On January 15, 2009, the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) issued final rules mandating new or expanded registration of Institutional Review Boards (IRBs). The rules are effective July 14, 2009, however, IRBs have until September 14, 2009 to complete initial registration. The Office for Human Research Protections (OHRP) IRB registration system will be compatible with the requirements of both OHRP and FDA regulations.
To access the FDA IRB registration final rule (new 21CFR 56.106) in its entirety, please click on the following link: http://edocket.access.gpo.gov/2009/E9-682.htm
IntegReview is in compliance with current IRB registration requirements as it is registered with the Office of Human Research Protections (OHRP). Registration numbers assigned by OHRP/FDA under the IRB Organization (IORG) number IORG0000689 are:
IRB Board 1 = IRB00001035
IRB Board 2 = IRB00003657
IRB Board 3 = IRB00004920
IRB Board 4 = IRB00006075
IRB Board 5 = IRB00008463
The registration number assigned by OHRP/FDA for the IntegReview Canadian REB under the IRB Organization (IORG) number IORG0007169 is IRB00008585.
The following is IntegReview’s most recent formal IRB registration verification documentation:
IRB Registration (February 14, 2012) (effective through February 14, 2015)
REB Registration (December 5, 2011) (effective through December 5, 2014)
All registered IRB(s) may be found on the OHRP website
You may obtain answers to questions, express concerns, and convey suggestions regarding IntegReview’s Human Research Protection Program (HRPP) via e-mail to Robert Orozco, Director of Compliance or by dialing (512) 326-3001, extension 207.
