Newsletter: May 2005
Nancy Vuckovic and Janelle S. Taylor, Contributing Editors
Congratulations to Dr. Cecil Helman, recipient of the SMA’s Career Achievement Award!
An MD, Dr. Helman has worked to create and promote the subfield of clinically applied medical anthropology through his teaching, his applied work, and his numerous publications. Please see the “Rites of Passage” section of this issue, for a photo and the full description of Dr. Helman’s remarkable accomplishments.
What Does a Comparison of Informed Consent in Oral History and Ethnography Reveal About Contemporary Research Ethics in the Health Sciences?
Mark Padilla, Ph.D. and Amy Fairchild, Ph.D.
Department of Sociomedical Sciences, Mailman School of Public Health, Columbia U
An October 1993 memorandum from the Office for Human Research Protection (OHRP) in the Department for Health and Human Services (HHS) has been treated by many as having resolved a longstanding controversy over whether those conducting oral history studies must subject their work to institutional review board (IRB) review: “Oral history interviewing activities, in general, are not designed to contribute to generalizable knowledge and, therefore, do not involve research as defined by HHS regulations and do not need to be reviewed by an institution review board.”
Depending on the subject matter, oral history may represent very little risk of personal injury, embarrassment, or humiliation; it may, however, present, tremendous risk. When the risks are great, explicit informed consent procedures are appropriate. But when the risks are negligible or realistically non-existent, elaborate procedures that emphasize remote hazards may prove counterproductive. Standard oral history methodology as it is governed by copyright law, gives individual informants maximum control over their stories. But to champion the premise that oral history is not research, contributes little to “generalizable knowledge,” and merits little ethical or regulatory control suggests that it is somehow only marginally science. This perception is deepened by the informal advice that colleagues give to students and to one another as they face the prospect of presenting their research to an IRB, “Just call it oral history….”
In contrast, ethnographic research – which includes, but is not limited to, qualitative interviewing techniques akin to oral history analysis – has become very contentious for IRBs, particularly in the context of applied public health research. IRBs often have concerns about precisely how informed consent will be obtained in situations involving observation of human behavior in natural settings, and are thus often reluctant to approve research protocols involving participant observation, despite the American Anthropological Association’s argument that most ethnographic research involves minimal risk and qualifies for expedited review under category 7 of the OHRP Common Rule (Section 46.110). This has made the conduct of ethnography quite difficult in many settings in which applied medical anthropologists work today, and can occasionally require them to implement formal consent procedures in settings in which they are entirely inappropriate. The one-moment-in-time approach to formal consent procedures – while satisfying the contractual protections against litigation that motivate IRBs – also does not consider the continuous and dynamic nature of the relationship between ‘researcher’ and ‘subject’ in the context of extended ethnographic fieldwork. Ironically, then, it is not in the spirit of informed consent as a dynamic and continuous process, and may actually undermine the ongoing flow of information about the ethics of research that is particularly important in ethnographic studies.
That we treat oral history and ethnography so differently underscores the extent to which the question of whether they constitute research or not misses the point entirely: we need to ask what type of ethical guidance and oversight is most appropriate for different types of investigations involving different levels of risk, and this needs to be achieved on a case-by-case basis rather than making blanket declarations that problematize particular research methodologies and exempt others out-of-hand. As in the 1970s, when epidemiologists argued that the rules of clinical research would render records-based research virtually impossible, we have again reached a juncture where we must face the limits of the principles and regulations designed for clinical and biomedical research as they are applied to the social sciences. The true question before us is how to weigh the harms to the research enterprise as a whole against those that might fall on individuals? To address this question appropriately may require reevaluation of the ethics that should govern different types of investigations and the place and nature of informed consent within those undertakings.Jeffrey Brainard, “Federal Agency Says Oral History Is Not Subject to Rules on Human Research Volunteers,” The Chronicle of Higher Education Online (Tuesday, October 21, 2003).
American Anthropological Association, “Statement on Ethnography and Institutional Review Boards”, http://www.aaanet.org/stmts/irb.htm, accessed Feb. 11, 2005.
De Laine, M., Fieldwork, Participation and Practice: Ethics and Dilemmas in Qualitative Research (Thousand Oaks, CA: Sage, 2000).
Carolyn Fluehr-Lobban, “Ethics,” In Handbook of Research Methods in Cultural Anthropology, ed. R. Bernard (Walnut Creek: Altamira Press, 1998).185.
JW Buehler, KM MacQueen, “Ethics, Practice, and Research in Public Health,” American Journal of Public Health 94;6 (2004):928-31.
Amy L. Fairchild and Ronald Bayer, “Ethics and the Conduct of Public Health Surveillance,” Science 303 (January 30, 2004):631-632; Nancy E. Kass, “An Ethics Framework for Public Health,” American Journal of Public Health 2001; 91:11
Please send column contributions to the SMA Contributing Editors Nancy Vuckovic (nancy.vuckovic@kpchr.org) or Janelle Taylor (jstaylor@u.washington.edu)