Because of problems with the IRB system of review, NIH awarded a contract in 1992 to assess the status of the IRB system, in order to ensure that the criteria for the protection of human subjects is still adequate in light of the many changes that have occurred in biomedical, behavioral, and social science research in recent years. This study is designed to examine the costs and burdens borne by IRBs, and to make recommendations to improve the review process.

Hospital Ethics Committees and Physicians
Historical Development of Hospital Ethics Committees

In the last two decades many hospitals have instituted ethics committees charged with providing the institution and its staff with ethical guidance in policy and practice. The development of the hospital ethics committee (HEC) parallels the history of medical ethics and, more particularly, its rise as a clinical discipline (see the background paper by Heitman in this volume). HECs evolved as physicians and other health care professionals, hospital administrators, legal authorities, clergy, and patients and their families struggled to make good decisions about applying resuscitative and life-sustaining technologies. Hospital ethics committees constitute an evolving mechanism for sharing power that traditionally has belonged to physicians. The existence of HECs confirms that others also have the standing to define, discuss, and intervene when significant ethical problems interrupt the continuum of patient care. While most of the work on and by HECs has reflected developments in academic medical ethics, the constraints and practical nature of clinical ethics and institutional policy have sometimes led to significant divergence from theoretical ideals.

In 1990, the Joint Commission on Accreditation of the Health Care Organizations (JCAHO, formerly JCAH) proposed new accreditation standards on patient rights that included a requirement for "mechanism (s) for the consideration of ethical issues in the care of patients and to provide education to caregivers and patients on ethical issues in health care" (JCAHO, 1992). These standards took effect on January 1, 1992, making the existence of an ethics committee (or a similar body or process) a requirement for accreditation and eligibility for Medicare payments for all hospitals in the United States.

The actual prevalence of HECs has been difficult to determine, although there has clearly been remarkable growth in the last decade. The President's Commission survey of 602 hospitals found that in 1982 only 3 percent had an HEC or similar structure, all of them in hospitals with over 200 beds (President's Commission, 1983a). In 1983, 26 percent of hospitals responding to a national survey conducted by AHA's National Society



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