- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Medical Products and Tobacco, Office of Clinical Policy, Office of Good Clinical PracticeOffice of Medical Products and Tobacco, Center for Drug Evaluation and ResearchOffice of Medical Products and Tobacco, Center for Devices and Radiological HealthOffice of Medical Products and Tobacco, Center for Biologics Evaluation and Research
This guidance discusses the regulatory responsibilities of institutional review boards (IRBs), clinical investigators, and sponsors when oversight of a previously approved, ongoing clinical investigation under FDA’s jurisdiction is transferred from one IRB to another IRB. This guidance also addresses questions that have been previously raised concerning procedures and processes that are required and/or recommended by FDA when such oversight is transferred. FDA encourages individuals to contact the agency directly to discuss any unusual circumstances.
To enhance human subject protections and reduce regulatory burden, FDA and the Office for Human Research Protections (OHRP) have been actively working to harmonize the agencies' regulatory requirements and guidance for human subjects research. This guidance document was developed as a part of these efforts. For studies subject to 45 CFR part 46 (i.e., studies that are funded, conducted, or supported by the Department of Health and Human Services), OHRP issued a draft guidance entitled, “Considerations in Transferring a Previously Approved Research Project to a New IRB or Research Institution.”
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2011-D-0835.