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Second Opinion

Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

NIH Issues Notices on Proposed Changes in Grant Application and Peer Review Process

June 12, 2015—The National Institutes of Health (NIH) Office of Extramural Research (OER) issued two notices on June 9 regarding plans to enhance reproducibility of research findings through clarifications and updates to grant application instructions and review criteria.

The first notice proposes changes in four areas deemed critical for enhancing rigor and transparency in NIH-funded research which are addressed in the proposed changes:

  • The scientific premise of the proposed research
  • Rigorous experimental design for robust and unbiased results
  • Consideration of sex and other relevant biological variables
  • Authentication of key biological and/or chemical resources

A second notice provides further details on the expectation that investigators factor sex as a biological variable into the research design, analysis, and reporting components of grant applications involving vertebrate animal or human studies. The AAMC previously submitted comments to the NIH [see Washington Highlights, Oct. 10, 2014] endorsing consideration of sex differences in preclinical research.

In a June 9 blog post, Sally Rockey, Ph.D., NIH Deputy Director for Extramural Research, and Larry Tabak, D.D.S., Ph.D., Principal Deputy Director of NIH, write: “These changes will prompt applicants and reviewers to consider issues, which—if ignored—may impede the transparency needed to reproduce key results and thereby slow scientific progress.”

The updates are currently pending approval by the White House Office of Management and Budget (OMB). NIH expects to incorporate changes into funding opportunity announcements and the Standard Form 424 (Research and Related) Grant Application Guide in Fall 2015. The revisions will apply to grant applications submitted in January 2016 and beyond. Additionally, peer reviewer training starting in Spring 2016 will include the four highlighted areas of reproducibility. For further information, NIH has created a site describing ongoing efforts in rigor and reproducibility.

Contact:

Anurupa Dev, Ph.D.
Senior Science Policy Analyst
Telephone: 202-862-6048
Email: adev@aamc.org

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org