Statement by Mary K. Pendergast, Deputy Commissioner, Senior Advisor to the Commissioner, Food and Drug Administration, Department of Health and Human Services

C. Responsibilities of..Institutional.Review Boards
An IRB is a group formally designated to review, approve the
initiation of, and periodically review the progress of,
biomedical research involving human subjects. The primary
function of IRBs is to protect the rights and welfare of the
people who are in clinical trials.
FDA's regulations, 21 CFR Part 56, contain the general
standards for the composition, operation, and responsibility of
an IRB that reviews clinical investigations submitted to FDA
under sections 505(i), 507(d), and 520(g) of the FD&C Act.
IRBs must scrutinize and approve each of the more than 3,000
clinical trials that are conducted on FDA-regulated products in
this country each year. IRBs must develop and follow
procedures for their initial and continuing review of the
integrity of each trial. Among other requirements, IRBs must
make sure that the risks to subjects are minimized and do not
outweigh the anticipated study benefits, that the selection of
participants is equitable, that there are adequate plans to
monitor data gathered in the trial and provisions to protect
the privacy of subjects and the confidentiality of data. The
IRB has the authority to approve, modify, or disapprove a
clinical trial. If an IRB decides to disapprove a research
activity, it must notify, in writing, the investigator of its
decision, state its reasons for the decision, and give the
researcher an opportunity to respond in person or in writing.