula
available that can provide guidance or that can be modified to provide
training in this area. See
<http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp>
for computer-based training developed for NIH that can be downloaded at
no charge. For information on facilitating education and developing
curricula, see <http://www.nih.gov/sigs/bioethics>.

## 5.6 NIH Policy on the Inclusion of Women and Minorities in Clinical Research

NIH policy requires that women and members of minority groups and their
subpopulations must be included in all NIH-supported biomedical and
behavioral research projects involving [clinical
research](#Human_Subjects_Defs_ClinicalResearch) unless a clear and
compelling rationale and justification establishes to the satisfaction
of the relevant IC Director that inclusion is inappropriate with respect
to the health of the subjects or the purpose of the research. Exclusion
under other circumstances may be made by the Director, NIH, upon the
recommendation of an IC Director based on a compelling rationale and
justification. Cost is not an acceptable reason for exclusion except
when the study would duplicate data from other sources. Women of
childbearing potential should not be routinely excluded from
participation in clinical research. All NIH-supported biomedical and
behavioral research involving human subjects is defined as clinical
research. This policy applies to research subjects of all ages.

The inclusion of women and members of minority groups and their
subpopulations must be addressed in developing a research design
appropriate to the scientific objectives of the study. The Research Plan
should describe the composition of the proposed study population in
terms of sex/gender and racial/ethnic group, and provide a rationale for
selection of such subjects. Such a plan should contain a description of
the proposed outreach programs for recruiting women and minorities as
participants. See
<http://grants.nih.gov/grants/funding/women_min/women_min.htm>.

## 5.7 NIH Policy on Inclusion of Children 

Research involving children (see definition of
"[child](#Human_Subjects_Defs_Child)") must comply with the NIH Policy
and Guidelines on the Inclusion of Children in Clinical Research.
Investigators should obtain full copies of the Policy and Guidelines
from NIH staff, or from
<http://grants.nih.gov/grants/funding/children/children.htm>.

NIH policy requires that children (i.e., individuals under the age of
21) must be included in all clinical research, conducted or supported by
the NIH unless there are clear and compelling reasons not to include
them. Therefore, proposals for clinical research must include a
description of plans for including children. If children will be
excluded from the research, the application or proposal must present an
acceptable justification for the exclusion.

The involvement of children as subjects in research must be in
compliance with all applicable subparts of [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm) as well
as with other pertinent Federal laws and regulations.

IRBs have special review requirements to protect the well-being of
children who participate in research. These requirements relate to risk,
benefit, parental/guardian consent, and assent by children, and to
research involving children who are wards of the state or of another
institution. The local IRB approves research that satisfies the
conditions set forth in the regulations.

## 5.8 NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research

The Office of Management and Budget (OMB)
(<http://www.whitehouse.gov/omb/fedreg/ombdir15.html>) defines minimum
standards for maintaining, collecting and presenting data on race and
ethnicity for all Federal reporting agencies (including NIH). The
standards were revised in 1997 and include two ethnic categories
(Hispanic or Latino and Not Hispanic or Latino) and five racial
categories (American Indian or Alaska Native, Asian, Black or African
American, Native Hawaiian or Other Pacific Islander, and White). Reports
of data on race and ethnicity shall use these categories. The categories
in this classification are social-political constructs and should not be
interpreted as being anthropological in nature. NIH is required to use
these definitions to allow comparisons to other federal databases,
especially the census and national health databases. The following
definitions apply to the minimum standards for the ethnic and racial
categories.

#### Ethnic Categories: {#ethnic-categories .Subhead---No-TOC}

**Hispanic or Latino:** A person of Cuban, Mexican, Puerto Rican, South
or Central American, or other Spanish culture or origin, regardless of
race. The term, "Spanish origin," can be used in addition to "Hispanic
or Latino."

**Not Hispanic or Latino**

#### Racial Categories:  {#racial-categories .Subhead---No-TOC}

**American Indian or Alaska Native:** A person having origins in any of
the original peoples of North, Central, or South America, and who
maintains tribal affiliation or community attachment.

**Asian:** A person having origins in any of the original peoples of the
Far East, Southeast Asia, or the Indian subcontinent including, for
example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the
Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the
Philippine Islands have been recorded as Pacific Islanders in previous
data collection strategies.)

**Black or African American:** A person having origins in any of the
black racial groups of Africa. Terms such as "Haitian" or "Negro" can be
used in addition to "Black or African American."

**Native Hawaiian or Other Pacific Islander:** A person having origins
in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific
Islands.

**White:** A person having origins in any of the original peoples of
Europe, the Middle East, or North Africa.

**Ethnic/Racial Subpopulations:** In addition to OMB ethnic and racial
categories, NIH uses the following definition for ethnic/racial
subpopulations:

Subpopulations: Each ethnic/racial group contains subpopulations that
are delimited by geographic origins, national origins, and/or cultural
differences. It is recognized that there are different ways of defining
and reporting racial and ethnic subpopulation data. The subpopulation to
which an individual is assigned depends on self-reporting of specific
origins and/or cultural heritage. Attention to subpopulations also
applies to individuals who self identify with more than one race. These
ethnic/racial combinations may have biomedical, behavioral, and/or
social-cultural implications related to the scientific question under
study.

#### Guidance on Collecting Race and Ethnicity Data from Human Subjects {#guidance-on-collecting-race-and-ethnicity-data-from-human-subjects .Subhead---No-TOC}

When an investigator is planning to collect data on ethnicity and race,
the categories identified above should be used. The collection of
greater detail is encouraged, for example on ethnic/racial
subpopulations. However, any collection that uses more detail must be
designed in a way that data can be aggregated into these minimally
required categories. Use self-report or self-identification to collect
this information by asking two separate questions -- one on ethnicity
and one on race. Collect ethnicity information first followed by the
question on race and provide subjects with the option to select more
than one racial category. An example of a format for collecting
information from study subjects in the US that meets the OMB
requirements can be found in the Ethnic Origin and Race section of the
Personal Data Form Page
<http://grants.nih.gov/grants/funding/phs398/phs398.html> in the PHS
398.

See NIH Policy on [Inclusion of Women and
Minorities](#nih-policy-on-the-inclusion-of-women-and-minorities-in-clinical-research)
and <http://grants.nih.gov/grants/funding/women_min/women_min.htm>.

## 5.9 Research on Transplantation of Human Fetal Tissue

In signing the application Face Page, the Authorized Organizational
Representative of the applicant organization certifies that if research
on the transplantation of human fetal tissue is conducted, the applicant
organization will make available, for audit by the Secretary, DHHS, the
physician statements and informed consents required by section 498A
(b)(2) and (c) of the Public Health Service Act, 42 U.S.C. 289g (b)(2)
and (c), or ensure DHHS access to those records, if maintained by an
entity other than the applicant organization.

## 5.10 Research Using Human Embryonic Stem Cells

In signing the application Face Page, the Authorized Organizational
Representative of the applicant organization certifies that if research
using human embryonic stem cells is proposed, the applicant organization
will be in compliance with the "Notice of Extended Receipt Date and
Supplemental Information Guidance for Applications Requesting Funding
that Proposes Research with Human Embryonic Stem Cells"
(<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-006.html>).
See <http://stemcells.nih.gov/index.asp> for additional information on
stem cells, and <http://stemcells.nih.gov/policy/guidelines.asp> for
Federal policy statements and guidelines on federally funded stem cell
research.

## 5.11 ClinicalTrials.gov Requirements

In signing the application Face Page, the Authorized Organizational
Representative of the applicant organization certifies that if the
research is an applicable clinical trial under Public Law 110-85, the
applicant organization will be in compliance with the registration and
reporting requirements of Public Law 110-85 (see Part III, [Section
2.1.6](#clinicaltrials.gov)).

[]{#Policy_PartIII .anchor}PART III\
\
Policies, Assurances, Definitions,\
and Other Information

# 1. Policy

## 1.1 Applications That Include Consortium/Contractual Facilities and Administrative Costs 

See:
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html>.

NIH policy provides for exclusion of consortium/contractual F&A when
determining if an applicant is in compliance with a direct cost
limitation. This policy extends to all applications involving
consortium/contractual facilities and administrative (F&A) costs,
regardless of budget amount or budget format (e.g., modular and
non-modular). (See also Notice
[OD-04-040](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html).)

This policy applies to all solicited and investigator-initiated
applications and to all currently active announcements (Request for
Applications and Program Announcements), regardless of the announcement
issue date.

This policy is particularly relevant to all applications that include a
limitation on direct costs. While consortium F&A costs will continue to
be requested and awarded, applicants will now separate these costs when
determining if a budget exceeds a direct cost limit.

This policy impacts eligibility to submit a modular budget. The modular
budget format is used for applications requesting \$250,000 or less in
direct costs per year. Consortium/contractual F&A costs are not factored
into this direct cost limit, however, they may be requested in addition
to the \$250,000.

The policy also impacts applications requesting a budget of \$500,000
direct costs or more for any year. These applications require prior
approval from Institute/Center staff; however, the limit is exclusive of
any consortium F&A costs.

The implications of this policy do not affect the Small Business
Innovation Research (SBIR) and Small Business Technology Transfer (STTR)
programs since the statutory budget guidelines are based on total costs,
not direct costs.

## 1.2 Resubmission of Unpaid RFA Applications and Resubmission of Applications with a Changed Grant Activity Code

See
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-019.html>.

The majority of grant applications submitted to NIH each year are
investigator-initiated. However, the Institutes and Centers of NIH also
solicit grant applications on specific topics through the use of
Requests for Applications (RFAs). Resubmissions of grant applications
fall into the following categories:

1\. Applications that were originally submitted in response to an RFA
and then resubmitted as an investigator-initiated application.

2\. Applications that were originally submitted as
investigator-initiated applications and subsequently resubmitted in
response to an RFA.

3\. Applications that were originally submitted using one activity code
and subsequently resubmitted using a different activity code (for
example, an application that was originally an R01 and is resubmitted as
an R21).

Since an RFA often has special considerations of eligibility, scientific
scope, and review criteria, unfunded RFA applications must be
resubmitted as **new** applications to another FOA. Similarly, a change
of activity code (e.g., from an R01 to an R21, or from an R03 to an R01)
usually involves a change of eligibility criteria, application
characteristics, dollar limits, time limits, or review criteria. This
also suggests that consideration as a new application is the most
appropriate course. Because the application will be new it will be
easier to conform to the new application requirements, which should be
an advantage to the applicant in the review process. Additionally,
submission of a new application will allow the applicant to benefit
fully from the NIH policy that allows an applicant one resubmission (see
<http://grants.nih.gov/grants/policy/amendedapps.htm>).

NEW APPLICATIONS: The new application must be submitted on the scheduled
due dates for new applications (see
<http://grants.nih.gov/grants/funding/submissionschedule.htm>). Do
**not** include an Introduction describing the changes and improvements
made and do **not** mark text to indicate the changes. Although the
investigator may still benefit from the previous review, the applicant
should not explicitly address reviewers' comments. The reviewers will
not be provided with the previous Summary Statement. The investigator
will be allowed to submit the new application and one resubmission of
the application, should that be necessary.

POLICY: This general policy on application resubmission, stated below,
applies to all grant mechanisms that might be solicited via an RFA and
to instances where there is a change in activity code. There may,
however, be exceptions to this policy, which will be clearly identified
in the original RFA or in a follow-up RFA.

1\. When an application that was submitted in response to an RFA is not
funded and the investigator wishes to resubmit an application on this
topic as an investigator-initiated application, it is to be submitted as
a **new** application, unless provision for a resubmission is clearly
delineated in the RFA. In addition, if a subsequent RFA specifically
solicits resubmissions of unfunded applications from a previous RFA, the
instructions in the second RFA should be followed. In all other cases,
an application submitted in response to an RFA and then resubmitted as
an investigator-initiated application must be prepared as a **new**
application.

2\. When a previously unfunded application that was originally submitted
as an investigator-initiated application is to be submitted in response
to an RFA, it is to be prepared as a **new** application.

3\. When an unfunded application that was reviewed for a particular
research grant mechanism (for example, R01) is to be submitted for a
different grant mechanism (for example, R03), it is to be prepared as a
**new** application.

## 1.3 NIH Policy on Resubmission Applications

See:
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html>.

For all original new (i.e., never submitted) and competing renewal
applications submitted for the January 25, 2009 due date and beyond, NIH
will accept only a single amendment (A1) to the application (called a
"resubmission" application).There is no time limit for the resubmission
application. Any second resubmission will be administratively withdrawn
and not accepted for review. For original new and competing renewal
applications submitted prior to January 25, 2009, applicants are
permitted two resubmissions (A1 and A2). For these "grandfathered"
applications, any second resubmission (A2) must be submitted no later
than January 7, 2011, and NIH will not accept any A2 resubmissions after
that date. This resubmission policy applies to all NIH extramural
applications.

See
[NOT-OD-07-083](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-083.html)
for special conditions and due dates for new investigator resubmission
applications submitted for consecutive review cycles. Note this applies
only to new investigator R01s submitted for standard receipt dates and
reviewed in recurring study sections in CSR.

Although there is no time limit for the A1 resubmission, a lengthy
hiatus after the initial submission may be marked by significant
advances in the scientific field and the comments of the reviewers may
no longer be relevant. PD/PIs and their institutions need to exercise
their best judgment in determining the advisability of a Resubmission
application after several years have elapsed.

The policy limiting the number of Resubmissions was established
following analysis of data indicating that investigators who receive
initial funding for a resubmitted application have a lower success rate
in obtaining support for a subsequent Renewal application. The
likelihood of subsequent success decreased with an increasing number of
Resubmissions.

Investigators who have submitted three versions of an application and
have not been successful often ask NIH staff how different the next
application submitted has to be to be considered a new application. It
is recognized that investigators are trained in a particular field of
science and are not likely to make drastic changes in their research
interests; however, a new application following three reviews is
expected to be substantially different in content and scope with more
significant differences than are normally encountered in a Resubmission
application. Simply re-wording the title and/or Specific Aims or
incorporating minor changes in response to comments in the previous
Summary Statement does not constitute a substantial change in scope or
content. Changes to the Research Plan should produce a significant
change in direction and approach for the research project. Thus, a new
application would include substantial changes in all sections of the
Research Plan, particularly the Specific Aims and the Research Design
and Methods sections.

In the referral process, NIH staff look at all aspects of the
application, not just the title and description (abstract). Requesting
review by a different review committee does not affect the
implementation of this policy. When necessary, previous applications are
analyzed for similarities to the present one. Thus, identical
applications or those with only minor changes will not be accepted for
review.

## 1.4 Policy on the Acceptance for Review of Unsolicited Applications That Request \$500,000 or More in Direct Costs

Applicants must seek agreement to accept assignment from
Institute/Center staff at least six weeks prior to the anticipated
submission of any application requesting \$500,000 or more in direct
costs for any year. Note that for the purposes of determining whether
this policy applies, this \$500,000 limit excludes any consortium F&A
costs.

See
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html>.

The NIH supports research projects with large budgets but needs to
consider such awards as early as possible in the budget and program
planning process. Regardless of the merit of the application or the
budget justification, unanticipated requests for unusually high amounts
of direct costs are difficult for NIH to manage. It is in the best
interest of all parties if applicants anticipating large direct costs
contact the appropriate NIH program staff as early as possible to ensure
that an Institute/Center (IC) would be willing to accept the
application.

Applicants must seek agreement from IC staff at least six weeks prior to
the anticipated submission of any application requesting \$500,000 or
more in direct costs for any year. Note for the purposes of determining
whether or not this policy applies, this limit excludes any consortium
F&A costs (see
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html>).
If the proposed budget excluding consortium F&A costs equals or exceeds
the \$500,000 level, then prior approval is required. If staff is
contacted less than six weeks before submission, there may be
insufficient time to make a determination about assignment prior to the
intended submission date. If the requested dollars are significantly
greater than \$500,000, then approval should be sought even earlier.

This prior acceptance policy does not apply to applications submitted in
response to RFAs or in response to other Announcements that include
specific budgetary limits. Such applications must be responsive to any
budgetary limits specified; however, any specified budgetary limit
excludes consortium F&A costs.

PROCEDURES

-   An applicant planning to submit a grant application with \$500,000
    or more in direct costs for any year (excluding consortium F&A
    costs) is required to contact in writing or by telephone NIH IC
    program staff. This contact should be made during the development
    process of the application but no later than six weeks before the
    anticipated submission date. If the IC is willing to accept
    assignment of the application for consideration of funding, the
    staff will notify the Center for Scientific Review before the
    application is submitted.

-   The PD/PI must include a cover letter with the application. That
    cover letter must identify the program staff member contacted and
    the Institute/Center that has agreed to accept assignment of the
    application.

-   An application received without indication of prior staff
    concurrence and identification of program staff contacted will be
    returned to the applicant without review. Therefore, NIH strongly
    encourages applicants to contact appropriate IC staff at the
    earliest possible time.

For additional information about this policy, contact the program staff
at any Institute/Center. Applicants who are uncertain about which IC may
have the greatest interest in the research for which support is sought
should contact the NIH CSR Receipt and Referral Office at (301)
435-0715.

## 1.5 Sharing Research Resources

[]{#Policy_DataSharing .anchor}Investigators conducting biomedical
research frequently develop unique research resources. NIH considers the
sharing of such unique research resources (also called research tools)
an important means to enhance the value of NIH-sponsored research.
Restricting the availability of unique resources can impede the
advancement of further research. Therefore, when these resources are
developed with NIH funds and the associated research findings have been
published or after they have been provided to NIH, it is important that
they be made readily available for research purposes to qualified
individuals within the scientific community. At the same time NIH
recognizes the rights of grantees and contractors to elect and retain
title to subject inventions developed with federal funding pursuant to
the Bayh Dole Act. See the NIH Grants Policy Statement, and the Office
of Extramural Research, Division of Extramural Inventions & Technology
Resources (DEITR), Intellectual Property Policy page:
[http://inventions.nih.gov](http://inventions.nih.gov/).

The adequacy of resource sharing plans are considered by reviewers when
a competing application is evaluated. Reviewers are asked to describe
their assessment of the sharing plan in an administrative note, and will
not normally include their assessment in the overall priority score.
Program staff are responsible for overseeing resource sharing policies
and for assessing the appropriateness and adequacy of any proposed
resource sharing plans.

### 1.5.1 Data Sharing Policy

All investigator-initiated applications with direct costs of \$500,000
or greater in any single year are expected to address data-sharing in
their application. Applicants are encouraged to discuss data-sharing
plans with their program contact at the time they negotiate an agreement
with the Institute/Center (IC) staff to accept assignment of their
application as described at [http://grants.nih.gov/grants/guide/
notice-files/NOT-OD-02-004.html](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html).

Applicants are reminded that agreement to accept assignment of
applications \$500,000 or greater must be obtained at least six weeks in
advance of the anticipated submission date. Instructions related to the
data-sharing policy as it is applied to applications and proposals
responding to a specific Request for Application (RFA) or Request for
Proposals (RFP) will be described in the specific solicitation. In some
cases, other Funding Opportunity Announcements (FOAs) may request
data-sharing plans for applications that are less than \$500,000 direct
costs in any single year.

NIH recognizes that in some cases data-sharing may be complicated or
limited by institutional policies, local IRB rules, as well as local,
state and Federal laws and regulations, including the HIPAA Privacy
Rule. The rights and privacy of individuals who participate in
NIH-sponsored research must be protected at all times. Thus, data
intended for broader use should be free of identifiers that would permit
linkages to individual research participants and variables that could
lead to deductive disclosure of the identity of individual subjects.
When data-sharing is limited, applicants should explain such limitations
in their data-sharing plans.

For more information on data-sharing, please see:
[http://grants.nih.gov/grants/
policy/data_sharing/](http://grants.nih.gov/grants/policy/data_sharing/)
and the [NIH Final Policy on Sharing Research
Data](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html).

### 1.5.2 Sharing Model Organism Policy

All applications where the development of model organisms is anticipated
are expected to include a description of a specific plan for sharing and
distributing unique model organism research resources generated using
NIH funding so that other researchers can benefit from these resources,
or state appropriate reasons why such sharing is restricted or not
possible. Model organisms include but are not restricted to mammalian
models, such as the mouse and rat; and non-mammalian models, such as
budding yeast, social amoebae, round worm, fruit fly, zebra fish, and
frog. Research resources to be shared include genetically modified or
mutant organisms, sperm, embryos, protocols for genetic and phenotypic
screens, mutagenesis protocols, and genetic and phenotypic data for all
mutant strains.

This expectation is for **all** applications where the development of
model organisms is anticipated, regardless of funding amount.

For additional information on this policy, see the NIH Model Organism
for Biomedical Research Website at: <http://www.nih.gov/science/models/>
and NIH Guide Notices OD-04-042:
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html>,
and OD-04-066:
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-066.html>.

### 1.5.3 Policy for Genome-Wide Association Studies (GWAS)

NIH is interested in advancing genome-wide association studies (GWAS) to
identify common genetic factors that influence health and disease
through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of
genetic variation across the entire human genome that is designed to
identify genetic associations with observable traits (such as blood
pressure or weight), or the presence or absence of a disease or
condition.

All applications, regardless of the amount requested, proposing a
genome-wide association study are expected to provide a plan for
submission of GWAS data to the NIH-designated GWAS data repository, or
provide an appropriate explanation why submission to the repository is
not possible. Data repository management (submission and access) is
governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, [NIH Guide
NOT-OD-07-088](http://www.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
For additional information see: <http://grants.nih.gov/grants/gwas/>.

## 1.6 Inventions and Patents

NIH Grants Policy and Federal law require NIH recipient organizations to
promptly report all inventions that are either conceived or first
actually reduced to practice using NIH funding. Invention reporting
compliance is described at
[http://www.iedison.gov](http://www.iedison.gov/). Grantees are
encouraged to submit reports electronically using Interagency Edison
([http://www.iedison.gov](http://www.iedison.gov/)). Information from
these reports is retained by the NIH as confidential and submission does
not constitute any public disclosure. Failure to report as described at
37 CFR Section 401.14 is a violation of 35 U.S.C. 202 and may result in
loss of the rights of the recipient organization. Inquiries or
correspondence should be directed to **Division of Extramural Inventions
and Technology Resources, Office of Policy for Extramural Research
Administration, OER, NIH, 6705 Rockledge Dr., Suite 310, MSC 7980,
Bethesda, MD 20892-7980, Telephone: (301) 435-1986.**

## 1.7 Just-In-Time Policy

Several elements of an application are not required at the time the
application is submitted. Instead, this information is requested later
in the review cycle (i.e., "just-in-time") to minimize burden to
institutions and to ensure that the information is current. The
information eligible for just-in-time submission includes:

-   Current Other Support: See 1.8 [Other Support](#Section_7_4_7)
    policy information below. Use the sample format provided on the
    Other Support Format Page ([MS
    WORD](http://grants.nih.gov/grants/funding/phs398/othersupport.doc)
    or
    [PDF](http://grants.nih.gov/grants/funding/phs398/othersupport.pdf)).
    For all Senior/key Personnel, provide details on adjustment of any
    budgetary, scientific, or effort overlap if the application is
    funded.

    For Career Development Award applicants, information on all active
    support for the candidate, mentor(s), co-mentor(s), and Senior/key
    Personnel may be requested by the awarding component prior to award.

-   Certifications:

```{=html}
<!-- -->
```
-   If research involving human subjects is proposed, the Federal-wide
    Assurance number (if not previously provided) and the Certification
    of IRB Review and Approval of the research proposed in the
    application. Pending or out-of-date approvals cannot be accepted.
    See [Part II.5.4 IRB Approval](#Section_7_4_7).

-   If research involving live vertebrate animals is proposed, Animal
    Welfare Assurance number of the applicant organization, date of
    IACUC approval of the research proposed in the application, and any
    IACUC-imposed changes. Pending or out-of-date approvals cannot be
    accepted. IACUC approval must be dated within the last three years
    to be valid.

```{=html}
<!-- -->
```
-   Human Subjects Education: For applications that propose human
    subjects research, certification that each person identified as
    Senior/key Personnel involved in the design or conduct of research
    involving human subjects has completed an educational program in the
    protection of human subjects. For further information refer to the
    separate section on [Required Education in the Protection of Human
    Research Participants](#Section_7_4_7) in Part II, 5.5.

-   Applicants for **Research Career Development Awards** will be asked
    to provide detailed, categorical budget and narrative justification
    pages (Form Page 4 and Form Page 5) prior to award.

Applicants are advised to submit just-in-time information only when
requested by the awarding component. Guidance for submitting this
information will be provided at the time of the request. Alternatively,
this information may be submitted using the Just-In-Time feature of the
eRA Commons found in the **Status** section. For information on the
Commons see: [https://commons.era.nih.gov/
commons/index.jsp](https://commons.era.nih.gov/commons/index.jsp).

## 1.8 Other Support

Do not submit information on Other Support with the application beyond
that required in the biographical sketch. See 1.7 Just-in-Time Policy.

Information on Other Support is required for all applications that are
to receive grant awards; NIH will request complete and up to date
information from applicants at an appropriate time *after peer review*.
The Institute/Center scientific program and grants management staff will
review this information prior to award.

Do not confuse Research Support with Other Support. Though they sound
similar, these parts of the application are distinctly different. As
part of the biosketch section of the application, Research Support
highlights your accomplishments, and those of your colleagues, as
scientists. This information will be used by the reviewers in the
assessment of each individual's qualifications for a specific role in
the proposed project, as well as to evaluate the overall qualification
of the research team. In contrast, Other Support information is required
for all applications that are selected to receive grant awards and
includes detailed financial information. NIH staff will request complete
and up-to-date "other support" information *after* peer review. This
information will be used to check that the proposed research is not
already funded through other sources.

#### Other Support Policy {#other-support-policy .Subhead---No-TOC}

Other Support includes all financial resources, whether Federal,
non-Federal, commercial or institutional, available in direct support of
an individual's research endeavors, including but not limited to
research grants, cooperative agreements, contracts, and/or institutional
awards. Training awards, prizes, or gifts are not included.

Information on Other Support assists awarding agency staff in the
identification and resolution of potential overlap of support. Overlap,
whether scientific, budgetary, or commitment of an individual's effort
greater than 100 percent (i.e., 12 person months), is not permitted. The
goals in identifying and eliminating overlap are to ensure that
sufficient and appropriate levels of effort are committed to the
project; that there is no duplication of funding for scientific aims,
specific budgetary items, or an individual's level of effort; and that
only funds necessary to the conduct of the approved project are included
in the award.

Budgetary overlap occurs when duplicate or equivalent budgetary items
(e.g., equipment, salary) are requested in an application but are
already provided for by another source.

Commitment overlap occurs when a person's time commitment exceeds 100
percent (i.e., 12 person months), whether or not salary support is
requested in the application. While information on other support is only
requested for Senior/key Personnel (excluding consultants), no
individuals on the project may have commitments in excess of 100 percent
or 12 person months.

Scientific overlap occurs when: (1) substantially the same research is
proposed in more than one application or is submitted to two or more
different funding sources for review and funding consideration, or (2) a
specific research objective and the research design for accomplishing
that objective are the same or closely related in two or more
applications or awards, regardless of the funding source. Potential
scientific overlap is to be addressed by the SRG *only* by its
identification in an Administrative Note in the Summary Statement.

**Resolution of Overlap.** Resolution of overlap occurs at the time of
award in conjunction with applicant institution officials, the PD/PI,
and awarding agency staff.

## 1.9 Graduate Student Compensation

The maximum amount NIH will award for the support of a graduate student
on a research grant or a cooperative agreement is tied to the National
Research Service Award (NRSA) zero-level stipend in effect at the time
the grant award is issued. The schedule for NRSA stipends can be found
at <http://grants.nih.gov/training/nrsa.htm>. Consistent with cost
principles for educational institutions described in Office of
Management and Budget (OMB) Circular A-21 at section J.41.b
([http://www.whitehouse.gov/omb/
circulars/a021/a021.html](http://www.whitehouse.gov/omb/circulars/a021/a021.html)),
the compensation of graduate students supported by research grants must
be reasonable. These operating principles associated with the
compensation of students performing necessary work on NIH funded
research projects are described in detail in the *NIH Grants Policy
Statement* at
<http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm>. The
amount provided for compensation includes salary or wages, fringe
benefits, and tuition remission.

These guidelines apply to graduate students at the grantee institution
who are supported by NIH research grants and cooperative agreements and
not to individuals supported by NRSA training grants and fellowships.
NIH has separate appropriations to support research training under the
NRSA authorization at Section 487 of the Public Health Service Act.

The stipends provided to recipients of NRSA support offset the
cost-of-living during the period of training and are not considered
equivalent to salaries or other forms of compensation provided to
individuals supported on research grants. Nevertheless, the entry-level
postdoctoral NRSA stipend provides a useful benchmark for an award
amount that approximates a reasonable rate of compensation for graduate
students. Anticipated escalations in NRSA stipends (see
<http://grants.nih.gov/training/nas_report/NIHResponse.htm>) in future
years should permit annual increases in the maximum award amount for
such individuals.

For all new and competing grant and cooperative agreement awards, the
NIH will provide reasonable amounts for graduate compensation,
consistent with the requested budget for the position(s) and up to the
currently effective NRSA zero postdoctoral stipend level. NIH staff will
review the compensation requested for graduate students on competing and
cooperative agreement applications for which a detailed budget is
submitted. NIH will neither request nor accept budgets for those
applications using a modular budget format solely for the purpose of
reviewing graduate student compensation. However, applicants should use
this policy when estimating the number of modules.

When submitting detailed budgets that request support for a graduate
student, grantees are reminded to request actual institutional-based
compensation and to provide information justifying the requested
compensation level. If this information is not provided, NIH staff will
obtain this information from the institution\'s business office for any
request that appears excessive.

NIH institutes and centers will review the requested compensation level
and, if considered reasonable, will award the actual amount requested,
up to a maximum equal to the NRSA zero level postdoctoral stipend.
Revised budgets submitted solely to adjust requested levels for graduate
students will not be accepted.

Institutions may continue to rebudget funds to charge more than the
awarded amount provided that OMB cost principles requiring reasonable
compensation are observed. In general, graduate student compensation
will not be considered reasonable if in excess of the amount paid to a
first-year postdoctoral scientist at the same institution performing
comparable work.

## 1.10 DUNS Number

Applicant organizations **must** have a DUN and Bradstreet (D&B) Data
Universal Numbering System (DUNS) number as the Universal Identifier
when applying for Federal grants or cooperative agreements. See
instructions in Part I, Section 4.1, [item
11](#item-11.-entity-identification-number-duns-number-congressional-district).

## 1.11 Public Access Policy

The Public Access Policy ensures that the public has access to the
published results of NIH funded research at the NIH National Library of
Medicine\'s (NLM) PubMed Central (PCM), a free digital archive of
full-text biomedical and life sciences journal literature
\[[http://www.pubmedcentral.nih.gov/](http://www.pubmedcentral.nih.gov/index.html)\].
Under the Policy NIH-funded investigators are required by Federal law to
submit (or have submitted for them) to PMC an electronic version of the
final, peer-reviewed manuscript upon acceptance for publication, to be
made publicly available no later than 12 months after the official date
of publication. The author\'s final peer-reviewed manuscript is defined
as the final version accepted for journal publication on or after
4/7/2008, and includes all modifications from the publishing peer review
process, and all graphics and supplemental material associated with the
article. Institutions and investigators are responsible for ensuring
that any publishing or copyright agreements concerning submitted
articles fully comply with this Policy. Applicants citing articles in
NIH applications, proposals, and progress reports that fall under the
Policy, were authored or co-authored by the applicant and arose from NIH
support must include the PubMed Central reference number (PCMID) or NIH
Manuscript Submission reference number (NIHMS ID).

This policy applies to all peer-reviewed articles resulting from
research supported in whole or in part with direct costs from NIH,
including research grant and career development award mechanisms,
cooperative agreements, contracts, Institutional and Individual Ruth L.
Kirschstein National Research Service Awards, SBIR/STTR awards, and NIH
intramural research studies.

Additional information can be found at:
[http://publicaccess.nih.gov/.](http://publicaccess.nih.gov/)

## 1.12 PHS Metric Program

Consistent with Government-wide implementing regulations, 15 CFR Part
19, Subpart B and/or any other Government-wide requirements, PHS policy
is to support Federal transition to the metric system and to use the
metric system of measurement in all grants, cooperative agreements, and
all other financial assistance awards. Likewise, measurement values in
reports, publications, and other communications regarding grants will be
in metric.

## 1.13 Transition to the SF424 (R&R) Application and Electronic Submission through Grants.gov

As first announced in August 2005
([NOT-OD-05-067](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-067.html)),
NIH is transitioning from the PHS 398 application to the SF424 (R&R)
application and electronic submission through Grants.gov. This
transition is being done by grant mechanism. Applicants should refer to
the Timeline to determine when a particular mechanism has transitioned
to the new form and electronic submission. Information on Transition
Strategy and Timeline can be found at:
<http://era.nih.gov/ElectronicReceipt/strategy_timeline.htm>.

For more information on NIH's transition plans, see the website for
Electronic Submission of Grant Applications:
<http://era.nih.gov/ElectronicReceipt/>.

# 2. Assurances and Certifications

Each application to the PHS requires that the following assurances and
certifications be verified by the signature of the Official Signing for
Applicant Organization on the Face Page of the application.

The assurances listed and explained below may or may not be applicable
to the project, program, or type of applicant organization. There are a
number of additional public policy requirements with which applicants
and grantees must comply. Contact the institution\'s research grant
administrative office or consult the *NIH Grants Policy Statement* for
additional information. A copy of the [NIH Grants Policy
Statement](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm)
may be obtained from the NIH website
(<http://grants.nih.gov/grants/policy/policy.htm>). In signing the
application Face Page, the Authorized Organizational Representative of
the applicant organization certifies that the applicant organization
will comply with the following policies, assurances and/or
certifications:

[Human Subjects Research](#human-subjects-research)

[Research on Transplantation of Human Fetal
Tissue](#research-on-transplantation-of-human-fetal-tissue-1)

[Research Using Human Embryonic Stem Cells](#Section_7_4_7)

[Women and Minority Inclusion Policy](#Section_7_4_7)

[Inclusion of Children Policy](#Section_7_4_7)

[ClinicalTrials.gov Requirements](#clinicaltrials.gov)

[Vertebrate Animals](#vertebrate-animals-2)

[Debarment and Suspension](#debarment-and-suspension)

[Drug-Free Workplace](#drug-free-workplace)

[Lobbying](#Section_7_4_7)

[Non-Delinquency on Federal Debt](#Section_7_4_7)

[Research Misconduct](#Section_7_4_7)

[Civil Rights](#Section_7_4_7)

[Handicapped Individuals](#Section_7_4_7)

[Sex Discrimination](#Section_7_4_7)

[Age Discrimination](#Section_7_4_7)

[Recombinant DNA, including Human Gene Transfer
Research](#Section_7_4_7)

[Financial Conflict of Interest](#financial-conflict-of-interest)

[Smoke-Free Workplace](#Section_7_4_7)

[Prohibited Research](#Assur_Prohib_Res)

[Select Agent Research](#select-agent-research-2)

[Program Director/Principal Investigator(s)
Assurance](#program-directorprincipal-investigator-assurance)

[Impact of Grant Activities on the Environment and Historic
Properties](#impact-of-grant-activities-on-the-environment-and-historic-properties)

## 2.1 Human Subjects Research

(See also [Part II: Supplemental Instructions for Preparing the
Protection of Human Subjects Section of the Research
Plan](#Human_Subjects_PartII).)

The DHHS regulations for the protection of human subjects provide a
systematic means, based on established, internationally recognized
ethical principles, to safeguard the rights and welfare of individuals
who participate as subjects in research activities supported or
conducted by the DHHS. The regulations stipulate that the awardee
organization, whether domestic or foreign, bears responsibility for
safeguarding the rights and welfare of human subjects in DHHS-supported
research activities. The regulations require that applicant
organizations proposing to involve human subjects in non-exempt research
hold a Federal-wide Assurance (FWA) with the [Office for Human Research
Protections (OHRP)](http://www.hhs.gov/ohrp/), and establish appropriate
policies and procedures for the protection of human subjects. These
regulations, [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm),
Protection of Human Subjects, are available from the OHRP, Department of
Health and Human Services, The Tower Building, 1101 Wootton Parkway,
Suite 200, Rockville, MD 20852; telephone: 1-866-447-4777 (toll-free) or
(240) 453-6900; email: <ohrp@osophs.dhhs.gov>.

Non-exempt research involving human subjects may only be conducted under
a DHHS award if the organization is operating in accord with an approved
FWA and provides verification that an Institutional Review Board (IRB)
that is registered under the specific FWA has reviewed and approved the
proposed activity in accordance with the DHHS regulations. No award to
an individual will be made unless that individual is affiliated with an
assured organization that accepts responsibility for compliance with the
DHHS regulations. Foreign applicant organizations must also comply with
the provisions of the regulations unless a determination of equivalent
protections is made in accord with 45 CFR 46.101(h).

Under DHHS regulations to protect human subjects, certain research areas
are exempt. (See [Exemption Categories](#Human_Subjects_Exemption_Cat)).
With the exception of research projects that meet the criteria for
Exemption 4, studies that are exempt from the human subjects regulatory
requirements must still address the inclusion of women, minorities and
children in the study design.

Regulations of the Food and Drug Administration (21 CFR 50; 21 CFR 56)
generally apply to biomedical research involving an unapproved drug,
device or biologic, and may apply to certain studies of approved
products. Additional information on FDA regulations is available at
<http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm>.
If work falls under FDA's regulatory requirements, the grantee must
follow both DHHS and FDA human subject protection regulations.

#### Vulnerable Populations

Investigators who conduct research involving pregnant women, human
fetuses and neonates, prisoners, or children, must follow the provisions
of the regulations in Subparts
[B](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartb),
[C](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartc),
and
[D](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd)
of [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm),
respectively. The subparts describe the additional protections required
for conducting research involving these populations. Relevant
information may be obtained at the OHRP website
(<http://www.hhs.gov/ohrp/policy/index.html>).

REMINDER: DHHS regulations at [45 CFR Part 46, subpart
C](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartc)
describe requirements for additional protections for research involving
prisoners as subjects *or* individuals who become prisoners after the
research has started. Refer to:
[[http://www.hhs.gov/ohrp/humansubjects/guidance/prisoner.htm]{.underline}](http://www.hhs.gov/ohrp/humansubjects/guidance/prisoner.htm)
for complete instructions.

[Exemptions 1-6](#Human_Subjects_Exemption_Cat) (see Exemptions under
Human Subjects Research Definitions and Terms, Part III.3) do **not**
apply to research involving prisoners or subjects who become prisoners
([see Subpart
C](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartc)).
Although Exemptions 1 and 3-6 apply to research involving children ([see
Subpart
D](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd)),
[Exemption 2](#Human_Subjects_Exemption2) can only be used for research
involving educational testing or observations of public behavior when
the investigator(s) do not participate in the activities being observed.

#### Data and Safety Monitoring

For each proposed clinical trial, NIH requires a data and safety
monitoring plan that describes oversight and monitoring to ensure the
safety of participants and the validity and integrity of the data. The
level of monitoring should be commensurate with the risks and the size
and complexity of the clinical trial. Prior to the accrual of human
subjects, a detailed data and safety monitoring plan must be submitted
to the applicant's IRB and to the funding entity for approval. Adverse
Events must be reported to the IRB, the NIH funding Institute or Center,
and other appropriate offices or agencies. This policy requirement is in
addition to any monitoring requirements imposed by [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

NIH Policy specifically requires the establishment of Data and Safety
Monitoring Boards (DSMBs) for multi-site clinical trials involving
interventions that entail potential risk to the participants, and
generally for Phase III clinical trials. A DSMB also may be appropriate
for clinical trials if the studies are blinded (masked), employ
high-risk interventions, or involve vulnerable populations.

Summary reports of adverse events must be provided to the NIH funding IC
and to individual IRBs in order for them to address reports related to
the site for which they have responsibility. Grantees should address
questions on this subject to the NIH Program Official.

Further information concerning these requirements is contained in
several *NIH Guide for Grants and Contracts* notices
(<http://grants.nih.gov/grants/guide/notice-files/not98-084.html> and
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html>).

#### Required Education in the Protection of Human Research Participants

NIH requires education on the protection of human research participants
for all individuals identified in PHS applications as Senior/key
Personnel who will be involved in the design or conduct of human
subjects research, before funds are awarded for applications or contract
proposals involving human subjects. For information relating to this
requirement, see the following notices:
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html> and
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-061.html>,
and Frequently Asked Questions at
<http://grants.nih.gov/grants/policy/hs_educ_faq.htm>. Prior to award,
applicants will be required to provide a description of education
completed in the protection of human subjects for all Senior/key
Personnel involved in the design or conduct of human subjects research.
Although NIH does not endorse specific programs, there are curricula
available that can provide guidance or that can be modified to provide
training in this area. See
<http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp>
for computer-based training developed for NIH that can be downloaded at
no charge. For information on facilitating education and developing
curricula, see <http://www.nih.gov/sigs/bioethics>.

### 2.1.1 Research on Transplantation of Human Fetal Tissue

In signing the application Face Page, the Authorized Organizational
Representative of the applicant organization certifies that if research
on the transplantation of human fetal tissue is conducted, the applicant
organization will make available, for audit by the Secretary, DHHS, the
physician statements and informed consents required by section 498A
(b)(2) and (c) of the Public Health Service Act, 42 U.S.C. 289g (b)(2)
and (c), or ensure DHHS access to those records, if maintained by an
entity other than the applicant organization.

### 2.1.2 Research Using Human Embryonic Stem Cells

In signing the application Face Page, the Authorized Organizational
Representative of the applicant organization certifies that if research
using human embryonic stem cells is proposed, the applicant organization
will be in compliance with the "Notice of Extended Receipt Date and
Supplemental Information Guidance for Applications Requesting Funding
that Proposes Research with Human Embryonic Stem Cells"
(<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-006.html>).
See also <http://stemcells.nih.gov/index.asp> for additional guidance on
stem cells and <http://stemcells.nih.gov/policy/guidelines.asp> for
Federal policy statements and guidelines on federally funded stem cell
research.

### 2.1.3 NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research

NIH policy requires that women and members of minority groups and their
subpopulations must be included in all NIH-supported biomedical and
behavioral research projects involving [clinical
research](#Human_Subjects_Defs_ClinicalResearch) unless a clear and
compelling rationale and justification establishes to the satisfaction
of the relevant IC Director that inclusion is inappropriate with respect
to the health of the subjects or the purpose of the research. Exclusion
under other circumstances may be made by the Director, NIH, upon the
recommendation of an IC Director based on a compelling rationale and
justification. Cost is not an acceptable reason for exclusion except
when the study would duplicate data from other sources. Women of
childbearing potential should not be routinely excluded from
participation in clinical research. All NIH-supported biomedical and
behavioral research involving human subjects is defined as clinical
research. This policy applies to research subjects of all ages.

The inclusion of women and members of minority groups and their
subpopulations must be addressed in developing a research design
appropriate to the scientific objectives of the study. The Research Plan
should describe the composition of the proposed study population in
terms of sex/gender and racial/ethnic group, and provide a rationale for
selection of such subjects. Such a plan should contain a description of
the proposed outreach programs for recruiting women and minorities as
participants. See
<http://grants.nih.gov/grants/funding/women_min/women_min.htm>.

### 2.1.4 NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research

See NIH Policy on Reporting Ethnicity/Race and Sex/Gender in Clinical
Research in [Part II,
5.8](#nih-policy-on-reporting-race-and-ethnicity-data-subjects-in-clinical-research).

The Office of Management and Budget (OMB) defines minimum standards for
maintaining, collecting, and presenting data on race and ethnicity for
all grant, contract, and intramural proposals and for all active
research grants, cooperative agreements, contracts, and intramural
projects. The minimum standards are described in the 1997 OMB Directive
15, <http://www.whitehouse.gov/omb/fedreg/ombdir15.html>.

The standards were revised in 1997 and include two ethnic categories
(Hispanic or Latino, and Not Hispanic or Latino) and five racial
categories (American Indian or Alaska Native, Asian, Black or African
American, Native Hawaiian or Other Pacific Islander, and White). The
categories in this classification are social-political constructs and
should not be interpreted as being anthropological in nature. NIH is
required to use these definitions to allow comparisons to other Federal
databases, especially the census and national health databases. Federal
agencies will not present data on detailed categories if doing so would
compromise data quality or confidentiality standards.

Collection of this information and use of these categories is required
for research that meets the NIH definition of [clinical
research](#Human_Subjects_Defs_ClinicalResearch). See Part II, 5.8 for
additional information.

### 2.1.5 NIH Policy on Inclusion of Children

Research involving children (see definition of
"[child](#Human_Subjects_Defs_Child)") must comply with the NIH Policy
and Guidelines on the Inclusion of Children in Clinical Research.
Investigators should obtain full copies of the Policy and Guidelines
from NIH staff, or from
<http://grants.nih.gov/grants/funding/children/children.htm>.

NIH policy requires that children (i.e., individuals under the age of
21) must be included in all clinical research, conducted or supported by
the NIH unless there are clear and compelling reasons not to include
them. Therefore, proposals for clinical research must include a
description of plans for including children. If children will be
excluded from the research, the application or proposal must present an
acceptable justification for the exclusion.

The involvement of children as subjects in research must be in
compliance with all applicable subparts of [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm) as well
as with other pertinent Federal laws and regulations.

IRBs have special review requirements to protect the well-being of
children who participate in research. These requirements relate to risk,
benefit, parental/guardian consent, and assent by children, and to
research involving children who are wards of the state or of another
institution. The local IRB approves research that satisfies the
conditions set forth in the regulations.

### 2.1.6 ClinicalTrials.gov

In signing the application Face Page, the Authorized Organizational
Representative of the applicant organization assures compliance with
Public Law 110-85, enacted 09/27/2007, if applicable
(<http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf>).
The law amends the Public Health Service Act to expand the scope of
clinical trials that must be registered in ClinicalTrials.gov. It also
increases the number of registration fields that must be submitted,
requires certain results information to be included, and sets penalties
for noncompliance.

The trials that must be registered are called "applicable clinical
trials." Under the statute these trials generally include: (1) Trials of
Drugs and Biologics: Controlled, clinical investigations, other than
Phase 1 investigations, of a product subject to FDA regulation; and (2)
Trials of Devices: Controlled trials with health outcomes, other than
small feasibility studies, and pediatric postmarket surveillance. NIH
encourages registration of ALL trials whether required under the law or
not.

For additional information see NIH Guide Notices at
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html> and
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html>.

## 2.2 Vertebrate Animals

The *PHS Policy on Humane Care and Use of Laboratory Animals* (PHS
Policy) mandates that an approved Animal Welfare Assurance must be on
file with the Office of Laboratory Animal Welfare (OLAW) at the time of
award for all grantee organizations receiving PHS support to conduct
research using live vertebrate animals. The PHS Policy requires grantee
organizations to establish appropriate policies and procedures to ensure
the humane care and use of animals. The PHS policy stipulates that the
grantee organization, whether domestic or foreign, bears responsibility
for the humane care and use of animals in PHS supported research
activities. This policy incorporates the *U.S. Government Principles for
the Utilization and Care of Vertebrate Animals Used in Testing,
Research, and Training* and requires that institutions base their animal
care and use programs on the *Guide for the Care and Use of Laboratory
Animals*. This policy does not supersede state or local laws or
regulations that impose more stringent standards for the care and use of
laboratory animals. All institutions are required to comply with the
applicable regulations (9 CFR, Subchapter A) issued by the U.S.
Department of Agriculture (USDA) under the Animal Welfare Act and other
federal statutes and regulations relating to animals. These documents
are available from the Office of Laboratory Animal Welfare, National
Institutes of Health, Bethesda, MD 20892, (301) 496-7163
(<http://grants.nih.gov/grants/olaw/olaw.htm>).

The PHS policy defines *animal* as any live vertebrate animal used or
intended for use in research, research training, experimentation or
biological testing or for related purposes including custom antibody
preparation.

In addition to an approved Animal Welfare Assurance, the grantee
organization must provide verification that the Institutional Animal
Care and Use Committee (IACUC) has reviewed and approved the proposed
activity. IACUC approval must be dated within the last three years in
order to be valid. IACUCs are not authorized to administratively extend
approval beyond three years. Verification of IACUC approval is requested
under Just-in-Time policy (prior to award) (see
[1.7](#just-in-time-policy)). Foreign grantees receiving direct support
are not required to provide IACUC approval, but must have an approved
Assurance.

Under consortium (subaward) agreements in which the grantee collaborates
with one or more other organizations, the grantee, as the direct and
primary recipient of NIH grant funds, is accountable for the performance
of the project, the appropriate expenditure of grant funds by all
parties, and all other obligations of the grantee as specified in the
NIHGPS (See NIH GPS, Part II, Terms and Conditions of NIH Grant Awards,
Consortium Agreements). The animal welfare requirements that apply to
grantees also apply to consortium participants and subprojects. The
prime grantee is responsible for including these requirements in its
agreements with collaborating organizations, and for ensuring that all
sites engaged in research involving the use of live vertebrate animals
have an approved Animal Welfare Assurance and that the activity has a
valid IACUC approval.

If the prime grantee does not have an Animal Welfare Assurance and the
animal work will be conducted at an institution with an Assurance, the
grantee must obtain an Inter-institutional Assurance from OLAW. When the
grantee is a domestic institution and there is a foreign
Project/Performance Site using animals, the grantee must ensure that the
Project/Performance Site has an approved Assurance and must provide
verification of IACUC approval by the domestic grantee's IACUC. This is
to certify to NIH that the activity as conducted at the foreign
Project/Performance Site is acceptable to the grantee organization.
Foreign applicant organizations applying for PHS awards for activities
involving vertebrate animals must comply with the Council for
International Organizations of Medical Sciences' *International Guiding
Principles for Biomedical Research Involving Laboratory Animals*
(<http://www.cioms.ch/frame_1985_texts_of_guidelines.htm> ) and all
laws, regulations and policies governing the care and use of laboratory
animals in the jurisdiction in which the research will be conducted.

## 2.3 Debarment and Suspension

Executive Order 12549, "Debarment and Suspension," mandated development
of a Government-wide debarment and suspension system for nonprocurement
transactions with Federal agencies. Executive Order 12689 and Section
2455 of the Federal Acquisition Streamlining Act of 1994 further
required Federal agencies to establish regulations for reciprocal
Government-wide effect across procurement and nonprocurement debarment
and suspension actions. This reciprocity rule is effective for any
debarment, suspension or other Government-wide exclusion initiated on or
after August 25, 1995.

DHHS regulations implementing Executive Orders 12549 and 12689 and
Section 2455 of the Federal Acquisition Regulation are provided in 2 CFR
180 and 376, "Government-wide Debarment and Suspension
(Nonprocurement)." Changes in this Government-wide requirement implement
this as a term and condition of an award.

## 2.4 Drug-Free Workplace

DHHS regulations implementing the Drug-Free Workplace Act of 1988
(Public Law 100-690, Title V, Subtitle D) are now provided in 45 CFR 82,
"Government-wide Requirements for Drug-Free Workplace (Financial
Assistance)." Changes in this Government-wide requirement (adopted in
the November 26, 2003 Federal Register Notice) now implement this as a
term and condition of an award.

## 2.5 Lobbying

a\) Title 31, United States Code, Section 1352, entitled "Limitation on
Use of Appropriated Funds to Influence Certain Federal Contracting and
Financial Transactions," generally prohibits recipients of Federal
grants and cooperative agreements from using Federal (appropriated)
funds for lobbying the Executive or Legislative Branches of the Federal
Government in connection with a specific grant or cooperative agreement.
Section 1352 also requires that each person who requests or receives a
Federal grant or cooperative agreement must disclose lobbying undertaken
with non-Federal (nonappropriated) funds. These requirements apply to
grants and cooperative agreements exceeding \$100,000 in total costs.
DHHS regulations implementing Section 1352 are provided in 45 CFR Part
93, "New Restrictions on Lobbying."

The complete Certification Regarding Lobbying is provided below:

"The undersigned (authorized official signing for the applicant
organization) certifies, to the best of his or her knowledge and belief
that:

\(1\) No Federal appropriated funds have been paid or will be paid, by
or on behalf of the undersigned, to any person for influencing or
attempting to influence an officer or employee of any agency, a Member
of Congress, an officer or employee of Congress, or an employee of a
Member of Congress in connection with the awarding of any Federal
contract, the making of any Federal grant, the making of any Federal
loan, the entering into of any cooperative agreement, and the extension,
continuation, renewal, amendment, or modification of any Federal
contract, grant, loan, or cooperative agreement.

\(2\) If any funds other than Federally appropriated funds have been
paid or will be paid to any person for influencing or attempting to
influence an officer or employee of any agency, a Member of Congress, an
officer or employee of Congress, or an employee of a Member of Congress
in connection with this Federal contract, grant, loan, or cooperative
agreement, the undersigned shall complete and submit Standard Form LLL,
"Disclosure of Lobbying Activities," in accordance with its
instructions.

\(3\) The undersigned shall require that the language of this
certification be included in the award documents for all subawards at
all tiers (including subcontracts, subgrants, and contracts under
grants, loans and cooperative agreements) and that all subrecipients
shall certify and disclose accordingly.

This certification is a material representation of fact upon which
reliance was placed when this transaction was made or entered into.
Submission of this certification is a prerequisite for making or
entering into this transaction imposed by section 1352, U.S. Code. Any
person who fails to file the required certification shall be subject to
a civil penalty of not less than \$10,000 and not more than \$100,000
for each such failure."

Standard Form LLL, "Disclosure of Lobbying Activities," its
instructions, and continuation sheet are available from GrantsInfo,
National Institutes of Health, e-mail:
[GrantsInfo@nih.gov](mailto:grantsinfo@nih.gov), (301) 435-0714.

b\) Organizations described in section 501(c)4 of the Internal Revenue
Code of 1968 that engage in lobbying are not eligible to receive
grant/cooperative agreement awards. This is not to be confused with 45
CFR Part 93, Section 1352, New Restrictions on Lobbying.

## 2.6 Non-Delinquency on Federal Debt

The Federal Debt Collection Procedure Act, 28 U.S.C. 3201 (e), provides
that an organization or individual that is indebted to the United
States, and has a judgment lien filed against it, is ineligible to
receive a Federal grant. NIH cannot award a grant unless the authorized
organizational official of the applicant organization (or individual as
in the case of an individual Ruth L. Kirschstein National Research
Service Award) certifies, by means of his/her signature on the
application, that the organization is not delinquent in repaying any
Federal debt. If the applicant discloses delinquency on a debt owed to
the Federal Government, NIH may not award the grant until the debt is
satisfied or satisfactory arrangements are made with the agency to which
the debt is owed.

## 2.7 Research Misconduct 

Each institution that receives or applies for a research, research
training, or research-related grant or cooperative agreement under the
Public Health Service Act must certify that the institution has
established administrative policies as required by 42 CFR Part 93,
"Public Health Service Policies on Research Misconduct."

The signature of the official signing for the applicant organization on
the Face Page of the application serves as certification that:

1\. The institution will comply with the requirements of the PHS
regulations for dealing with reporting possible research misconduct
under 42 CFR Part 93;

2\. The institution has established policies and procedures
incorporating the provisions set forth in 42 CFR Part 93;

3\. The institution will provide its policies and procedures to the
Office of Research Integrity upon request; and

4\. The institution will submit an Annual Report on Possible Research
Misconduct (Form 6349). A copy of Form 6349, covering the previous year,
will be automatically sent to all PHS awardees by the Office of Research
Integrity each January.

Research Misconduct is defined by the Public Health Service as
"fabrication, falsification or plagiarism in proposing, performing, or
reviewing research, or in reporting research results."

\(a\) Fabrication is making up data or results and recording or
reporting them.

\(b\) Falsification is manipulating research materials, equipment, or
processes, or changing or omitting data or results such that the
research is not accurately represented in the research record.

\(c\) Plagiarism is the appropriation of another person's ideas,
processes, results, or words without giving appropriate credit.

\(d\) Research misconduct does not include honest error or differences
of opinion.

For further information, please contact:

> U.S. Dept of Health and Human Services
>
> Office of Research Integrity
>
> 1101 Wootton Parkway, Suite 750
>
> Rockville, MD 20852
>
> <AskORI@osophs.hhs.gov>
>
> Phone: (240) 453-8200
>
> Fax: (301) 443-5351.

## 2.8 Assurance of Compliance (Civil Rights, Handicapped Individuals, Sex Discrimination, Age Discrimination)

Before a grant award can be made, a domestic applicant organization must
certify that it has filed with the DHHS Office for Civil Rights: an
Assurance of Compliance (Form DHHS 690) with Title VI of the Civil
Rights Act of 1964 (P.L. 88352, as amended), which prohibits
discrimination on the basis of race, color, or national origin; Section
504 of the Rehabilitation Act of 1973 (P.L. 93-112, as amended), which
prohibits discrimination on the basis of handicaps; Title IX of the
Education Amendments of 1972 (P.L. 92-318, as amended), which prohibits
discrimination on the basis of sex; and the Age Discrimination Act of
1975 (P.L. 94-135), which prohibits discrimination on the basis of age.

The Assurance of Compliance Form DHHS 690 is available from
<http://www.hhs.gov/ocr/ps690.pdf>.

Assurance of Compliance Form DHHS 690 is now used in lieu of individual
assurances: Form DHHS 441, Civil Rights; Form DHHS 641, Handicapped
Individuals; Form DHHS 639-A, Sex Discrimination; and Form DHHS 680, Age
Discrimination.

## 2.9 Research Involving Recombinant DNA, including Human Gene Transfer Research

The *National Institutes of Health Guidelines for Research Involving
Recombinant DNA Molecules (NIH Guidelines)* apply to all projects
(NIH-funded and non-NIH-funded) involving recombinant DNA molecules that
are conducted at or sponsored by an institution that receives NIH
support for recombinant DNA research. As defined by the *NIH
Guidelines,* recombinant DNA molecules are either: (1) molecules that
are constructed outside living cells by joining natural or synthetic DNA
segments to DNA molecules that can replicate in a living cell; or (2)
DNA molecules that result from the replication of those described in
(1).

The *NIH Guidelines* set forth principles and standards for safe and
ethical conduct of recombinant DNA research and apply to both basic and
clinical research studies. The *NIH Guidelines* should be carefully
reviewed and implemented to ensure that proper biosafety and containment
practices are employed for all projects involving recombinant DNA
research, including review by an Institutional Biosafety Committee that
meets the requirements of the *NIH Guidelines*. More information about
the NIH Guidelines and IBCs can be found at:
<http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm>. Further, the *NIH
Guidelines,* in Appendix M, include special review and reporting
requirements for the conduct of human gene transfer studies. Failure to
comply with the *NIH Guidelines* may result in suspension, limitation,
or termination of NIH funds for recombinant DNA research at the
organization or a requirement for NIH prior approval of any or all
recombinant DNA projects at the organization. A copy of the NIH
Guidelines is posted at the following URL:
<http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html> and may be
obtained from the NIH Office of Biotechnology Activities, 6705 Rockledge
Drive, Suite 750, Bethesda, MD 20892, 301-496-9838. Additional
information on the special requirements that pertain to human gene
transfer can be found in a series of Frequently Asked Questions at:
<http://www4.od.nih.gov/oba/RAC/RAC_FAQs.htm>.

## 2.10 Financial Conflict of Interest

NIH requires grantees and investigators (except Phase I SBIR/STTR
applicants) to comply with the requirements of 42 CFR Part 50, Subpart
F, "Responsibility of Applicants for Promoting Objectivity in Research
for which PHS Funding is Sought." These requirements promote objectivity
in research by establishing standards to ensure there is no reasonable
expectation that the design, conduct, or reporting of research funded
under PHS grants or cooperative agreements will be biased by any
conflicting financial interest of an investigator.

The signature of the authorized organizational official on the Face Page
of the application serves as certification of compliance with the
requirements of 42 CFR Part 50, Subpart F, including that:

1\. There is in effect at the organization a written and enforced
administrative process to identify and manage, reduce, or eliminate
conflicting financial interests with respect to research projects for
which NIH funding is sought.

2\. Prior to the expenditure of any NIH funds awarded under a new award,
the organization will inform NIH of the existence of any conflicting
financial interests of the type covered by 42 CFR 50.605 and assure that
the interest has been managed, reduced, or eliminated in accordance with
the regulations.

3\. The Institution will continue to make similar reports on
subsequently identified conflicts within 60 days of identification.

4\. When the Institution determines that a financial conflict of
interest exists (see #2 and #3 above), the institution must notify the
NIH awarding component Chief Grants Management Officer of its existence
and provide the following information:

-   Grant number and Principal Investigator;

-   Name of Investigator with FCOI; and

-   Distinguish which method was used to protect the involved PHS funded
    research from bias (i.e., managed, reduced, or eliminated).

5\. When requested, the institution will make information available to
NIH regarding all identified conflicting interests and how those
interests have been managed, reduced, or eliminated to protect the
research from bias.

## 2.11 Smoke-Free Workplace

The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and to promote the non-use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and advance
the physical and mental health of the American people.

## 2.12 Prohibited Research

NIH Appropriation Acts have limited the use of NIH funding for a number
of years and typically continue the same limitations from year to year.
These legislative mandates appear in the Public Law 110-005 that
authorizes NIH appropriations:

#### BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

NIH is prohibited from using appropriated funds to support human embryo
research. Grant, cooperative agreement, and contract funds may not be
used for: \"(a)...(1) the creation of a human embryo or embryos for
research purposes; or (2)research in which a human embryo or embryos are
destroyed, discarded, or knowingly subjected to risk of injury or death
greater than that allowed for research on fetuses in utero under 45 CFR
Part 46.208(a)(2) and section 498(b) of the Public Health Service Act
(42 U.S.C. 289g(b)). (b) For purposes of this section, the term \`human
embryo or embryos\' includes any organism not protected as a human
subject under [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm) as of
the date of the enactment of this Act, that is derived by fertilization,
parthenogenesis, cloning, or any other means from one or more human
gametes or human diploid cells.\"

The NIH has published final guidelines on the allowability of Federal
funds to be used for research on existing human embryonic stem cell
lines at <http://stemcells.nih.gov/index.asp>.

#### LIMITATION ON USE OF FUNDS FOR PROMOTION OF LEGALIZATION OF CONTROLLED SUBSTANCES

\"(a) None of the funds made available in this Act may be used for any
activity that promotes the legalization of any drug or other substance
included in schedule I of the schedules of controlled substances
established by section 202 of the Controlled Substances Act (21
U.S.C.812). (b)The limitation in subsection (a) shall not apply when
there is significant medical evidence of a therapeutic advantage to the
use of such drug or other substance or that federally sponsored clinical
trials are being conducted to determine therapeutic advantage.\"

#### RESTRICTION ON DISTRIBUTION OF STERILE NEEDLES 

\"Notwithstanding any other provision of this Act, no funds appropriated
under this Act shall be used to carry out any program of distributing
sterile needles or syringes for the hypodermic injection of any illegal
drug.\"

#### RESTRICTION ON ABORTIONS

\"(a) None of the funds appropriated under this Act, and none of the
funds in any trust fund to which funds are appropriated under this Act,
shall be expended for any abortion.\"

## 2.13 Select Agent Research

The Public Health Security and Bioterrorism Preparedness and Response
Act of 2002 (P.L. 107-188) is designed to provide protection against
misuse of select agents and toxins whether inadvertent or the result of
terrorist acts against the United States homeland or other criminal
acts. The Act was implemented, in part, through regulations published by
CDC at 42 CFR 73
<http://www.cdc.gov/od/sap/pdfs/42_cfr_73_final_rule.pdf>, Select Agents
and Toxins.

As a term of award, grantees who conduct research involving Select
Agents (see 42 CFR 73 for the list; and 7 CRF 331 and 9 CFR 121 for the
relevant animal and plant pathogens) are reminded that they must
complete registration with CDC (or USDA, depending on the agent) before
using NIH funds. No funds can be used for research involving Select
Agents if the final registration certificate is denied.

In addition to the above requirements, research involving **both select
agents and recombinant DNA** is also subject to the NIH Guidelines for
Research Involving DNA Molecules (NIH Guidelines) (see [Section 2.9
Research Involving Recombinant DNA, including Human Gene Transfer
Research](#Section_7_4_7) in this subsection for applicability of these
guidelines).

For additional information regarding Select Agent research, see the
following websites maintained by NIH, CDC, and USDA:

NIH Office of Extramural Research Select Agent Information:
<http://grants.nih.gov/grants/policy/select_agent/>

Center for Disease Control Select Agent Program:\
<http://www.cdc.gov/od/sap/index.htm>

Center for Disease Control Select Agent Program Guidelines:
<http://www.cdc.gov/od/sap/guidelines.htm>

Center for Disease Control Select Agent Program Public Laws and
Regulations: <http://www.cdc.gov/od/sap/regulations.htm>

Center for Disease Control Select Agent Program Related Links:
<http://www.cdc.gov/od/sap/regulations.htm>

Animal and Plant Health Inspection Service (APHIS) Select Agent Program:
<http://www.aphis.usda.gov/programs/ag_selectagent/>

## 2.14 Program Director/Principal Investigator Assurance

It is a compliance requirement that the applicant organization secure
and retain a written assurance from the PD/PI prior to submitting an
application to the PHS. Therefore, organizations must retain a unique
signature and date for each submitted application. This assurance must
be available to the sponsoring agency or other authorized DHHS or
Federal officials upon request. Such an assurance must include at least
the following certifications: 1) that the information submitted within
the application is true, complete and accurate to the best of the
PD/PI's knowledge; 2) that any false, fictitious, or fraudulent
statements or claims may subject the PD/PI to criminal, civil, or
administrative penalties; and 3) that the PD/PI agrees to accept
responsibility for the scientific conduct of the project and to provide
the required progress reports if a grant is awarded as a result of the
application. If multiple PD/PIs are proposed in an application, this
assurance must be retained for all named PD/PIs.

## 2.15 Impact of Grant Activities on the Environment and Historic Properties

All NIH grants, whether or not they include construction or major
alteration and renovation activities, are subject to the requirements of
the National Environmental Policy Act of 1969 (ACT), as amended. This
Act requires Federal agencies to consider the probable environmental
consequences of all grant-supported activities. As part of NIH's
implementation of this Act, grantees are required to promptly notify NIH
of any probable impacts on the environment from grant-supported
activities, or certify that no such activities exist upon receipt of a
grant award. This requirement is in addition to the other public policy
requirements for grants for construction and alteration and renovation
activities discussed more fully in the NIH Grants Policy Statement
Construction Grants -- Public Policy Requirements and Objectives.

Additionally, all NIH grant awards should not involve activities that
violate provisions of the National Historic Preservation Act of 1966 or
other statutory requirements. All grantees are subject to the
requirements of Executive Order 13287 -- Preserve America, requiring
notification to NIH of all activities that would affect any historic
property, or certification that no impact will occur upon receipt of the
grant award or in a post-award action without NIH prior approval. For
the purposes of the Order, historic property is defined to include any
prehistoric or historic district, site, or object included in, or
eligible for inclusion in, the National Register of Historic Places
maintained by the Secretary of the Interior. This term includes
artifacts, records, and remains that are related to and located within
such properties. The term includes properties of traditional religious
and cultural importance to an Indian tribe or Native Hawaiian
organization and that meet the National Register criteria.

# 3. Definitions

**AIDS Related.** Includes: (1) projects relating to the etiology,
epidemiology, natural history, diagnosis, treatment, or prevention of
AIDS; (2) various sequelae specifically associated with the syndrome;
and (3) preparation and screening of anti-AIDS agents as well as vaccine
development, including both preclinical and clinical studies. Not all
applications examining various influences on T-lymphocytes or
retroviruses will be appropriate for the expedited AIDS review process.
Applications only indirectly related to AIDS will be evaluated by
established Scientific Review Groups (SRGs) appropriate to the
scientific discipline during regular NIH review cycles and should not be
submitted in response to the expedited AIDS receipt dates. Applicants
are urged to take note of the yearly NIH Plan for HIV-Related Research
and indicate how their application addresses the NIH priorities set
forth in that Plan. The Plan can be found on the [NIH Office of AIDS
Research](http://www.oar.nih.gov/) homepage.

**Animal.** Any live vertebrate animal used or intended for use in
research, research training, experimentation or biological testing or
for related purposes at the applicant organization, any collaborating
site, or other Project/Performance Site.

#### Applicant Organization Types.

***[Federal:]{.underline}*** A cabinet-level department or independent
agency of the Executive Branch of the Federal Government or any
component part of such a department or agency that may be assigned the
responsibility for carrying out a grant-supported program.

***[State:]{.underline}*** Any agency or instrumentality of a state
government of any of the United States or its territories.

***[Local:]{.underline}*** Any agency or instrumentality of a political
subdivision of government below the State level.

***[Nonprofit:]{.underline}*** An institution, corporation, or other
legal entity no part of whose net earnings may lawfully inure to the
benefit of any private shareholder or individual.

***[For profit:]{.underline}*** An institution, corporation, or other
legal entity, which is organized for the profit or benefit of its
shareholders or other owners. A "for profit" organization is considered
to be a small business if it is independently owned and operated, if it
is not dominant in the field in which research is proposed, and if it
employs no more than 500 persons. Also see definition for Small Business
Concern.

***[Small Business Concern:]{.underline}*** A small business concern is
one that, at the time of award of Phase I and Phase II, meets **all** of
the following criteria:

1\. Is independently owned and operated, is not dominant in the field of
operation in which it is proposing, has its principal place of business
located in the United States, and is organized for profit.

2\. Is at least 51% owned and controlled by either: (a) one or more
natural persons (individuals who are citizens of, or permanent resident
aliens in, the United States); or (b) another for-profit business
concern that is itself at least 51% owned and controlled by one or more
natural persons (individuals who are citizens of, or permanent resident
aliens in, the United States)(See 13 CFR 121.105 (defining "business
concern")).

3\. Has, including its affiliates, *a number of employees not exceeding
500*, and meets the other regulatory requirements found in 13 CFR Part
121. Business concerns, other than investment companies licensed, or
state development companies qualifying under the Small Business
Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one
another when either directly or indirectly, (a) one concern controls or
has the power to control the other; or (b) a third-party/parties
controls or has the power to control both.

Control can be exercised through common ownership, common management,
and contractual relationships. The term "affiliates" is defined in
greater detail in 13 CFR Part 121, as is the process for calculating
"number of employees."

Business concerns include, but are not limited to, any individual (sole
proprietorship), partnership, corporation, joint venture, association,
or cooperative. Further information may be obtained by contacting the
Small Business Administration Size District Office at
<http://www.sba.gov/size/>.

***[Socially and Economically Disadvantaged Small Business
Concern:]{.underline}*** A socially and economically disadvantaged small
business concern is one that is at least 51% owned by (a) an Indian
tribe or a native Hawaiian organization, or (b) one or more socially and
economically disadvantaged individuals; **and** whose management and
daily business operations are controlled by one or more socially and
economically disadvantaged individuals.

***[Women-Owned Small Business Concern]{.underline}***: A small business
concern that is at least 51% owned by a woman or women who also control
and operate it. "Control" in this context means exercising the power to
make policy decisions. "Operate" in this context means being actively
involved in the day-to-day management.

**Clinical Trial.** See [Human Subjects Research Definitions and
Terms](#Human_Subjects_Res_Defs).

**Coded.** See [Human Subjects Research Definitions and
Terms](#Human_Subjects_Res_Defs)

**Co-investigator.** An individual involved with the PD/PI in the
scientific development or execution of the project. The co-investigator
(collaborator) may be employed by, or be affiliated with, the
applicant/grantee organization or another organization participating in
the project under a consortium agreement. This individual would
typically devote a specific percent of effort to the project and would
be identified as Senior/key Personnel. The designation of a
co-investigator, if applicable, does not affect the PD/PI's roles and
responsibilities as specified in the [*Grants Policy
Statement*](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).

**Commercialization.** The process of developing markets and producing
and delivering products for sale (whether by the originating party or by
others). As used here, commercialization includes both government and
private sector markets.

**Consortium Agreement.** A formalized agreement whereby a research
project is carried out by the grantee and one or more other
organizations that are separate legal entities. Under the agreement, the
grantee must perform a substantive role in the conduct of the planned
research and not merely serve as a conduit of funds to another party or
parties. These agreements typically involve a specific percent of effort
from the consortium organization's PD/PI and a categorical breakdown of
costs, such as personnel, supplies, and other allowable expenses,
including Facilities and Administrative costs.

[]{#Definitions_Consultant .anchor}**Consultant.** An individual who
provides professional advice or services for a fee, but normally not as
an employee of the engaging party. In unusual situations, an individual
may be both a consultant and an employee of the same party, receiving
compensation for some services as a consultant and for other work as a
salaried employee. To prevent apparent or actual conflicts of interest,
grantees and consultants must establish written guidelines indicating
the conditions of payment of consulting fees. Consultants may also
include firms that provide paid professional advice or services.

**Consulting fees.** The fee paid by an institution to a salaried member
of its faculty is allowable only in unusual cases and only if both of
the following conditions exist: (1) the consultation crosses
departmental lines or involves a separate operation; and (2) the work
performed by the consultant is in addition to his or her regular
workload.

In all other cases, consulting fees paid to employees of recipient or
cost-type contractor organizations in addition to salary may be charged
to PHS grant-supported projects only in unusual situations and when all
of the following conditions exist: (1) the policies of the recipient or
contractor permit such consulting fee payments to its own employees
regardless of whether Federal grant funds are received; (2) the
consulting services are clearly outside the scope of the individual's
salaried employment; and (3) it would be inappropriate or not feasible
to compensate the individual for these services through payment of
additional salary.

For additional clarification on the allowance and appropriateness of
consulting fees, refer to the [*NIH Grants Policy
Statement*](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).

**Cooperative Agreement.** A financial assistance instrument that will
have substantial Federal scientific and/or programmatic involvement.
Substantial involvement means that after award, scientific or program
staff will assist, guide, coordinate, or participate in programmatic
activities beyond the normal stewardship responsibility in the
administration of grants. Proposed cooperative agreements will be
published as policy announcements, Program Announcements, or Requests
for Applications.

[]{#Definitions_Equipment .anchor}**Equipment.** An article of tangible
nonexpendable personal property that has a useful life of more than one
year and an acquisition cost per unit that equals or exceeds \$5,000 or
the capitalization threshold established by the organization, whichever
is less.

**Essentially Equivalent Work.** This term is meant to identify
"scientific overlap," which occurs when (1) substantially the same
research is proposed for funding in more than one contract proposal or
grant application submitted to the same Federal agency; **or** (2)
substantially the same research is submitted to two or more different
Federal agencies for review and funding consideration; **or** (3) a
specific research objective and the research design for accomplishing
that objective are the same or closely related in two or more proposals
or awards, regardless of the funding source.

**Feasibility.** The extent to which a study or project may be done
practically and successfully.

[]{#Definitions_Foreign .anchor}**Foreign Component.** The performance
of any significant scientific element or segment of a project outside of
the United States, either by the grantee or by a researcher employed by
a foreign organization, whether or not grant funds are expended.
Activities that would meet this definition include, but are not limited
to: (1) the involvement of human subjects or animals; (2) extensive
foreign travel by grantee project staff for the purpose of data
collection, surveying, sampling, and similar activities; or (3) any
activity of the grantee that may have an impact on U.S. foreign policy
through involvement in the affairs or environment of a foreign country.
Foreign travel for consultation is not considered a foreign component.

**Full-Time Appointment.** The number of days per week and/or months per
year representing full-time effort at the applicant/grantee
organization, as specified in organizational policy. The organization\'s
policy must be applied consistently regardless of the source of support.

**Grant.** A financial assistance mechanism providing money, property,
or both to an eligible entity to carry out an approved project or
activity. A grant is used whenever the NIH Institute or Center
anticipates no substantial programmatic involvement with the recipient
during performance of the financially assisted activities.

[]{#Human_Subjects_Res_Defs .anchor}**Human Subjects Research
Definitions and Terms.**

***[Autopsy Materials.]{.underline}*** The use of autopsy materials is
governed by applicable federal, state and local law and is not directly
regulated by 45 CFR Part 46.

[]{#Human_Subjects_Defs_Child .anchor}***[Child.]{.underline}*** The NIH
Policy on Inclusion of Children defines a child as an individual under
the age of 21 years. The intent of the NIH policy is to provide the
opportunity for children to participate in research studies when there
is a sound scientific rationale for including them, and their
participation benefits children and is appropriate under existing
Federal guidelines. Thus, children must be included in NIH conducted or
supported clinical research unless there are scientific or ethical
reasons not to include them.

DHHS Regulations ([45 CFR Part 46, Subpart
D](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd),
Sec.401-409) provide additional protections for children involved as
subjects in research, based on this definition: \"Children are persons
who have not attained the legal age for consent to treatments or
procedures involved in research, under the applicable law of the
jurisdiction in which the research will be conducted.\" Generally, state
laws define what constitutes a "child." Consequently, the age at which a
child\'s own consent is required and sufficient to participate in
research will vary according to state law. For example, some states
consider a person age 18 to be an adult and therefore one who can
provide consent without parental permission.

[]{#Human_Subjects_Defs_ClinicalResearch .anchor}***[Clinical
Research.]{.underline}*** NIH defines human clinical research as
research with human subjects that is: (1) Patient-oriented research.
Research conducted with human subjects (or on material of human origin
such as tissues, specimens and cognitive phenomena) for which an
investigator (or colleague) directly interacts with human subjects.
Excluded from this definition are *in vitro* studies that utilize human
tissues that cannot be linked to a living individual. Patient-oriented
research includes: (a) mechanisms of human disease, (b) therapeutic
interventions, (c) clinical trials, or (d) development of new
technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes
research and health services research. Note: Studies falling under
Exemption 4 for human subjects research are not considered clinical
research by this definition.

[]{#Human_Subjects_Defs_ClinicalTrial .anchor}***[Clinical
Trial.]{.underline}*** The NIH defines a *clinical trial* as a
prospective biomedical or behavioral research study of human subjects
that is designed to answer specific questions about biomedical or
behavioral interventions (drugs, treatments, devices, or new ways of
using known drugs, treatments, or devices).

Clinical trials are used to determine whether new biomedical or
behavioral interventions are safe, efficacious, and effective.

Behavioral human subjects research involving an intervention to modify
behavior (diet, physical activity, cognitive therapy, etc.) fits this
definition of a clinical trial.

Human subjects research to develop or evaluate clinical laboratory tests
(e.g. imaging or molecular diagnostic tests) might be considered to be a
clinical trial if the test will be used for medical decision making for
the subject or the test itself imposes more than minimal risk for
subjects.

Biomedical clinical trials of experimental drug, treatment, device or
behavioral intervention may proceed through four phases:

***[Phase I]{.underline}*** clinical trials test a new biomedical
intervention in a small group of people (e.g., 20-80) for the first time
to evaluate safety (e.g., to determine a safe dosage range and to
identify side effects).

***[Phase II]{.underline}*** clinical trials study the biomedical or
behavioral intervention in a larger group of people (several hundred) to
determine efficacy and to further evaluate its safety.

***[Phase III]{.underline}*** studies investigate the efficacy of the
biomedical or behavioral intervention in large groups of human subjects
(from several hundred to several thousand) by comparing the intervention
to other standard or experimental interventions as well as to monitor
adverse effects, and to collect information that will allow the
intervention to be used safely.

***[Phase IV]{.underline}*** studies are conducted after the
intervention has been marketed. These studies are designed to monitor
effectiveness of the approved intervention in the general population and
to collect information about any adverse effects associated with
widespread use.

[]{#Human_Subjects_Defs_NIH_PhaseIIIl .anchor}***[NIH-Defined Phase III
Clinical Trial.]{.underline}*** An NIH-defined Phase III clinical trial
is a broadly based prospective Phase III clinical investigation, usually
involving several hundred or more human subjects, for the purpose of
evaluating an experimental intervention in comparison with a standard or
controlled intervention or comparing two or more existing treatments.
Often the aim of such investigation is to provide evidence leading to a
scientific basis for consideration of a change in health policy or
standard of care. The definition includes pharmacologic,
non-pharmacologic, and behavioral interventions given for disease
prevention, prophylaxis, diagnosis, or therapy. Community trials and
other population-based intervention trials are also included.

[]{#Human_Subjects_Defs_Coded .anchor}***[Coded.]{.underline}*** With
respect to private information or human biological specimens, *coded*
means that:

-   identifying information (such as name or social security number)
    that would enable the investigator to readily ascertain the identity
    of the individual to whom the private information or specimens
    pertain has been replaced with a number, letter, symbol or
    combination thereof (i.e., the code); and

-   a key to decipher the code exists, enabling linkage of the
    identifying information with the private information or specimens.

Research that involves only coded private information/data or coded
human biological specimens may not constitute human subjects research
under the DHHS human subjects regulations (45 CFR 46) if:

-   the specimens and/or information/data are not obtained from an
    interaction/intervention with the subject specifically for the
    research; and

-   the investigator(s) cannot readily ascertain the identity of the
    individual(s) to whom the coded private information or specimens
    pertain (e.g., the researcher\'s access to subject identities is
    prohibited).

Individuals who provide coded information or specimens for proposed
research and who also collaborate on the research involving such
information or specimens are considered to be involved in the conduct of
human subjects research.

(See the following guidance from the Office for Human Research
Protections (OHRP) for additional information and examples:
<http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf>.)

***[Data and Safety Monitoring Plan.]{.underline}*** For each clinical
trial, NIH requires a data and safety monitoring plan that will provide
oversight and monitoring to ensure the safety of participants and the
validity and integrity of the data. The level of monitoring should be
commensurate with the risks and the size and complexity of the clinical
trial. A detailed data and safety monitoring plan must be submitted to
the applicant's IRB and subsequently to the funding IC for approval
prior to the accrual of human subjects. The reporting of Adverse Events
must be reported to the IRB, the NIH funding Institute or Center, and
other required entities. This policy requirement is in addition to any
monitoring requirements imposed by [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

***[Data and Safety Monitoring Board (DSMB).]{.underline}*** NIH
requires the establishment of a Data and Safety Monitoring Board (DSMB)
for multi-site clinical trials involving interventions that entail
potential risk to the participants, *and generally for Phase III
clinical trials*.

[]{#Human_Subjects_Exemption_Cat .anchor}***[Exemptions.]{.underline}***
The six categories of research exempt from the DHHS human subject
regulations are:

***[Exemption 1:]{.underline}*** Research conducted in established or
commonly accepted educational settings, involving normal educational
practices, such as (i) research on regular and special education
instructional strategies, or (ii) research on the effectiveness of or
the comparison among instructional techniques, curricula, or classroom
management methods.

[]{#Human_Subjects_Exemption2 .anchor}***[Exemption 2:]{.underline}***
Research involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures, or
observation of public behavior, unless:

\(i\) information obtained is recorded in such a manner that human
subjects can be identified directly or through identifiers linked to the
subjects and (ii) any disclosure of the human subjects\' responses
outside the research could reasonably place the subjects at risk of
criminal or civil liability or be damaging to the subjects\' financial
standing, employability, or reputation.

> Exemption 2 for research involving survey or interview procedures or
> observation of public behavior, does not apply to research with
> children (see [45 CFR Part 46, Subpart
> D](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartd)),
> except for research involving observations of public behavior when the
> investigator(s) do not participate in the activities being observed.

***[Exemption 3:]{.underline}*** Research involving the use of
educational tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures, or observation of public behavior that
is not exempt under paragraph (b)(2) of this section if: (i) the human
subjects are elected or appointed public officials or candidates for
public office; or (ii) Federal statute(s) require(s) without exception
that the confidentiality of the personally identifiable information will
be maintained throughout the research and thereafter.

***[Exemption 4:]{.underline}*** Research involving the collection or
study of existing data, documents, records, pathological specimens, or
diagnostic specimens, if these sources are publicly available or if the
information is recorded by the investigator in such a manner that
subjects cannot be identified, directly or through identifiers linked to
the subjects.

The humans subjects regulations decision charts
(<http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm>) of
the Office of Human Research Protection (OHRP) will determine whether
the research falls under the human subjects regulations and if so,
whether it meets the criteria for Exemption 4. The NIH Office of
Extramural Research website also contains information that is helpful
for determining whether human subjects research meets the criteria for
Exemption 4. See <http://grants.nih.gov/grants/policy/hs/index.htm>.

> Research that meets the criteria for Exemption 4 is not considered
> "clinical research" as defined by NIH. Therefore the NIH policies for
> inclusion of women, minorities and children in clinical research, and
> targeted/planned enrollment tables, do not apply to research projects
> covered by Exemption 4.

***[Exemption 5:]{.underline}*** Research and demonstration projects
that are conducted by or subject to the approval of Department or Agency
heads and that are designed to study, evaluate, or otherwise examine:
(i) public benefit or service programs (ii) procedures for obtaining
benefits or services under those programs (iii) possible changes in or
alternatives to those programs or procedures or (iv) possible changes in
methods or levels of payment for benefits or services under those
programs.

***[Exemption 6:]{.underline}*** Taste and food quality evaluation and
consumer acceptance studies (i) if wholesome foods without additives are
consumed or (ii) if a food is consumed that contains a food ingredient
at or below the level and for a use found to be safe, or agricultural,
chemical, or environmental contaminant at or below the level found to be
safe, by the Food and Drug Administration or approved by the
Environmental Protection Agency or the Food Safety and Inspection
Service of the U.S. Department of Agriculture.

***[Gender.]{.underline}*** Refers to the classification of research
subjects into either or both of two categories: women and men. In some
cases, representation is unknown because gender composition cannot be
accurately determined (e.g., pooled blood samples or stored specimens
without gender designation).

[]{#Human_Subjects_Defs_Human .anchor}***[Human
Subjects.]{.underline}*** The DHHS regulations \"Protection of Human
Subjects\" (45 CFR 46, administered by OHRP) define a ***[human
subject]{.underline}*** as a living individual about whom an
*investigator* conducting *research obtains*:

-   data through *intervention* or *interaction* with the individual or

-   *identifiable private information.*

Italicized words and phrases in the definition of human subjects are
defined as follows:

***[Investigator.]{.underline}*** The OHRP considers the term
investigator to include anyone involved in conducting the research. OHRP
does not consider the act of solely providing coded private information
or specimens (for example, by a tissue repository) to constitute
involvement in the conduct of the research. However, if the individuals
who provide *coded* information or specimens also collaborate on other
activities related to the conduct of the research with the investigators
who receive such information or specimens, they will be considered to be
involved in the conduct of the research. (See OHRP's [2004 Coded
Specimen
Guidance](http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.htm).)

***[Research.]{.underline}*** DHHS regulations define *research* at 45
CFR 46.102(d) as follows:\
*Research* means a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute
to generalizable knowledge. Activities which meet this definition
constitute research for purposes of this policy, whether or not they are
conducted or supported under a program which is considered research for
other purposes. For example, some demonstration and service programs may
include research activities.

***[Obtains.]{.underline}*** In its guidance for use of coded specimens,
OHRP has determined that under the definition of human subject at 45 CFR
46.102(f), *obtaining* identifiable private information or identifiable
specimens for research purposes constitutes human subjects research.
*Obtaining* means receiving or accessing identifiable private
information or identifiable specimens for research purposes. OHRP
interprets *obtaining* to include an investigator's use, study, or
analysis for research purposes of *identifiable private information* or
identifiable specimens already in the possession of the investigator.

***[Intervention]{.underline}*** includes both physical procedures by
which data are gathered (for example, venipuncture) and manipulations of
the subject or the subject\'s environment that are performed for
research purposes. (45 CFR 46.102(f))

***[Interaction]{.underline}*** includes communication or interpersonal
contact between investigator and subject. (45 CFR 46.102(f))

***[Private information]{.underline}*** includes information about
behavior that occurs in a context in which an individual can reasonably
expect that no observation or recording is taking place, and information
that has been provided for specific purposes by an individual and that
the individual can reasonably expect will not be made public (for
example, a medical record). Private information must be *individually
identifiable* (i.e., the identity of the subject is or may readily be
ascertained by the investigator or associated with the information) in
order for obtaining the information to constitute research involving
human subjects. (45 CFR 46.102(f))

***[Individually Identifiable Private Information.]{.underline}***
According to its guidance for use of coded specimens, OHRP generally
considers private information or specimens to be *individually
identifiable* as defined at 45 CFR 46.102(f) when they can be linked to
specific individuals by the investigator(s) either directly or
indirectly through *coding* systems. Conversely, OHRP considers private
information or specimens not to be individually identifiable when they
cannot be linked to specific individuals by the investigator(s) either
directly or indirectly through coding systems.

***[Significant Difference.]{.underline}*** For purposes of NIH policy,
a \"significant difference\" is a difference that is of clinical or
public health importance, based on substantial scientific data. This
definition differs from the commonly used \"statistically significant
difference,\" which refers to the event that, for a given set of data,
the statistical test for a difference between the effects in two groups
achieves statistical significance. Statistical significance depends upon
the amount of information in the data set. With a very large amount of
information, one could find a statistically significant, but clinically
small difference that is of very little clinical importance. Conversely,
with less information one could find a large difference of potential
importance that is not statistically significant.

***[Valid Analysis.]{.underline}*** This term means an unbiased
assessment. Such an assessment will, on average, yield the correct
estimate of the difference in outcomes between two groups of subjects.
Valid analysis can and should be conducted for both small and large
studies. A valid analysis does not need to have a high statistical power
for detecting a stated effect. The principal requirements for ensuring a
valid analysis of the question of interest are: allocation of study
participants of both sexes/genders (males and females) and from
different racial/ethnic groups to the intervention and control groups by
an unbiased process such as randomization; unbiased evaluation of the
outcome(s) of study participants; and use of unbiased statistical
analyses and proper methods of inference to estimate and compare the
intervention effects among the gender and racial/ethnic groups.

**Innovation.** Something new or improved, including research for (1)
development of new technologies, (2) refinement of existing
technologies, or (3) development of new applications for existing
technologies. For the purposes of PHS programs, an example of
"innovation" would be new medical or biological products for improved
value, efficiency, or costs.

[]{#Definitions_Salary .anchor}**Institutional Base Salary.** The annual
compensation paid by an organization for an employee's appointment,
whether that individual's time is spent on research, teaching, patient
care, or other activities. Base salary excludes any income that an
individual may be permitted to earn outside of duties for the
applicant/grantee organization. Base salary may not be increased as a
result of replacing organization salary funds with NIH grant funds.

Some PHS grant programs are currently subject to a legislatively imposed
salary limitation. Any adjustment for salary limits will be made at time
of award. Applicants are encouraged to contact their offices of
sponsored programs or see the [*NIH Guide for Grants and
Contracts*](http://www.grants.nih.gov/grants/guide) for current guidance
on salary requirements.

**Other Significant Contributors.** This category identifies individuals
who have committed to contribute to the scientific development or
execution of the project, but are not committing any specified
measurable effort to the projects. These individuals are typically
presented at \"zero percent\" effort or \"as needed\" (individuals with
measurable effort cannot be listed as Other Significant Contributors).
Consultants should be included if they meet this definition. This is
also be an appropriate designation for mentors on Career awards.

**Person Months.** A metric for expressing the effort (amount of time)
that PD/PIs, faculty and other Senior/key Personnel devote to a specific
project. Effort is expressed as a percentage of the total institutional
appointment and is based on the organization's regular academic-year,
summer or calendar-year.

**Principal Investigator, Program Director, or Project Director.** The
individual(s) designated by the applicant organization to have the
appropriate level of authority and responsibility to direct the project
or program to be supported by the award. The applicant organization may
designate multiple individuals as principal investigators (PD/PIs) who
share the authority and responsibility for leading and directing the
project, intellectually and logistically. When multiple principal
investigators are named, each is responsible and accountable to the
applicant organization, or as appropriate, to a collaborating
organization for the proper conduct of the project or program including
the submission of all required reports. The presence of more than one
PD/PI on an application or award diminishes neither the responsibility
nor the accountability of any individual PD/PI.

[]{#Definitions_ProgramIncome .anchor}**Program Income.** Gross income
earned by the applicant organization that is directly generated by a
supported activity or earned as a result of the award. The *PHS Grants
Policy Statement* or [*NIH Grants Policy
Statement*](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm)
contains a detailed explanation of program income, the ways in which it
may be generated and accounted for, and the various options for its use
and disposition.

Examples of program income include:

-   Fees earned from services performed under the grant, such as those
    resulting from laboratory drug testing;

-   Rental or usage fees, such as those earned from fees charged for use
    of computer equipment purchased with grant funds;

-   Third party patient reimbursement for hospital or other medical
    services, such as insurance payments for patients when such
    reimbursement occurs because of the grant-supported activity;

-   Funds generated by the sale of commodities, such as tissue cultures,
    cell lines, or research animals;

-   Patent or copyright royalties (exempt from reporting requirements);
    and

-   Registration fees generated from grant-supported conferences.

**Prototype.** A model of something to be further developed and includes
designs, protocols, questionnaires, software, and devices.

**Research or Research and Development (R/R&D).** Any activity that is:

-   A systematic, intensive study directed toward greater knowledge or
    understanding of the subject studied; or

-   A systematic study directed specifically toward applying new
    knowledge to meet a recognized need; or

-   A systematic application of knowledge toward the production of
    useful materials, devices, and systems or methods, including design,
    development, and improvement of prototypes and new processes to meet
    specific requirements.

[]{#Definitions_KeyPersonnel .anchor}**Senior/key Personnel.** The PD/PI
and other individuals who contribute to the scientific development or
execution of the project in a substantive, measurable way, whether or
not salaries or compensation is requested under the grant.

Typically these individuals have doctoral or other professional degrees,
although individuals at the masters or baccalaureate level may be
considered if their involvement meets the definition of Senior/key
Personnel. Consultants should also be included if they meet the
definition of Senior/key Personnel. Senior/key Personnel must devote
measurable effort to the project whether or not salaries are
requested\--\"zero percent\" effort or "as needed" are not acceptable
levels for those designated as Senior/key Personnel.

**Socially and Economically Disadvantaged Individual.** A member of any
of the following groups: Black Americans; Hispanic Americans; Native
Americans; Asian-Pacific Americans; Subcontinent Asian Americans; other
groups designated from time to time by the Small Business Administration
(SBA) to be socially disadvantaged; or any other individual found to be
socially and economically disadvantaged by SBA pursuant to Section 8(a)
of the Small Business Act, 15 U.S.C. 637(a).

**United States.** The 50 states, territories and possessions of the
U.S., Commonwealth of Puerto Rico, Trust Territory of the Pacific
Islands, and District of Columbia.

# 4. General Information

## 4.1 Research Grant Mechanisms

The following tables summarize the major mechanisms NIH uses to fund
research grants. For more detailed information, visit the OER website
<http://grants.nih.gov/grants/funding/funding_program.htm>.

NIH continues to transition applications from the PHS398 to the SF424
(R&R) and electronic submission through Grants.gov by grant mechanism.
Some of the mechanisms described in the chart below have already
transitioned; others will transition in the near future. Applicants
should refer to the Timeline to determine when a particular mechanism
has transitioned to the new form and electronic submission:
<http://era.nih.gov/ElectronicReceipt/strategy_timeline.htm> .

For more information on NIH's transition plans, see the website for
Electronic Submission of Grant Applications:
<http://era.nih.gov/ElectronicReceipt/>.

#### Research Grants

+-----------------------------+----------------------------------------+
| type (mechanism)            | description                            |
+=============================+========================================+
| Basic Research Grant (R01)  | Basic Research Grants are awarded to   |
|                             | eligible institutions on behalf of a   |
| <http://grants.nih.         | principal investigator to support a    |
| gov/grants/funding/r01.htm> | discrete project related to the        |
|                             | investigator\'s area of interest and   |
|                             | competence. These grants make up the   |
|                             | largest category of NIH funding.       |
+-----------------------------+----------------------------------------+
| Small Research Grant (R03)  | Small Research Grants support small    |
|                             | research projects that can be carried  |
| <http://grants.nih.         | out in a short period of time with     |
| gov/grants/funding/r03.htm> | limited resources for projects such as |
|                             | pilot or feasibility studies;          |
|                             | secondary analysis of existing data;   |
|                             | small, self-contained research         |
|                             | projects; development of research      |
|                             | methodology and/or development of new  |
|                             | research technology. Not all awarding  |
|                             | components accept                      |
|                             | investigator-initiated R03             |
|                             | applications.\                         |
|                             | Applicants interested in the small     |
|                             | research grant program of PHS-awarding |
|                             | components other than NIH should       |
|                             | contact an official of the appropriate |
|                             | PHS-awarding component (See [Part I,   |
|                             | 1.4](#phs-agency-contacts)).           |
+-----------------------------+----------------------------------------+
| Academic Research           | Academic Research Enhancement Awards   |
| Enhancement Award (AREA)    | provide support to scientists at       |
| (R15)                       | eligible domestic institutions for     |
|                             | small-scale health-related research    |
| <http://grants.nih.g        | projects, such as pilot research       |
| ov/grants/funding/area.htm> | projects and feasibility studies;      |
|                             | development, testing, and refinement   |
|                             | of research techniques; and similar    |
|                             | discrete research projects that        |
|                             | demonstrate research capability. This  |
|                             | award is directed toward those smaller |
|                             | public and private colleges and        |
|                             | universities that provide              |
|                             | undergraduate training for a           |
|                             | significant number of the U.S.         |
|                             | research scientists.                   |
+-----------------------------+----------------------------------------+
| Exploratory/Developmental   | Exploratory/Developmental Research     |
| Research Grant (R21/R33)    | Grants seek to broaden the base of     |
|                             | inquiry in fundamental biomedical      |
| <http://grants.nih.         | research by encouraging applications   |
| gov/grants/funding/r21.htm> | for research projects that involve an  |
|                             | especially high degree of innovation   |
|                             | and novelty. NIH provides pilot-scale  |
|                             | support for potentially                |
|                             | ground-breaking ideas, methods, and    |
|                             | systems that meet the following        |
|                             | criteria: they lack sufficient         |
|                             | preliminary data for feasibility to be |
|                             | established, their successful          |
|                             | demonstration would have a major       |
|                             | impact on biomedical research, and     |
|                             | they fall within the areas supported   |
|                             | by the awarding I/C. Not all awarding  |
|                             | components accept R21/R33              |
|                             | applications.                          |
+-----------------------------+----------------------------------------+
| Small Business Innovation   | SBIR and STTR grants are made to       |
| Research Grant (SBIR:       | eligible domestic for-profit small     |
| R43/R44)                    | business concerns conducting           |
|                             | innovative research that has the       |
| Small Business Technology   | potential for commercialization.       |
| Transfer Grant (STTR:       |                                        |
| R41/R42)                    | SBIR/STTR awards are intended to       |
|                             | stimulate technological innovation,    |
| <http://grants.nih.g        | use small business to meet Federal     |
| ov/grants/funding/sbir.htm> | research and development needs,        |
|                             | increase private sector                |
|                             | commercialization of innovations       |
|                             | derived from Federal research and      |
|                             | development, and foster and encourage  |
|                             | participation by minority and          |
|                             | disadvantaged persons in technological |
|                             | innovation.                            |
+-----------------------------+----------------------------------------+
| []{#P01 .anchor}Program     | Program Project Grants are more        |
| Project Grant (P01)         | complex in scope and budget than the   |
|                             | individual basic research (R01) grant. |
|                             | While R01s are awarded to support the  |
|                             | work of one principal investigator     |
|                             | who, with supporting staff, is         |
|                             | addressing a scientific problem,       |
|                             | program project grants are available   |
|                             | to a group of several investigators    |
|                             | with differing areas of expertise who  |
|                             | wish to collaborate in research by     |
|                             | pooling their talents and resources.   |
|                             | Program project grants represent       |
|                             | synergistic research programs that are |
|                             | designed to achieve results not        |
|                             | attainable by investigators working    |
|                             | independently. Not all awarding        |
|                             | components accept P01 applications.    |
+-----------------------------+----------------------------------------+
| []{#P50 .anchor}Research    | Research Center Grants serve varying   |
| Center Grant (P50/P60)      | scientific and IC-specific purposes,   |
|                             | but they have elements in common. The  |
|                             | grants are multidisciplinary in scope  |
|                             | and may focus more on an area or       |
|                             | discipline of science than on a        |
|                             | specific theme or goal. Independent    |
|                             | investigators direct the projects and  |
|                             | cores. Center grants offer a greater   |
|                             | opportunity for scientific             |
|                             | interactions and overall progress than |
|                             | with individually-funded projects. Not |
|                             | all awarding components accept P50/P60 |
|                             | applications.                          |
+-----------------------------+----------------------------------------+
| Scientific Meeting Support  | Most NIH ICs provide support for       |
| (R13)                       | scientific meetings, conferences, and  |
|                             | workshops that are relevant to its     |
| <http://grants.nih.gov/gr   | scientific mission. Any U.S.           |
| ants/funding/r13/index.htm> | institution or organization, including |
|                             | an established scientific or           |
|                             | professional society, is eligible to   |
|                             | apply. For more information and        |
|                             | guidelines, see                        |
|                             | <http://grants.nih.gov/g               |
|                             | rants/guide/pa-files/PAR-03-176.html>. |
|                             | Applicants must obtain IC approval     |
|                             | prior to submission.                   |
+-----------------------------+----------------------------------------+
| Research Grants to Foreign  | [http://gra                            |
| Institutions and            | nts.nih.gov/grants/policy/nihgps_2003/ |
| International Organizations | NIHGPS_Part12                          |
|                             | .htm#\_Toc54600260](http://grants.nih. |
|                             | gov/grants/policy/nihgps_2003/NIHGPS_P |
|                             | art12.htm#__RefHeading___Toc54600260). |
+-----------------------------+----------------------------------------+
| Health Services Project     | Substance Abuse and Mental Health      |
| Application (5161-1)        | Services Administration (SAMHSA)       |
|                             |                                        |
|                             | \(301\) 436-8451                       |
+-----------------------------+----------------------------------------+

#### Training, Fellowships and Career Development Programs

+-----------------------------+----------------------------------------+
| type (mechanism)            | description                            |
+=============================+========================================+
| []{#T32                     | These awards are made to domestic      |
| .anchor}Institutional       | institutions that have the facilities  |
| Research Training Including | and faculty to provide for research    |
| Ruth L. Kirschstein         | training programs in scientific        |
| National Research Service   | specialties. Grant funds may be used   |
| Awards (T32/T34/T35)        | for personnel, equipment, supplies,    |
|                             | trainee stipends (both pre- and        |
| <http://grants              | postdoctoral), and related costs. See  |
| .nih.gov/training/nrsa.htm> | Part I, Section 8 Instructions for     |
|                             | Preparing an Institutional Research    |
|                             | Training Application.                  |
+-----------------------------+----------------------------------------+
| []{#NRSA .anchor}Individual | These fellowships are awarded to       |
| Ruth L. Kirschstein         | qualified individuals at the           |
| National Research Service   | predoctoral, postdoctoral, or senior   |
| Award Fellowships) (NRSA:   | investigator level to pursue full-time |
| F30/F31/F32/F33)            | research training in designated        |
|                             | biomedical or behavioral science       |
| <http://grants              | areas. NRSA APPLICANTS MUST USE PHS    |
| .nih.gov/training/nrsa.htm> | 416-1 FORMS/INSTRUCTIONS               |
|                             | (<http://grants.n                      |
|                             | ih.gov/grants/funding/416/phs416.htm>) |
+-----------------------------+----------------------------------------+
| []{#KAward .anchor}Career   | Among NIH components, several types of |
| Development Award (K Award) | career development awards are          |
|                             | available to research and academic     |
| <http:                      | institutions on behalf of scientists   |
| //grants.nih.gov/training/c | who require additional independent or  |
| areerdevelopmentawards.htm> | mentored experience in a productive    |
|                             | scientific environment in order to     |
|                             | further develop their careers in       |
|                             | independent biomedical or behavioral   |
|                             | research. See Part I, Section 7        |
|                             | Preparing an Individual CDA            |
|                             | Application.                           |
+-----------------------------+----------------------------------------+

#### Applications Available from Other Offices

+-----------------------------+----------------------------------------+
| type (mechanism)            | description                            |
+=============================+========================================+
| International Research      | Fogarty International Center (FIC)\    |
| Fellowship Award            | (301) 496-1653                         |
| Application (NIH 1541-1)    |                                        |
+-----------------------------+----------------------------------------+
| Nonresearch Training Grant  | Health Resources and Services          |
| Application (PHS 6025)      | Administration (HRSA)\                 |
|                             | (301) 443-6960                         |
+-----------------------------+----------------------------------------+
| Health Services Project     | Substance Abuse and Mental Health      |
| Application (5161-1)        | Services Administration (SAMHSA)       |
|                             |                                        |
|                             | \(301\) 436-8451                       |
+-----------------------------+----------------------------------------+

## 4.2 Mail Addressed to the National Institutes of Health

All United States Postal Service (USPS) mail addressed to the National
Institutes of Health must use the unique NIH zip code 20892. All USPS
mail addressed to the National Library of Medicine should use the unique
NLM zip code of 20894. All mail using 20892 and 20894 zip codes will be
cleared through the NIH North Stonestreet Mail Facility. This will
ensure that special procedures and precautions will be used to screen
the mail before it is delivered to the various NIH offices on and off
campus. This is an important measure to provide for the safety of all
individuals who must handle mail.

This procedure does not apply to commercial courier deliveries (i.e.
FEDEX, UPS, DHL, etc.) of grant applications addressed to the Center for
Scientific Review. The zip code for these deliveries is 20817. All
applications and other deliveries to the Center for Scientific Review
must either come via courier delivery or the USPS.

NIH WILL NOT ACCEPT APPLICATIONS **DELIVERED BY INDIVIDUALS** TO THE
CENTER FOR SCIENTIFIC REVIEW. This restriction does not apply to USPS or
courier delivery personnel.

Mail addressed to NIEHS in North Carolina should continue to show zip
code 27709.

## 4.3 Government Use of Information Under Privacy Act

The Privacy Act of 1974 (5 U.S.C. 552a) is a records management statute
and regulates the collection, maintenance, use, and dissemination of
personal information by Federal agencies. In accordance with the Act,
the PHS is required to provide the following notification to each
individual whom it asks to supply information.

The PHS maintains applications and grant records pursuant to its
statutory authority for awarding grants. The purpose of the information
collection is to aid in the review, award, and administration of PHS
programs. Provision of information is voluntary; however, a lack of
sufficient information may hinder the ability of the PHS to review
applications, monitor grantee performance, or perform overall management
of grant programs.

The Privacy Act authorizes discretionary disclosure of this information
within the Department of Health and Human Services and outside the
agency to the public, as required by the Freedom of Information Act and
the associated DHHS regulations (45 CFR 5), including the Congress
acting within its legislative authority, the National Archives, the
General Accounting Office, the Bureau of Census, law enforcement
agencies, and pursuant to a court order. Information also may be
disclosed outside the Department, if necessary, for the following
purposes:

1\. To a Congressional office at the request of the record subject;

2\. To the Department of Justice as required for litigation;

3\. To the cognizant audit agency for auditing;

4\. To qualified experts not within the definition of Department
employees as prescribed in Department Regulations (45 CFR 5b.2) for
opinions as part of the application review/award process;

5\. For an authorized research purpose under specified conditions;

6\. To contractors for the purpose of processing, maintaining, and
refining records in the system. Contractors will be required to maintain
Privacy Act safeguards with respect to such records;

7\. To a Federal agency, in response to its request, in connection with
the letting of a contract, or the issuance of a license, grant, or other
benefit by the requesting agency, to the extent that the records are
relevant and necessary to the requesting agency's decision on the
matter; and

8\. To the applicant organization in connection with the review of an
application or performance or administration under the terms and
conditions of the award, or in connection with problems that might arise
in performance or administration if an award is made.

## 4.4 Information Available to the Program Director(s)/Principal Investigator(s)

Under the provisions of the Privacy Act, PD/PIs may request copies of
records pertaining to their grant applications from the PHS component
responsible for funding decisions. PD/PIs are given the opportunity
under established procedures to request that the records be amended if
they believe they are inaccurate, untimely, incomplete, or irrelevant.
If the PHS concurs, the records will be amended.

## 4.5 Information Available to the General Public

PHS makes information about grant awards available to the public,
including the title of the project, the grantee institution, the PD/PI,
and the amount of the award. The description on Form Page 2 of a funded
research grant application is sent to the National Technical Information
Service (NTIS), U.S. Department of Commerce, where the information is
available to the public and used for the dissemination of scientific
information and for scientific classification and program analysis
purposes. In addition, NIH routinely places information about awarded
grants, including project title, name of the PD/PI, and project
description (abstract) in the [CRISP](http://crisp.cit.nih.gov/) system.

The Freedom of Information Act and implementing DHHS regulations (45 CFR
Part 5) require the release of certain grant documents and records when
requested by the public, regardless of the intended use of the
information. These policies and regulations apply to information in the
possession of NIH and generally do not require grantees to permit access
to their records except as described in 4.6 Access to Research Data,
below. Generally available for release upon request are: all funded
grant applications and progress reports including their derivative
funded noncompeting supplemental grant progress reports; pending and
funded noncompeting continuation progress reports; progress reports of
grantees; and final reports of any review or evaluation of grantee
performance conducted or caused to be conducted by the DHHS. Generally
**not** available for release to the public are: competing grant
progress reports (new, Renewal, and Revision) for which awards have
**not** been made; evaluative portions of site visit reports; and
summary statements of findings and recommendations of review groups.
Trade secrets and commercial, financial, or otherwise proprietary
information may be withheld from disclosure. Information, which, if
disclosed, would be a clearly unwarranted invasion of personal privacy,
may also be withheld from disclosure. Although the grantee institution
and the principal investigator will be consulted about any such release,
the PHS will make the final determination. If a requested document
contains both disclosable and nondisclosable information, the
nondisclosable information will be deleted and the balance of the
document will be released.

## 4.6 Access to Research Data

As required by regulation 45 CFR 74.36, grantees that are institutions
of higher education, hospitals, or non-profit organizations must release
"research data" first produced in a project supported in whole or in
part with Federal funds if they are cited publicly and officially by a
Federal agency in support of an action that has the force and effect of
law (i.e., regulations and administrative orders). The term "research
data" is defined as the recorded factual material commonly accepted in
the scientific community as necessary to validate research findings. It
does not include preliminary analyses; drafts of scientific papers;
plans for future research; peer reviews; communications with colleagues;
physical objects (e.g., laboratory samples, audio or video tapes); trade
secrets; commercial information; materials necessary to be held
confidential by a researcher until publication in a peer-reviewed
journal; information that is protected under the law (e.g., intellectual
property); personnel and medical files and similar files, the disclosure
of which would constitute an unwarranted invasion of personal privacy;
or information that could be used to identify a particular person in a
research study.

This requirement to release research data does not apply to commercial
organizations or to research data produced by state or local
governments. However, if a state or local governmental grantee contracts
with an educational institution, hospital or non-profit organization,
and the contract results in covered research data, those data are
subject to these disclosure requirements. See
<http://grants.nih.gov/grants/policy/data_sharing/index.htm>.

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