NIH Implementation of FDAAA

Update: New HHS rule and NIH policy, effective January 18, 2017, affect all NIH-funded clinical trials. Read the summary.

Identifying the "Responsible Party" under FDAAA for Applicable Clinical Trials Conducted Under NIH Grants

  • This flowchart presents basic guidance on determining what entity or individual would be considered the "responsible party" under FDAAA for applicable clinical trials conducted under NIH grants (including cooperative agreements). It maps out the guidance provided in the “Elaboration of Definitions of Responsible Party and Applicable Clinical Trial,” and is also available as a PDF (177 KB).
  • This flow chart may not address every situation. The grantee institution's sponsored research office, general counsel, or other similar official should be involved in identifying the responsible party for applicable clinical trials.
Does the applicable clinical trial involve an investigational new drug application (IND) or investigational device exemption (IDE)?

The NIH encourages registration and results reporting for all NIH-supported clinical trials, regardless of whether or not they are subject to FDAAA.

This page last updated on September 16, 2016 
Content Manager: 
Technical Issues: E-mail OER Webmaster