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2. CSR and Institute/Center (IC) Review: History Anne P. Clark, Ph.D. Associate Director for Receipt and Referral Center for Scientific Review National Institutes of Health

3. History: definition “An account of what has or might have happened, esp. in the form of a narrative, play, story, or tale” Webster’s New World Dictionary, Third College Edition, Simon & Schuster (1988)

4. CSR and IC Review in 2004  CSR (24 IRGs)  47,000 applications  Investigator-initiated Projects  Fellowship  Small Business  Miscellaneous: some Program Projects, Centers, and Career Development  Initiatives: some Requests for Applications  Special Reviews for some Program Announcements (PARs)  IC (23 ICs)  21,000 applications  Research and Development Contract Proposals  Conference Grants  Institutional Training Grants  Program Projects, Centers  Multi-center Clinical Trials  Career Development  Initiatives (Requests for Applications, Requests for Proposals)

5. Questions for this Presentation  How did we (the NIH peer review system) get here?  When did the central features of peer review appear?  What events contributed to the current distribution between CSR and IC review?

6. Key Sources Used for this Presentation  A Half Century of Peer Review 1946-1996, Richard Mandel (1996)  Report of the Peer Review Panel, Claude Lenfant, Chairman (1992)  Report of the Working Group on the Division of Research Grants, Marvin Cassman, Chairman (1995)

7. 1940196019501970198019902000 Extramural Beginnings at NIH – authority for extramural grants National Cancer Institute (NCI) Division of Research Grants (DRG)

8. 1940196019501970198019902000 Key Elements of Peer Review Set Early Reviewers are non-governmental scientists Separation of program and review functions Reviewers recused for conflicts of interest Referees or assigned reviewers to lead discussion Priority ratings on a 1-5 scale

9. 1940196019501970198019902000 All NIH Applications Reviewed Centrally Research project applications increased from 2,750 to 8,000 DRG also reviewed program grants, training grants, fellowships Special study sections, ad hoc reviewers for flexibility

10. 1940196019501970198019902000 Study Section Approach Not Ideal for All Reviews Program project site visits – several ICs review their own Issue regarding review of clinical studies Increased numbers of program project applications and R&D proposals Recognition of need for an evaluation component responsible to management by the program ICs

11. 1940196019501970198019902000 Take Nothing for Granted Appropriations Committee appeared to favor contracts over grants Concerns voiced about loss of investigator-initiated applications and elimination of peer review for certain research Office of Management and Budget called for abolition of study section function Assurance that peer review would be maintained came after the Administration’s Watergate controversy

12. 1940196019501970198019902000 Strengthening of the Peer Review Process Grants Peer Review Study Team, Dr. Ruth Kirschstein, Chairperson Mechanism for appeals Provision of summary statements to applicants Codified procedures, restored credibility of peer review Amended “Sunshine Acts”, established procedures so that peer review was consistent with current legislation

13. 1940196019501970198019902000 IC and CSR (DRG) Review Supported “Centralized review”…”was rejected in favor of a flexible combination of DRG and Institute review functions” ICs should maintain separate review and program organizations

14. 1940196019501970198019902000 Procedures for Peer Review Further Spelled Out Review Policy Committee formed – with IC and DRG representation NIH Manual Chapters produced regarding review of grant applications, program projects, training applications, and site visits

15. 1940196019501970198019902000 Further Assessments of CSR and IC Review “Today, the key elements of peer review exist in both the DRG and ICs. Current policies and principles are set forth so as to provide a framework that maintains the integrity of the system yet allows for difference in practice regarding initial review among ICs.” Report of the Peer Review Panel, 1992 “Peer review should be conducted in both DRG and the ICs.” Report of the Working Group on the Division of Research Grants, 1995

16. 1940196019501970198019902000 CSR and IC Review: What I Experienced Role of Scientific Review Administrator in each is the same – to ensure fair and competent reviews Underlying principles and procedures are the same

17. 1940196019501970198019902000 CSR and IC Review: What I Learned from the History Workload increased dramatically several times, doubling within a few years. Criticism and increased scrutiny of the peer review system appeared to occur at times when the success rate had dropped.

20. Summary  Key elements of peer review were established early (1940-1950).  Recommendations to increase accountability of the peer review system were enacted (1976).  Many ICs assumed the review of program projects in 1962.  IC and CSR review was affirmed (1970s/1990s).  Although numbers of applications have increased, the proportion of applications reviewed in the ICs and in CSR has been relatively stable since 1970.  The Review Policy Committee and numerous NIH Manual Chapters have helped to provide a common basis for review in CSR and the ICs.