As discussed in the preamble to both the proposed and final rules, the information that OHRP
presently has publicly available on its website will remain available. That information includes
the name and location of all organizations operating an IRB and the name and location of the
associated IRB(s). (This information is available at http://ohrp.cit.nih.gov/search/).
Other available information is subject to public disclosure under the Freedom of Information Act
(FOIA) as well as our public information regulations in 21 CFR Part 20 and therefore can be
requested. Please note, however, that certain information may be withheld from public
disclosure or may require an individual’s consent for public disclosure [see, e.g., 21 CFR
20.63(e)].
In addition, we will not issue reports on IRB registration nor certificates to show that an IRB is
registered. As noted previously, IRB registration does not address issues regarding an IRB’s
competence or expertise nor does it require IRBs to meet a particular standard in order to
conduct a review.
