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

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

**National Institutes of Health and\
Agency for Healthcare Research and Quality**

**Ruth L. Kirschstein National Research\
Service Award\
Individual Fellowship Application (PHS 416-1)**

Instructions for PHS 416-1 Form Approved Through 09/30/2011\
Rev. 09/2008 OMB No. 0925-0002

####### TABLE OF CONTENTS

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

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

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

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

[1.3 Fellowship Mechanisms and Program Guidelines
I-6](#fellowship-mechanisms-and-program-guidelines)

[1.4 Interactions with PHS Staff I-7](#interactions-with-phs-staff)

[1.5 Grants Policy Statements I-10](#grants-policy-statements)

[1.6 Quick References I-10](#quick-references)

[1.7 Authorization I-12](#authorization)

[1.8 Paperwork Burden I-12](#paperwork-burden)

[2. General Instructions I-13](#general-instructions)

[2.1 Introduction I-13](#introduction)

[2.2 Registration Processes I-13](#registration-processes)

[2.2.1 (Reserved) I-13](#reserved)

[2.2.2 DUNS Registration for Applicant Organization
I-13](#duns-registration-for-applicant-organization)

[2.2.3 Central Contractor Registration (CCR) for the Applicant
Organization
I-14](#central-contractor-registration-ccr-for-the-applicant-organization)

[2.2.4 eRA Commons Registration I-14](#era-commons-registration)

[2.3 (Reserved) I-16](#reserved-1)

[2.4 Funding Opportunities I-16](#funding-opportunities)

[2.4.1 NIH Guide for Grants and Contracts
I-17](#nih-guide-for-grants-and-contracts)

[2.4.2 Funding Opportunities Announcements (FOAs)
I-17](#funding-opportunities-announcements-foas)

[2.5 (Reserved) I-17](#reserved-2)

[2.6 Format Specifications I-17](#format-specifications)

[2.7 Resubmission Applications I-20](#resubmission-applications)

[2.8 Revision Applications I-21](#revision-applications)

[2.9 Similar, Essentially Identical, or Identical Applications
I-21](#similar-essentially-identical-or-identical-applications)

[2.10 (Reserved) I-21](#reserved-3)

[2.11 (Reserved) I-21](#reserved-4)

[2.12 (Reserved) I-22](#reserved-5)

[2.13 Submission of Supplementary or Corrective Information
I-22](#submission-of-supplementary-or-corrective-information)

[2.14 Application Submission Dates I-22](#application-submission-dates)

[2.15 Submission and Review Cycles I-22](#submission-and-review-cycles)

[2.16 Resources for Finding Help I-23](#resources-for-finding-help)

[2.16.1 (Reserved) I-23](#reserved-6)

[2.16.2 Finding Help for the eRA Commons Registration
I-23](#finding-help-for-the-era-commons-registration)

[2.16.3 Finding Help for Application Preparation
I-24](#finding-help-for-application-preparation)

[3. Submission of the Grant Application
I-24](#submission-of-the-grant-application)

[3.1 Cover Letter I-24](#cover-letter)

[3.2 Number of Copies I-25](#number-of-copies)

[3.3 Binding and Packaging I-26](#binding-and-packaging)

[3.4 Application Mailing Address I-26](#application-mailing-address)

[4. Completing the PHS 416-1 Forms and Format Pages
I-27](#completing-the-phs-416-1-forms-and-format-pages)

[4.1 Face Page (Form Page 1) (Application Section I)
I-30](#face-page-form-page-1-application-section-i)

[4.2 Form Page 2 I-38](#form-page-2)

[4.2.1 Sponsor and Co-Sponsor Contact Information
I-38](#sponsor-and-co-sponsor-contact-information)

[4.2.2 Department, Service, Laboratory, or Equivalent
I-38](#department-service-laboratory-or-equivalent)

[4.2.3 Major Subdivision I-38](#major-subdivision)

[4.2.4 Co-Sponsor I-38](#co-sponsor)

[4.2.5 Research Proposal Description: Project Summary and Relevance
I-38](#research-proposal-description-project-summary-and-relevance)

[4.3 Form Page 3 I-39](#form-page-3)

[4.3.1 Career and Training Goals I-39](#career-and-training-goals)

[4.3.2 Activities Planned Under This Award
I-39](#activities-planned-under-this-award)

[4.3.3 Training Site(s) I-39](#training-sites)

[4.3.4 Human Embryonic Stem Cells I-40](#human-embryonic-stem-cells)

[4.4 Table of Contents (Form Page 4)
I-40](#table-of-contents-form-page-4)

[4.5 Applicant/Fellow Biographical Sketch
I-40](#applicantfellow-biographical-sketch)

[4.6 Previous Research Experience (Form Page 5)
I-41](#previous-research-experience-form-page-5)

[4.6.1 Prior and Current Kirschstein-NRSA Support (Individual or
Institutional)
I-41](#prior-and-current-kirschstein-nrsa-support-individual-or-institutional)

[4.6.2 Application(s) for Concurrent Support
I-42](#applications-for-concurrent-support)

[4.6.3 Title(s) of Thesis/Dissertation(s)
I-42](#titles-of-thesisdissertations)

[4.6.4 Dissertation Advisor or Chief of Service
I-42](#dissertation-advisor-or-chief-of-service)

[4.6.5 Doctoral Dissertation and Other Research Experience
I-42](#doctoral-dissertation-and-other-research-experience)

[4.7 Personal Data I-42](#personal-data)

[5. Preparing the Research Training Plan
I-43](#preparing-the-research-training-plan)

[5.1 (Reserved) I-43](#reserved-7)

[5.2 (Reserved) I-43](#reserved-8)

[5.3 (Reserved) I-43](#reserved-9)

[5.4 Research Training Plan Format and Notice of Proprietary Information
I-43](#research-training-plan-format-and-notice-of-proprietary-information)

[5.4.1 Research Training Plan Format
I-43](#research-training-plan-format)

[5.4.2 Notice of Proprietary Information
I-44](#notice-of-proprietary-information)

[5.5 Contents of Research Training Plan
I-44](#contents-of-research-training-plan)

[5.6 Checklist I-50](#checklist)

[5.7 Appendix I-50](#appendix)

[5.8 Sponsor and Co-Sponsor Information (Application Section II)
I-51](#sponsor-and-co-sponsor-information-application-section-ii)

[5.9 Letters of Reference (Application Section III)
I-53](#letters-of-reference-application-section-iii)

[6. The Peer Review Process I-54](#the-peer-review-process)

[6.1 Individual Fellowship Application Review Criteria
I-54](#individual-fellowship-application-review-criteria)

[7. Fields of Training I-56](#fields-of-training)

[8. KIRSCHSTEIN-NRSA Payback Assurance
I-59](#kirschstein-nrsa-payback-assurance)

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

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

[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-8](#instructions-pertaining-to-non-exempt-human-subjects-research)

[4.1 Protection of Human Subjects II-8](#protection-of-human-subjects-1)

[4.1.1 Risks to Human Subjects II-8](#risks-to-human-subjects)

[4.1.2 Adequacy of Protection Against Risks
II-9](#adequacy-of-protection-against-risks)

[4.1.3 Potential Benefits of the Proposed Research to Human Subjects
and\
Others
II-10](#potential-benefits-of-the-proposed-research-to-human-subjects-and-others)

[4.1.4 Importance of the Knowledge to be Gained
II-10](#importance-of-the-knowledge-to-be-gained)

[4.1.5 Data and Safety Monitoring Plan
II-10](#data-and-safety-monitoring-plan)

[4.1.6 ClinicalTrials.gov Requirements
II-11](#clinicaltrials.gov-requirements)

[4.2 Inclusion of Women and Minorities
II-12](#inclusion-of-women-and-minorities-1)

[4.2.1 Additional Instructions and Requirements When NIH-Defined Phase
III\
Clinical Trials Are Proposed
II-14](#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-14](#instructions-for-completing-the-targetedplanned-enrollment-tables-for-reporting-race-and-ethnicity-data-for-subjects-in-clinical-research)

[4.4 Inclusion of Children II-16](#inclusion-of-children-1)

[5. Human Subjects Research Policy
II-17](#human-subjects-research-policy)

[5.1 Protection of Human Subjects
II-17](#protection-of-human-subjects-2)

[5.2 Vulnerable Populations II-18](#vulnerable-populations)

[5.3 Data and Safety Monitoring Plans for Clinical Trials
II-19](#data-and-safety-monitoring-plans-for-clinical-trials)

[5.4 IRB Approval II-19](#irb-approval)

[5.5 Required Education in the Protection of Human Research Participants
II-20](#required-education-in-the-protection-of-human-research-participants)

[5.6 NIH Policy on the Inclusion of Women and Minorities in Clinical
Research
II-20](#nih-policy-on-the-inclusion-of-women-and-minorities-in-clinical-research)

[5.7 NIH Policy on Inclusion of Children
II-20](#nih-policy-on-inclusion-of-children)

[5.8 NIH Policy on Reporting Race and Ethnicity Data: Subjects in
Clinical Research
II-21](#nih-policy-on-reporting-race-and-ethnicity-data-subjects-in-clinical-research)

[5.9 Research on Transplantation of Human Fetal Tissue
II-22](#research-on-transplantation-of-human-fetal-tissue)

[5.10 Research Using Human Embryonic Stem Cells
II-22](#research-using-human-embryonic-stem-cells)

[5.11 ClinicalTrials.gov Requirements
II-23](#clinicaltrials.gov-requirements-1)

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

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

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

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

[1.3 Sharing Research Resources III-3](#sharing-research-resources)

[1.3.1 Data Sharing Policy III-3](#data-sharing-policy)

[1.3.2 Sharing Model Organism Policy
III-3](#sharing-model-organism-policy)

[1.3.3 Policy for Genome-Wide Association Studies (GWAS)
III-4](#policy-for-genome-wide-association-studies-gwas)

[1.4 Inventions and Patents III-4](#inventions-and-patents)

[1.5 Just-In-Time Policy III-4](#just-in-time-policy)

[1.6 DUNS Number III-5](#duns-number)

[1.7 Public Access Policy III-5](#public-access-policy)

[1.8 PHS Metric Program III-6](#phs-metric-program)

[1.9 Transition to the SF424 (R&R) Application and Electronic Submission
through\
Grants.gov
III-6](#transition-to-the-sf424-rr-application-and-electronic-submission-through-grants.gov)

[2. Assurances and Certifications III-6](#assurances-and-certifications)

[2.1 Human Subjects Research III-7](#human-subjects-research-1)

[2.1.1 Research on Transplantation of Human Fetal Tissue
III-9](#research-on-transplantation-of-human-fetal-tissue-1)

[2.1.2 Research Using Human Embryonic Stem Cells
III-9](#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-10](#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-10](#nih-policy-on-reporting-race-and-ethnicity-data-subjects-in-clinical-research-1)

[2.1.5 NIH Policy on Inclusion of Children
III-10](#nih-policy-on-inclusion-of-children-1)

[2.1.6 ClinicalTrials.gov III-11](#clinicaltrials.gov)

[2.2 Vertebrate Animals III-11](#vertebrate-animals-1)

[2.3 Debarment and Suspension III-12](#debarment-and-suspension)

[2.4 Drug-Free Workplace III-12](#drug-free-workplace)

[2.5 Lobbying III-13](#lobbying)

[2.6 Non-Delinquency on Federal Debt
III-13](#non-delinquency-on-federal-debt)

[2.7 Research Misconduct III-13](#research-misconduct)

[2.8 Assurance of Compliance (Civil Rights, Handicapped Individuals,
Sex\
Discrimination, Age Discrimination)
III-14](#assurance-of-compliance-civil-rights-handicapped-individuals-sex-discrimination-age-discrimination)

[2.9 Research Involving Recombinant DNA, including Human Gene Transfer\
Research
III-14](#research-involving-recombinant-dna-including-human-gene-transfer-research)

[2.10 Financial Conflict of Interest
III-15](#financial-conflict-of-interest)

[2.11 Smoke-Free Workplace III-15](#smoke-free-workplace)

[2.12 Prohibited Research III-16](#prohibited-research)

[2.13 Select Agent Research III-16](#select-agent-research-1)

[2.14 Fellow and Sponsor Assurance
III-17](#fellow-and-sponsor-assurance)

[2.15 Impact of Grant Activities on the Environment and Historic
Properties
III-18](#impact-of-grant-activities-on-the-environment-and-historic-properties)

[3. Definitions III-19](#definitions)

[4. General Information III-27](#general-information)

[4.1 Research Grant Mechanisms III-27](#research-grant-mechanisms)

[4.2 Mail Addressed to the National Institutes of Health
III-27](#mail-addressed-to-the-national-institutes-of-health)

[4.3 Government Use of Information Under Privacy Act
III-28](#government-use-of-information-under-privacy-act)

[4.4 Information Available to the Program Director(s)/Principal
Investigator(s)
III-28](#information-available-to-the-program-directorsprincipal-investigators)

[4.5 Information Available to the General Public
III-29](#information-available-to-the-general-public)

[4.6 Access to Research Data III-29](#access-to-research-data)

[]{#Part_I .anchor}PART I\
\
Instructions

# 1. Foreword

The PHS 416-1 instructions contain information for preparing Fellowship
applications to the National Institutes of Health (NIH) and the Agency
for Healthcare Research and Quality (AHRQ).

Applicants to PHS agencies other than NIH should contact the agency
using the PHS Agency Contacts Table in 1.5 below because some awarding
components have application requirements that differ from those for NIH.

NIH continues to transition grant mechanisms to the SF424 (R&R) and
electronic submission through Grants.gov. This PHS 416-1 is required for
use until the Fellowship mechanisms are transitioned to the SF424 (R&R).
Once the Fellowship mechanisms have transitioned to electronic
submission the applicant must apply through Grants.gov using the SF424
(R&R) and electronic PHS Fellowship Supplemental components that will be
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/416/phs416.htm> for easy
electronic access to this document.

#### Summary of Changes {#summary-of-changes .Subhead---No-TOC}

These instructions include numerous clarifications and updates. The
following table is a summary of policy changes and notifications
implemented since the 10/2005 revision of the PHS 416-1 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> |
+-------------------------------+--------------------------------------+
| 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                |                                      |
+-------------------------------+--------------------------------------+
| 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> |
+-------------------------------+--------------------------------------+
| New Limits on Appendix        | NOTICE-OD-07-018\                    |
| Materials for All             | <http://grants.nih.gov/grants/gu     |
| NIH/AHRQ/NIOSH Grant          | ide/notice-files/NOT-OD-07-018.html> |
| Applications Beginning with   |                                      |
| Receipt Dates on or After     |                                      |
| January 3, 2007               |                                      |
+-------------------------------+--------------------------------------+
| Change in Standing Receipt    | NOTICE OD-07-053\                    |
| Dates for AIDS and            | <http://grants.nih.gov/grants/gu     |
| AIDS-related applications for | ide/notice-files/NOT-OD-07-053.html> |
| NIH/AHRQ Beginning in May     |                                      |
| 2007                          |                                      |
+-------------------------------+--------------------------------------+
| Revision: Ruth L. Kirschstein | NOTICE OD-07-057\                    |
| National Research Service     | <http://grants.nih.gov/grants/gu     |
| Award (NRSA)\                 | ide/notice-files/NOT-OD-07-057.html> |
| Stipend and Other Budgetary   |                                      |
| Levels\                       |                                      |
| Effective for Fiscal Year     |                                      |
| 2007                          |                                      |
+-------------------------------+--------------------------------------+
| Revision: Streamlined Review  | NOTICE OD-07-085\                    |
| Process to be used for Ruth   | <http://grants.nih.gov/grants/gu     |
| L. Kirschstein National       | ide/notice-files/NOT-OD-07-085.html> |
| Research Service Awards       |                                      |
| (NRSA) Postdoctoral           |                                      |
| Fellowship Applications (F32) |                                      |
+-------------------------------+--------------------------------------+
| Policy for Sharing of Data    | NOTICE OD-07-088\                    |
| Obtained in NIH Supported or  | <http://grants.nih.gov/grants/gu     |
| Conducted Genome-Wide         | ide/notice-files/NOT-OD-07-088.html> |
| Association Studies (GWAS)    |                                      |
+-------------------------------+--------------------------------------+
| Implementation Guidance and   | NOTICE OD-08-013\                    |
| Instructions for Applicants:  | <http://grants.nih.gov/grants/gu     |
| Policy for Sharing of Data    | ide/notice-files/NOT-OD-08-013.html> |
| Obtained in NIH-Supported or  |                                      |
| Conducted Genome-Wide         |                                      |
| Association Studies (GWAS)    |                                      |
+-------------------------------+--------------------------------------+
| Clinical Trials Registration  | NOTICE OD-08-023\                    |
| in ClincialTrials.gov (Public | <http://grants.nih.gov/grants/gu     |
| Law 110-85): Competing        | ide/notice-files/NOT-OD-08-023.html> |
| Applications and              |                                      |
| Non-Competing Progress        |                                      |
| Reports                       |                                      |
+-------------------------------+--------------------------------------+
| NIH Policy on Late Submission | NOTICE OD-08-027\                    |
| of Grant Applications         | <http://grants.nih.gov/grants/gu     |
|                               | ide/notice-files/NOT-OD-08-027.html> |
+-------------------------------+--------------------------------------+
| Notice Regarding the          | NOTICE OD-08-032\                    |
| Applicability of the Federal  | <http://grants.nih.gov/grants/gu     |
| Information Security          | ide/notice-files/NOT-OD-08-032.html> |
| Management Act to NIH         |                                      |
| Grantees                      |                                      |
+-------------------------------+--------------------------------------+
| NIH Renews Focus on           | NOTICE OD-08-066\                    |
| Protecting Sensitive Data and | <http://grants.nih.gov/grants/gu     |
| Information Used in Research  | ide/notice-files/NOT-OD-08-066.html> |
+-------------------------------+--------------------------------------+
| Extension of Several NRSA     | NOTICE OD-08-069\                    |
| Training (T), NRSA Fellowship | <http://grants.nih.gov/grants/gu     |
| (F), and Career Development   | ide/notice-files/NOT-OD-08-069.html> |
| (K) Funding Opportunity       |                                      |
| Announcements                 |                                      |
+-------------------------------+--------------------------------------+
| NIH Implements New Procedures | NOTICE OD-08-071\                    |
| to Protect NIH Application    | <http://grants.nih.gov/grants/gu     |
| Data Sent to Peer Reviewers   | ide/notice-files/NOT-OD-08-071.html> |
| on Compact Disks              |                                      |
+-------------------------------+--------------------------------------+
| NIH/AHRQ Set Transition from  | NOTICE OD-08-073\                    |
| PureEdge to Adobe Application | <http://grants.nih.gov/grants/gu     |
| Forms for December 2008 and   | ide/notice-files/NOT-OD-08-073.html> |
| Plan Subsequent Transition of |                                      |
| Remaining Mechanisms to       |                                      |
| Electronic Submission         |                                      |
+-------------------------------+--------------------------------------+
| Clarification of NIH Policy   | NOTICE OD-08-111\                    |
| on Late Submission of Grant   | <http://grants.nih.gov/grants/gu     |
| Applications                  | ide/notice-files/NOT-OD-08-111.html> |
+-------------------------------+--------------------------------------+
| New NIH Policy on             | NOTICE OD-09-003\                    |
| Resubmission (Amended)        | <http://grants.nih.gov/grants/gu     |
| Applications                  | ide/notice-files/NOT-OD-09-003.html> |
+-------------------------------+--------------------------------------+

#### Changes to instructions are highlighted as follows: {#changes-to-instructions-are-highlighted-as-follows .Subhead---No-TOC}

Implementation of Grants.Gov Terminology

-   As part of the ongoing effort to keep the PHS 416-1, 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

  Training site                 Project/performance site -\
                                \
                                For fellowships this is also known as the
                                Training Site.

  Duly authorized               Authorized Organizational Representative
  representative                --\
                                \
                                For fellowships this is the
                                representative of the Sponsoring
                                Institution.
  -----------------------------------------------------------------------

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.

-   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.

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

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

Appendix Format

-   Incorporates the new NIH policy requiring appendix material to be
    submitted only on CDs in PDF format, and no longer on paper. See
    [NIH Guide Notice
    NOT-OD-08-031](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html).

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

-   All six human subjects exemptions are provided in one scenario
    (Scenario C).

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

Select Agent Research

-   The requirements of the Research Training Plan have been revised to
    include a new section dedicated specifically to Select Agent
    Research. This new section is only required when applicable.

#### Changes to specific form and format pages are noted below:  {#changes-to-specific-form-and-format-pages-are-noted-below .Subhead---No-TOC}

416-1 Face Page

-   4k. Citizenship data fields updated to include check boxes for:
    Permanent Resident of U.S. *Pending*; and Non-U.S. Citizenship with
    temporary U.S. Visa. Note the additions to the Citizenship section
    are to allow broader use of these forms for individual Fellowship
    programs outside of the Ruth L. Kirschstein National Research
    Service Award (NRSA) authority. There are no changes in NRSA policy
    regarding citizenship requirements.

-   9b. Human Subjects Assurance has been changed to Federalwide
    Assurance.

-   10a. IACUC approval date deleted since information is collected only
    as a Just-in-Time submission.

Signatures

-   Implements a change in business process by replacing the Applicant
    (Fellow) and Sponsor Signatures on the Face Page with a Sponsoring
    Institution assurance (see companion [NIH Guide Notice
    NOT-OD-09-007](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-007.html)).
    This change in business process removes these signatures from the
    Face Page. The only required signature on the Face Page is that of
    the Official signing for the Sponsoring Institution (see Part III,
    Section 2.14 for signature requirements for Fellowships).

416-1 Form Page 3

-   Updated to collect specific information for each Training
    (Project/Performance) Site; added DUNS and Congressional District
    fields for each Training (Project/Performance) Site. This structured
    data requirement is necessary to comply with the Federal Financial
    Accountability and Transparency Act of 2006.

Checklist Form Page

-   Deleted Section II for the Sponsoring Institution.
    Assurances/Certifications are listed in Part I of the 416-1.

#### Important Reminders for all Applicants {#important-reminders-for-all-applicants .Subhead---No-TOC}

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 Training Plan. There is no requirement for
applicants to use the maximum allowable pages allotted to the Research
Training Plan (Sections 2-5). The remaining sections of the Research
Training Plan 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. 1.5.

## 1.1 Application Guide Format

This edition of the PHS 416-1 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 416-1 are
described below:

**Part I: Instructions for Preparing and Submitting an Application**

Part I includes instructions on submitting a grant application,
completing the PHS 416-1 forms and format pages, submission and review
of your application,

**[Part II](#Human_Subjects_PartII): Supplemental Instructions for
Preparing the Human Subjects Section of the Research Training Plan**

Part II of the PHS 416-1 is to be used if your proposed research will
involve [human subjects](#Human_Subjects_Defs_Human). These instructions
assist you in determining whether human subjects are involved and
include six possible scenarios and detailed instructions to assist you
in completing [Item 8 of the Research Training Plan (Human Subjects
Research)](#human-subjects-research).

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

Part III of the PHS 416-1 includes information on policies, assurances,
definitions, and other information relating to submission of
applications to the PHS. Applicants should refer to this as well as the
PHS 416-1 instructional materials, [Grants Information](#GrantsInfo)
(GrantsInfo), and [*Grants Policy
Statement*](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm)
sections for additional sources of information.

THESE INSTRUCTIONS AND APPLICATION FORMS (revised 09/2008) 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, many fellowship
programs have additional specific instructions. Applicants should
contact an official listed in the [table](#phs-agency-contacts) to
obtain the most current information and instructions.

Bookmark this website <http://grants.nih.gov/grants/forms.htm> for easy
electronic access to the forms and instructions.

## 1.2 NIH and AHRQ Extramural Research and Research Training Programs

The NIH Office of Extramural Research Grants homepage
(<http://grants.nih.gov/grants/oer.htm>) provides an array of helpful
information. Applicants are encouraged to bookmark this site and visit
it often.

Information about the NIH extramural research and research training
programs, funding opportunities, and the grant application process, can
be obtained by emailing your request to:
[[GrantsInfo@nih.gov]{.underline}](mailto:GrantsInfo@nih.gov) or by
calling (301) 435-0714, TTY (301) 451-5936.

Guidelines for Kirschstein-NRSA Individual Fellowships and non-NRSA may
be found on the NIH Web Site at
<http://grants.nih.gov/training/nrsa.htm>. Guidelines for the AHRQ
fellowships may be found on the AHRQ Web Site at
<http://www.ahrq.gov/fund/hhspolicy.htm>.

## 1.3 Fellowship Mechanisms and Program Guidelines

The Kirschstein-NRSA program helps ensure that a diverse pool of highly
trained scientists is available in adequate numbers and in appropriate
research areas to carry out the Nation's biomedical and behavioral
research agenda. Kirschstein-NRSA fellowships are awarded as a result of
national competition for research training in specified health-related
areas. Certain specialized individual fellowships, such as the
predoctoral fellowships (F31 and F30), postdoctoral fellowships (F32),
Senior Fellowships (F33), and other institute-specific fellowship
programs are provided under this authority. For individual predoctoral
fellowships, NIH Institutes and Centers (ICs) have differing
requirements. All NIH ICs except Fogarty International Center (FIC) and
National Library of Medicine (NLM) award Kirschstein-NRSA fellowships.
FIC and NLM have unique funding authorities for fellowships that are not
under the Kirschstein-NRSA authority.

This Application Guide contains information for preparing applications
for Individual Fellowships available from the National Institutes of
Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ).
These fellowships are available at the predoctoral, postdoctoral, and
senior fellowship levels. These include both Ruth L. Kirschstein
National Research Service Award (NRSA) and non-NRSA programs. It is
important to note that not all predoctoral, postdoctoral, and senior
fellowships are supported by each IC and AHRQ. Therefore, individuals
interested in this type of award are strongly encouraged to consult with
the appropriate NIH IC and AHRQ before submitting an application. (For
example, Postdoctoral (F32) fellowships are provided by the NIH ICs and
AHRQ. AHRQ does not provide senior fellowships.) *[This action is of
utmost importance because applications with marginal or no relevance to
the mission of the participating ICs or AHRQ will not be accepted for
review or funding.]{.underline}* Thus, specific FOAs always should be
consulted for guidance.

Contact information can be found in each Funding Opportunity
Announcement (FOA) published as a program announcement or request for
applications and below in the [Interactions with PHS Staff
section](#phs-agency-contacts).

For more information, see the NIH Research Training and Career
Development website at <http://grants.nih.gov/training/extramural.htm>
and the AHRQ Research Training website at
<http://www.ahrq.gov/fund/training/rsrchtng.htm>.

A partial list of research training and career development award grant
mechanisms is provided below. As noted in the descriptions in [Part III:
Policies, Assurances, Definitions, and Other
Information](#research-grant-mechanisms), 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>.

#### Kirschstein-NRSA Programs: {#kirschstein-nrsa-programs .Subhead---No-TOC}

[Individual Ruth L. Kirschstein National Research Service Award
Fellowships (NRSA) (F30, F31, F32, F33, F34,
etc.)](#institutional-research-training-including-ruth-l.-kirschstein-national-research-service-awards-t32t34t35)

#### Other Individual Fellowship (non-NRSA) Programs: {#other-individual-fellowship-non-nrsa-programs .Subhead---No-TOC}

> Information for other non-NRSA Fellowship programs can be found at\
> <http://grants.nih.gov/training/extramural.htm>

## 1.4 Interactions with PHS Staff

NIH and AHRQ encourage applicants to communicate with staff throughout
the entire application, review and award process. Web site addresses and
staff phone numbers of NIH and AHRQ contacts are listed below. A list of
contacts specifically for extramural training at the NIH ICs can also be
found at: [http://grants.nih.gov/training/
tac_training_contacts.doc](http://grants.nih.gov/training/tac_training_contacts.doc).
Individuals are encouraged to always check this website for the most
current contact information.

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     301-496-0104
  (NIH)](http://www.nih.gov/)      Child Health and Human                              
                                   Development](http://www.nichd.nih.gov/)             

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

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

  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                              301-496-9322
                                   Aging](http://www.nih.gov/nia/)                     

  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                301-594-2463
                                   Musculoskeletal and Skin                            
                                   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           301-496-1804
                                   Communication 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   301-594-8834
                                   Kidney Diseases](http://www.niddk.nih.gov/)         

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

  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                       301-443-3367
                                   Health](http://www.nimh.nih.gov/)                   

  NIH                              [National Institute of Neurological Disorders and   301-496-4188
                                   Stroke](http://www.ninds.nih.gov/)                  

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

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

  NIH                              [Center For Scientific                              301-435-0715\
                                   Review](http://www.csr.nih.gov/)                    TTY 301-
                                                                                       451-5936

  NIH                              [Study Section                                      301-435-1115
                                   Information](http://www.csr.nih.gov/studysec.htm)   

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

#### Before Submission

You may wish to contact NIH or AHRQ staff with a variety of questions
before submitting an application. Each FOA includes names of staff
members.

Contact [GrantsInfo](#GrantsInfo) and/or the [Division of Receipt and
Referral, Center for Scientific Review (CSR),
NIH](#receiptreferral-of-an-application):

-   To identify Institutes/Centers (ICs) at NIH or other non-NIH
    agencies and/or a Scientific Review Group (SRG) that might be
    appropriate for your application. Note requests for assignment to an
    Institute/Center and/or 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).

Contact program staff in the relevant awarding component:

-   To determine whether your proposed application topic would fit into
    the NIH IC's or AHRQ's programmatic area.

-   To learn about programmatic areas of interest to the IC or AHRQ.

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

-   To discuss whether you should respond to an RFA.

-   To receive scientific guidance on preparing and submitting an
    application

-   To discuss appropriate fellowship level, particularly predoctoral
    and senior fellowships

Contact Scientific Review Officers in the CSR to discuss requesting
assignment to a SRG.

#### After Submission

If the initial assignment to an IC or SRG seems inappropriate, the
Applicant Fellow (to be designated as the Project Director/Principal
Investigator, or 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 your Scientific Review Officer 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 your 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](#Summary_Statement) in the eRA Commons, the
appropriate awarding component program official (noted on 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

A paper copy of the Peer Review Outcome Letter and Summary Statement
will not be mailed to the Applicant Fellow 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/) serves as
a term and condition of NIH grant awards and is a compilation of the
salient features of policies and various policy issues regarding the
administration of NIH awards.

AHRQ uses the [*HHS Grants Policy
Statement*](http://www.ahrq.gov/fund/hhspolicy.htm) in administering its
grant awards. It 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 PHS awards, excluding NIH awards.

## 1.6 Quick References

#### Applicants New to NIH: Getting Started [**grants.nih.gov/grants/useful_links.htm**](http://grants.nih.gov/grants/useful_links.htm) {#applicants-new-to-nih-getting-started-grants.nih.govgrantsuseful_links.htm .Subhead---No-TOC}

#### Award Data ([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)) [**grants.nih.gov/grants/award/award.htm**](http://grants.nih.gov/grants/award/award.htm)  {#award-data-crisp-extramural-research-grants-award-trends-training-and-career-awards-grants.nih.govgrantsawardaward.htm .Subhead---No-TOC}

#### Contact Information for an AHRQ Staff Person [**training@ahrq.hhs.gov**](mailto:training@ahrq.hss.gov) Technical Assistance: Telephone: (301) 427-1349  {#contact-information-for-an-ahrq-staff-person-trainingahrq.hhs.gov-technical-assistance-telephone-301-427-1349 .Subhead---No-TOC}

#### Contact Information for an NIH Staff Person [**directory.nih.gov**](http://directory.nih.gov/) NIH locator: Telephone: (301) 496-4000  {#contact-information-for-an-nih-staff-person-directory.nih.gov-nih-locator-telephone-301-496-4000 .Subhead---No-TOC}

> []{#GrantsInfo .anchor}Grants Information\
> [**grants.nih.gov/grants/giwelcome.htm**](http://grants.nih.gov/grants/giwelcome.htm)\
> E-mail: [GrantsInfo@nih.gov](mailto:grantsinfo@nih.gov)\
> Telephone: (301) 435-0714\
> TTY: (301) 451-5936

#### Grant Writing Tips and Frequently Asked Questions [**http://grants.nih.gov/grants/planning_application.htm**](http://grants.nih.gov/grants/planning_application.htm) [**http://grants.nih.gov/grants/writing_application.htm**](http://grants.nih.gov/grants/writing_application.htm) [**http://grants.nih.gov/training/faq_fellowships.htm**](http://grants.nih.gov/training/faq_fellowships.htm)  {#grant-writing-tips-and-frequently-asked-questions-httpgrants.nih.govgrantsplanning_application.htm-httpgrants.nih.govgrantswriting_application.htm-httpgrants.nih.govtrainingfaq_fellowships.htm .Subhead---No-TOC}

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

Institutions are invited to register with the eRA Commons and to
register individuals. Registered Applicants/Fellows can check
assignment/contact information, review outcome, and other important
information. Note this is the only way Applicants/Fellows can now access
information on review and Institute assignments, review outcomes, and
summary statements. This information is no longer mailed to the
Applicants/Fellows.

[**https://commons.era.nih.gov/commons/index.jsp**](https://commons.era.nih.gov/commons/index.jsp).
At this time the eRA Commons is available to NIH grantees only. Plans
are underway to incorporate data for other DHHS agencies.

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

This site provides, in one place, DHHS and NIH requirements and
resources for the extramural community involved in human subjects
research
[**http://grants.nih.gov/grants/policy/hs/index.htm**](http://grants.nih.gov/grants/policy/hs/index.htm)

#### Office for Human Research Protections {#office-for-human-research-protections .Subhead---No-TOC}

(Human Subject Protections, Institutional Review Boards, or related
assurances) [**http://www.hhs.gov/ohrp**](http://www.hhs.gov/ohrp)\
Telephone: 1-866-447-4777 or (301) 496-7005

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

(Animal Welfare and related regulations and assurances)
[**grants.nih.gov/grants/olaw/olaw.htm**](http://grants.nih.gov/grants/olaw/olaw.htm)\
Telephone: (301) 496-7163

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

Division of Receipt and Referral\
Center for Scientific Review\
[**http://cms.csr.nih.gov/ResourcesforApplicants/Submission+And+Assignment+
Process.htm**](http://cms.csr.nih.gov/ResourcesforApplicants/Submission+And+Assignment+Process.htm)\
Telephone: (301) 435-0715\
TTY: (301) 451-5936\
Fax: (301) 480-1987

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

Telephone or e-mail the Scientific Review Officer named on the
electronically-generated "notification of assignment" that is available
in the eRA Commons. **In order to avoid delays in the e-notification
process, it is vital that all Individual Fellows are registered in the
eRA Commons and e-mail addresses are checked periodically for
accuracy.**

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

Telephone or e-mail the NIH or AHRQ Program Official named on the
summary statement of your application which can be viewed in the eRA
Commons.

## 1.7 Authorization

NIH and AHRQ request the information described in these instructions
pursuant to the statutory authorities contained in Section 487 of the
PHS Act, as amended (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 to review
an application and to monitor the awardee\'s performance.

The statutory authorities for the Fellowship programs are contained in
the following:

F30, F31, F32, F33 Authority: Sections 301(a) and 487 of the PHS Act, as
amended (42 USC 241a and 42 USC 288), 42 CFR Part 66.

F05 Authority: Section 307, 42USC 2421 and 42 CFR Part 63a.

F37 Authority: Section 472, 42 USC 286B-3 and 42 CFR Part 61.

AHRQ Authority: Section 487,Sections 304, 902, and 935 of the PHS Act,
42 USC 242b, 299, and 299c-4 and 42 CFR 67, Subpart A.

## 1.8 Paperwork Burden

NIH, which maintains this application form and instructions, estimates
that it will take approximately 20 hours to complete. This estimate does
not include time for development of the research training plan. Items
such as human subjects and vertebrate animals have separate clearances
and are not included in this estimate. An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number. If
you have comments regarding this burden estimate or any other aspect of
this collection of information, including suggestions for reducing this
burden, send comments to: NIH Project Clearance Office, 6705 Rockledge
Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0002). *Do not
send applications to this address*.

# 2. General Instructions

## 2.1 Introduction 

Read all of the instructions thoroughly before preparing your
application.

Use this application to apply for new and competing continuation
(renewal) Kirschstein-NRSA Individual Fellowships from NIH or AHRQ.
Applications for these Individual Fellowships will not be accepted on
other forms.

Further details on policies governing the Kirschstein-NRSA program are
available on the NIH web site at
<http://grants.nih.gov/training/nrsa.htm>, by contacting
<GrantsInfo@nih.gov>, or by calling (301) 435-0714, TTY (301) 451-5936.

[]{#Section_2_1_2 .anchor}Read and follow these instructions carefully
to avoid delays, misunderstandings, and possible return of applications.
Adherence to font and margin requirements is necessary for several
reasons. No applicant should have an advantage over other applicants by
providing more content in his/her application by 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 301-451-5936; Fax: 301- 480-1987*

## 2.2 Registration Processes

### 2.2.1 (Reserved)

### 2.2.2 DUNS Registration for Applicant Organization

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 (i.e. Applicant Fellow) 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/PI must be registered in the Commons
before they can take advantage of retrieval of grant information.
Institutional/organizational officials are responsible for registering
the Fellow in the eRA Commons. Fellows should work with their AOR (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 the submission date. A valid PD/PI eRA
Commons user name ID must be entered in item 4b 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 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).

This registration is independent of Grants.gov and may be done at any
time.

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 DUNS 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 AOR/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 your 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 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 Applicant Fellow (designated as Project Director/Principal Investigator; or PD/PI)

The individual Fellow for whom support is being requested is to be
designated as the PD/PI on the application, and 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 PDs/PIs in the Commons, refer to the 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, review, and update as needed, all
Personal Information located within the Personal Profile tab in the eRA
Commons System. 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 need to
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.

For additional information on how to prepare for electronic submission,
see: <http://era.nih.gov/ElectronicReceipt/preparing.htm>.

#### Guidance for Affiliating Individual Fellows in the eRA Commons

In October 2006, NIH issued "Guidance to Applicant Organizations about
Registering Research Fellows in the eRA Commons" (Notice Number:
[NOT-OD-07-003](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-003.html);
see
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-003.html>).
The purpose of this Notice is to remind applicant organizations that
they should register in the eRA Commons any individual research fellows
who are submitting applications to NIH and AHRQ. Many individuals who
are submitting Individual Fellowship applications have the unique
circumstance of actually submitting an application through a Sponsoring
Organization that is different than their current organization. This is
perfectly appropriate considering the nature of Individual Fellowship
programs. However, this does pose a complexity with respect to eRA
Commons registration. Many prospective individual fellows have already
been registered in the eRA Commons by their current organization.
However, to be able to view the records for an application submitted
through a different organization, that individual must also be
"affiliated" with the new sponsoring organization. Note a separate eRA
Commons registration is NOT required. However, the proposed sponsoring
organization must take steps to affiliate the prospective fellow.

This process assumes the Prospective Fellow has already been registered
in the eRA Commons by another organization and assigned the PI Role. If
a Prospective Fellow has not yet been registered in the eRA Commons,
they should work with the appropriate officials within the sponsoring
organization to be properly registered. When the sponsoring organization
handles the initial eRA Commons registration, no further affiliation is
required.

**To Affiliate a Prospective Fellow with a Different Sponsoring
Organization:**

1\) Prospective Fellow gives Commons user ID and email address to the
administrator of the new sponsoring organization. (The email address
must be the one that is contained in the Personal Profile for the
Fellow.)

2\) Administrator of the new sponsoring organization logs into the
Commons. (The administrator can be the Signing Official, Administrative
Official, or the Accounts Administrator.)

3\) Administrator selects \"Administration\" tab and then \"Accounts\"
tab.

4\) Administrator selects \"Create Affiliation\" tab.

5\) Administrator enters the Commons User ID and Email address into the
appropriate fields and clicks \"Submit.\"

Note: The account cannot have any other roles attached to it other than
the PD/PI and IAR (Internet Assisted Review). For additional information
on Creating Affiliations for Users in the eRA Commons, see:
<https://commons.era.nih.gov/commons-help/175.htm>.

## 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 originate with individual investigators who develop proposed
plans for research or research training within an area that is relevant
to the NIH.

### 2.4.1 NIH Guide for Grants and Contracts

The *NIH Guide for Grants and Contracts*, 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) from the NIH and
other PHS agencies. The *Guide* also contains vital information about
policies and procedures. To subscribe to the *Guide*, visit
<http://grants.nih.gov/grants/guide/listserv.htm>.

### 2.4.2 Funding Opportunities Announcements (FOAs)

An NIH IC or AHRQ may issue Funding Opportunity Announcements (FOAs) in
the form of program announcements (PAs) or requests for applications
(RFAs) soliciting Kirschstein-NRSA Individual Fellowship applications.
The PA/RFAs are available from the sponsoring IC or AHRQ and are issued
in the *NIH Guide for Grants and Contracts*
(<http://grants.nih.gov/grants/guide/index.html>).

Before preparing an application, applicants should thoroughly review the
pertinent PA/RFA, noting the research area(s), eligibility requirements,
any program-specific instructions, application receipt date, award
provisions, and service payback provisions.

Definitions are as follows:

***[Program Announcement (PA)]{.underline}***: 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)]{.underline}***: 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.

Specific PAs and RFAs are 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](http://www.gpoaccess.gov/nara/index.html)), and Grants.gov
\"Find Grant Opportunities\"
(<http://www.grants.gov/applicants/find_grant_opportunities.jsp>). Read
the RFA or PA carefully for special instructions. The instructions in
the RFA or PA may differ from the general instructions, and they
supersede the general instructions. Each RFA or PA 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
Grant
Opportunities](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 RFA or PA.

Individual Fellowship RFAs and PAs are also located at
<http://grants.nih.gov/training/nrsa.htm>.

## 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 Fellow'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.

##### Photographs and Images

-   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 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 two (2)
    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 authorized organizational
    official) and two exact, 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. Note: Photographs may be included in the appendix;
    however, a photocopy of each must also be included within the page
    limitations of the Research Training Plan.

##### 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.

##### Page Limitations and Content Requirements

All applications for NIH or AHRQ funding must be self-contained within
the specified page limitations (see table below).

Unless otherwise specified in an NIH or AHRQ PA or RFA, internet Web
site addresses (URLs) may not be used to provide information necessary
to the review because reviewers are under no obligation to view the
Internet sites. Moreover, reviewers are cautioned that they should not
directly access an Internet site as it could compromise their anonymity.

+--------------------+-----------------------+-------------------------+
| section            | page limit            | content                 |
+====================+=======================+=========================+
| Research           | Limited to space      | Succinct and accurate   |
| Propo              | provided on form      | description of proposed |
| sal---Description\ |                       | work when separated     |
| (Form Page 2, Item |                       | from application        |
| 17)                |                       |                         |
+--------------------+-----------------------+-------------------------+
| Applicant/Fellow   | 4                     | See Instructions        |
| Biographical       |                       |                         |
| Sketch             | (no limits on         |                         |
|                    | subsections)          |                         |
+--------------------+-----------------------+-------------------------+
| Previous Research  |                       |                         |
| Experience (Form   |                       |                         |
| Page 5)            |                       |                         |
+--------------------+-----------------------+-------------------------+
| > Doctoral         | 2                     | See Instructions.       |
| > Dissertation and |                       |                         |
| > Other Research   |                       |                         |
| > Experience       |                       |                         |
+--------------------+-----------------------+-------------------------+
| Research Training  |                       |                         |
| Plan               |                       |                         |
+--------------------+-----------------------+-------------------------+
| Introduction       | 1                     | Required for            |
|                    |                       | Resubmission            |
|                    |                       | Applications only       |
+--------------------+-----------------------+-------------------------+
| Sections 2-5 only  | 10                    | Text plus all figures   |
|                    |                       | and tables              |
| (Sections 6-21 are |                       |                         |
| not included in    |                       |                         |
| the 10-page limit) |                       |                         |
+--------------------+-----------------------+-------------------------+
| S                  | 4 (per person)        | May use Biographical    |
| ponsor/Co-Sponsor\ |                       | Sketch in PHS 398       |
| Biographical       |                       |                         |
| Sketch             |                       |                         |
+--------------------+-----------------------+-------------------------+

## 2.7 Resubmission Applications

For all original new (i.e. never submitted) Individual Fellowship
applications intended for the April 2009 due dates and beyond, NIH will
accept only a single amendment application (now known as a
"Resubmission" application) and there is no time limit for the
resubmission application. Any second resubmission will be
administratively withdrawn and not accepted for review. A new
application following two reviews is expected to be substantially
different in content and scope with more significant differences than
are normally encountered in a resubmission application. For original new
applications submitted prior to April 2009, applicants are permitted two
resubmissions. For these "grandfathered" applications, any second
resubmission must be submitted no later than January 7, 2011 and NIH
will not accept any second resubmissions after that date. See [NIH
Policy on Submission of a Revised/Resubmission (amended)
Application](#nih-policy-on-resubmission-applications) in Part III.

NIH has established new policies for application resubmissions of
certain categories. See Resubmission of Unpaid RFA Applications and
Resubmission of Applications with a Changed Grant Activity Mechanism in
Part III.

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 Fellow must make significant changes to the application.

-   An Introduction of no more than one page 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 should be placed immediately before item 2 of the
    Research Training Plan.

-   The substantial scientific changes must be marked in the text of the
    Research Training Plan 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.

A resubmission application will be returned without review if it does
not comply with all of these requirements.

Acceptance of a resubmission application will not automatically withdraw
the prior version. As of February 2008, eRA keeps all versions (e.g.,
01, A1) of a grant application active and provides an internal MAA
("Multiple Active Applications") 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.

***[Reference Letters for Resubmission Application]{.underline}***.
Applicants must resubmit three sealed reference letters with the
application. See [Reference Letter instructions](#sealed_references) for
additional details.

## 2.8 Revision Applications

Revision applications (formerly called a competing supplement) are
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.
**Revision applications are generally not applicable to individual
fellowships supported by NIH and AHRQ.**

#### 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 416-1
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 training 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 Applicant Fellow are the
original work of the Applicant Fellow 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.

## 2.10 (Reserved)

## 2.11 (Reserved)

## 2.12 (Reserved)

## 2.13 Submission of Supplementary or Corrective Information

Unless specifically required by these instructions (e.g., vertebrate
animals verification), do not send supplementary or corrective material
after the submission date unless the Scientific Review Officer of the
Initial Review Group's study section 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.

**Funding Opportunity Announcements (RFAs and Pas). 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: This differs from the procedures for
submitting applications for those dates listed in the table, which are
considered submission or "send by" dates.

**Weekend/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 holiday, the submission date will be extended to the
following business day. The application will be on time if it is sent on
the following business day.

**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 NOT-OD-08-027, dated January 4, 2008
(<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-027.html>)
and clarification in NOT-OD-08-111, dated September 2, 2008
(<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-111.html>).

## 2.15 Submission and Review 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 416-1 is not scheduled
to transition until April, 2009 so applicants should continue to use
this version of the instructions and forms. 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 must be
submitted through the Division of Receipt and Referral, CSR, NIH unless
otherwise stated. Administrative information about the application is
entered into a computer system. The application is then assigned to an
appropriate Scientific Review Group (SRG) and Institute(s). Assignment
is based on the scientific content of the application using established
referral guidelines.

After the submission date, usually within four (4) weeks, the
applicant/fellow and the sponsoring organization will be able to access
in the eRA Commons the application's assignment number; the name,
address, and telephone number of the Scientific Review Officer (if the
review takes place in CSR) or the review official of an IC Scientific
Review Group to which the application has been assigned; and the
assigned Institute contact and phone number. Review outcome and other
important information are also available in the Commons.

If applicant 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; TTY (301) 451-5936. If
there is a change in assignment, you will receive another notification.

Applicant investigators must not communicate directly with any study
section or 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 your application is complete, you must direct all questions to the
Scientific Review Officer or review official outside of CSR. 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\
301-451-5936 (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

This section provides instructions for assembling the grant application,
the application mailing address, and a schedule of the Individual
Fellowship application receipt, review, and award cycles.

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.

-   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 two** identical, legible, single-sided
photocopies of each application. The **original must be signed** by the
Official Signing for Sponsoring Institution on the Face page.

## 3.3 Binding 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;

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

-   at least 3 sealed letters of reference;

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

Do not include more than one application (original plus 2 copies and
appendices) in each mailing envelope.

**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. Use rubber bands or
clips. Assemble the pages in the order specified in the table of
contents. Place the Personal Data page at the end of the original
application; it is **not** to be duplicated. If appropriate, attach the
RFA label provided in the application kit or a facsimile to the Face
Page.

**Two identical, single-sided copies of the original application.** Make
the copies **after** the Official Signing for Sponsoring Institution has
signed the Face Page so the signature is present on the copies. Do
**not** staple or otherwise bind the two copies of the original
application. Rubber bands are acceptable.

**Letters of reference**. At least **three sealed letters** of reference
attached firmly to the Face Page of the original application.

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

-   Use PDF format.

-   Label each disk with the Applicant Fellow 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

Use the mailing labels provided with the PHS 416-1.

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)**

The telephone number is (301) 435-0715\
TTY (301) 451-5936.

**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>.

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 416-1 Forms and Format Pages

-   Prepare the application using the [PHS
    416-1](http://grants.nih.gov/grants/funding/416/phs416.htm) form
    pages and format pages as provided.

-   *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.

-   The face page must not have any shading/colors.

-   Font sizes on some PHS 416-1 form pages vary due to field or space
    limitations. The PHS 416-1 Microsoft Word (MS WORD) and Portable
    Document File (PDF) Form Pages as provided are acceptable to NIH.
    All other sections of your application (e.g., Biographical Sketch;
    Introduction, if necessary; Literature Citations; and the Research
    Training 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.

#### Specific Instructions for Applicant Fellow

This application is mostly completed by the applicant with extensive
consultation with the sponsor and co-sponsor (if any), and institutional
officials at the sponsoring institution. Certain information is
completed by the sponsor and sponsoring institution administrative
officials. Items to be completed by anyone other than just the applicant
are clearly marked.

This application consists of three Sections:

***[Section I]{.underline}***: To be completed by you the
Applicant/Fellow. Sections of Section I are to be completed with
appropriate consultation with your sponsor, co-sponsor (if any) and
sponsoring institutional officials when applicable. These items are
clearly marked. Section I includes:

-   Face Page (Form Page 1)

-   Form Page 2

-   Form Page 3

-   Form Page 4, Table of Contents

-   Applicant/Fellow Biosketch

-   Form Page 5, Previous Research Experience

-   Research Training Plan, Sections 1 - 21, some with sponsor
    consultation

-   Checklist, A, C, and D

-   Personal Data on Kirschstein-NRSA Individual Fellowship Applicant
    Page

***[Section II]{.underline}***: To be completed by the Sponsor (and
Co-Sponsor when applicable)

-   Sponsor and Co-Sponsor Biosketch(es)

-   Sponsor and Co-Sponsor Information (see instructions)

***[Section III: References:]{.underline}*** To be completed by your
chosen referees and included in sealed envelopes along with this
application.

All sections must be submitted together in the same envelope; otherwise,
the application will be returned without review.

This application is used for all types of Kirschstein-NRSA Individual
Fellowships---Predoctoral, Postdoctoral, and Senior. Special
instructions may apply to Predoctoral or Senior Fellowships. The
following table summarizes where instructions differ for these types of
fellowships.

#### Special Instructions for Predoctoral and Senior Fellowships Applicants

+---------------------------------------------+------------------------+
| predoctoral fellowships                     |                        |
+=============================================+========================+
| [Face Page Item 2, Level of                 | Special Instructions   |
| Fellowship](#Item_2)                        |                        |
+---------------------------------------------+------------------------+
| [Face Page Item 3, Response to              | Special Instructions   |
| PA/RFA](#Item_3)                            |                        |
+---------------------------------------------+------------------------+
| [Form Page 3, Activities Planned Under This | Special Instructions   |
| A                                           |                        |
| ward](#activities-planned-under-this-award) |                        |
+---------------------------------------------+------------------------+
| Applicant/Fellow Biosketch                  | Special Instructions   |
|                                             |                        |
| > [C. Scholastic                            |                        |
| > Performance](#c.-scholastic-performance)  |                        |
+---------------------------------------------+------------------------+
| [Form Page 5](#Section_2_1_2), Item 24a &   | Omit                   |
| b, Thesis/Dissertation Title and Advisor.   |                        |
|                                             | Special Instructions   |
| Item 25, Doctoral Dissertation and Other    |                        |
| Research Experience                         |                        |
+---------------------------------------------+------------------------+
| [Checklist](#Section_2_1_2), C              | Omit                   |
+---------------------------------------------+------------------------+
| [Checklist](#Section_2_1_2), D, Tuition,    | Special Instructions   |
| Fees, Health Insurance                      |                        |
+---------------------------------------------+------------------------+
| [References](#sealed_references)            | Special Instructions   |
+---------------------------------------------+------------------------+
| Kirschstein-NRSA Payback Assurance          | Does not apply         |
+---------------------------------------------+------------------------+

[]{.mark}

  -----------------------------------------------------------------------
  senior fellowships                             
  ---------------------------------------------- ------------------------
  [Face Page, Item 2, Level of                   Special Instructions
  Fellowship](#Item_2)                           

  [Face Page, Item 3, Response to                Special Instructions
  RFA/PA](#Item_3)                               

  [Applicant/Fellow Biosketch](#Section_2_1_2)   Do not use. Use
                                                 traditional biosketch
                                                 found in the PHS398

  [Form Page 5](#Section_2_1_2), Item 24a & b,   Omit
  Thesis/Dissertation Title and Advisor          

  [Research Training Plan, Section               Special Instructions
  20](#selection-of-sponsor-and-institution).    
  Selection of Sponsor and Institution           

  [Checklist](#Section_2_1_2), C                 Special Instructions

  [Checklist](#Section_2_1_2), D. Tuition, Fees, Omit
  Health Insurance                               
  -----------------------------------------------------------------------

[]{.mark}

The applicant completes Section I of the application (see list above) in
consultation with the sponsor. The application should then be provided
to the sponsor and sponsoring institution, along with these instructions
and any other information required for completion and submission. *This
includes the [sealed reference letters](#sealed_references)*. The
sponsor should review the specific instructions for and complete
[Section II, Sponsor's Information](#Section_2_1_2). The applicant and
sponsor should verify that the application has been properly completed,
assembled, and paginated, and that appropriate institutional approvals
and signatures have been obtained.

Kirschstein-NRSA Individual Fellowships provide a stipend to the awardee
plus an allowance to the sponsoring institution to defray some of the
fellow's training expenses. Individuals sponsored by foreign
institutions may also receive travel funds. Detailed information is
provided in the Kirschstein-NRSA section of the *NIH Grants Policy
Statement* at <http://grants.nih.gov/grants/policy/nihgps_2003/>.

The only budget information requested in the application is that related
to tuition and fees for courses which support the research training
experience, health insurance (self-only or family) for predoctoral
applicants, and stipend/salary information for senior fellowship
applicants ([see Checklist, instructions for Section I, Items C and
D](#Section_2_1_2)). Other budget items are fixed, based on a formula or
determined at time of award, and the applicant need not provide any
information.

## 4.1 Face Page (Form Page 1) (Application Section I)

*The entire Face Page must be printed on a single page.* The Face Page
must not have any shading or colors.

Item 1, Title of Research Training Proposal

*Do not exceed* **81 characters***, including the spaces between words
and punctuation*. Choose a descriptive title that is specifically
appropriate. The title should not be worded in a way that could easily
be misconstrued if quoted out of context. A *new* application must have
a different title from any other PHS project with the same individual
applicant. A *resubmission application or renewal* should normally have
the same title as the previous application or grant. If the specific
aims of the project have significantly changed, choose a new title.

[]{#Item_2 .anchor}Item 2, Level of Fellowship

Indicate the level of fellowship requested in the Individual Fellowship
application (predoctoral, postdoctoral, senior). Postdoctoral
fellowships are provided by the NIH ICs and AHRQ.

Predoctoral fellowships are provided by a limited number of NIH ICs and
AHRQ. Therefore, individuals interested in this type of award are
strongly encouraged to consult with the appropriate IC or AHRQ before
submitting an application. **This action is of utmost importance because
applications with marginal or no relevance to the mission of the
participating NIH ICs or AHRQ will not be accepted for review or
funding.**

Senior fellowships are provided by a limited number of NIH ICs and some
ICs have specific criteria for accepting this type of fellowship.
Therefore, individuals interested in this type of award are strongly
encouraged to consult with the appropriate IC before submitting an
application. (AHRQ does not provide senior fellowships.) Eligibility for
a senior fellowship includes possession of a doctoral degree for at
least 7 years and an established research career.

[]{#Item_3 .anchor}Item 3, Program Announcement /Request for
Applications

If you are applying for a postdoctoral fellowship through the NIH-wide
postdoctoral program, leave this section blank. However, if you are
applying for a specific program announced by a particular Institute,
check Yes, and enter the appropriate PA number (e.g., PA-05-###) and
title.

If you are applying for a predoctoral fellowship program, check Yes, and
enter the appropriate PA number (e.g., PA-05-###) and title. Predoctoral
PA numbers are listed at:
<http://grants.nih.gov/training/nrsa.htm#fellowships>.

If you are applying for the senior fellowship program, check Yes, and
enter the appropriate PA number. Instead of the complete PA title, it is
OK to enter "Senior Fellowship" in the PA title field.

For responses to RFAs, attach the RFA label or a facsimile, including
the RFA number, to the bottom of the Face Page of the original
application. The RFA label is under the general mailing label at the end
of the forms section. Any special instructions in the RFA must be
followed when preparing the application.

Item 4a, Name of Applicant

Insert the name of the individual applying for the fellowship
(applicant). Provide last name followed by a comma, first name, and
middle name.

Item 4b. eRA Commons User Name

If you are registered in the [eRA
Commons](https://commons.era.nih.gov/commons/), enter the assigned
Commons User Name. The Commons User Name is the ID assigned to and used
by you to access the Commons. This data item is now required.

Item 4c, Highest Degree(s) at Activation

Indicate up to three academic and professional degrees held or expected
to be held on the start date of the requested fellowship. For foreign
degrees, give the U.S. equivalent.

Item 4d, Present Mailing Address

Provide complete information (including room number, building, and
street address) necessary for postal delivery of the address where the
applicant can be reached at any time before the beginning date of the
requested fellowship. Changes should be reported promptly in writing.

Item 4e, Permanent Mailing Address

If the information given in Item 4d is not a permanent address, provide
the complete address where you can always be contacted. Changes should
be reported promptly in writing. If this address is the same as in 4d,
indicate "same".

Items 4f to 4j

Self-explanatory.

Item 4k, Citizenship

Candidates must check the appropriate box. To be eligible for a
Kirschstein-NRSA Individual Fellowship (F30, F31, F32, F33), the
candidate must be a U.S. citizen, a non-citizen national, or have been
lawfully admitted to the U.S. for permanent residence before the award
is issued. U.S. non-citizen nationals are persons born in lands that are
not States but are under U.S. sovereignty, jurisdiction, or
administration, e.g., American Samoa. Individuals on temporary student
visas are not eligible for NRSA support.

If the candidate has been lawfully admitted for permanent residence,
i.e., is in possession of an Alien Registration Receipt Card or other
legal verification of such status, the candidate should check the
"Permanent Resident of U.S." box. Before the award is issued, a
permanent resident will be required to submit a notarized statement that
a licensed notary has seen the applicant's Alien Registration Receipt
Card or some other valid verification from the U.S. Immigration and
Naturalization Service of legal admission to the U.S. as a permanent
resident.

If the candidate is a non-citizen of the U.S. who has applied for, but
not yet been granted legal admission to the U.S. as a permanent
resident, the candidate should check the "Permanent Resident of U.S.
Pending" box, understanding that no award will be issued until such time
as the required permanent residency has been established and the
required documentation submitted to the NIH IC.

If the candidate is applying for a non-NRSA fellowship program supported
by the NIH, for which citizenship or permanent residency is not required
(e.g., Fogarty International Center programs), the candidate must have
in his/her possession a valid visa allowing him/her to remain in the
U.S. (or in a foreign research training setting, if applicable) long
enough to be productive on the proposed fellowship project. It is the
responsibility of the sponsoring institution to determine and retain
documentation indicating that the individual candidate's visa will allow
him/her to reside in the proposed research training setting for the
period of time necessary to complete the proposed fellowship. The
candidate should check the "Non-U.S. Citizen with temporary U.S. visa"
box. This information may be requested by the NIH IC prior to issuance
of an award except in certain circumstances, such as for F05 applicants,
who would have a temporary U.S. visa pending since a visa application
cannot be submitted until the grant is awarded. In general, it is highly
recommended that all non-U.S. citizens need to adhere to specific
requirements as stated in the FOA or contact the appropriate individual
listed on the FOA.

Item 5, Training Under Proposed Award

List the proposed area of research training according to the Fields of
Training in [Section 7](#Section_2_1_2) of these instructions. The
Fields of Training listing indicates several major areas, each with
subcategories. Select the subcategory that corresponds to the proposed
area of research training. Provide *both* the number and name of the
subcategory, e.g., 2470 Virology. If the Fields of Training listing does
not provide a good descriptor, use the closest subcategory from the
list.

This information is used for reporting purposes only and is not used for
study section assignments.

Item 6, Prior and/or Current Kirschstein-NRSA Support (Individual or
Institutional)

If \"Yes,\" refer to [Item
22](#prior-and-current-kirschstein-nrsa-support-individual-or-institutional)
(Form Page 5).

Item 7a, Dates of Proposed Award

Indicate the start and end dates of the requested support period. The
earliest possible start date and the length of Kirschstein-NRSA support
that can be provided are shown in a specific solicitation (i.e., PA/RFA)
or in Part I, Section 3.5 of these instructions, "[Application
Submission Dates](#application-submission-dates)."

Item 7b, Proposed Award Duration

Indicate the number of months (2 digits) covered by the dates in Item
7a.

Item 8, Degree Sought During Proposed Award

Complete if applicable. Completion of the degree requirements should be
coordinated with the sponsor.

Items 9 through 14 are completed in consultation with the Sponsor and
Administrative Officials at the Sponsoring Institution)

Item 9, 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 9
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
this information in Item 8 of the Research Training 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
Training 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 9a. 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 9a 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 the planned activities involving human subjects are not
exempt, and complete the remaining parts of Item 9.

#### Item 9b. Federalwide Assurance Number 

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

Enter "None" in Item 9b 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 9c. 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.

Item 9d. 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 10. Vertebrate Animals

Check "No" if activities involving vertebrate animals are not planned at
any time during the proposed project period, and leave item 10a 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 Training
Plan, Item 15, 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
the, Research Training Plan, Item 15, 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 10a. 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 10a. 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 10a 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 11, Sponsoring Institution

Name the one institution that will be legally responsible for committing
facilities for the applicant and financially responsible for the use and
disposition of any funds awarded based on this application. The address
should include the street, city, state, and zip code.

[]{#DUNS .anchor}Item 12a&b, Entity Identification Number and Dun &
Bradstreet Number (DUNS)

The Entity Identification Number (EIN) should be checked or supplied by
the business official of the sponsoring institution. The EIN is used by
DHHS for payment and accounting purposes. If a number has not yet been
assigned by DHHS, enter the institution\'s Internal Revenue Service
(IRS) employer identification number (nine digits). This number will
identify the organization to which funds will be disbursed.

A Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number
for the sponsoring institution must be entered. The DUNS number is a
nine-digit identification code assigned by Dun & Bradstreet. For
additional information on this requirement see NIH Guide Notice
OD-03-055 ([http://grants.nih.gov/grants/
guide/notice-files/NOT-OD-03-055.html](http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-055.html)).
The EIN and DUNS numbers are not applicable for fellows at Federal
laboratories.

Item 13, Official Signing for Sponsoring Institution

Name the sponsoring 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.

This information is to be supplied for the business official of the
sponsoring institution, including Federal laboratories.

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 duly authorized 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) Applicants and grantees
must comply with a number of additional public policy requirements.
Refer to your institution's research grant administrative office or the
[*NIH Grants Policy
Statement*](http://grants.nih.gov/grants/policy/nihgps_2003/index.htm)
(available from the NIH website at
<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 your project, program, or type of applicant
organization:

[Human Subjects Research](#human-subjects-research-1)

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

[Research Using Human Embryonic Stem Cells](#Section_2_1_2)

[Women and Minority Inclusion Policy](#Section_2_1_2)

[Inclusion of Children Policy](#Section_2_1_2)

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

[Vertebrate Animals](#vertebrate-animals-1)

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

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

[Lobbying](#Section_2_1_2)

[Non-Delinquency on Federal Debt](#Section_2_1_2)

[Research Misconduct](#Section_2_1_2)

[Civil Rights](#Section_2_1_2)

[Handicapped Individuals](#Section_2_1_2)

[Sex Discrimination](#Section_2_1_2)

[Age Discrimination](#Section_2_1_2)

[Recombinant DNA, including Human Gene Transfer
Research](#Section_2_1_2)

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

[Smoke-Free Workplace](#Section_2_1_2)

[Prohibited Research](#Section_2_1_2)

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

[Fellow and Sponsor Assurance](#fellow-and-sponsor-assurance)

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

## 4.2 Form Page 2 

### 4.2.1 Sponsor and Co-Sponsor Contact Information

Items 15 and 16. These sections are to be completed in consultation with
your sponsor and co-sponsor (if any).

Include complete contact information. If applicable, identify the
co-sponsor in the section (labeled co-sponsor) below and provide contact
information. A biographical sketch is required for the sponsor and any
co-sponsor. See other required information as specified in [Section
5.8](#Biosketch_Sponsor).

### 4.2.2 Department, Service, Laboratory, or Equivalent

Indicate the sponsor's organizational affiliation at the sponsoring
institution, e.g., Department of Medicine, Materials Research
Laboratory, or Social Science Institution. If the department, etc. is
part of a larger component, indicate both, e.g., Section on
Anesthesiology, Department of Surgery, or Division of Laboratory
Medicine, Department of Medicine.

### 4.2.3 Major Subdivision

The component named in Item 15c is a part of the Major Subdivision.

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

### 4.2.4 Co-Sponsor

If the research training proposed involves a co-sponsor, complete this
section. Otherwise leave blank.

### 4.2.5 Research Proposal Description: Project Summary and Relevance

Item 17. 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 NIH IC or AHRQ*). Describe concisely the research
design and methods 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.

## 4.3 Form Page 3 

### 4.3.1 Career and Training Goals 

Item 18. Describe your overall career goals and explain how the training
proposed here will enable you to reach these goals. Identify the skills,
theories, conceptual approaches, etc. to be learned or enhanced during
the award. You may use a continuation page if necessary.

### 4.3.2 Activities Planned Under This Award

Item 19. Using the chart provided, specify by year the activities
(research, course work, etc.) you will be involved in under the proposed
award and estimate the percentage of time to be devoted to each
activity. The percentages should total 100 for each year. Base the
percentage figures on a normal working day for a full-time fellow as
defined by the sponsoring institution. Also, briefly explain activities
other than research and relate them to the proposed research training.

For postdoctoral fellowships, do not exceed three years. Predoctoral
fellowships may reflect up to five years. MD/Ph.D. applicants may
request up to six years if this limit is stated in the program
announcement.

### 4.3.3 Training Site(s) 

Item 20. Is the Primary Training Site the same as the Sponsoring
Institution (check Yes or No)? If No, provide the detailed information
for the Primary Training Site Location.

If there is more than one Training (Project/Performance) Site, list all
the sites, including Department of Veterans Affairs (V.A.) facilities
and foreign sites, as required by the Federal Financial Accountability
and Transparency Act (FFATA), and provide an explanation. One of the
sites indicated must be the sponsoring organization. Provide the
explanation under the Research Training Plan, Item 20, Selection of
Sponsor and Institution.

If a Training (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
Federalwide 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 416-1 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 Training (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.

### 4.3.4 Human Embryonic Stem Cells

Item 21. If the proposed project involves human embryonic stem cells,
list in this section the registration number of the specific cell
line(s) from the stem cell registry found at:
<http://stemcells.nih.gov/registry/index.asp>. 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. See
<http://stemcells.nih.gov/research/registry/eligibilityCriteria.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.

## 4.4 Table of Contents (Form Page 4) 

Self-explanatory.

## 4.5 Applicant/Fellow Biographical Sketch 

*The Applicant/Fellow Biographical Sketch Format Page is available only
in MS Word format*.

The biographical sketch for you, the applicant/fellow, is very similar
to the traditional biographical sketch format used by your sponsor.
However, there are notable differences so follow these special
instructions and use the special sample format provided. If you are
applying for a predoctoral or postdoctoral fellowship, use this custom
biographical sketch format page. If you are applying for a Senior
Fellowship, use the traditional [PHS 398 Biographical Sketch Format
Page](http://grants.nih.gov/grants/funding/phs398/phs398.html).

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. 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.

The Biographical Sketch for you the Applicant/Fellow may not exceed four
pages. This page limit includes the information requested in the boxes,
tables and charts on the form. See [Sample Biographical
Sketch](http://grants.nih.gov/grants/funding/416/phs416.htm).

##### Education/Training. 

List all degree programs beginning with baccalaureate or other initial
professional education and licensure, such as nursing (RN). Include all
dates (month (mm) and year (yyyy)) of degrees received or expected, in
addition to other information requested.

###### A. Positions and Honors

List in chronological order all non-degree training, including
postdoctoral research training, all employment after college, and any
military service. Clinicians should include information on internship,
residency and specialty board certification (actual and anticipated with
dates) in addition to other information requested. This information is
used in reviewing the application and in determining the stipend level
for Postdoctoral Fellowships. State the Activity/Occupation and include
beginning/end dates, field, name of institution/company, and the name of
your supervisor/employer.

List any academic and professional honors that would reflect upon your
potential for a research career and qualifications for an Individual
Fellowship. Include all scholarships, traineeships, fellowships, and
development awards other than Kirschstein-NRSA. Indicates sources of
awards, dates, and grant or award numbers. List current memberships in
professional societies, if applicable.

###### B. Publications 

List your entire bibliography, separating research papers, abstracts,
book chapters, and reviews. Within each subsection the list should be
chronological. For each publication, list the authors in published
sequence, full title of article, journal, volume number, page numbers,
and year of publication. Indicate if you previously used another name
that is reflected in any of the citations. Manuscripts listed as
"pending publication" or "in preparation" should be included and
identified.

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 these
publications are not accepted as appendix material, see [Section
5.7](#appendix)).

###### C. Scholastic Performance

Predoctoral applicants: Using the chart provided, list by institution
and year all undergraduate and graduate courses with grades.

In addition, in the space following the chart, explain any marking
system if other than 1-100, A, B, C, D, F, or 0-4.0 if applicable. Show
levels required for a passing grade. Predoctoral applicants must also
provide scores for the Graduate Record Examination (GRE), if available.
MD/PhD applicants should provide MCAT scores, if available.

Postdoctoral applicants: Using the chart provided, list by institution
and year all undergraduate courses and graduate scientific and/or
professional courses germane to the training sought under this award
with grades. In the space following the chart, explain any marking
system if other than 1-100, A, B, C, D, F, or 0-4.0 if applicable. Show
levels required for a passing grade.

Predoctoral and postdoctoral candidates may be asked to send transcripts
prior to award. Unless specified in a particular announcement (RFA/PA),
do not include transcripts with the application.

## 4.6 Previous Research Experience (Form Page 5) 

### 4.6.1 Prior and Current Kirschstein-NRSA Support (Individual or Institutional)

Item 22. Follow the instructions on the form. An individual cannot
receive more than 5 years cumulative predoctoral Kirschstein-NRSA
support and 3 years cumulative postdoctoral Kirschstein-NRSA support
(the total of Institutional Grants and Individual Fellowships) without a
waiver from the NIH IC or AHRQ. The NIH ICs have different policies on
waiving the statutory limits on support. Therefore, you must request a
waiver from the probable funding IC or AHRQ before requesting a period
of support that would exceed these limits.

Promptly report to the NIH IC to which this application is assigned or
to AHRQ any additional NRSA support received while this application is
pending.

### 4.6.2 Application(s) for Concurrent Support

Item 23. Check the appropriate box. If the candidate has applied or will
be applying for other support that would run concurrently with the
period covered by this application check "Yes" and include the type,
dates, source(s) and amount. The candidate must promptly report to the
NIH IC to which this application is assigned any support resulting from
other such applications.

### 4.6.3 Title(s) of Thesis/Dissertation(s)

Item 24a. Self-explanatory. Applications for Predoctoral and Senior
Fellowships should omit this item.

### 4.6.4 Dissertation Advisor or Chief of Service

Item 24b. Include name, title, department, and institution of this
individual. If this individual is not submitting a reference, explain
why not. Applications for Predoctoral and Senior Fellowships should omit
this item.

### 4.6.5 Doctoral Dissertation and Other Research Experience

Item 25. Summarize in chronological order your research experience,
including the areas studied and conclusions. Specify which areas were
part of your thesis or dissertation and which were part of a previous
postdoc project, if any. If you have no research experience, list other
scientific experience. Do not list academic courses here. Do not exceed
two pages.

**Unless otherwise instructed in a specific Funding Opportunity
Announcement**, applicants for early (pre-dissertation) Predoctoral and
Senior Fellowships should omit their doctoral dissertation, but should
include any other research experience, if applicable. Advanced graduate
students (ONLY) must also include a narrative of their doctoral
dissertation (may be preliminary) and any other research experience. The
information is required of advanced graduate students who have
successfully completed their comprehensive examinations or the
equivalent by the time of award and will be performing dissertation
research.

## 4.7 Personal Data

Follow the instructions on the form. Place the form at the end of the
signed original application after the Checklist. *Do not copy*. The
Personal Data page applies only to the fellow.

# 5. Preparing the Research Training Plan

## 5.1 (Reserved)

## 5.2 (Reserved)

## 5.3 (Reserved)

## 5.4 Research Training Plan Format and Notice of Proprietary Information

### 5.4.1 Research Training Plan Format

**No Specific Form Page -** Use [Continuation
Page](http://grants.nih.gov/grants/funding/416/phs416.htm)

The Research Training Plan consists of Items 1-21, 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>.

This section should be well-formulated and presented in sufficient
detail that it can be evaluated for both its research training potential
and scientific merit. It is important that it be developed *in
collaboration with your sponsor*, but it should be *written by you the
applicant*.

##### Page Limitations

The Research Training Plan includes multiple subsections, some of which
have page limits. Sections 2 through 5 of this section must not exceed
10 pages, including all tables graphs, figures, diagrams, and charts.
Follow the format provided below.

##### 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 Training Plan.

***[Reference Letters for Resubmission Application]{.underline}***.

Applicants must resubmit three sealed reference letters with the
application. See [Reference Letter instructions](#sealed_references) for
additional details.

### 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 (\*) in the left-hand margin
and providing the page numbers before Item 2. Specific Aims, in the
Research Training Plan.

When information in the application constitutes trade secrets,
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 such information shall be used or
disclosed only for evaluation of this application. If an award is issued
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 Contents of Research Training Plan

###### 1. Introduction (Resubmission Applications Only)

All resubmission applications must include an Introduction of no more
than one page that summarizes the substantial additions, deletions, and
changes. The Introduction must also include responses to criticisms and
issues raised in the summary statement for the previous application.
Insert the Introduction just before the very beginning of the Research
Training Plan*.*

Application processing may be delayed or the application may be returned
if it does not comply with all of these requirements.

###### 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.

###### 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 broad, long-term objectives
and to the **mission of the NIH IC or AHRQ**.

###### 4. Preliminary Studies/Progress Report

***[(a) Preliminary Studies]{.underline}***. Use this section to provide
an account of preliminary studies, if any, that are pertinent to this
application. This information will help reviewers and NIH staff evaluate
your experience and determine your competence to pursue the proposed
project. It will also help demonstrate the utility of the proposed
project as a training experience.

When applicable, provide a succinct account of published and unpublished
results, indicating progress toward their achievement.

***[(b) Progress Report for Competing Continuation
Applications]{.underline}***. Competing Continuation applications for
individual fellowships are rare. You should consult with your program
official before preparing such an application. If you are submitting a
Competing Continuation, a Progress Report must be provided. 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. Include the complete
references to appropriate publications and manuscripts accepted for
publication (not part of the page limitations).

If the competing continuation application involves clinical research,
then you must report on the enrollment of research subjects and their
distribution by ethnicity/race and sex/gender.

See [Part II, Section 4.3](#Human_Subjects_Population_Tracking) for more
detailed instructions on which Target and Enrollment Report or Table to
use.

###### 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. Include how the data will be collected, analyzed, and
interpreted. 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.

For Postdoctoral and Senior Fellowship applications, include any courses
that you plan to take to support the research training experience.

###### 6. Inclusion Enrollment Report (for RENEWAL applications only)

In the rare instance that you are submitting a renewal application, and
it 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 of each protocol. (Not
part of the page limitations of the Research Training Plan.)

###### 7. Progress Report Publication List (for RENEWAL applications only)

In the rare instance when you are submitting a renewal application, 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. (Not part of the page limitations of the Research
Training Plan.)

###### 8. Human Subjects Research

If you have marked Item 9 on the face page of the application as "Yes"
consult with your *sponsor* before completing this section and refer to
Part II of the PHS 416-1, [Supplemental Instructions for Preparing the
Human Subjects Section of the Research Training
Plan](#Human_Subjects_PartII)*.* Human subjects requirements may apply
even if you are obtaining specimens/data from collaborators or if you
are subcontracting the human research to another organization. For all
research involving human subjects, a part of the peer review process
will include careful consideration of protections from research risks,
as well as the appropriate inclusion of women, minorities, and children.
The Scientific Review Group (SRG) will assess the adequacy of safeguards
of the rights and welfare of research participants, and the appropriate
inclusion of women, minorities, and children, based on the information
in the application. The evaluation of the inclusion plans will be
factored into the overall score that the SRGs award for scientific and
technical merit of the application. Much of the information on the
protection of human subjects that you are required to provide in this
section of the Fellowship application is identical to information that
you will be required to provide for IRB review at your own institution.

###### 9. Clinical Trial

If you have checked "yes" to item 9c.and this project involves a
clinical trial refer to Part II of the 416-1 [Part II, Supplemental
Instructions for Preparing the Human Subjects Section of the Research
Training Plan for further details.](#clinicaltrials.gov-requirements)

###### 10. Agency-Defined Phase III Clinical Trial

If you have checked "yes" to item 9d.and this project involves a
agency-defined phase III clinical trial refer to Part II of the 416-1
[Part II, Supplemental Instructions for Preparing the Human Subjects
Section of the Research Training Plan for further
details.](#clinicaltrials.gov-requirements)

###### 11. Protection of Human Subjects

Refer to Part II of the PHS 416-1 [Part II, Supplemental Instructions
for Preparing the Human Subjects Section of the Research Training
Plan](#Human_Subjects_PartII) if the proposed research will involve
human subjects.

###### 12. 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 Training 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).

###### 13. 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 Training Plan, [Section
4.3](#Section_2_1_2).

###### 14. 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 Training Plan, Sections
[4.4](#inclusion-of-children-1) and
[5.7](#nih-policy-on-inclusion-of-children).

###### 15. 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.

###### 16. 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.

###### 17. Bibliography and References Cited (formerly Literature Cited)

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.

###### 18. Resource Sharing

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 (*G*WAS):* Regardless of the
amount requested, applicants seeking funding for a genome-*w*ide
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/>.

###### 19. Respective Contributions

Describe the collaborative process between you and your
sponsor/co-sponsor in the development, review, and editing of this
research training plan. Do not include the respective roles in
accomplishing the proposed research (limit to one page).

###### 20. Selection of Sponsor and Institution

1\. Explain why the sponsor, co-sponsor (if any), and institution were
selected to accomplish the research training goals. If the proposed
research training is to take place at a site other than the sponsoring
organization, provide an explanation here.

2\. Doctorate or Current Institution. Since research training is
expected to broaden a fellow\'s perspective, postdoctoral applicants
requesting training at either their doctorate institution or at the
institution where they have been training for more than a year must
explain why further training at that institution would be valuable.
Individuals applying for Senior Fellowships who are requesting training
at the institution at which they are employed should provide a similar
explanation. Ordinarily, the new training value of an environment
diminishes as your association there lengthens. If you are staying at
the same institution, explain briefly.

3\. Foreign Institution. If you are proposing a research training
experience at a foreign institution, show that the foreign institution
and sponsor offer special opportunities for training that are not
currently available in the United States. Key factors in the selection
of a foreign institution should be described. If applicable, the need
for and level of proficiency in reading, speaking, and comprehending the
foreign language should be addressed.

###### 21. Responsible Conduct of Research

[Note: No award will be made if an application lacks this
component.]{.underline}

Every fellow must receive instruction in the responsible conduct of
research
(http://grants.nih.gov/grants/guide/notice-files/not92-236.html).
Applications must include the sponsoring institution's plans to provide
and the candidate\'s plans for obtaining instruction in the responsible
conduct of research, including the rationale, subject matter,
appropriateness, format, frequency and duration of instruction. The
amount and nature of faculty participation must be described. The plan
will be discussed after the overall determination of merit, so that the
review panel\'s evaluation of the plan will not be a factor in the
determination of the priority score. The plan will be judged as
acceptable or unacceptable. The acceptability of the plan will be
described in an administrative note of the summary statement. Regardless
of the priority score, an application with an unacceptable plan will not
be funded until the applicant provides a revised acceptable plan. Staff
in the NIH awarding component will judge the acceptability of the
revised plan.

In most cases, the applicant's plan for Responsible Conduct of Research
will include participation in an established course or seminar series,
as either an instructor or a student (for-credit or non-credit). If the
institution does not offer a course or seminar series that fulfills the
Responsible Conduct of Research requirement, the applicant may lead or
participate in a discussion group in lieu of a formal activity. If
neither option is possible, the applicant may obtain on-line instruction
in Responsible Conduct of Research. Suggested topics for courses,
seminars, and discussion groups include conflict of interest,
responsible authorship, policies for handling misconduct, data
management, data sharing, policies regarding the use of animals and/or
human subjects, and institutional vs. individual responsibilities for
scientific integrity. Courses, seminars, and discussion groups taken to
fulfill the Responsible Conduct of Research requirement need not cover
all of these topics but should include a majority of them.

Attach a description, limited to no more than one page, of plans for
obtaining instruction in the responsible conduct of research. This must
include the rationale, subject matter, appropriateness, format,
frequency and duration of instruction. The amount and nature of faculty
participation must be described.

## 5.6 Checklist

**A. Type of Application**

Check applicable.

**B. Assurances/Certifications**

Each application to the PHS requires that the policies, assurances, and
certifications provided in Part III and listed in Part I, under Item 14
of the Face Page, be verified by the signature of the official signing
for the applicant organization on the Face Page of the application. If
unable to certify compliance, where applicable, provide an explanation.

**C. Kirschstein-NRSA Senior Fellowship Applicants**

Section to be completed only by Senior Fellowships applicants, providing
requested salary/stipend budgetary information. Predoctoral and
postdoctoral applicants should leave this section blank.

**D. Tuition and Fees**

Sections to be completed by pre- and postdoctoral applicants, providing
requested budgetary information as applicable. Senior Fellowship
applicants should leave this section blank.

## 5.7 Appendix

Do not use the appendix to circumvent the page limitations of the
Research Training Plan. Graphs, diagrams, tables, and charts should be
included in the body of the Research Training 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 Applicant Fellow 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 10-page limit
    of Items A-D of the Research Training Plan. No images may be
    included in the appendix that are not also represented within the
    Research Training 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 Training Plan, and/or in the
Biographical Sketch.

## 5.8 Sponsor and Co-Sponsor Information (Application Section II)

*All the information in this section is to be completed by the sponsor
and any co-sponsor (if any)*.

[]{#Biosketch_Sponsor .anchor}**[Sponsor's and Co-Sponsor's Biographical
Sketch Format Page]{.underline}**

See [Sponsor\'s and Co-Sponsor\'s Biographical Sketch
Sample](http://grants.nih.gov/grants/funding/416/phs416.htm).

The Biographical Sketch format used by the Sponsor and Co-Sponsor (if
any) is identical to the Biographical Sketch Format Page in the
Application for Public Health Service Grant (PHS 398). Therefore the PHS
398 Format Page may be used in lieu of the Format Page provided in the
416-1. If the PHS 398 page is used, place the name of the fellowship
applicant in the upper right corner in lieu of the Principal
Investigator/Program Director. *The Biographical Sketch for the Sponsor
and Co-Sponsor (if any) may not exceed four pages for each person. This
4-page limit includes the table at the top of the first page.*

If this application involves a co-sponsor who has a substantial
involvement and/or critical role in the Research Training Proposal,
include their Biographical Sketch; a letter of commitment from that
individual; and required information for the items addressed below.

#### Sponsor's and Co-Sponsor's Information 

**No Specific Form Page - Use** [Continuation
Page](http://grants.nih.gov/grants/funding/416/phs416.htm)

Create a heading at the top of the first page titled "Section
II\--Sponsor and Co-Sponsor Information".

Complete these items as comprehensively as possible so that a meaningful
evaluation of the training environment can be made by the reviewers. Use
continuation pages as needed.

##### 1. Research Support Available

In a table, list all current and pending research and research training
support specifically available to the applicant for this particular
training experience. Include funding source, complete identifying
number, title of the research or training program, and name of the
principal investigator, dates, and amount of the award. Include this
information for any co-sponsor as well.

##### 2. Sponsor\'s/Co-Sponsor's Previous Fellows/Trainees

Give the total number of predoctoral and postdoctoral individuals
previously sponsored. Select five that are representative and, for those
five, provide their present employing organizations and position titles
or occupations. Include this information for any co-sponsor as well.

##### 3. Training Plan, Environment, Research Facilities

Describe the research training plan that you have developed specifically
for the applicant/fellow. Include items such as classes, seminars, and
opportunities for interaction with other groups and scientists. Describe
the research environment and available research facilities and
equipment. Indicate the relationship of the proposed research training
to the applicant\'s career goals. Describe the skills and techniques
that the applicant will learn. Relate these to the applicant\'s career
goals.

##### 4. Number of Fellows/Trainees to be Supervised During the Fellowship

Indicate whether pre- or postdoctoral. Include this information for any
co-sponsor as well.

##### 5. Applicant\'s Qualifications and Potential for a Research Career

Self-explanatory.

## 5.9 Letters of Reference (Application Section III)

[]{#sealed_references .anchor}*At least three completed, sealed
references must be submitted with the application*. Referees should
complete the form and return it in a sealed envelope to you as soon as
possible. Remind them that reference reports should be provided on the
form and any continuation pages. You are asked not to open the reference
envelopes to ensure the confidentiality of such information. The sealed
envelopes must be attached to the original application. If you are
*submitting a resubmission application or a competing continuation
application, you also must submit three sealed reference letters*.

Your references should be carefully selected. Only those individuals who
can make the most meaningful comments about your qualifications for a
research career should be used. *The sponsor of this application cannot
be counted as a reference. The sponsor\'s recommendation is included as
part of the application (See Sponsor/Co-Sponsor Information)*. Whenever
possible, select at least one referee who is not in your current
department. If not submitting a reference from the dissertation advisor
or chief of service, provide an explanation in Item 24b on Form Page 5.
For postdoctoral applications, references from graduate or medical
school are preferred over those from undergraduate school.

Request reference reports only from individuals who will be able to
return them in time for submission of the application. Consider any
factor (e.g., illness or extended vacation) that might cause an
inordinate delay. Give these reference forms to the referees well in
advance of the application submission date.

Failure to provide references may delay processing of your application
or may result in the application being returned to you without review.

# 6. The Peer Review Process

A description of what happens to your individual fellowship application
after it is received for peer review can be found at the following
location: <http://grants.nih.gov/grants/peer_review_process.htm>. Most
applications submitted to the NIH or AHRQ will be reviewed through a
two-tier system. The first level of review will be performed by a
Scientific Review Group (SRG), often called a study section or review
committee. The purpose of the SRG is to evaluate the scientific and
technical merit of applications. The SRG does not make funding
decisions. Additional detailed information on review procedures for
scientific review group meetings is located at:
<http://www.csr.nih.gov/guidelines/proc.pdf>. The complete listing of
[Rosters for NIH Scientific Review Groups
(SRGs)](http://era.nih.gov/roster/index.cfm) is available at
<http://era.nih.gov/roster/index.cfm>.

SRG members will be instructed to evaluate research applications by
addressing four review criteria (see below) and assigning a single,
global score for each application. *Requests for Applications (RFAs) and
other types of grants may have different and/or additional review
criteria.*

[]{#Summary_Statement .anchor}As part of the initial merit review, all
applicants will receive a written critique, called a Summary Statement.
Predoctoral fellowship Summary Statements represent a combination of the
reviewers\' written comments, the Scientific Review Officer's
resume/summary of discussion, the recommendations of the study section,
and administrative notes of special considerations.

Staff members within the assigned NIH IC or ARHQ provide a second level
of review.

## 6.1 Individual Fellowship Application Review Criteria

The criteria for reviewing Individual Fellowship applications focus on
four main components: the candidate, the sponsor/training environment,
the research proposal, and the training potential. Since each
application is considered on an individual basis, these four areas do
not necessarily receive equal weight in the SRG\'s consideration, as
reflected by the priority score. Within each of the four main areas, the
following is given consideration:

***[Candidate]{.underline}***: The candidate\'s previous academic and
research performance and the potential to become an important
contributor to biomedical, behavioral, or clinical science.

***[Sponsor and Training Environment]{.underline}***: The quality of the
training environment and the qualifications of the sponsor as a mentor
within the proposed research training experience.

***[Research Proposal]{.underline}***: The merit of the scientific
proposal and its relationship to the candidate's career plans.

***[Training Potential]{.underline}***: The value of the proposed
fellowship experience as it relates to the candidate\'s needs in
preparation for a career as an independent researcher.

**In addition to the above criteria, the following items will be
considered in the determination of scientific merit and the priority
score.**

***[Protection of Human Subjects]{.underline}***: In conducting peer
review for scientific and technical merit, SRGs also will evaluate the
involvement of human subjects and proposed protections from research
risk relating to their participation in the proposed non-exempt research
training plan according to the following five review criteria: (1) Risk
to subjects, (2) Adequacy of protection against risks (3) Potential
benefits of the proposed research to the subjects and others; (4)
Importance of the knowledge to be gained; and (5) Data and safety
monitoring for clinical trials.

When human subjects are involved in research that involves one of the
six categories of research that are exempt under [45 CFR Part
46](http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm), the SRG
will evaluate the justification for the exemption and (1)
Characteristics of the population, and (2) Sources of Materials.

***[Inclusion of Women, Minorities, and Children]{.underline}***: When
human subjects are involved in the proposed clinical research, the SRG
will also evaluate the proposed plans for inclusion of minorities and
members of both sexes/genders, as well as the inclusion of children in
clinical research, as part of the scientific assessment of the Research
Proposal.

***[Vertebrate animals]{.underline}***: As part of the peer review
process, the SRG will evaluate the proposed involvement and protection
of vertebrate animals as part of the scientific assessment of the
Research Proposal and Sponsor and Environment criteria and according to
the following five points: (1) detailed description of the proposed use
of the animals; (2) justification for the use of animals and for the
appropriateness of the species and numbers proposed; (3) adequacy of
proposed veterinary care; (4) procedures for limiting pain and distress
to that which is unavoidable; and (5) methods of euthanasia.

***[Consideration Outside of the Priority Score]{.underline}***

***[Responsible Conduct of Research]{.underline}***: While not a factor
in the scientific merit or priority score, reviewers will also access
the adequacy of the research training plan in Responsible Conduct of
Research.

# 7. Fields of Training

**1000 I. PREDOMINANTLY NON‑CLINICAL\
OR LAB-BASED RESEARCH TRAINING**

**1100 BIOCHEMISTRY**\
1110 Biological Chemistry\
1120 Bioenergetics\
1130 Enzymology\
1140 Metabolism

**1200 BIOENGINEERING**\
1210 Bioelectric/Biomagnetic\
1220 Biomaterials\
1230 Biomechanical Engineering\
1240 Imaging\
1250 Instrumentation and Devices\
1260 Mathematical Modeling\
1270 Medical Implant Science\
1280 Nanotechnology\
1290 Rehabilitation Engineering\
1310 Tissue Engineering

**1400 BIOPHYSICS\
**1410 Kinetics\
1420 Spectroscopy\
1430 Structural Biology\
1440 Theoretical Biophysics

**1500 BIOTECHNOLOGY\
**1510 Applied Molecular Biology\
1520 Bioprocessing and Fermentation\
1530 Metabolic Engineering

**1600 CELL AND DEVELOPMENTAL\
BIOLOGY**

1610 Cell Biology\
1620 Developmental Biology

**1700 CHEMISTRY\
**1710 Analytical Chemistry\
1720 Bioinorganic Chemistry\
1730 Bioorganic Chemistry\
1740 Biophysical Chemistry\
1750 Medicinal Chemistry\
1760 Physical Chemistry\
1770 Synthetic Chemistry

**1900 ENVIRONMENTAL SCIENCES**

**2000 GENETICS\
**2010 Behavioral Genetics\
2020 Developmental Genetics\
2030 Genetic Epidemiology\
2040 Genetics of Aging\
2050 Genomics\
2060 Human Genetics\
2070 Molecular Genetics\
2080 Population Genetics

**2200 IMMUNOLOGY\
**2210 Asthma and Allergic Mechanisms\
2220 Autoimmunity\
2230 Immunodeficiency\
2240 Immunogenetics\
2250 Immunopathology\
2260 Immunoregulation\
2270 Inflammation\
2280 Structural Immunology\
2290 Transplantation Biology\
2310 Vaccine Development

**2400 MICROBIOLOGY AND INFECTIOUS DISEASES**

2410 Bacteriology\
2420 Etiology\
2430 HIV/AIDS\
2440 Mycology\
2450 Parasitology\
2460 Pathogenesis of Infectious Diseases\
2470 Virology

**2600 MOLECULAR BIOLOGY**

**2800 NEUROSCIENCE**\
2810 Behavioral Neuroscience\
2820 Cellular neuroscience\
2830 Cognitive neuroscience\
2840 Communication Neuroscience\
2850 Computational Neuroscience\
2860 Developmental Neuroscience\
2870 Molecular Neuroscience\
2880 Neurochemistry\
2890 Neurodegeneration\
2910 Neuropharmacology\
2920 Systems/Integrative Neuroscience

**3100 NUTRITIONAL SCIENCES**

**3200 PHARMACOLOGY\
**3210 Molecular Pharmacology\
3220 Pharmacodynamics\
3230 Pharmacogenetics\
3240 Toxicology

**3300 PHYSIOLOGY**\
3310 Aging\
3320 Anesthesiology (basic science)\
3330 Endocrinology (basic science)\
3340 Exercise Physiology (basic science)\
3350 Integrative Biology\
3360 Molecular Medicine\
3370 Physiological Optics\
3380 Reproductive Physiology

**3500 PLANT BIOLOGY**

**3600 PSYCHOLOGY, NON‑CLINICAL**\
3610 Behavioral Communication Sciences\
3620 Behavioral Medicine (non-clinical)\
3630 Cognitive Psychology\
3640 Developmental and Child Psychology\
3650 Experimental & General Psychology\
3660 Mind-Body Studies\
3680 Neuropsychology\
3690 Personality and Emotion\
3710 Physiological Psychology &\
Psychobiology\
3720 Psychology of Aging\
3730 Psychometrics\
3740 Psychophysics\
3750 Social Psychology

**3900 PUBLIC HEALTH**\
3910 Disease Prevention and Control\
3920 Epidemiology\
3930 Health Economics\
3940 Health Education\
3950 Health Policy Research\
3960 Health Services Research\
3970 Occupational and Environmental Health

**4100 RADIATION, NON-CLINICAL\
**4110 Nuclear Chemistry\
4120 Radiation Physics\
4130 Radiobiology

**4200 SOCIAL SCIENCES\
**4210 Anthropology\
4220 Bioethics\
4230 Demography & Population Studies\
4240 Economics\
4250 Education\
4260 Language and Linguistics\
4270 Sociology

**4400 STATISTICS AND/OR RESEARCH METHODS AND/OR INFORMATICS**

4410 Biostatistics and/or Biometry\
4420 Bioinformatics\
4430 Computational Science\
4440 Information Science\
4450 Clinical Trials Methodology

**4600 TRAUMA, NON CLINICAL**

**5000 OTHER, Predominantly Non-Clinical or Lab-Based Research
Training**

**6000 II. PREDOMINANTLY CLINICAL RESEARCH TRAINING (can include any
degree):**

**6100 ALLIED HEALTH**\
6110 Audiology\
6120 Community Psychology\
6130 Exercise Physiology (clinical)\
6140 Medical Genetics\
6150 Occupational Health\
6160 Palliative Care\
6170 Physical Therapy\
6180 Pharmacy\
6190 Social Work\
6210 Speech-language Pathology\
6211 Rehabilitation

**6400 DENTISTRY**

**6500 CLINICAL DISCIPLINES**\
6510 Allergy\
6520 Anesthesiology\
6530 Behavioral Medicine (clinical)\
6540 Cardiovascular Diseases\
6550 Clinical Laboratory Medicine\
6560 Clinical Nutrition\
6570 Clinical Pharmacology\
6580 Complementary and Alternative\
Medicine\
6590 Clinical Psychology\
6610 Connective Tissue Diseases\
6620 Dermatology\
6630 Diabetes\
6640 Gastroenterology\
6650 Endocrinology\
6660 Immunology\
6670 Gene Therapy (clinical)\
6680 Geriatrics\
6690 Hematology\
6710 HIV/AIDS\
6820 Infectious Diseases\
6830 Liver Diseases\
6840 Metabolic Diseases\
6850 Nephrology\
6860 Neurology\
6870 Ophthalmology\
6880 Nuclear Medicine\
6890 OB-GYN\
6910 Oncology\
6920 Orthopedics\
6930 Otorhinolarynology\
6940 Preventive Medicine\
6950 Radiation, Interventional\
6960 Pulmonary Diseases\
6970 Radiology, Diagnostic\
6980 Rehabilitation Medicine\
6990 Psychiatry\
7110 Surgery\
7120 Trauma\
7130 Urology

**7300 PEDIATRIC DISCIPLINES\
**7310 Pediatric Endocrinology\
7320 Pediatric Hematology\
7330 Pediatric Oncology\
7340 Pediatric, Prematurity & Newborn

**7500 NURSING**

**7700 VETERINARY MEDICINE**

**8000 OTHER, Predominantly Clinical Research Training**

# 8. KIRSCHSTEIN-NRSA Payback Assurance

Section 487 of the Public Health Service Act, as, amended (42 USC 288),
and implementing regulations (42 CFR Part 66) require satisfactory
assurance from a prospective recipient of a Kirschstein-NRSA Individual
Fellowship that, in the first 12 months of Kirschstein-NRSA postdoctoral
support, he or she will meet the following service requirement.
Kirschstein-NRSA predoctoral fellows or other fellows who have already
had 12 months of Kirschstein-NRSA postdoctoral support do not incur a
service payback obligation.

Kirschstein-NRSA Individual Fellowships will be governed by the service
payback requirements articulated in the National Research Service Award
Guidelines for Individual Awards and Institutional Grants. These
guidelines can be found in the NRSA portion of the most recent version
of the NIH Grants Policy Statement found at:
<http://grants.nih.gov/grants/policy/policy.htm#gps>. Applicants
accepting an approved Kirschstein-NRSA Individual Fellowship agree to
the following assurance:

***[I. Service Requirement]{.underline}*** - In accepting a Ruth L.
Kirschstein National Research Service Award to support my postdoctoral
research training, I understand that my first 12 months of
Kirschstein-NRSA Individual Fellowship support for postdoctoral research
training carry with it a payback obligation. I hereby agree to engage in
a month of health-related research, health-related research training,
health-related teaching, and/or health-related activities for each month
I receive a Kirschstein-NRSA Individual Fellowship for postdoctoral
research training up to and including 12 months. If I receive a
Kirschstein-NRSA Individual Fellowship for postdoctoral research
training for more than 12 months, I agree that the 13th month and each
subsequent month of Kirschstein-NRSA-supported postdoctoral research
training will satisfy a month of my payback obligation incurred in the
first 12 months. This service shall be initiated within 2 years after
the end of Kirschstein-NRSA support. The health-related research,
teaching, and/or activities shall be on a continuous basis and shall
average more than 20 hours per week of a full work year.

***[II. Financial Payback Provisions]{.underline}*** - I understand that
if I fail to undertake or perform such service in accordance with
Section I above, the United States will be entitled to recover from me
an amount determined in accordance with the following formula:

A = F \[(t-s)/t\]

where \"A\" is the amount the United States is entitled to recover;
\"F\" is the sum of the total amount paid to me under the initial 12
months of my postdoctoral Ruth L. Kirschstein National Research Service
Award support; \"t\" is the total number of months in my service
obligation; and \"s\" is the number of months of such obligation served.

Except as provided in Section III below, any amount the United States is
entitled to recover from me shall be paid within the 3-year period
beginning on the date the United States becomes entitled to recover such
amount. The United States becomes entitled to recover such amount 2
years after termination of my Ruth L. Kirschstein National Research
Service Award support if I do not engage in acceptable service payback
activities in accordance with Section I. If I elect to engage in
financial repayment before the end of the 2-year period, the United
States becomes entitled to recover such amount on the date of my
election. Interest on the amount begins on the date the United States
becomes entitled to recover such amount and is at the rate fixed by the
Secretary of the Treasury after taking into consideration private
consumer rates prevailing on that date. I understand that I will be
allowed an initial 30-day interest-free period in which to fully pay
such amount, and that I may prepay any outstanding balance after that
period to avoid additional interest. I further understand that I will be
subject to authorized debt collection action(s) (including any accrued
interest and late fees) should I fail to comply with the payback
provisions of this Section II.

***[III. Conditions for Break in Service, Waiver, and
Cancellation]{.underline}*** - I hereby understand that the Secretary of
Health and Human Services:

A. May extend the period for undertaking service, permit breaks in
service, or extend the period for repayment, if it is determined that:

1\. Such an extension or break in service is necessary to complete my
clinical training or to participate in a NIH Loan Repayment Program;

2\. Completion would be impossible because of temporary disability; or

3\. Completion would involve a substantial hardship and failure to
extend such period would be against equity and good conscience;

B. May waive my obligation, in whole or in part, if it is determined
that:

1\. Fulfillment would be impossible because I have been permanently or
totally disabled; or

2\. Fulfillment would involve a substantial hardship and the enforcement
of such obligation would be against equity and good conscience;

C. Will, in the event of my death, cancel any obligation incurred under
this payback agreement.

***[IV. Termination Notice-Annual Report of Employment-Change of Address
and/or Name]{.underline}*** - I agree to complete and submit a
termination notice immediately upon completion of support. Thereafter,
on an annual basis I agree to complete and submit all Payback Activities
Certification forms sent to me by the National Institutes of Health or
the Agency for Healthcare Research and Quality concerning post-award
activities, and agree to keep those agencies advised of any change of
address and/or name until such time as my total obligation is fulfilled.

***[V. Program Evaluation]{.underline}*** - I understand that I also may
be contacted from time to time, but no more frequently than once every 2
years, after the end of this award to determine how the training
obtained has influenced my career. Any information thus obtained would
be used only for statistical purposes and would not identify me
individually.

***[VI. Certification]{.underline}*** - By signing the certification
block on the application form, I certify that I have read and understood
the requirements and provisions of this assurance and that I will abide
by them if an award is made.

[]{#Human_Subjects_PartII .anchor}PART II\
\
Supplemental Instructions for Preparing the Protection of Human Subjects
Section of the Research Training Plan

# 1. Introduction

A Protection of Human Subjects section of the Research Training Plan is
required for all applications submitted using the PHS 416-1 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_2_1_2).
Where appropriate, Section 3 provides instructions on addressing the
Inclusion of Women and Minorities, the Targeted/Planned Enrollment
Table, and the Inclusion of Children (item E. of the Research Training
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_2_1_2) 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 416-1 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 9 on the PHS 416-1
face page. In the Protection of Human Subjects section of the Research
Training 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 9 and in item 9a on the
PHS 416-1 face page. In the section on Protection of Human Subjects in
the Research Training 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 Training 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_2_1_2).

#### 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 9. on the PHS 416-1 face page. In the
section on Protection of Human Subjects in the Research Training 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_2_1_2).

#### 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 9 on the PHS 416-1 face
page, "No" in Item 9a on the PHS 416-1 face page, and "Yes" in Item 9c
on the PHS 416-1 face page.

In the section on Protection of Human Subjects in the Research Training
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_2_1_2).

#### 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 9 on the PHS 416-1 face page,
"No" in Item 9a on the PHS 416-1 face page, and "Yes" in Item 9d on the
PHS 416-1 face page. In the section on Protection of Human Subjects in
the Research Training 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_2_1_2).

# 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_2_1_2)

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_2_1_2)

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 Training 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 Training
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_2_1_2)

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_2_1_2)

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_2_1_2)

Targeted/Planned Enrollment Table - [Section 4.3](#Section_2_1_2)

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:

```{=html}
<!-- -->
```
-   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/>

```{=html}
<!-- -->
```
-   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 Training 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\. Applicant Fellow (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 Training 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 Training 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

[]{#Human_Subjects_Population_Tracking .anchor}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/416/416-1-enrollment_report.doc>)
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/416/416-1-enrollment_report.doc>)
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 Training 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 Training
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
Federalwide Assurance (FWA) from OHRP. Instructions for applying for a
Federalwide Assurance (FWA) are available from the OHRP website at
<http://www.hhs.gov/ohrp/assurances/assurances_index.html>.

Any modifications to the Research Training 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 Fellow 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-08-054.html>,
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-061.html>,
<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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://phrp.nihtraining.com](http://phrp.nihtraining.com/) 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
Training 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/416/phs416.htm> in the PHS 416-1.

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/research/registry/eligibilityCriteria.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 Resubmission of Unpaid RFA Applications and Resubmission of Applications with a Changed Grant Activity Mechanism 

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 grant
mechanism and subsequently resubmitted using a different grant mechanism
(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, most unfunded applications should be
resubmitted as **new** applications. Similarly, a change of grant
mechanism (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.

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 up to one resubmission
of this 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 mechanism. 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 provisions for submission of a
resubmission application are clearly delineated in the RFA. In addition,
if a subsequent RFA specifically solicits revisions of unfunded
applications from a previous RFA, the instructions in the second RFA
should be followed. In all other cases, applications submitted in
response to an RFA and then resubmitted as an investigator-initiated
application must be submitted as a **new** application.

2\. When a previously unfunded application, 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.

## 1.2 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) Individual Fellowship
applications intended for the April 2009 due dates and beyond, NIH will
accept only a single amendment application (now known as a
"Resubmission" application) and there is no time limit for the
resubmission application. Any second resubmission will be
administratively withdrawn and not accepted for review. For applications
submitted prior to April 2009 applicants are permitted two
resubmissions. For these "grandfathered" applications, any second
resubmission must be submitted no later than January 7, 2011 and NIH
will not accept any second resubmissions after that date.

With regard to Resubmission applications, 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. Fellows and their sponsoring 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 release of a report on the NIH Peer Review System that was
drafted with extensive consultation with the external community, and
which found a marked reduction in the number of awards made in response
to original applications. Data in the report showed an increasing number
of projects were funded only after one or two resubmissions. As a
result, there has been greater burden placed on applicants and reviewers
as well as a delay in funding for meritorious science. To change this
trend and increase the likelihood that meritorious original applications
will be funded, NIH is decreasing the number of resubmissions allowed.

Investigators who have submitted multiple versions of an application and
have not been successful often ask NIH staff how different the next
application submitted has to be in order 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
multiple 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 Training
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 Training 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.

## 1.3 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.

### 1.3.1 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).

### 1.3.2 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>.

### 1.3.3 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/>.

## 1.4 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.**

## 1.5 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](#duns-number) 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 current
    institutional salary and all active support for the candidate, as
    well as active support for 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.

-   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_2_1_2) 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).

## 1.6 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, Face Page, [Item 12](#DUNS).

## 1.7 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/>.

## 1.8 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.

## 1.9 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 416-1 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](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-1)

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

[Research Using Human Embryonic Stem Cells](#Section_2_1_2)

[Women and Minority Inclusion Policy](#Section_2_1_2)

[Inclusion of Children Policy](#Section_2_1_2)

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

[Vertebrate Animals](#vertebrate-animals-1)

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

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

[Lobbying](#Section_2_1_2)

[Non-Delinquency on Federal Debt](#Section_2_1_2)

[Research Misconduct](#Section_2_1_2)

[Civil Rights](#Section_2_1_2)

[Handicapped Individuals](#Section_2_1_2)

[Sex Discrimination](#Section_2_1_2)

[Age Discrimination](#Section_2_1_2)

[Recombinant DNA, including Human Gene Transfer
Research](#Section_2_1_2)

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

[Smoke-Free Workplace](#Section_2_1_2)

[Prohibited Research](#Section_2_1_2)

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

[Fellow and Sponsor Assurance](#fellow-and-sponsor-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 Training
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/research/registry/eligibilityCriteria.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
Training 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
[1.5](#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. For Kirschstein-NRSA
Individual Fellowships, this policy applies to the individual applicant
as well as the sponsoring institution.

## 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

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.dhhs.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_2_1_2) 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 Fellow and Sponsor Assurance

The signature of the Fellow and Sponsor is no longer required as a part
of a submitted Fellowship application. Instead, a new compliance
requirement is now implemented whereby the applicant organization agrees
to secure and retain at the organization a written assurance from the
Fellow and Sponsor prior to submitting an application to the PHS. While
this assurance is no longer required as part of the submitted
application, it remains a compliance requirement. 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 HHS 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 Fellow's and Sponsor's knowledge; (2) that
any false, fictitious, or fraudulent statements or claims may subject
the Fellow and Sponsor to criminal, civil, or administrative penalties;
(3) that the Sponsor will provide appropriate training, adequate
facilities, and supervision if a grant is awarded as a result of the
application; (4) that the Fellow has read the Ruth L. Kirschstein
National Research Service Award Payback Assurance (See link below,
section I. Service Requirement) and will abide by the Assurance if an
award is made; and (5) that the award will not support residency
training.

Other helpful links:

Guide Notice for Payback Obligation:
<http://grants.nih.gov/grants/guide/notice-files/not93-201.html>

Full Payback Agreement:
<http://grants.nih.gov/grants/funding/416/phs6031.doc>

## 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

**AHRQ.** Agency for Healthcare Research and Quality, which is a
component of HHS.

**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.

**CFR.** Code of Federal Regulations.

**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)

**Competing Continuation Application**. A request for financial
assistance to extend for one or more additional budget periods a project
period that would otherwise expire. Competing continuation applications
compete with other competing continuation, competing supplemental, and
new applications for funds.

**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.

**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.

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

[]{#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 and 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:

\(1\) 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

\(2\) 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.** 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.** 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.

**IC.** An Institute or Center of the National Institutes of Health.

**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.

**Institutional Review Board (IRB).** A committee at the sponsoring
institution that is required to review and approve all non-exempt
research activities involving human subjects.

**Noncompeting Continuation Application.** A request for financial
assistance for a second or subsequent budget period within a previously
approved project period.

**NRSA Individual Fellowship.** Ruth L. Kirschstein National Research
Service Award provided to individuals for research training in
biomedical and behavioral research.

**OHRP.** Office for Human Research Protections.

**OLAW.** Office of Laboratory Animal Welfare.

**Payback.** Requirement that the recipient engage in biomedical or
behavioral health-related research and/or health-related teaching or
subsequent Kirschstein-NRSA-supported research training for a period
equal to the period during which he or she received a postdoctoral
Kirschstein-NRSA fellowship up to and including 12 months or, if more
than 12 months, in the 13th month and each subsequent month of
Kirschstein-NRSA-supported postdoctoral research training, or else
reimburse the Government for the Kirschstein-NRSA funds paid the during
this period.

**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;

-   A systematic study directed specifically toward applying new
    knowledge to meet a recognized need;

-   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.

**Resubmission Application.** (Formerly Revised/Amended Application).
Resubmission of an unfunded application that has been changed
significantly based on feedback from the initial peer review.

**Scientific Review Officer.** Health Scientist Administrator who
manages a Scientific Review Group (SRG).

**Second-Level Review (Council).** Kirschstein- NRSA Individual
Fellowship applications are not required by law to be reviewed by the
pertinent NIH National Advisory Council; but they receive a second
review by IC staff, who consider program relevance and the SRG\'s
recommendation in advising the IC on funding.

**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).

**Sponsor/Co-Sponsor.** One or more designated individual(s) responsible
for providing the applicant with research training and career guidance
throughout the grant award period.

**Sponsoring Institution.** Institution legally responsible for
committing facilities for the Kirschstein-NRSA Individual Fellowship
applicant and financially responsible for the use and disposition of
fellowship funds.

**SRG.** Scientific Review Group or Study Section, which is a panel of
primarily non-Federal scientific experts that provide the initial review
for scientific merit of applications.

**Summary Statement.** Written record of an SRG\'s evaluation of an
application. Following the SRG\'s review meeting, summary statements are
available to applicants in the eRA Commons.

**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 table summarizes the Training and Career Development
Program mechanisms NIH uses. For more detailed information, visit the
OER website <http://grants.nih.gov/grants/funding/funding_program.htm>.

#### Training, Fellowships and Career Development Programs

+-----------------------------+----------------------------------------+
| type (mechanism)            | description                            |
+=============================+========================================+
| ####                        | These awards are made to domestic      |
| Institutional Research Trai | institutions that have the facilities  |
| ning Including Ruth L. Kirs | and faculty to provide for research    |
| chstein National Research S | training programs in scientific        |
| ervice Awards (T32/T34/T35) | specialties. Grant funds may be used   |
|                             | for personnel, equipment, supplies,    |
| <http://grants              | trainee stipends (both pre- and        |
| .nih.gov/training/nrsa.htm> | postdoctoral), and related costs. See  |
|                             | Part I, Section 8 Instructions for     |
|                             | Preparing an Institutional Research    |
|                             | Training Application.                  |
+-----------------------------+----------------------------------------+
| #### Individual Ruth L.     | These fellowships are awarded to       |
|  Kirschstein National Resea | qualified individuals at the           |
| rch Service Award Fellowshi | predoctoral, postdoctoral, or senior   |
| ps) (NRSA: F30/F31/F32/F33) | investigator level to pursue full-time |
|                             | research training in designated        |
| <http://grants              | biomedical or behavioral science       |
| .nih.gov/training/nrsa.htm> | areas. **NRSA APPLICANTS MUST USE PHS  |
|                             | 416-1 FORMS/INSTRUCTIONS**             |
|                             | (<http://grants.n                      |
|                             | ih.gov/grants/funding/416/phs416.htm>) |
+-----------------------------+----------------------------------------+
| #### 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.                           |
+-----------------------------+----------------------------------------+

## 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>.