New HHS Final Rule and NIH Policy on Releasing Study Results on ClinicalTrials.gov

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Released on September 16, the U.S. Department of Health and Human Services (HHS) issued a final rule on requirements for registering specific clinical trials on ClinicalTrials.gov and for releasing summary study results to ClinicalTrials.gov.

On the same day, the National Institutes of Health (NIH) issued a tandem policy for all NIH-funded trials, which includes registering and submitting summary results information to ClinicalTrials.gov, including studies not included as part of the HHS final rule.

According to the HHS final rule, most interventional studies of drug, biological and device products that are regulated by the FDA should be registered on ClinicalTrials.gov. The final rule specifies how and when information collected in a clinical trial must be submitted. Important elements of the final rule include:

  • A checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting required information
  • Expansion of the scope of trials for which summary results information must be submitted, to include trials involving FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA
  • Additional requirements for trial registration and summary results to be submitted to ClinicalTrials.gov, including the race and ethnicity of trial participants, if collected, and the full protocol
  • Additional requirements for adverse event information
  • A list of potential legal consequences for non-compliance.

The NIH policy applies to all NIH-funded trials, including phase 1 clinical trials of FDA-regulated products, small feasibility device trials, as well as projects not regulated by the FDA, such as behavioral interventions.

This policy applies to all grants/contracts applications and new/competing proposals received by NIH on or after September 16, 2016. MHRI studies that are not considered applicable clinical trials and that are currently funded by an NIH grant are not required to be registered if funded prior to September 16, 2016. However, applicants for new/competing NIH funding are now required to submit a plan with the grant/contract application outlining how they will comply with this new final rule. The Final Rule has a compliance date of 90 days after January 18, 2017, at which time MHRI needs to be in compliance with the requirements of the Rule.

If you have any questions, please contact Priscilla Adler in the MHRI Office of Research Integrity at [email protected].