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Strategies for NIH Grant Success: Strategies for NIH Grant Success: Overview of the NIH Peer Review Process Overview of the NIH Peer Review Process Cheryl Kitt, Ph.D. Cheryl Kitt, Ph.D. Deputy Director, CSR Deputy Director, CSR March 15, 2012 National Institutes of Health U.S. Department of Health and Human Services Women's Health 2012: The 20th Annual Congress

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Strategies for NIH Grant Success:Strategies for NIH Grant Success:

Overview of the NIH Peer Review ProcessOverview of the NIH Peer Review Process

Cheryl Kitt, Ph.D.Cheryl Kitt, Ph.D.

Deputy Director, CSRDeputy Director, CSR

March 15, 2012

National Institutes of HealthU.S. Department of Health and Human Services

Women's Health 2012: The 20th Annual Congress

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National Institutes of HealthNational Institutes of Health

National Instituteon Alcohol Abuseand Alcoholism

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis andMusculoskeletal

and Skin Diseases

National Instituteof Arthritis andMusculoskeletal

and Skin Diseases

National CancerInstitute

National CancerInstitute

National Instituteon Drug Abuse

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Instituteof Environmental Health Sciences

National Instituteon Aging

National Instituteon Aging

Eunice KennedyShriver National Institute

of Child Health andHuman Development

Eunice KennedyShriver National Institute

of Child Health andHuman Development

National Institute onDeafness and Other

CommunicationDisorders

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National EyeInstitute

National HumanGenome Research

Institute

National HumanGenome Research

Institute

National Instituteof Mental Health

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical Sciences

National Instituteof General

Medical Sciences

National Instituteof Nursing Research

National Instituteof Nursing Research

National Libraryof Medicine

National Libraryof Medicine

Center for Scientific Review

National Centerfor Complementary

and AlternativeMedicine

National Centerfor Complementary

and AlternativeMedicine

National Instituteof Allergy and

Infectious Diseases

National Instituteof Allergy and

Infectious Diseases

John E. FogartyInternational

Center

John E. FogartyInternational

Center

National Centerfor ResearchResources

National Centerfor ResearchResources

Clinical Center

Clinical Center

National Center on Minority Health andHealth Disparities

National Center on Minority Health andHealth Disparities

National Institute of Biomedical Imagingand Bioengineering

National Institute of Biomedical Imagingand Bioengineering

Office of the DirectorOffice of the Director

Center for InformationTechnology

Center for InformationTechnology

National Heart,Lung, and Blood

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Dental andCraniofacial

Research

National Instituteof Dental andCraniofacial

Research

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

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Preparing an Application

Electronic Application Process

• Register with Grants.gov &

eRA Commons

• Submit in response to

FOA

• Follow Application

Guide & Instructions

• Submit via your organizational representative

• Use error correction window

• Use eRA Commons to track

Prepare to Apply & Register

Find Opportunity*

Prepare Application

Submit, Track & View

*Funding Opportunity Announcement (FOA)

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National Institutes of Health

Center for Scientific ReviewCenter for Scientific Review

Study SectionStudy Section

Institute

Advisory Councils and Boards

Institute Director

Assigns to IC & IRG/Study Section

Reviews for Scientific Merit

Evaluates for Relevance

Recommends Action

Takes Final Action

InitiatesInitiatesResearch IdeaResearch Idea

ConductsResearch

Allocates FundsAllocates Funds

Submits ApplicationSubmits Application

Review Process for a Research Grant

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• Receives all NIH applications

• Refers them to NIH Institutes/Centers and to scientific review groups

• Reviews grant applications for scientific merit

• ICs review RFAs, P’s, T’s, K’s

All Applications Go Through Center for Scientific Review (CSR)

Focal Point for Initial Review at NIH

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CSR Divisions and Integrated Review GroupsCSR Divisions and Integrated Review Groups

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Help Your Application Get to the Right Study SectionHelp Your Application Get to the Right Study Section

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• If you submit an R01 grant application:

If you are a New Investigator (PD/PI who has not yet competed successfully for a substantial NIH research grant; for multiple PD/PI R01s-all PD/PIs must meet requirements for NI status

or Early Stage Investigator (PD/PI who qualifies as a New Investigator AND is within 10 years of completing the terminal research degree or is within 10 years of completing medical residency (or equivalent)

• Clustered for review in the study section

Your Career Stage Is Considered

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CSR Study Sections

• Each CSR standing study section has about 23-40 members

• CSR standing study sections convene face-to-face, or virtual (electronic) meetings

• As many as 60-100 applications are reviewed by each study section

• Scientific Review Officer-Designated Federal Official with overall responsibility for the review process

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What Reviewers Look for In Applications

Impact

Make It Exciting

Be Very Clear

Realistic Aims & Timelines – Not Overly Ambitious

Be Brief With Things That Everybody Knows

Note the Study Limitations

Proofread the Application

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ScoringScoring

Overall Impact/Priority Score*:

• Reflects the reviewers’ assessment of the likelihood

for the project to exert a sustained, powerful influence on exert a sustained, powerful influence on the research field(s) involvedthe research field(s) involved

SignificanceInvestigator(s)InnovationApproachEnvironment

**each scored from 1-each scored from 1-99

Core Criteria*:

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ScoringScoring

Applications scored on five review criteria and overall impact using a scale of 1-9.

o Discussed applications Discussed applications receive an overall impact score from each eligible (i.e., without conflicts of interest) panel member and these scores are averaged to one decimal place, and multiplied by 10.

All applications receive scores:o Not DiscussedNot Discussed applications receive only initial criterion

scores from the three assigned reviewers

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Scoring DescriptionsScoring DescriptionsImpact Score

DescriptorAdditional Guidance on Strengths/Weaknesses

High Impact

1 Exceptional Exceptionally strong with essentially no weaknesses

2 Outstanding Extremely strong with negligible weaknesses

3 Excellent Very strong with only some minor weaknesses

Moderate Impact

4 Very Good Strong but with numerous minor weaknesses

5 Good Strong but with at least one moderate weakness

6 Satisfactory Some strengths but also some moderate weaknesses

Low Impact

7 Fair Some strengths but with at least one major weakness

8 Marginal A few strengths and a few major weaknesses

9 Poor Very few strengths and numerous major weaknesses

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Overall Impact/Merit. Likelihood fellowship will enhance candidate's potential for, and commitment to, a productive independent scientific research

•Applicant•Sponsors, Collaborators, and Consultants•Research Training Plan •Training Potential •Institutional Environment & Commitment to Training

Fellowship Reviews

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Overall Impact. Reviewers should provide their assessment of the likelihood for the candidate to maintain a strong research program, taking into consideration the criteria below in determining the overall impact/priority score.

•Candidate•Career Development Plan/Career Goals & Objectives/Plan to Provide Mentoring•Research Plan•Mentor(s), Co-mentor(s), Consultant(s), Collaborator(s)•Environment and Institutional Commitment to the Candidate

Career Awards (K)

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• Personal Statement: Personal Statement:

• Why your experience and qualifications makes you particularly well-suited for your role(s) in the project

• Publications:Publications:

• Recommended: no more than 15---up to five of the best; up to five of the most relevant to the proposed research; up to five of the most recent

• If Early Stage Investigators or New InvestigatorsEarly Stage Investigators or New Investigators, do you have appropriate experience and training?

• If Established,Established, have you demonstrated ongoing record of accomplishments that have advanced their field(s)?

InvestigatorsInvestigators

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• Does application challenge/seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?

• Concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?

• Refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Innovation Innovation

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Approach Approach

• Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?

• Are potential problems, alternative strategies, and benchmarks for success presented?

• If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

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• Will the scientific environment in which the work will be done contribute to the probability of success?

• Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?

• Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

EnvironmentEnvironment

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Other Issues Reviewers Consider Before Other Issues Reviewers Consider Before Final ScoringFinal Scoring

• Protections of human subjects• Inclusions of women, children and minorities• Appropriate use of vertebrate animal • Management of hazardous conditions

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Critiques (Summary Statements)

DiscussedDiscussed applications applications receive a resume andresume and summarysummary of of the panel’s discussiondiscussion at the meeting.

•ALL applications are scored ALL applications are scored and receive critiques

Not discussed Not discussed applications receive applications receive criterion scorescriterion scores only only

Overall Impact ParagraphOverall Impact Paragraph

• Each assigned reviewer writes a paragraph summarizing the factors that informed his/her Overall Impact score

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After the ReviewAfter the Review

• NIH Program Officer = Point of Contact• Wait for summary statement• Read summary statement carefully before calling!

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http://www.csr.nih.gov/video/video.asp

What Happens to Your NIH Grant Application Videohttp://www.csr.nih.gov/video/2010/FinalCaptioned_E

dited_PeerReviewProcessVideo.mov

[email protected]

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CSR Early Career Reviewer Program CSR Early Career Reviewer Program

National Institutes of HealthU.S. Department of Health and Human Services

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Purpose of the ECR ProgramPurpose of the ECR Program

• To train and educate qualified scientists without significant prior review experience so that they may develop into critical and well trained reviewers

• To benefit faculty scientific careers by exposing them to an experience that will make them more competitive as applicants

• To enrich the existing pool of NIH reviewers by recruiting scientists from less research-intensive institutions

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Definition of ECRDefinition of ECR::

• Has not reviewed for CSR beyond 1 mail review and has not been to a face-to-face meeting (except ARRA face-face-meetings)

• Has a faculty appointment or equivalent

• Has an active research program and is publishing in high-impact journals

• Does not necessarily have NIH or equivalent funding

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Responsibilities of ECR

• Attends study section meeting (face-to-face meetings but no Fellowship panels)

• Is assigned no more than 2 applications as 3rd reviewer

• Writes a full critique of each application

• Participates in no more than one study section per year and no more than twice total

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Progress of ECR ProgramProgress of ECR Program

• The administrators of 343 less research-intensive institutions (AREA eligible) were emailed a request for suggestions of faculty who would be candidates for the ECR program

• There are currently over 500 names in the database• Over 300 additional researchers have applied for the

program and once vetted they will be added to the database

ECRs Included in 2012/01 Council Round:ECRs Included in 2012/01 Council Round:

127 ECRs participated across over 240 eligible study sections

o ~50% women

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CSR Web Site: http://www.csr.nih.govCSR Web Site: http://www.csr.nih.gov

[email protected]