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 22.214.171.124).
- 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.