<P> Although "IRB" is a generic term used in the United States by the FDA and HHS, each institution that establishes such a board may use whatever name it chooses . Many simply capitalize the term "Institutional Review Board" as the proper name of their instance . Regardless of the name chosen, the IRB is subject to the FDA's IRB regulations when studies of FDA - regulated products are reviewed and approved . At one time such a committee was named the "Committee for the Protection of Human Subjects". Originally, IRBs were simply committees at academic institutions and medical facilities to monitor research studies involving human participants, primarily to minimize or avoid ethical problems . Today, some of these reviews are conducted by for - profit organizations known as' independent' or' commercial' IRBs . The responsibilities of these IRBs are identical to those based at academic or medical institutions, and they are governed by the same U.S. federal regulations . </P> <P> The regulations set out the board's membership and composition requirements, with provisions for diversity in experience, expertise, and institutional affiliation . For example, the minimum number of members is five, at least one scientist, and at least one non-scientist . The guidance strongly suggests that the IRB contain both men and women, but there is no regulatory requirement for gender balance in the IRB's membership . The full requirements are set out in 21 CFR 56.107 . </P> <P> Unless a research proposal is determined to be exempt (see below), the IRB undertakes its work either in a convened meeting (a "full" review) or by using an expedited review procedure . When a full review is required, a majority of the IRB members must be present at the meeting, at least one of whom has primary concern for the nonscientific aspects of the research . The research can be approved if a majority of those present are in favor . </P> <P> An expedited review may be carried out if the research involves no more than minimal risk to subjects, or where minor changes are being made to previously approved research . The regulations provide a list of research categories that may be reviewed in this manner . An expedited review is carried out by the IRB chair, or by their designee (s) from the board membership . Research activity cannot be disapproved by expedited review . </P>

Purpose of an institutional review board (irb)