Newsletter: April 2003
Nancy Vuckovic and Janelle Taylor, Contributing Editors
SMA Website Milestone
The SMA's new website, www.medanthro.net,
logged its ten thousandth visitor in February
2003! Indeed, the SMA seems to be making a name
for itself as a key news resource for well-informed
and would-be-successful people. In an article
titled "Beware the Rhodes Hog," from
the Financial Times of Jan 22 '03, Michael Skapinker
describes the intense coaching of candidates for
Rhodes scholarships that takes place at the University
of Arkansas, under the guidance of "fellowship
advisor" Suzanne McCray. Among other things,
Ms. McCray sends out to Rhodes candidates "daily
e-mails of articles from various publications."
Skapinker notes that "Ms. McCray's daily
reading list...came from The Economist,
the New Yorker, Foreign Affairs,
The New York Times, and the Society for
Medical Anthropology." ... Not bad company!
(Thanks to M. Estrella Smith for sending the article.)
IRBs and Anthropological Research
By Patricia A. Marshall (Case Western Reserve
U)
In the United States, in 1974, the National Research Act was passed in response to public outrage over the Tuskegee experiment on untreated syphilis among Iow-income African-American men in Alabama. This act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report, published in 1978 by the National Commission, described basic ethical principles regarding research with human subjects. Federal regulations governing research on human subjects, known as the Common Rule, were issued in 1981 by the Department of Health and Human Services and reissued a decade later. 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).
While there is consensus about the general purpose of IRBs, significant problems remain in the application of the federal guidelines in the review process. Although committees must include representatives from diverse scientific fields and the community, IRBs have a strong orientation to biomedical research. Most IRBs do not have members with expertise in anthropological methods. This often results in misunderstandings concerning study designs proposed by medical anthropologists. The Common Rule allows for the waiver or modification of requirements for the consent process if the research is minimal risk, the waiver or alteration would not adversely affect participants’ rights and welfare, the research could not be carried out otherwise, and whenever appropriate, participants would be provided with information after participation. Signed written consent may be waived if the signed form would link the participant to the study and disclosure of participation would be the primary risk for the subject. IRBs are generally reluctant to forego written informed consent from research participants.
IRB requirements for written documentation of informed consent may be problematic for medical anthropologists conducting ethnographic research. Challenges associated with requirements for signed consent forms are heightened when medical anthropologists are working with vulnerable populations, illiterate populations, or in cultural settings where, historically, individuals have been exploited after “signing” a legal document with a thumb-print or written signature. In addition, anthropologists may work in areas where decisional authority for research participation does not necessarily rest with the individual “signing” the consent document or agreeing to participate in a research investigation.
Anthropologists should take a proactive role in relation to their IRBs. First, in university and other research settings, anthropologists should seek representation on the IRB. Second, investigators should contact the IRB chair or staff member to discuss questions relevant to their studies. Third, in preparing research protocols, anthropologists should be explicit about strategies for obtaining and documenting informed consent, protecting participants from unintentional risks and harms, and methods for ensuring confidentiality. Fourth, anthropologists and their professional organizations should become involved in efforts to educate policy makers—at national and institutional levels—about appropriate application of federal regulations for research employing anthropological methods.
In recent years, the Office for Human Research Protections (OHRP) has shut down research at several US-based institutions because of violations of human subjects’ protections. In this climate, IRBs may be overly zealous in their interpretation and application of federal guidelines, exacerbating the challenges faced by medical anthropologists in seeking approval for studies. Paradoxically, policy makers have begun to review national guidelines governing both biomedical and behavioral research. In 2001, the National Science Foundation and the National Academy of Sciences established committees to evaluate social science research and IRB practices. Medical anthropologists are on each of these committees. Recommendations highlight the need to consider carefully the particular requirements of social and behavioral research, including anthropological investigations.
We welcome your comments and stories about
your experiences with IRBs. Please email your
contributions to us at the addresses below.
Please send your comments, contributions,
news and announcements to the SMA Contributing
Editors Nancy Vuckovic (nancy.vuckovic@kpchr.org)
or Janelle Taylor (jstaylor@u.washington.edu).