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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
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
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)
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
• 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
CSR Divisions and Integrated Review GroupsCSR Divisions and Integrated Review Groups
Help Your Application Get to the Right Study SectionHelp Your Application Get to the Right Study Section
• 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
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
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
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*:
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
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
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
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)
• 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
• 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
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?
• 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
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
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
After the ReviewAfter the Review
• NIH Program Officer = Point of Contact• Wait for summary statement• Read summary statement carefully before calling!
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
CSR Early Career Reviewer Program CSR Early Career Reviewer Program
National Institutes of HealthU.S. Department of Health and Human Services
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
25
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
26
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
27
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
28
CSR Web Site: http://www.csr.nih.govCSR Web Site: http://www.csr.nih.gov