Presentation on theme: "Peer Review at the NIH Center for Scientific Review"— Presentation transcript:
1 Peer Review at the NIH Center for Scientific Review Dan Gerendasy, Ph.D.Scientific Review OfficerNovember 5, 2008National Institutes of Health U.S. Department of Health and Human Services
2 Fundamental Tenets for NIH 1. “The only possible source for adequate support of our medical research is the taxing power of the Federal Government . . .“ (Surgeon General Thomas Parran, 1945).Federal government and the politicians must assure complete freedom for the individual scientists in developing and conducting their research work.3. Reviews should be conducted by outside experts essentially without compensation.Program management and review functions should be separated.
3 Dual Review System for Grant Applications First Level of ReviewScientific Review Group (SRG)Second Level of Review NIH Institute/Center Council
4 Review Process for an NIH Research Grant Submits ApplicationCenter for Scientific ReviewAssigns to Institute & Study SectionStudy SectionReviews for Scientific MeritSchool orResearch CenterPrinciple InvestigatorInstituteEvaluates for RelevanceAdvisory Councils and BoardsRecommends ActionInstitute DirectorAllocates FundsTakes Final Action
5 Assignment to Institutes Applications are referred to an Institute or Center as the potential funding component:Assignment is based on a match between the research proposed and the overall mission of the Institute or Center. For example:National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)National Heart, Lung, and Blood Institute (NHLBI)National Institute of Biomedical Imaging and BioEngineering (NIBIB)National Human Genome Research Institute (NHGRI)Applications can be assigned to multiple Institutes or Centers.
6 Assignment to CSR Integrated Review Groups Applications are assigned to Integrated Review Groups (IRGs) for review. IRGs are clusters of scientifically related study sections.Assignment is based on specific referral guidelines for each IRG.Each of the 25 IRGs has 6-10 standing study sections.
7 Example IRGs Cystic Fibrosis Diabetes Nanotechnology Sensors Respiratory Sciences IRGRenal and Urological Sciences IRGHealth of the Population IRGDiabetesEndocrinology, Metabolism, Nutrition and Reproductive Sciences IRGDigestive Sciences IRGNanotechnologyBioengineering Sciences and Technologies IRGSurgical Sciences, Biomedical Imaging and Bioengineering IRGSensorsBiological Chemistry and Macromolecular Biophysics IRG
8 Assignment to CSR Study Sections Within an IRG, applications are assigned for review to:Standing Study Sections when the subject matter of the application matches the referral guidelines for the study sectionAd Hoc Special Emphasis Panels (SEPs) when the subject matter does not fit into any study section, or when assignment of an application to the most appropriate study section would create a conflict of interest. Also used for special mechanisms (e.g., fellowships, SBIRs, AREAS)
9 CSR Study SectionsEach CSR standing study section has about members who are primarily from academia.CSR standing study sections convene face-to-face, or virtual (electronic) meetings.As many as applications are reviewed by each study section.
10 Role of the Scientific Review Officer Designated Federal official with overall responsibility for the review processDoctoral level scientist with expertise complimentary to science reviewed in their study section.Legal responsibility for study section and management of review including the selection of reviewersProvides written (summary statement) reports to Institutes and Centers for secondary review.
11 Role of Program Officer This designated federal official has overall responsibility for recommending meritorious applications for funding. The PO:Observes study section meetingProvides feedback to investigator about study section resultsMakes recommendations to Institutes/Centers and National Advisory Councils/Boards about funding decisions11
12 Role of Study Section Chair Partners with Scientific Review Officers to ensure the best scores for the highest quality scienceGuides study section discussionEnsures all study section member opinions are given careful considerationManages meeting logistics during the meeting, e.g., timeliness, thoroughness, scientific integrity12
13 How Reviewers Are Selected Demonstrated Scientific ExpertiseDoctoral Degree or EquivalentMature JudgmentWork Effectively in a Group ContextBreadth of PerspectiveImpartialityInterested in ServingBalanced Gender, Minority and Geographical representation (for chartered Study Sections)
14 Sources for Reviewer Recruitment Research databases (e.g., CRISP, Pub Med, PsychInfo, etc.)Professional societiesVolunteer Reviewer Registry: Now includes recommendations from the Science Foundation Ireland and Department of Employment and Learning (N. Ireland).Scientific community consultationNIH Program StaffConference attendanceStudy section chairsStudy section members
15 Pre-Meeting Review Process SRO assigns appropriate reviewers to each application.Conflicts of interest identified.Applications sent 6 weeks prior to meeting.Reviewers post critiques and provisional scores on NIH Web site 3-4 days prior to meeting.Reviewers read colleagues’ critiques (excluding conflicts) prior to meeting.
16 Conflict of Interest (COI) InstitutionalFamily Member/Close FriendCollaboratorLongstanding Scientific DisagreementPersonal BiasAppearance of Conflict
17 Certification of No Conflict of Interest This will certify that in the review of applications and proposals by (study section) on (date) , I did not participate in an evaluation of any application or proposal: (1) from any applicant institution or offer or where I am a full- or part-time salaried employee or where I am negotiating for such employment; (2) from any applicant institution or offer or where I have received or could receive a direct financial benefit in relation to the application or proposal under review or have received or could receive a financial benefit from the applicant institution or offer or principal investigator valued at $10,000 or more per year that is unrelated to the application or proposal under review; (3) submitted by a close personal relative, a member of my household, or professional associate, or if such person receives financial benefits from or provides financial benefits to an applicant or offer or. If there was an appearance or real conflict of interest, or (4) any application submitted by my former (within the past year) employer I recused myself from the review of the application/proposal or was granted an appropriate waiver.SIGNATURES
18 Certification of Confidentiality and Non-Disclosure I fully understand the confidential nature of the review process and agree: (1) to destroy or return all materials related to the evaluation; (2) not to disclose or discuss the materials associated with the review, my evaluation, or the review meeting outside of that meeting or with any other individual except as authorized by the Scientific Review Officer (SRO) or other NIH designated official; (3) not to disclose procurement information prior to the award of a contract; and (4) to refer all inquiries concerning the review to the SR0 or other designated NIH official.SIGNATURES
19 Review ProcessLower half of applications identified, not discussed (“streamlined”)Remaining applications discussed (average of 15 minutes/application)3 Assigned ReviewersConflicts absent from roomAssigned reviewers establish a range of priority scores, and all present vote.
20 Review Criteria Advice to Applicants: Significance: Does the study address an important problem? How will scientific knowledge or clinical practice be advanced?Approach: Are design and methods well-developed and appropriate? Are problem areas addressed?Innovation: Are there novel concepts or approaches? Are the aims original and innovative?Investigator: Is the investigator appropriately trained?Environment: Does the scientific environment contribute to the probability of success? Are there unique features of the scientific environment or subject populations?Advice to Applicants:Think about how the reviewers will review it
21 Other Review Criteria Protection of Human Subjects Enrollment of Women, Children and ethnic minoritiesVertebrate Animal CareBiohazardsBudget
22 What Reviewers Look for In Applications Significance/Impact – Will it more the field forward?Is it exciting?Is it clearly written?Does the applicant assume I know more than I do?Are the Aims & Timelines realistic or are they overly ambitious?Does it contain unnecessarily long descriptions of well known methods and approaches?Are the study’s limitations discussed?Did they bother to proofread the application?
23 Priority Scores/Percentile Rank For each study section, applications in the upper half generally are scored from , with 1.0 the best score. Scores as low as 5.0 are possible.Individual scores are averaged and multiplied by 100 to give the final priority score.plus past two meetings
24 Post Meeting Review Process Reviewers have opportunity to revise written critiques based on discussion & reading of colleagues’ critiques.SRO writes Resume & Summary of Discussion for scored applications’ summary statements. Unscored applications receive critiques only.Summary statements available within 30 days of meeting (10 days for new investigators).
25 Summary Statement Results are documented by SRO in a summary statement and forwarded to the PI and the assigned NIH Institute or Center, wherea funding decision is made.The Summary Statement ContainsSummary of Review DiscussionEssentially Unedited CritiquesBudget RecommendationsAdministrative NotesPriority Score and Percentile Ranking
26 What Determines Which Awards Are Made? Scientific meritProgram or public health prioritiesAvailability of funds
27 Review Process for an NIH Research Grant Submits ApplicationCenter for Scientific ReviewAssigns to Institute & Study SectionStudy SectionReviews for Scientific MeritSchool orResearch CenterPrinciple InvestigatorInstituteEvaluates for RelevanceAdvisory Councils and BoardsRecommends ActionInstitute DirectorAllocates FundsTakes Final Action
28 Inside the NIH Grant Review Process Video CSR has developed a video of a mock study section meeting to show how NIH grant applications are reviewed.