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What's New in Peer Review
Friday, January 30, 2015
New Biosketch Format. The NIH is transitioning to a new biosketch format. The NIH encourages applicants to use the newly published biosketch format for all grant and cooperative agreement applications submitted for due dates on or after January 25, 2015, and will require use of the new format for applications submitted for due dates on or after May 25, 2015. See NOT-OD-15-032 and NOT-OD-14-024.
Simplified Late Application Policy. The NIH simplified the policy for late application submissions. A two week window after the application due date now applies, during which NIH might consider accepting a late application. The new policy is effective for applications submitted for due dates on or after January 25, 2015. RFAs and PARs with special due dates published on or before December 17, 2014 will follow the former policy described in NOT-OD-11-035. See NOT-OD-15-039.
Revised NIH Definition of "Clinical Trial". The NIH has revised its definition of "clinical trial" to clarify the distinction between clinical trials and clinical research studies and to enhance the precision of the information NIH collects, tracks, and reports on clinical trials. The new definition applies to competing grant applications that are submitted to NIH for the January 25, 2015 due date and subsequent due dates. See NOT-OD-15-015.
Genomic Data Sharing Policy. The NIH Genomic Data Sharing Policy applies to all NIH-funded research that generates large-scale human or non-human genomic data as well as the use of these data for subsequent research. Beginning with applications submitted for the January 25, 2015 due date, NIH expects investigators and their institutions to provide basic plans for following this Policy in the Resource Sharing Plan section of grant applications. See NOT-OD-14-124, NOT-OD-14-111, and NOT-OD-15-027.
Marking Changes in Resubmission Applications. NIH has removed the requirement to identify substantial scientific changes in the text of a Resubmission application by 'bracketing, indenting, or change of typography'. It is sufficient to outline the changes made to the Resubmission application in the Introduction attachment. See NOT-OD-15-030.
Updated Submission Policy. The NIH announced an updated policy for application submissions that allows applicants to come in with a new application after an unsuccessful resubmission.See NOT-OD-14-074 and NOT-OD-14-082, NOT-OD-15-059, and FAQs on application submission.
Information for Reviewers
How to Volunteer. Consider volunteering to serve in the NIH peer review process. See Becoming a Peer Reviewer.
Incentives for Reviewers: Continuous Submission. Certain reviewers may be eligible for Continuous Submission. The continuous submission policy has been changed.
Guidance for Reviewers: Find pre-meeting, meeting and post-meeting activities on the new ‘Guidance for Reviewers’ website to help guide reviewers through the peer review process. The site includes useful and important information such as reviewer guidelines, policy documents, step-by-step instructions and videos for using the Internet Assisted Review (IAR) system. In addition, critique templates are located on the website; reviewers must check with their Scientific Review Officer on which template to use.
Protecting NIH Grant Applications. Reviewers must take every reasonable precaution to safeguard NIH grant applications and related materials, which are considered highly confidential. See:
- Open Letter on Proper Handling of Electronic Materials (10/04/2005) - (PDF - 15 KB)
- NIH Implements New Procedures to Protect NIH Application Data Sent to Peer Reviewers on Compact Disks
Maintaining Confidentiality. Each NIH reviewer must certify that s/he has read and will abide by the NIH confidentiality and nondisclosure rules. See Confidentiality in NIH Peer Review.
- NOT-OD-14-069 (3/28/2014): Maintaining Confidentiality in NIH Peer Review
- NIH Confidentiality and Nondisclosure Rules (PDF - 16 KB)
Declaring Lobbyist Status. Each NIH reviewer must certify that s/he is not a federally-registered lobbyist before participating in NIH peer review. See OFACP Policy of October 2014 (PDF - 114 KB).
- Ban on Lobbyists Serving on Advisory Committee (PDF - 21 KB)
Managing Conflicts of Interest. Before the review meeting, each NIH reviewer must certify that s/he has declared all known conflicts of interest, and after the meeting, that s/he did not participate in the evaluation of an application or proposal with which s/he has a conflict of interest. See:
- Managing Conflict of Interest in NIH Peer Review of Grants and Contracts
- NIH Conflict of Interest Rules for Reviewers (PDF - 33 KB)
NOT-OD-14-069 (3/20/2014): NIH Policy for managing conflict of Interest in the Peer Review of Concepts and Proposals for Research and Development Contract Projects
- Contracts: COI Review Guidance (PDF - 37 KB)
NOT-OD-13-010 (11/30/2012): Advance Notice: Revised Policy for Managing Conflict of Interest in the Initial Peer Review of NIH Grant and Cooperative Agreement Applications
- Grants: COI Review Guidance (PDF - 36 KB)
Evaluating Human Embryonic Stem Cells. In assessing overall impact, reviewers evaluate the scientific appropriateness of proposed hESC lines or the justification for using a cell line that is not listed on the NIH Registry for Stem Cells. See NOT-OD-12-111 (6/11/2012).
Information for Applicants
Regulations Governing NIH Peer Review. View 42 CFR 52h: Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects:
- Final Rules and Regulations (PDF - 61 KB) or
- Federal Register Notice (PDF - 67 KB) January 15, 2004.
Appeals of NIH Initial Peer Review. The NIH policy and procedure for handling appeals of the outcome of initial peer review are explained in:
- NOT-OD-11-064 (04/15/2011): Appeals of Initial Peer Review
- NOT-OD-11-101 (7/29/2011): Resubmission of Applications with Pending Appeals of NIH Initial Peer Review
Post-submission Materials.The NIH accepts certain materials and videos as application materials after the application has been submitted but before peer review. See:
- NOT-OD-13-030 (1/29/2013): Reminders and Updates: NIH Policy on Post-Submission Application Materials
- NOT-OD-12-141 (9/27/2012): Interim Guidance for Videos Submitted as NIH Application Materials
- NOT-OD-12-111 (6/11/2012): Notice of Impending Change in Peer Review Criteria and Submission Requirements for NIH Applications Involving Human Embryonic Stem Cells
NIH Advisory Councils and Boards perform the second level of NIH peer review, and make recommendations to the Institutes and Centers.
Assessing Objectivity. Professional situations may cause an objective observer to question the integrity of Council review. See Guidance for Members of NIH Advisory Councils and Boards (PDF - 389 KB).
Special Council Review. Notice of NIH Special Council Review of Research Applications from PDs/PIs with More than $1.0 Million Direct Costs in Annual NIH Support. See NOT-OD-12-140 (8/20/2012).