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Peer Review Michael A. Steinmetz, PhD Center for Scientific Review. Overview. NIH Organization Dual Review Process Grant Receipt and Referral The Study Section The Review Process Grant Writing Tips. NIH Organization. NIH consists of 27 independent institutes and centers (ICs)
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Peer ReviewMichael A. Steinmetz, PhDCenter for Scientific Review
Overview • NIH Organization • Dual Review Process • Grant Receipt and Referral • The Study Section • The Review Process • Grant Writing Tips
NIH Organization • NIH consists of 27 independent institutes and centers (ICs) • Director and Advisory Council • 24 ICs award grants • National Cancer Institute (NCI) • National Institute of Allergy and Infections Diseases (NIAID) • 3 ICs provide services • Clinical Center • Center for Scientific Review (CSR)
Grant Review is a Dual Process • Study Section Evaluation • Study Sections evaluate scientific merit • CSR reviews 70% of all proposals • Review Division of ICs review the rest • Advisory Councils at ICs • Concur and recommend funding • May conduct independent review
Receipt and Referral • CSR receives all NIH grant applications • Most proposals are assigned to a CSR Study Section for review • Each proposal is also assigned to one or more ICs for funding consideration
Receipt and Referral • Referral Officers use guidelines to make study section and IC assignments • Study section assignments are reviewed by IRG chiefs and SRAs • Many applications receive dual IC assignments • ICs can reject or trade proposals with other ICs • Cover letter can help to direct the process toward appropriate assignments
CSR Study Sections • 230 study sections designed to have some degree of overlap • Study sections are clustered into Initial Review Groups (IRGs) led by a chief • Each section is run by a Scientific Review Administrator (SRA) • Each section has about 20 regular members • CSR web pages give descriptions and rosters
The Role of the SRA • Organizes study section meetings with help of Extramural Support Assistants (ESAs) • Acts as government official to assure fairness in review process • Mediates conflicts of interest between reviewers and applicants • Represents study section review at IC council meetings
The Role of the SRA • Appoints all regular members • Appoints chairman to moderate discussions • Appoints ad hoc members to insure sufficient expertise and adequate manpower • Assigns reviewers to each application • Writes a resume of any discussion • Generates summary statements
The Study Section • Regular members are appointed to 4-year terms • Chair serves 2-year term • Review 60-100 grants in each of 3 rounds • Each member is assigned to 8-10 proposals • Must have requisite expertise • Gender, Minority, and Geographical balance • Members must have peer-reviewed support
Study Section Membership • Recruited and appointed by SRA • Ideal Candidate • Associate Professor + • Competitive renewal of grant • Review experience (12 year limit) • Annual Slates • 25% of members replaced each October • 6 levels of approval
Becoming a Member • Why? • Chance to have significant influence on the field • Will drastically change the way you write grants • How? • Get to know SRA • Talk to Program Officer at IC • Be responsive and committed (e.g. SEPs) • Be critical but fair in reviews • Be on-time
Pre-meeting Review • Administrative review • Reviewer assignments by SRA • Conflicts of interest • Same institution • Mentor/Mentee • Recent Co-author • Financial gain • Long-standing scientific disagreement • Confidentiality
The Review Meeting • Internet Assisted Review • Attendance • Regular and ad-hoc members • Program officials • Streamlining • Lower half of scores • Unanimous consent required • No discussion of grant
Grant Discussions • Chair moderates discussion • Preliminary scores from assigned reviewers • 1.0 – 5.0 range • Reviewer description and comments • Discussion • Final scores • Voting outside the range • Deferral by SRA
Review Criteria • Significance • Approach • Innovation • Investigator • Environment • Overall evaluation
Significance Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge orclinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field?
Approach Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
Innovation Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators Are the investigators 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studiesbenefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
Other Criteria • Response to prior critique • Preliminary data • Progress • Human subjects – should be factored in score • Safety issues • Participation of women, minorities, and children • Must have specific inclusion/recruitment plan • NIH children = under 21 • Animal welfare
Budget • Discussed after the grant is scored • Cut years if duration is not appropriate for work proposed • Modular budgets need some justification • Specific items can be recommended for deletion from non-modular budgets • Study section can recommend a target amount • Budget recommendations are to be negotiated with program officials at ICs
Post-meeting • Scores from all reviewers are averaged • Scores are percentiled using previous two rounds • Summary statements • Resume of discussion by SRA • Written reviews from assigned reviewers • Scores and reviews sent to ICs for funding decisions
Grant Writing Tips • An overarching umbrella • Ties together specific aims • Specific and realistic • Critical test of competing theories • Discover missing element in a working hypothesis • Specific Aims • Focus on 3-5 related aims • Innovative not incremental • No weak aims