CSR’s Mission and Function and What’s New in Peer Review

1. CSR’s Mission and Function and What’s New in Peer Review Martha M. Faraday, Ph.D. Scientific Review Officer Division of AIDS, Behavioral & Population Sciences Risk Prevention & Health Behavior IRG Psychosocial Risk & Disease Prevention Study Section Date : April 22, 2009 National Institutes of HealthU.S. Department of Health and Human Services

2. National Institutes of Health Office of the Director National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Institute of Biomedical Imaging and Bioengineering National Center for Complementary and Alternative Medicine National Library of Medicine National Center on Minority Health and Health Disparities Fogarty International Center National Center for Research Resources Center for Scientific Review Clinical Center Center for Information Technology

3. CSR Mission Statement To see that NIH grant applications receive fair, independent, expert, and timely reviews - free from inappropriate influences - so the Institutes and Centers within the NIH can fund the most promising research.

4. CSR Peer Review: 2008 Statistics • 77,000 applications received • 56,000 applications reviewed • 16,000 reviewers • 240 Scientific Review Officers • 1,600 review meetings

5. Scientific Review Process Dual Review System for Grant Applications First Level of Review : CSR/Institute Review Scientific Review Group (SRG) (Study Section) Second Level of Review NIH Institute/Center Council

6. AIDS, Behavioral and Population Sciences Basic and Integrative Biological Sciences Physiological and Pathological Sciences Translational and Clinical Sciences Neuroscience, Development and Aging Endocrinology, Metabolism, Nutrition & Reproductive Sciences Biobehavioral & Behavioral Processes Biological Chemistry & Macromolecular Biophysics Cardiovascular and Respiratory Sciences Brain Disorders & Clinical Neuroscience Risk, Prevention& Health Behaviors Surgical Sciences, Biomedical Imaging and Bioengineering Molecular, Cellular & Developmental Neuroscience Bioengineering Sciences & Technologies Immunology Population Sciences & Epidemiology Integrative, Functional & Cognitive Neuroscience Cell Biology Infectious Diseases & Microbiology Musculoskeletal, Oral And Skin Sciences Healthcare Delivery & Methodologies Genes, Genomes & Genetics Emerging Technologies & Training in Neuroscience Oncology 2 – Translational Clinical Digestive, Kidney & Urological Systems AIDS & Related Research Oncology 1 – Basic Translational Vascular and Hematology Biology of Development & Aging Interdisciplinary Molecular & Training CSR Review Divisions

7. Standing Study Sections when the subject matter of the application matches the referral guidelines for the study section 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) Assignment to CSR Review Groups Within an IRG, applications are assigned for review to

8. When Preparing Your Application • Read the instructions • Never assume that reviewers “will know what you mean” • Refer to the literature thoroughly • State rationale of proposed investigation • Include well-designed tables and figures • Present an organized, lucid write-up • Remember to address human subjects, vertebrate animals, potential biohazards; these could affect your score • Obtain pre-review from faculty at your institution NIH Grant Writing Tips:http://grants.nih.gov/grants/grant_tips.htm

9. Directing Your Application to a Specific Study Section • Peruse CSR Study Section Guidelines* to Identify a Possible Home for Your Application http://csr.nih.gov/ * Recently revised; alternative study sections listed in approximate order of degree of overlap • Submit a Cover Letter

10. CSR Web Site: http://www.csr.nih.gov • About CSR • News and Reports • Peer Review Meetings • Resources for Applicants • Study Section Descriptions & Rosters

11. Role of Scientific Review Officer (SRO) • Performs administrative and technical review of applications to ensure completeness and accuracy • Selects reviewers based on broad input • Manages study section meetings • Prepares summary statements • Provides any requested information about study section recommendations to Institutes/Centers and National Advisory Councils/Boards Designated Federal official with overall responsibility for the review process

12. WHOM DO I CONTACT? • Before review, contact the Scientific Review Officer in CSR • After review, contact your Program Officer in the NIH funding institute or center

13. Pre-Meeting Review Process • Appropriate reviewers recruited by SRO; minimum of 3 “interactive” reviewers per application • Conflicts of interest identified • Applications made available to reviewers ~6 weeks prior to meeting • Critiques and preliminary scores posted by assigned reviewers on NIH web site at least 2-3 days prior to meeting • Critiques and preliminary scores (excluding conflicts) available to review group prior to meeting

14. Where Do We Find Reviewers? • National Registry for Society-Recommended Reviewers • Successful applicants • Word of mouth • Recommendations from study section members • Recommendation from NIH IC staff • CRISP (crisp.cit.nih.gov) • PubMed • Scientific Conferences

15. Traditional* Review Meeting Process • Upper half applications discussed: • Reviewers are guided by specific review criteria • Protections for Humans, Vertebrate Animals, Environment (Biohazard) may affect final score • Assigned reviewers recommend scores for each application in upper half; all members not in conflict vote their conscience (outlier score policy pertains) • Other considerations not affecting final score are discussed (e.g., budget, foreign applicants, resource sharing plans) • Lower half applications not discussed, not assigned an overall score * Aspects of this process will change in May, 2009 http://enhancing-peer-review.nih.gov

16. Post Meeting Review Process • Scores are provided to investigators within 3 working days • Summary Statements for discussed and scored applications include Resume & Summary of Discussion, (largely unedited) critiques, and other recommendations (e.g., Budget) • Summary Statements for lower half (Not Discussed) applications receive (largely unedited) critiques and review criteria scores but no overall impact scores • All Summary Statements are made available within 30 days of meeting (10 days for new investigators’ R01s)

17. What’s New in Peer Review?

18. 2008: The Year of Peer Review Enhancing Peer Review “Fund the best science, by the best scientists, with the least administrative burden…” Elias Zerhouni, MD, Former Director, NIH

19. Recommendations

20. Amended Applications: To speed the funding of meritorious science and minimize reviewer burden: • As of January 25, 2009, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1).

21. What’s New in Peer Review • New Investigators/Early Stage Investigators • Enhanced Review Criteria • Template-Based Critiques • Scoring Scale (9 point scale) • Criterion Scoring • Overall Impact Score

22. New Investigators/Early Stage Investigators • New Investigator (NI): • PD/PI who has not yet competed successfully for a substantial NIH research grant • For multiple PD/PIs-all PD/PIs must meet requirements for NI status • Early Stage Investigator (ESI): • 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) • Applies only to R01 applications • New Investigators/Early Stage Investigators will be clustered together for review

23. Enhanced Review Criteria • Overall Impact: • Assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved • New Core Criteria Order: • Significance • Investigator(s) • Innovation • Approach • Environment • Review criteria enhanced and expanded

24. Template-Based Critiques Critiques Goal: To improve the quality of the critiques and to focus reviewer attention on the review criteria: • Provide clear, concise, and explicit information • Aid in identifying the strengths and weaknesses of each criterion

25. Template-Based Critiques • Critique template contains a total of 18 boxes • Reviewers should provide text for only those criteria that are applicable.

26. Template-Based Critiques • Goal: is to write evaluative statements and to discourage summarizing the application • Comments should be in the form of bullet points or if necessary short narratives • Do not record scores on the critique template • The entire template is uploaded to IAR to become part of the summary statement.

27. Scoring – 9 Point Scale Goal: To improve the transparency of the scoring process: • Score applications on five review criteria using a scale of 1-9. • Preliminary overall impact score using 1-9 scale. • Should not be the average of the criterion scores. • Not Discussedapplications will receive initial criterion scores from the three assigned reviewers

28. Scoring Descriptions Strengths

29. Clustering • NI/ESI R01 applications will be clustered together in review. • ESI applications will not be separately clustered within the NI\ESI group. • NI/ESI applications will be identified for reviewers so there can be appropriate review in context of career stage. • Expectations of preliminary data and publication track record less than for established investigators.

30. Order of Review Goal: Discuss applications in order of average preliminary score. Why: • Concern - variation of scores during different times of the meeting. • One recommendation was to recalibrate scores at the end of the meeting . Solution: • Recalibrate “dynamically” throughout meeting.

31. Order of Review • For calibration purposes: • Begin meeting by discussing the best scored application (any activity code) • NI/ESI R01s clustered beginning of meeting • All other activity codes clustered if feasible (if at least 10 discussed (may include R03, R15, and R21s as a group that can be clustered)

32. Order of Review Summary • Discussion order is based on the average of the impact scores from assigned reviewers • Final scores of discussed applications may differ from preliminary scores as re-calibration happens dynamically

33. Not Discussed • Discuss ~ 50-60% of applications • SRO will then ask if there are any other applications that panel wishes to discuss • The remaining applications will not be discussed (applications receive criterion scores only) • Same after review of ~60% of SBIR applications

34. Final Scores Discussed applications will receive an overall score from each eligible (i.e., without conflicts of interest) panel member and these scores will be averaged to one decimal place, and multiplied by 10. The 81 possible priority scores will thus range from 10-90. Percentiles will be reported in whole numbers.

35. Summary Statements • Summary statement will be shorterand more focused. • Discussed applications will also have a summaryof the panel’s discussion at the meeting. • ALL applications will be scored. • Not discussed applications will receive criterion scoresonly.

36. Recruiting the Best Reviewers Move a meeting a year to the West Coast Additional review platforms Develop a national registry of volunteer reviewers Searchable database with 4,000 reviewers Provide tangible rewards for reviewers No submission deadlines for chartered members of study sections (effective February 2008). 1574 chartered members used flexible deadlines during the last 6 months Provide flexible time for reviewers Choice of 3 times/year for 4 years or 2 times/year for 6 years

37. THANK YOU! This is CSR