Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19

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Notice Number: NOT-OD-20-087

Release Date: March 16, 2020

Issued by: National Institutes of Health (NIH)

The purpose of this notice is to provide guidance outlining the flexibilities available to recipients conducting NIH-funded clinical trials and human subject studies, that are impacted by the declared public health emergency for COVID-19. NIH recognizes the significant effects that this emergency is having on NIH-funded clinical trials and other human subjects studies. First and foremost, NIH is concerned about the safety and welfare of human subject participants and research staff. Institutions should take all steps necessary to ensure the safety of all human participants and research staff involved in NIH-funded clinical trials and human subjects studies.

At this time, NIH encourages recipients to consult with their IRB and institutions about potential measures to protect participants and research staff. Examples of such measures are:

  • Limiting study visits to those needed for participant safety or coincident with clinical care.
  • Conducting virtual study visits
  • Arranging flexibilities for required laboratory tests or imaging needed for safety monitoring to occur at local laboratories or clinics
  • Canceling large gatherings of 50 or more people
  • Limiting or suspending unnecessary travel

Recipients will likely encounter delays to ongoing research based on the effects of COVID-19. As outlined in NOT-OD-20-086, recipients may submit late financial and progress reports, if research is delayed due to COVID-19, and may carryover unobligated balances on active grants without requesting prior approval.

Click here for additional details related to current and expanded flexibilities.