FDA IRB Registration Requirement

Please be aware that VA investigators involved in FDA-regulated clinical trials may receive letters from sponsors concerning a new FDA regulatory requirement for IRB Registration (21 CFR 56.106.) and 45 CFR 46 Subpart E.  FDA has implemented a requirement for IRB Registration effective July 14, 2009.

There is no change to the IRB registration and reporting requirements in VHA Handbook 1058.03,Assurance of Protection for Human Subjects in Research.  

IRB Registration must be renewed every 3 years.  However, VAMCs are required to update their IRB Registration through ORO within 30 days of any change to the IRB roster or other parts of the registration.  This includes the information for the Institutional Official.  VAMCs that use the IRB(s) of their academic affiliates are responsible for reporting changes in the affiliate IRB rosters to ORO.  Reporting requirements are also found in "Requirements for Reporting Research Events to Facility Oversight Committees and to the Office of Research Oversight" VHA Handbook 1058.01 par 6c.

Study sponsors may ask for documentation of IRB registration during monitoring visits. Most research offices maintain copies of IRB Registration updates.  Proof of registration can also be shown on the Office for Human Research Protections (OHRP) website at http://www.hhs.gov/ohrp/assurances/assurances/index.html.   

For questions about reporting or updating IRB Registration, please contact:

Priscilla A. Craig
Health Science Specialist
Office of Research Oversight (10R)
Dept of Veterans Affairs
810 Vermont Avenue, NW 
Washington, DC 20420
202 632-7624 phone
202 445-8849 cell
priscilla.craig@va.gov