NIH Peer Review Process – Grant Renewal Angela Y Ng, MBA, PhD Scientific Review and Referral Officer Center for Scientific Review NCI DCB New Grantee Workshop March 18, 2015

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 Eunice Kennedy Shriver 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 John E. Fogarty International Center National Center for Advancing Translational Research National Library of Medicine National Institute on Minority Health and Health Disparities Clinical Center Center for Information Technology Center for Scientific Review

NIH Peer Review System for Grant Applications First Level of Review Scientific Review Group (Study Section) Second Level of Review NIH Institute/Center Council

CSR Peer Review – Fiscal Year 2014 86,000 applications received 16,000 reviewers 237 Scientific Review Officers 1,500 review meetings

Electronic Application Process Prepare to Apply & Register Find Opportunity Prepare Application Submit, Track & View Register with Grants.gov & eRA Commons Submit in response to Funding Opportunity Announcement (FOA) Submit via your organizational representative Use eRA Commons to view & track Follow Application Guide & Instructions

Help Your Application Get to the Right Study Section http://www.csr.nih.gov/

Help Your Application Get to the Right Institute Match your application to NIH: Projects: related research on the same scientific topic FOAs: Funding Opportunity Announcements for the topic area Institutes: Programs that are funding research in this topic area http://ProjectRePORTER.NIH.gov

Cover Letter The cover letter should be used for a number of important purposes: Suggest Institute/Center assignment Suggest review assignment Identify individuals in potential conflict and explain why Identify areas of expertise needed to evaluate the application Discuss any special situations It is NOT appropriate to use the cover letter to suggest specific reviewers. http://www.csr.nih.gov/coverletter

Role of the Scientific Review Officer Designated Federal Official with overall responsibility for the review process Performs administrative review of applications to ensure completeness and accuracy Selects reviewers based on broad input Manages study section meetings Prepares summary statements

Review Criteria Overall Impact Assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved Core Review Criteria Significance Investigator(s) Innovation Approach Environment Review criteria each scored from 1-9

9-Point Scoring Scale Impact Score Descriptor High Impact 1 Exceptional 2 Outstanding 3 Excellent Medium Impact 4 Very Good 5 Good 6 Satisfactory Low Impact 7 Fair 8 Marginal 9 Poor

For Renewal R01 Application Review includes: The application as submitted, including Progress Report ( in “Approach” )& Progress Report Publication List ( Attachment )

Additional Criteria Contribute to Overall Impact Scores Protections for human subjects Inclusions of women, minorities, and children Appropriate use of vertebrate animals Management of biohazards

Other Considerations that Do Not Affect Overall Impact Scores Resource Sharing Plans: Data Model Organisms Genomic Data (Human and nonhuman) Foreign Organizations Select Agents Budget

NIH’s Resubmission Policy After an unsuccessful new (A0) application or an unsuccessful resubmission (A1) application, you may submit a new (A0) application with the same idea as long as your summary statement has been issued. NIH Guide Notices NOT-OD-14-074 NOT-OD-14-082 Resubmission FAQs http://grants.nih.gov/grants/policy/resubmission_q&a.htm

Your New Application Must Be Written as New Your new (A0) application should not contain information that might bias the review or provide a competitive advantage: You Cannot Refer to a Previous Review No mention of previous score No mention of previous reviewer comments No mention of how the A0 is responsive to previous review No marks in text to indicate changes You Cannot Submit Elements of a Renewal No Progress Report No Progress Report Publication List

NIH Will Not Accept An A0 or A1 application that overlaps a funded application Simultaneous submissions of overlapping applications An A0 or A1 application before NIH issues the summary statement of an earlier, overlapping application.

Recent NIH New Policies NOT-OD-14-124: Genomic Data Sharing Policy (effective Jan 25, 2015) (NOT-OD-15-027: reminder) NOT-OD-15-030: Modification on Marking Changes in Resubmission Applications (effective Dec 4, 2014) NOT-OD-15-032: New Biosketch Format Required After May 25, 2015 NOT-OD-15-039: Late Submission Policy (uniform 2 weeks of consideration for all types of applications; with some RFAs or PARs specific exception in which NOT-OD-11-035 applies)

When Preparing an Application Read instructions Never assume that reviewers will know what you mean Refer to pertinent literature Don’t overstate the significance of your research State rationale of proposed investigation Include well-designed tables and figures Present an organized, lucid write-up Don’t be overly ambitions Obtain pre-review from colleagues at your organization Insider’s Guide to Peer Review for Applicants: http://www.csr.nih.gov/applicantresources/insider

What Reviewers Look for in Applications Significance and impact Exciting ideas Clarity Ideas they can understand -- Don’t assume too much Realistic aims and timelines -- Don’t be overly ambitious Brevity with things that everybody knows Noted limitations of the study A clean, well-written application In thinking upon what one of your peers might generally look for as a reviewer of an application keep the following practical ideas in mind: Insider’s Guide to Peer Review for Applicants: http://www.csr.nih.gov/applicantresources/insider

View the Videos http://www.csr.nih.gov/video/video.asp NIH Peer Review Revealed Jumpstart Your Research Career with CSR’s Early Career Reviewer Program NIH Tips for Applicants What Happens to Your NIH Grant Application http://www.csr.nih.gov/video/video.asp

Meet the Experts in NIH Peer Review Webinars For Researchers Seeking: R01 Grants Fellowship Awards AREA/R15 Grants Small Business Grants www.csr.nih.gov/webinar

Early Career Reviewer Program Train and educate qualified scientists to become critical and well-trained reviewers Expose investigators to the peer review experience to help make them more competitive as applicants Enrich the existing pool of NIH reviewers Information available at www.csr.nih.gov/ECR