# Presentation: 719084

## RFA CA05-010 Review

- Dr. Mary Jane Slesinski
- National Cancer Institute
- Division of Extramural Activities
- August 2004

## Review Process for a Grant Application

**National Institutes of Health**

**Center for Scientific Review**

**Study Section**

**Institute**

**Advisory Councils and Boards**

**Institute Director**

**Institution**

**Principal **
**Investigator**

**Submits Application**

**  ****Allocates**
**    ****Funds**

**Initiates Research Idea**

**Conducts Research**

**    ****Assign to IC &  IRG/Study Section**

**   ****Review for       Scientific Merit**

**  ****Evaluate for        Relevance**

** ****Recommend        Action**

**   ****Takes final action**

## Applications Submitted to NIH

**Approximately  50,000 grant applications are submitted to NIH each year, of which 25-30% are funded**
**Competing grant applications are received for three review cycles per year**

## Flow of a Competing Grant ApplicationThrough the CSR Referral Section

**Application**
**(Original & 5 Copies)**

**Mailroom**
**(Receive, Date Stamp,**
**Preliminary Sort, Add Bar Code)**

**Project Control Unit:**
**Receipt & Record Group**
**(Process, Enter Skeletal **
**Data into Computer,**
**Print Status)**

**Assignment Unit:**
**(Assign to Scientific Review Group and Awarding Organization)**

**(Advance Copy)**
**Scientific Review**
**Group**

**(2 Copies)**
**Scientific Review**
**Group**

**Project Control Unit:**
**Review & Control Group**
**(Add Labels, Send Data to IMPAC,**
**Print Mailers, Distribute)**

**(Original)**
**Print Shop**

**(1 copy)**
**OPERA**
**EIS,****DMC**

**(1 copy)**
**Project**
**Control****Files**

**(35 copies)**
**SRG**

**(20 copies)**
**Original**
**Awarding**
**Organization**

**(1 copy)**
**Project**
**Control**

**(1 copy)**
**Research**
**Documents**
**(IC only)**

## Most Common Peer Review Locus for Different Types of Applications

_**Center for Scientific Review**_**:  Unsolicited Applications**
- Research Projects (R01)
- Fellowships (F32/33)
- Pilot Studies (R21)
- Small Grants (R03)
- SBIR (R43/44)
- STTR (R41/42)
- Program Projects for some I/Cs
- Applications for simple PAs

_**Institute Review Offices**_**:  Solicited and I/C Mission-targeted Applications**
- Training Grants (T32)
- Career Awards (K’s)
- Program Projects (P01)
- Centers (P20/30/50)
- Cooperative Agreements
- Multi-institutional clinical trials
- Applications for RFAs and complex PAs
- Contract Proposals for RFPs

## Sample Application Number

-            Individual               Serial              Amended
-              Research             Number
-                Grant
-          1	  R01	  CA	12345	01	A1
-       New             National                  Grant
- Application         Cancer                  Support
-                           Institute                    Year

##  NIH Solicitations for Applications

**Announcements in the *****NIH Guide for Grants and Contracts***** indicate new or ongoing interest of one or more NIH I/Cs in supporting research, training, and resources in a field**
_**Program Announcement (PA)**_
**Addresses a relatively broad field/category of research**
**Usually **_**no**_** set-aside I/C budget **
**Usually submitted on **_**regular**_** receipt dates**
_**Regular**_** review criteria for type of applications**
_**Request for Applications (RFA)**_
**Addresses a well defined area of research**
_**Set-aside**_** I/C budget**
**Submit on **_**special**_**, one time only receipt dates**
**Often **_**special**_** eligibility and/or review criteria**
**Often special application format and/or submission instructions**

## NIH Extramural Staff Responsibilities 

**Scientific Review Administrator (SRA) **MJ Slesinski
- In Center for Scientific Review and in each Institute’s Scientific  Review Office
- Organizes, manages, conducts, and reports results of scientific peer review of grant applications and/or contract proposals
- Liaison between applicants and reviewers
**Program Officer/Director **Linda Nebeling
- In NIH Institutes
- Manages a portfolio of awarded grants/contracts
- Monitors _scientific progress_ made on grants/contracts
**Grants/Contracts Management Officer **Crystal Wolfrey
- Fiscal stewardship of portfolio of awarded grants/contracts
- Negotiates fiscal aspects of awards
- Monitors _financial progress_ made on grants/contracts

##   Dual Review System for Grant Applications

-   **Dual Review System for Grant Applications**

-   **Second Level of Review**
**    **_**Advisory Council/Board**_
**Assesses quality of  SRG**
**review of grant applications**
**Makes recommendation to**
**Institute staff on funding**
**Evaluates program priorities**
**and relevance**
**Advises on policy**

**     ****First Level of Review**
_**Scientific Review Group (SRG)**_
**Provides initial Scientific Merit**
**Review of grant applications**
**Rates applications and makes       recommendations for appropriate level of support and duration of award**

## Submitting an Application for RFA CA-05-010

- _[http://grants1.nih.gov/grants/guide/rfa-files/RFA-CA-05-010.html](http://grants1.nih.gov/grants/guide/rfa-files/RFA-CA-05-010.html)_
- Must be _received_ by November 16, 2004
- Use PHS 398 instructions and forms
- URL for PHS 398 on p. 16 of RFA
- Face Page
- On item 2, check yes
- Number = RFA CA-05-010
- Transdisciplinary Research on Energetics and Cancer

## Submitting an Application for RFA CA-05-010

- Humans refer to living persons
- Budget: follow instructions on p. 17-18
- Be sure to justify payment to all personnel and carefully outline the role of each person, especially where there is any doubt of overlap of duties or responsibility

## Submitting an Application for RFA CA-05-010

- Research Components (Projects)
- p19-20 of RFA
- There must be a minimum of 3 projects scored in the “fundable range” for the application to receive a score
- There is required, at a minimum, three research projects concurrently active in any given year of the TREC

## Submitting an Application for RFA CA-05-010

- Core Resources
- P. 20-21
- Each Core of shared Administrative, Clinical, Statistical, Training or other resources or activities should be written as a separate 398 application
- May include laboratory and clinical facilities, equipment and services

## Submitting an Application for RFA CA-05-010

- Developmental Projects
- P. 21-22
- Career Development Component
- P. 22
- Checklist
- P. 22
- NO APPENDICES, color images later

## Criteria For Selection of Peer Reviewers

- Demonstrated Scientific Expertise
- Doctoral Degree or Equivalent
- Mature Judgment
- Work Effectively in a Group Context
- Breadth of Perspective
- Impartiality
- Interest in Serving
- Adequate Representation of Women and Minority Scientists
- Consumer Advocate

## NIH Review Criteria for Research Center GrantsOverall Score

- Significance
- Approach
- Innovation
- Investigator
- Environment

## NIH Review Criteria for Research Projects 

_**Significance**_: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced?  What will be the effect of these studies on the concepts or methods that drive this field?
_**Approach**_: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
_**Innovation:**_ Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?
_**Investigator:**_ Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)?
_**Environment**__**:**_ Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?

## Core Facilities and Resources

- Are the core or shared facilities essential?
- Is each core/facility justified?
- Are the plans for management reasonable?
- Does the staff of each propose _interacting_ with staff of other components? (≥2 projects)
- Do they facilitate progress, interaction &/or data sharing?
- Is the budget appropriate?

## Career Development Program

- Is the training and outreach plan appropriate?
- Does it _integrate_ will with existing resources?
- Does it include minorities, women and persons with disabilities?
- Are there individuals to serve as mentors?
- Is the proposed budget adequate?
- Are there complementary activities?
- Is there an infrastructure in place?

## Overall Program Organization and Capability

- Is the Principal Investigator appropriately trained and experienced?
- Is there adequate access to populations? Women, minorities and children? (‘reflects the population’ is not sufficient)
- Is the management plan appropriate?
- Are the individual components _transdisciplinary in nature and do they exhibit a high degree of interrelatedness and synergy?_
- Is there a plan for _external_ scientific and managerial oversight of the TREC Center, _including selection of developmental studies for funding_?

## Overall Program Organization and Capability (contd.)

- Is there strong organization and leadership to promote interactions?
- Is there an adequate time commitment of the Principal Investigator and co-Investigators?
- Is there evidence of strong _interaction and feedback among the components_?
- Is an effective evaluation component proposed?

## Overall Program Organization and Capability (contd.)

**Is there strong evidence of **_**protection of human subjects and management of research data**_**?**
**Is there evidence of recruitment and retention plans?**
**Are there plans for communication with other TREC Centers?**
**Is there willingness to **_**interact**_** with other TREC Centers**
**Are there plans for evaluation and dissemination of evidence-based interventions?**

## Review Criteria:Other Considerations

- Human Subjects Protection(physical, psychological, legal, etc.)
- Data and Safety Monitoring Plan(for ALL clinical trials)
- Plans for Inclusion of Women, Minorities and Children in Clinical Research
- Animal Welfare Protection
- _Sharing Research Data (see URL p.40)_
- Appropriateness of Budget

## Award Criteria

- Scientific Merit (as determined by peer review)
- Availability of Funds
- Programmatic Priorities

## Initial Review Group Actions

**Not Scored (UN)**
- Application not in top half of all applications
**Not Recommended for Further Consideration (NRFC)**
- Lacks significant and substantial merit or has serious ethical problems in Human Subject or Animal use
**Deferred**
- Review Committee needs more information to decide on the scientific merit of the application
**Scientific Merit Rating (Priority Score) Assigned**
- 1.0 (best) to 5.0 (worst)
- Target is a mean score of 3.0 for all applications

## Review Criteria:Priority Score

- A single global score is assigned by each review committee member for each scored application.
- This score is derived from weighting the scores (Outstanding, Excellent, Very Good, Good or Acceptable) of each project and the descriptive scores (Outstanding, Acceptable or Not Acceptable)  for each core.
- The averaged global scores will be the score assigned to the application and appear on the face page of the summary statement.

## Review Criteria:Priority Score

- The score is to reflect the ***overall impact that the Center could have on the field***.
- The emphasis on each review criterion may vary from one application to another, depending on the nature of the application and its relative strengths.  An application does not need to be strong in all criteria to receive a high priority score.

## Summary Statement

- After applications are reviewed, results are documented by the SRA in a summary statement which is forwarded to the Program Office where a funding decision is made. The program office also forwards a copy of the summary statement to the PI of the application. The summary statement contains
- Overall Resume and Summary of Review Discussion
- Essentially Unedited Reviewers’ Critiques or Coherent Narrative, depending on the type of application
- Priority Score
- Codes for Human Subjects/Animal Protection, Inclusion of Women, Minorities and Children, and clinical trials
- Budget Recommendations
- Administrative Notes about overlap, over commitment, etc

## National Advisory Council or Board Review

## Executive Secretary-IC Council

- Authority
- Function
- Operating Procedures
- Voting Rights
- Secondary Level of Review of Applications
- Appeals

## Council Actions

- Concurrence with study section action
- Modification of study section action
- Deferral for re-review

## What Determines Which Applications are Awarded?

**Scientific merit**, as indicated by priority score and/or percentile ranking
- Each NIH Institute or Center sets its own “paylines”
- Programmatic considerations of the awarding NIH Institute/Center
- Availability of funds