Human subjects protections, institutional review boards, and cultural anthropological research.

Abstract

The protection of human participants involved in scientific research is a fundamental obligation of any investigator. Societal concerns with ethical issues surrounding human experimentation were heightened following World War II during the Nuremberg Trials. These proceedings judged medical experiments conducted by Nazis on concentration camp prisoners and resulted in the Nuremberg Code for ethical conduct in scientific research. The Declaration of Helsinki (World Medical Association 2001 [1964]) reiterated concerns for voluntary and informed consent to research, as have subsequent national and international guidelines for ethical conduct in social, behavioral, and biomedical research.1'2 In the United States, during the 1960's and 1970's, a number of scandals involving the abuse of human subjects in social and medical research were brought to the attention of the public (Beecher 1966; Katz 1972; Faden and Beauchamp 1986; Levine 1986). The Tuskegee experiment, for example, generated public outrage when it was learned that low-income African-American men in Alabama were subjects in a study of the natural course of syphilis and remain untreated even after effective therapy became available (Jones 1981). Concerns over the Tuskegee experiment prompted the appointment of a panel by the Department of Health, Education, and Welfare to review the study and, in 1974, the National Research Act was passed. This act established the National Commission for the Protection of Human of Biomedical and Behavioral Research. The widely cited Belmont Report, published in 1978 by the National Commission, described three basic ethical principles regarding research with human subjects: respect for persons, beneficence, and justice. Institutional Review Boards Currently, throughout the world, institutional ethics committees have been established to provide oversight and approval for proposals to conduct studies involving human subjects (Brody 1998; Vanderpool 1996). In the U.S., in 1966, the Public Health Service required the establishment of ethics committees at research institutions. Final regulations concerning policies governing research on human subjects were issued in 1981 by the Department of Health and Human Service and reissued a decade later (USDHHS 1991). The Federal Policy for the Protection of Human Subjects is known as the Common Rule and has been adopted by most federal agencies that conduct or fund research on human populations. The federal mandates were clear: any research involving human subjects funded by a Department agency, with certain exemptions, must be evaluated by an Institutional Review Board (IRB). Eight criteria for IRB approval are listed, including minimization of risk, documentation of informed consent, and the protection of privacy and confidentiality. The Office for Human Research Protection (OHRP) plays an important role in the federal regulation of human research subjects' protections, including oversight of Institutional Review Boards. OHRP was established in 2001 when responsibilities were transferred from the National Institute of Health's Office for the Protection of Research Risks (OPRR). IRBs have had a profound impact on the regulation of all research with human participants. In recent years, the Office for Human Research Protections has shut down research at several US-based institutions because of violations of human subjects' protections (Greenberg 1999, 2001; Holden 1999). In this climate, IRBs may be overly zealous in their interpretation and application of federal guidelines, exacerbating the challenges faced by anthropologists and other professionals in seeking approval for studies. Moreover, in recent years, there has been increased debate in both public and professional arenas about a range of ethical issues involving research with human participants (see e.g., Kass et al. 1996; Kahn, Mastroianni and Sugarman 1998; King, Henderson and Stein 1999; Emmanuel, Wendler and Cray 2000; Killen et al. …