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  • Slide 106 from 1/22 reviewer training

CSR's Mission and Function and CSR's Mission and Function and Presentation Transcript

  • 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 Health U.S. Department of Health and Human Services
  • National Institute on Alcohol Abuse and Alcoholism National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute on Drug Abuse National Institute of Environmental Health Sciences National Institute on Aging National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Eye Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of General Medical Sciences National Institute of Nursing Research National Library of Medicine National Center for Complementary and Alternative Medicine National Institute of Allergy and Infectious Diseases Fogarty International Center National Center for Research Resources Clinical Center National Center on Minority Health and Health Disparities National Institute of Biomedical Imaging and Bioengineering Office of the Director Center for Information Technology National Heart, Lung, and Blood Institute National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health Center for Scientific Review
  • 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.
  • CSR Peer Review: 2008 Statistics
    • 77,000 applications received
    • 56,000 applications reviewed
    • 16,000 reviewers
    • 240 Scientific Review Officers
    • 1,600 review meetings
  • Scientific Review Process Dual Review System for Grant Applications Second Level of Review NIH Institute/Center Council First Level of Review : CSR/Institute Review Scientific Review Group (SRG) (Study Section)
  • Translational and Clinical Sciences Cardiovascular and Respiratory Sciences Surgical Sciences, Biomedical Imaging and Bioengineering Musculoskeletal, Oral And Skin Sciences Oncology 2 – Translational Clinical Vascular and Hematology Physiological and Pathological Sciences Endocrinology, Metabolism, Nutrition & Reproductive Sciences Immunology Infectious Diseases & Microbiology Digestive, Kidney & Urological Systems Neuroscience, Development and Aging Brain Disorders & Clinical Neuroscience Molecular, Cellular & Developmental Neuroscienc e Integrative, Functional & Cognitive Neuroscience Emerging Technologies & Training in Neuroscience Biology of Development & Aging Biobehavioral & Behavioral Processes Risk, Prevention& Health Behaviors Population Sciences & Epidemiology Healthcare Delivery & Methodologies AIDS & Related Research AIDS, Behavioral and Population Sciences Basic and Integrative Biological Sciences Biological Chemistry & Macromolecular Biophysics Bioengineering Sciences & Technologies Genes, Genomes & Genetics Oncology 1 – Basic Translational Cell Biology Interdisciplinary Molecular & Training CSR Review Divisions
    • 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
    • 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
    When Preparing Your Application
  • 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
  • CSR Web Site: http://www.csr.nih.gov
    • About CSR
    • News and Reports
    • Peer Review Meetings
    • Resources for Applicants
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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)
  • What’s New in Peer Review?
  • 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
  • Recommendations
  • 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) .
  • 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
  • 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
  • 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
  • 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
    Template-Based Critiques
  • Template-Based Critiques
    • Critique template contains a total of 18 boxes
      • Reviewers should provide text for only those criteria that are applicable.
    1. Significance 6. Resubmission 13. Overall Impact 2. Investigator(s) 7. Renewal 14. Budget and Period of Support 3. Innovation 8. Revision 15. Select Agents 4. Approach 9. Protection of Human Subjects 16. Applications from Foreign Organization 5. Environment 10. Inclusion of Women, Minorities, and Children 17. Resource Sharing Plan 11 Vertebrate Animals 18. Additional Comments to Applicant 12. Biohazards
  • 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.
    1. Significance   Please limit text to ¼ page
    • Strengths
    • Weaknesses
    • 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 Discussed applications will receive initial criterion scores from the three assigned reviewers
    Scoring – 9 Point Scale
  • Scoring Descriptions Impact Score Descriptor Strengths/Weaknesses High Impact 1 Exceptional   Weaknesses 2 Outstanding 3 Excellent Moderate Impact 4 Very Good 5 Good 6 Satisfactory Low Impact 7 Fair 8 Marginal 9 Poor
  • Clustering
    • NI/ESI R01 applications will be clustered together in review.
      • ESI applications will not be separately clustered within the NIESI 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.
  • 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.
  • 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 )
  • 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
      • 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
    Not Discussed
  • 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.
    • Summary statement will be shorter and more focused.
    • Discussed applications will also have a summary of the panel’s discussion at the meeting.
    • ALL applications will be scored .
      • Not discussed applications will receive criterion scores only.
    Summary Statements
  • 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
    • THANK YOU!
    This is CSR