IRBs that are not already in the registration system must submit an initial registration. IRBs can
submit this registration electronically through http://ohrp.cit.nih.gov/efile. If your IRB lacks the
ability to register electronically, it must send its registration information, in writing, to the Good
Clinical Practice Program (HF-34), Office of Science and Health Coordination, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857.
As noted above, we are utilizing a modified version of the Internet-based system OHRP has
employed for registration of IRBs designated under FWAs. Both OHRP and FDA will be using
this same modified system.
The electronic registration system provides instructions to assist you in providing the appropriate
information, depending on whether your IRB is subject to regulation by only OHRP, only FDA,
or both OHRP and FDA.
