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Volume14 Number6
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November-December
1992
by PatriciaA. Marshall
CALENDAR
INDEX
10
ANNOTATIONS
11
by PatriciaA. Marshall
IRB
personal communication both contribute to the informed consent
process. In a recent study, Kaufert
and O'Neil examined the process of
signing consent agreements between
health professionals and Native
Canadians when negotiated through
a Native-speaking interpreter. While
the clinicians approached the consent process emphasizing a biomedical understanding of disease and
treatment, the Native patients drew
on their cultural understandings of
illness, their interpretations of hospital regulations, and their beliefs
about intergroup relations in the
broader society.
The nature and process of obtaining informed consent in nonwestern
cultures can be problematic.9For example, applying western standards
of research ethics to medical or social
studies conducted in developing
countries with different cultural
norms may be construed as a form of
ethical imperialism.10Maintaining a
posture of ethical relativism requires
that investigators are culturally sensitive to local customs. A relativist
perspective, however, does not license an investigator to conduct research without considering potential
risks and without striving to be informative about the purpose and consequences of the study.11 In particular, Angell cautions against an ethical
relativism that would promote the
exploitation or manipulation of Third
World populations in research that
would not be allowed in the investigator's home country.12
One problem surrounding informed consent in nonwestern settings involves identifying the appropriate person to provide consent,
especially when the concepts of autonomy and self-determination conflict with local customs that grant
decisionmaking authority to rehliious
elders or community leaders. The
practical aspects of obtaining consent
to conduct research from"authorities"
is not limited to nonwestern cultures.
Regardless of the specific cultural
setting, the implementation of an applied anthropological study normally
begins by initiating contact with key
persons at the community or institutional level.
An important justification for informed consent is that it provides
subjects with the opportunity to participate in research voluntarily. Freedom of choice requires an ability to
comprehend the meaning of the
study and the impact it may have on
one's life. Applied anthropologists,
however, often conduct studies with
institutionalizedindividualsorvulner-
November-December1992
populations with whom applied anthropologists work and the sensitive
nature of the information being collected, including, for example,
detailed descriptions of sexual behavior, drug use, and physical or
mental problems. Breaches of confidentiality could result in devastating consequences for individuals
participating in the research, in some
cases threatening their emotional,
physical, and economic well-being.
Studies involving populations engaged in illegal or stigmatized behavior present unique challenges.25
Leonard placed herself at personal
risk in soliciting subject participation
in her investigation of the sexual behavior of male clients of street prostitutes; her subjects were also at risk
if knowledge of their illicit sexual
transactions were made public.26 As
Leonard observes, individuals performing illegal activities "tend to be
distrustful of outsiders who probe
their attitudes, document their behaviors, and, perhaps most important, acknowledge their 'deviance.'"27
The issue here involves both the researcher's ability to elicit the participant's trust and the willingness of the
participant to divulge confidences.
Securing confidentiality can be
problematic for applied anthropologists working in institutionalized settings and community environments
in which the anonymity of participants is difficult to maintain. In certain circumstances, the assurance of
anonymity for subjects represents a
research ideal.28 Promises to secure
data and conceal identities and locations may be extended, but are
sometimes difficult to sustain as information is made public. Appliedanthropologists encounter difficulties
where the behavior of individuals is
closely monitored or in community
settings in which information about
individuals is easily accessed and
shared. Additionally, some investigators point to the special need to
protect confidentiality when interviewing multiple members of one
family. The anthropologist is obligated to create an environment of
trust in which informants understand that information that might
result in punitive sanctions or cause
anxiety for other family members will
not be divulged.
A different problem emerges when
the researcher experiences a conflict
of interest between the traditional
obligation to protect a subject's confidentiality and a broader social obligation to protect third parties who
may be endangered. Does an investigator have theright or the obligation
IRB
cide, first, who will be selected to
participate in the study, and second,
of these, who will be assigned to the
control and experimental groups. Randomization may be justified when the
benefit of the intervention is not fully
determined until after the study is
completed.34 Problems occur, however, if it is known prior to the study
that the control group would be
denied a potential benefit.
Institutional Review Boards and
Anthropological Research
Institutional review boards have
had a profound impact on the regulation of research with human subjects. There is general consensus
that the IRB's mandate is to protect
individuals from potential harm that
may result from participation in research projects. However, studies of
the nature and function of review
committees call attention to the ways
in which implementin
this charge
Veatch conmay be problematic.
tends that despite having representatives from nonscientific fields
and from the community, most IRBs
are dominated by scientists reviewing the research protocols of colleagues and friends. He expresses
concern that professional bias may
hinder reviewers' objectivity regarding consideration of harm to research
subjects and that the high value
placed on furthering scientific research among most (professional)
IRB members may outweigh the concerns of a lay member. Veatch argues
that both psychological pressure to
reach a consensus and the inclination to accept the arguments of a
"professional" influence assessments
of studies. A minority voice, while
recognized, is often not heeded in
making the final decision about
scientific merit and potential harm to
research participants.
Anthropologists and other social
scientists
have expressed serious
reservations about the applicability
of IRB regulations for basic and applied social research.37 Critics argue
enthat many
ethical
issues
countered in social science research,
especially ethnographic or phenomenological studies, are not addressed
by the federal regulations. Anthropologists working from a university
or federally funded institutional base
often confront obstacles in meeting
standards for IRB approval. For example, in a study of patients' fear of
contracting AIDS from physicians,
Marshall and associates were required by the IRB to obtain written
informed consent from each person
CALENDAR
January 14-15 1993 The National Institutes of Health and the Food
and Drug Administration, in coordination with the University of South
Florida, will sponsor a southeastern
workshop entitled "Barriers to
Informed Consent: Language, Age Factors, Trauma, and Women/Minority Issues" to be held at the Sheraton Sand Key Resort in Clearwater
Beach, Florida. The conference will address barriers to informed consent
in three main areas: mental competence, ethnic and gender issues, and
research with children and the elderly. For information: Ms. Eileen
Highsmith, Executive Secretary, University of South Florida, 4202 E.
Fowler Avenue (MP.FAO-126), Tampa, FL 33620-7900; (813) 974-2897.
workshop, "Contemporary Issues
February 12-13 A southwestern
in Human Subject Research: Challenges for Today's IRBs," to be held in
coordination with Arizona State University at the Sheraton Tempe Mission Palms Hotel, Tempe, AZ. The program is designed to be a practical
working session exploring such ethical/legal issues as regulations and
assurances, categorization of research protocols, experimental design
and scientific merit, and conflict of interest. For information: Ms. Carol
Jablonski, IRB Coordinator, Office of the Assistant Vice President for
Research, Arizona State University, Tempe, AZ 85287-3403; (602) 9656788.
interviewed in outpatient waiting
areas.38 The IRB insisted that a
"boiler plate" disclaimer used for all
biomedical clinical research within
the university be attached to the informed consent statement since the
within the
study was conducted
medical center. The university attachment indicated that biomedical
or behavioral research in which the
subject has agreed to participate involves the risk of injury and that
emergency medical treatment for
physical injuries resulting from participation would be provided. The
language suggested a scope of potential problems considerably beyond
the intended purpose of the study.
Ambiguity surrounding the extent
of IRB regulatory purview creates additional difficulties for anthropologists. For example, in their report on
a failed attempt to conduct unfunded
ethnographic student research, Murphy and Johannsen found that there
are no clear guidelines distinguishing research conducted by students
for the purposes of education and
research conducted by faculty and
staff.39 The review process may be
particularly problematic in evaluations of short-term participant-observation studies intended as trainin anthropological
ing exercises
fieldwork methods. Moreover, while
IRBs protect human subjects of research, these investigators found
that student researchers have little
recourse if they are the victims of
ethical misconduct or abuse.
Education and advocacy provide
the best means of achieving a fair and
realistic examination of anthropo-
logical and other social science projects. One step toward informing IRB
members about the nature, purpose,
and unique constraints in anthropological investigations might be for
professional associations to prepare
a written statement outlining general
goals and methods. This statement
could be distributed to IRB committee members; it might also be included with materials presented to
IRB members by anthropological inDisciplinary
reprevestigators.
sentation on the IRB, and in lieu of
this, identification of an "advocate"
for anthropological research among
IRB members, may also facilitate the
review process.
Conclusions
Ethical principles governing applied anthropological research are
not unique to this discipline. Respect
for persons, beneficence, and justice
are fundamental concerns for any
scientist. Constraints imposed by the
specific research context influence
the way in which these principles are
expressed in the implementation and
design of a study. In this regard,
anthropologists may encounter more
obstacles than other social scientists, especially anthropologists engaged in policy-related research in
which ethnographic and qualitative
measures are employed. The challenge for the applied anthropologist
is to maintain scientific and moral
integrity in a research reality of competing social values and ambiguous
social facts.
November-December1992
Note
This paper is an adaptation of the chapter, "Research Ethics in Applied Medical Anthropology,"by Patricia
Marshall, in TrainingManual in Medical Anthropology,ed. Carole E. Hill.
Washington, D.C.: American Anthropological Association, 1991.
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