Question

There are several historical events that led to the development of an Institutional Review Board (IRB). Name them and describe/discuss the one that you think was most influential.

Answer 1

# Institutional Review Board -

Scientific research has produced substantial social benefits and posed some troubling ethical questions. Some dates important in the development of institutional review boards, or IRBs, include the following:

In August 1947, during the Nuremburg War Crime Trials at the conclusion of World War II, the Nuremburg Code was drafted as a set of standards for judging those involved in reported abuses of human research subjects. It became the prototype for later efforts to ensure the protection of human subjects in research.

On July 12, 1974, the National Research Act established the existence of IRBs to review biomedical and behavioral research involving human subjects.

In March 1983, federal regulations detailing the basic U.S. Department of Health and Human Services policy for the protection of human research subjects were adopted.

On August 19, 1991, the 1983 regulations were updated. Known as Title 45, Public Welfare, Part 46, the current regulations provide comprehensively detailed information about the duties and responsibilities of IRBs.

Administration

Today, four IRBs review biomedical and behavioral research involving human subjects at Fred Hutch. The IRBs review all research submitted by Fred Hutch and the Fred Hutch/University of Washington Cancer Consortium. The Fred Hutch IRBs review any research project involving research participants, regardless of its funding source.

Fred Hutch IRBs review and approve research in accordance with U.S. Department of Health and Human Services regulations at 45 CFR 46. In addition, for studies involving products regulated by the U.S. Food and Drug Administration, the Fred Hutch IRBs comply with the requirements set forth in 21 CFR 50, 21 CFR 56, 21 CFR 312 and 21 CFR 812.

The chairs of each IRB are:

Committee A: Brenda Sandmaier, M.D.

Committee B: David Maloney, M.D., Ph.D

Committee C: Roland Walter, M.D., Ph.D., M.S.

Committee D: Margaret Madeleine, M.P.H., Ph.D.

The Institutional Review Office, or IRO, administers all activities requiring IRB review. The IRO reports directly to the Office of the Director of Fred Hutch.

Fred Hutch IRB meetings are held four times per month. View the schedule of meetings and submission deadlines.

While Fred Hutch does not provide copies of the membership lists, the Fred Hutch IRB rosters have been approved by, and are on file with, OHRP. If you require documentation of this, please see the belowIRB roster letter.