Changing policies impact NIH-funded studies involving human subjects

Message to NIH grant applicants/awardees, contractors, researchers and research administrators:

If you are conducting NIH-funded research that involves human subjects, or are considering applying to NIH for support of such research, we want to call your attention to important changes that may affect how you:

  • select the right NIH funding opportunity announcement
  • write the research strategy and human subjects sections of your application
  • comply with appropriate policies and regulations

First, familiarize yourself with the new PHS Human Subject and Clinical Trial Information form (for application due dates of January 25, 2018).  Learn about the new form here.

Second, review  the updated NIH definition of a clinical trialVisit the NIH webpage on the definition that includes case studies, FAQs and other resources that can help. Still unsure?  Contact your NIH program official or the scientific point of contact listed on the funding opportunity announcement to which you are applying.

Third, familiarize yourself with NIH policy changes related to enhancing stewardship of clinical trials.

Visit the new Clinical Trial Requirements for NIH Grantees and Contractors web page to bring together all the information you need to know.  Please review this information carefully.  Your attention to detail will be critical to ensuring successful funding of your clinical trial awards.