International Human Subjects Research Ethics

Informed consent is the mechanism by which healthcare professionals and researchers protect human self-determination in the context of participation in scientific research nationally and internationally. Informed consent requires the provision of information (including procedures, risks, benefits, ability to withdraw), ensuring subject comprehension, and voluntary participation (Council for International Organizations of Medical Sciences, 1993; U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978). Clinical research conducted internationally faces critical challenges in adhering to guidelines because of cultural factors—including the fact that codes of research ethics derive from Western cultural values of individual autonomy, the prevalence of language barriers and difficulties with using interpreters, different ethnomedical understandings of the body, and power dynamics between investigators and subjects (Barnes, Davis, Moran, Portillo, & Koenig, 1998; Kaufert & O'Neil, 1990; Kaufert & Putsch, 1997; Marshall, 2001). A compelling area of investigation determines whether research concepts translate into other languages or cultural world-views, and if not, determining how to translate them in such a way as to ethically justify the conduct of research in those cultures (see Marshall, 2001; Wertz, 1998). For example, comprehension of genetics research is minimized when translating the English consent form to Yoruba, as there are no words for "genotyping" or "gene" (Marshall, 2001). Implementing Western standards of research ethics is compounded when other cultures establish their own codes of research ethics shaped by local, cultural values, as in Egypt (Lane, 1994).

Conducting research in communities, nationally or internationally, raises additional questions about the application of standards set forth in Western research ethics. Traditionally, informed consent is obtained from the individual asked to participate in the research. However, decisional authority does not always rest within the individual, but among extended family, community groups, or with tribal leaders. In the United States, African Americans may be weary of participation in clinical research given a history of medical abuses (Jones, 1993; Reverby, 2000). Thus, anthropologists have illuminated the cultural processes for conducting community-based research that respect the needs of the local group through mechanisms of community involvement in the study design while simultaneously ensuring respect for individual autonomy (Marshall & Rotimi, 2001). These examples demonstrate the usefulness of employing anthropological approaches to analyze bioethical issues and develop health policy (Gordon, 2001a; Koenig et al., 1998; Siminoff et al., 1995).

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