Trials and tribulations of navigating IRBs: anthropological and biomedical perspectives of "risk" in conducting human subjects research.

Abstract

Introduction The Federal Policy for the Protection of Human Subjects or (1991) has undergone significant revision over the past decade, especially under the supervision of the National Bioethics Advisory Commission (NBAC), whose charter expired in October, 2001, and the Department of Health and Human Services. As a president-appointed committee designed to oversee the ethical dimensions of human subjects research, NBAC (2001) proposed various efforts to strengthen the protection of humans participating in research. While these efforts reflect a laudable goal, they do not necessarily apply or translate well to all kinds of research, particularly ethnographic research. Accordingly, anthropologists and other investigators commonly perceive the current and proposed human subjects regulations as to research (Koski 1999). Anthropologists and other social scientists typically encounter these impediments at the point of obtaining Institutional Review Board (IRB) approval. In order to obtain approval, IRBs require that human subjects studies comply with the Common Rule by ensuring primarily that the benefits of participation in outweigh the risks to subjects, and that subjects provide informed consent. I argue here that these regulations and interpretations of them are modeled heavily on a biomedical understanding of research, and that the biomedical model does not necessarily conform to anthropological approaches toward research. Anthropologists and other social scientists and humanities scholars (e.g., historians, journalists) have not sat idly by watching the Common Rule undergo revision. Rather, there is increasing debate over how the regulations affect anthropological and other research, generated by letters and reports from professional organizations to NBAC and other organizations requesting reconsideration of certain issues. This paper examines some of these perceived impediments and other issues that can emerge in the enterprise by drawing upon two sources of information. First, I present some of the concerns about the human subjects regulations that many social scientists and others raise based on a content analysis of some of the letters and reports written by leaders of professional organizations, including the American Anthropological Association and the American Association of University Professors. Second, I illuminate these issues by presenting personal experiences as a Principal Investigator (PI) having submitted, revised, and defended protocols for several projects to IRBs, and as a member of a medical center IRB. Considerable debate over the Common Rule focuses on the issue of and questions whether anthropological and other social and behavioral science actually poses real risks to study participants. Much discussion concentrates on describing just how is construed in biomedical terms, thereby making it difficult to apply Common Rule regulations to social science research. I frame concerns about risk in ethnographic by specifically addressing issues relating to: informed consent, the use of audio-tapes, perceptions of risk/benefit ratios, confidentiality, and remuneration for study participation. As will become clear below, a theme woven throughout this discussion is how some of the federal regulations paradoxically seem to protect the interests of investigators and institutions rather than subjects or participants. I have several goals. I identify impediments that anthropologists might encounter in order for others to be able to anticipate and proactively remedy before such problems delay their own endeavors. In addition, I suggest strategies for anthropologists or other social scientists to address these problems and provide information about relevant policies to support these strategies. Lastly, I explore the implications of the Federal regulations for ethnographic in the future. …