FDA Grants/Cooperative Agreements - Clinical Trial Insurance Requirements
Notice Number:

Key Dates

Release Date:

January 22, 2021

Related Announcements


Issued by

U.S. Food and Drug Administration (FDA)


The purpose of this Notice is to notify the FDA applicant and recipient community of FDA's requirement for recipients to acquire Clinical Trial insurance on FDA grants/cooperative agreements involving Clinical Trials.

The recipient is responsible for acquiring Clinical Trial liability insurance against all liabilities, damages, losses, injuries, complaints and/or claims arising from the trial including, but not limited to, claims that arise from malpractice and/or negligence.  In addition to funds required to support clinical trial conduct, the recipient should account for the costs of this insurance in the budget, and will be responsible for maintaining an insurance certificate that satisfies any relevant regulations/guidance/policies including local requirements.


Please direct all inquiries to:

Questions concerning this Notice may be directed to:

Food and Drug Administration (FDA)
Office of Acquisitions and Grants Services (OAGS)
Grants Management Branch
Email: OAGSGrantsPolicy@fda.hhs.gov

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