NIH issues additional guidance on NIH-funded Clinical Trials

Mar 17, 2020, 13:52 PM by Melodi Moore
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In a statement released through clinicaltrials.gov and in NOT-OD-20-087, the NIH issued the following guidance related to extensions and unanticipated costs. Questions about this guidance can be directed to the UTMB Office of Clinical Trials through the Ask a Human Subject-Related Question web form.

RE: Extensions
To support participant health and safety, and continuity of research during this public health emergency, NIH will allow for additional extensions, including mid-project period extensions, for awards supporting NIH-funded clinical trials and human subjects research. Recipients should contact the awarding Institute or Center (IC) to provide details on the effects of COVID-19, and the need for an extension. NIH is committed to working with its recipients during this public health emergency. 

RE: Unanticipated costs
As a result of COVID-19, recipients may incur unanticipated costs. For example:
  • Costs incurred to arrange for participants to receive care at their local sites or virtually, rather than the study site, for required visits.
  • Supply chain disruptions
  • Personnel disruptions due to illness or closure of facilities
  • Additional lab testing (e.g. for COVID-19)
  • Increased transportation costs

If unanticipated costs are identified due to impacts of COVID-19, and unobligated balances are not available to rebudget, recipients may request administrative supplements from the funding ICs (see PA-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). ICs will make funding decisions on a case by case basis in an effort to support the safety and welfare of participants and sustain research during any delays.

Additional NIH resources related to COVID-19 are available here which includes FAQs that include, but are not limited to, human research and clinical trials specific questions. NIH is continuing to monitor the situation and will publish any additional information regarding this ongoing public health emergency in the NIH Guide.