Because our information at the present time is derived from research and marketing applications,
FDA (we) cannot be certain that we have current information about IRBs that review FDA regulated
studies. For example, some drug and device studies are exempt from the
Investigational New Drug (IND, 21 CFR Part 312) and Investigational Device Exemptions (IDE,
21 CFR 812) submission requirements and are conducted without FDA involvement. In
addition, many device studies (e.g., non-significant risk and many in vitro diagnostic (IVD)
studies) are conducted with only IRB approval. We, therefore, do not have real-time information
about these studies or the IRBs that review them.
In addition, several reports from the HHS Office of Inspector General (OIG) regarding our
oversight of the conduct of clinical studies 3
recommended IRB registration, stressing the
importance of a comprehensive listing of all IRBs that review FDA-regulated research. The
2001 OIG report also expressed concern about our ability to assure an equivalent level of human
subject protection in clinical studies of FDA-regulated products conducted outside of the U.S. as
compared to those conducted in the U.S. While registration of non-U.S. IRBs (often referred to
as Independent or Research Ethics Committees – IECs/RECs) is voluntary, information we
receive from them will be helpful in addressing this concern.
