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

NOT-OD-20-087 provides guidance outlining 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.

At this time, NIH is encouraging recipients to consult with their IRBs about potential measures to protect participants and research staff. For example:

Limit study visits to those needed for participant safety or coincident with clinical care

  • Virtual study visits
  • Flexibility for laboratory tests or imaging needed for safety monitoring to occur at local laboratories or clinics
  • Canceling large gatherings of 50 or more
  • Limiting or suspending unnecessary travel

 

Delays to ongoing research due to the effects of COVID-19:

  • Recipients may submit late financial and progress reports
  • Recipients may carryover unobligated balances on active grants without prior approval

 

Delays in research progress on NIH-funded clinical trials & human subjects research due to COVID-19:

  • Recipients may extend the final budget period of approved projects on active grants one time for up to 12 months without prior approval (NIH GPS 8.1.1.3).
  • Recipients should contact awarding Institute or Center (IC) and provide details on the effect of COVID-19 to request additional extensions including mid-project period extensions.
  • NIH will allow clinical trial and other human subjects research to extend beyond the typical 7-year timeframe for extensions related to COVID-19.

 

Unanticipated costs incurred as a result of COVID-19:

If unobligated balances are not available to rebudget, recipients may request administrative supplements from the awarding IC (PA-18-591). ICs will make funding decisions on a case by case basis to support the safety and welfare of participants and sustain research during delays.

Examples of unanticipated costs:

  • Arrangements for participants to receive care at local sites or virtually, rather than at the study site
  • Supply chain disruptions
  • Personnel disruptions due to illness or closure of facilities
  • Additional lab testing (e.g. for COVID-19)
  • Increased transportation costs

 

Additional NIH resources are posted on the COVID-19 Information for NIH Applicants and Recipients webpage.