FDAAA for NIH Grantees: The Basics
Update: New HHS rule and NIH policy, effective January 18, 2017, affect all NIH-funded clinical trials. Read the summary.
This page provides a basic introduction to FDAAA specifically for NIH grantees. Review the entire website for fuller information about the statute and roles and responsibilities for compliance.
Overview of FDAAA
The Food and Drug Administration Amendments Act of 2007 (FDAAA) (PDF - 540 KB), Title VIII, expands the National Library of Medicine (NLM) clinical trials registry and results database known as ClinicalTrials.gov and imposes new requirements that apply to certain trials supported by NIH funds.
FDAAA and Clinical Trials Supported by NIH Grants
Trials subject to FDAAA are called “applicable clinical trials” (ACTs; see Definitions). Any ACT supported in whole or in part by an NIH grant (including cooperative agreements) must be in full compliance with FDAAA.
The trial’s “responsible party” (see Definitions) is responsible for two basic elements of compliance:
- the registration of the ACTs in ClinicalTrials.gov, and
- the reporting of summary results information (including adverse events)
A third basic element of compliance specific to the NIH implementation of FDAAA is a requirement for all NIH grantees, regardless of whether or not they are the “responsible party” under FDAAA:
- certify in the grant application and progress report forms that the responsible party has made all required submissions to ClinicalTrials.gov for ACTs funded in whole or in part by the NIH.
To help understand if a grant supports an ACT and which entity or individual is the responsible party for the trial, please review “Steps to Compliance for NIH Grantees.”
Registering and Reporting Results in ClinicalTrials.gov
The entity responsible for registering the trial is the “responsible party.” The statute defines the responsible party as the sponsor (see Definitions) of the trial, or the principal investigator of the trial if designated so by the sponsor. Under grants:
For the complete statutory definitions and more detailed information on the agency's current thinking about the meaning of ACT and responsible party, please access: Elaboration of Definitions of Responsible Party and Applicable Clinical Trial.
- For ACTs where there is an IND or IDE (see Definitions), the IND/IDE holder is generally considered to be the sponsor and therefore the responsible party. The sponsor may choose to designate the principal investigator of the trial (see Definitions) as the responsible party.
- For ACTs where there is no IND or IDE holder, the funding recipient is generally considered to be the sponsor and therefore the responsible party. For NIH grants, the funding recipient is the grantee institution, not the PI on the grant. The grantee institution, then, is generally considered to be the sponsor and therefore the responsible party. The sponsor may choose to designate the principal investigator of the trial (see Definitions) as the responsible party