Abstract

The concepts of informed consent and surveillance of human research designed to protect human subjects is commendable. The regulations of the Institutional Review Board (IRB) are having a major impact on clinical cancer research. There is greater administrative time needed of the investigator, the mechanisms of patient care have become cumbersome and some patients reject optional medical management that could be life saving. IRB regulations must be flexible to meet the needs of human subjects as well as those of the clinical investigator.

KIE:

Kennedy is Director of Medical Oncology at the University of Minnesota Medical School. He criticizes institutional review board (IRB) policies as impeding cancer research but acknowledges the need for informed consent and surveillance of research on human subjects. He argues that the administrative work involved in complying with IRB regulation wastes researchers' time and consumes research money, and that the required consent process discourages subject participation. Wigodsky counters that government involvement in IRB regulation was necessary to guarantee the right of self determination in health care when the research community failed to act. He also notes that present regulations, which reflect changes proposed by researchers, can still be revised; that IRBs as local institutions should reflect community values; and that the IRB is not the investigator's adversary but the research subject's champion.