CSR's Mission and Function andPresentation 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
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
* 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
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
Word of mouth
Recommendations from study section members
Recommendation from NIH IC staff
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
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
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
Scoring Scale (9 point scale)
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
Assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved
New Core Criteria Order:
Review criteria enhanced and expanded
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
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
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
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
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.
Concern - variation of scores during different times of the meeting.
One recommendation was to recalibrate scores at the end of the meeting .
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
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
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.
Recruiting the Best Reviewers
Move a meeting a year to the West Coast
Additional review platforms
Develop a national registry of volunteer reviewers