NIH Releases RFI, Delays Enforcement of New Clinical Trials Policy

On July 20, the National Institutes of Health (NIH) issued a Guide Notice (NOT-OD-18-212) outlining its plans to delay enforcement of key clinical trials reporting requirements for projects traditionally considered basic research.

The Notice, Delayed Enforcement and Short-Term Flexibilities for Some Requirements Affecting Prospective Basic Science Studies Involving Human Participants, follows months of feedback and pressure on NIH from the external research community, including COSSA and several COSSA members, to rescind or at least delay implementation of NIH’s clinical trials policy announced in 2016. As previously reported, in an effort to enhance its stewardship of and increase transparency over the clinical trials it funds, NIH established a new definition of “clinical trials,” which now captures some basic behavioral and social sciences research and comes with new reporting requirements (see COSSA’s Hot Topic piece for details).

NIH has now released a Request for Information (RFI) (NOT-OD-18-217) seeking input on the standards NIH should use in registration and results reporting for prospective basic science studies involving human participants. A blog post from the NIH Office of Extramural Research outlines the following specific topics for which the RFI is seeking comments:

  • “Examples of prospective basic science studies involving human participants that pose the greatest challenges in meeting the registration and results information submission requirements at ClinicalTrials.gov, including specific reasons for these challenges (e.g., specific data elements);
  • Strengths and weaknesses of potential alternative platforms that might function as conduits for timely registration and reporting of prospective basic science studies involving human participants;
  • Additional data elements or modification to existing data elements that could be applied to ClinicalTrials.gov to better meet the needs of the public and of researchers in assuring timely registration and results information submission of prospective basic science studies involving human participants;
  • Other existing reporting standards for prospective basic science studies involving human participants and how such standards would fulfill the aims described in the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information; and
  • Any other point the respondent feels is relevant for NIH to consider in implementing this policy for timely registration and reporting of prospective basic science studies involving human participants.”

Responses to the RFI must be submitted by November 12, 2018.

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Posted in Issue 17 (September 4), Update, Volume 37 (2018)

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