The costs of an institutional review board.

The Institutional Review Board (IRB) at the University of Texas Health Science Center at San Antonio is charged with the responsibility of review of all protocols involving human subjects in research. A large medical institution has many clinical protocols requiring review. The review of hundreds of protocols per year requires much time from the IRB staff, the committees which review the protocols, and the investigators who prepare them. This cost is borne by the institution. Additional federal regulations add to the complexity of review and require additional time on the part of all concerned. An attempt has been made to document the costs of operation of the IRB in a single group of institutions. About 850 new or renewal applications are reviewed each year for $100,000 or about $100 per application. This is a sizable financial burden to be placed on the average medical school. Legislation is now proposed to support IRB activities by direct grants from the federal government.