IEEE Technology and Society Magazine - Winter 2014 - 60

Fig. 1. The Nit-Picking IRB.

timeline/). For example, a human
subject died in 1999 after participating in a gene therapy study at
the University of Pennsylvania. In
2001, a healthy volunteer in a project at the Johns Hopkins University died in an asthma study, which
led to temporary closure of all
research activities at the medical

Making One-Size-Fits-All
Research
Federal regulations require IRBs
to have the professional competence necessary to review specific research activities. However,
studies show that IRBs tend to
be overshadowed by biomedical
researchers and bioethicists, fol-

The recent research misconduct
that has made Institutional Review
Boards more rigid has occurred in
biomedical and clinical research
rather than in social sciences.
school. In 1999, federally funded
research at the Duke University
Medical Center was suspended for
four days, mostly due to several
deficiencies in its IRB. A lawsuit
was filed against the IRB at the
University of Oklahoma when it
was discovered that the approved
informed consent for a study
involving subjects with melanoma
contained false information. It
should be noted that the recent
research misconduct that has made
IRBs more rigid has occurred in
biomedical and clinical research
rather than in social sciences.
60

lowed by psychologists who do
not have expertise in social science
research [40], [16]. If there are some
social scientists on local IRBs, they
tend to be trained in quantitative
methodology. Although they may
be open to a variety of research
methods, they still view qualitative
research as "soft science" [9], [12].
Many scholars believe that qualitative methodology does not fit well
with formal procedures familiar to
biomedical, behavioral, and quantitative social science reviewers.
According to federal regulations,
IRBs must determine that the risks

of participation in research are reasonable in relation to the potential
benefits that may be expected as a
result of the research. Scholars have
argued that IRBs ought to distinguish
between physical and non-physical
harms in biomedical, behavioral,
and social-science research. This is
due to social-science research more
often involving paper-pencil tests
(i.e., rather than drug trials), and to
social-science research being dialogue-oriented rather than clinically
oriented [9], [10]. Oakes has plotted
a chart of possible harms to human
subjects, which range from physical harms, such as death, in medical research, to non-physical harms,
such as annoyance, in journalism
research [41].
Scholars have further argued
that it is easy to evaluate physical
harms in the context of potential
direct benefits to the human subject [42], [43]. For example, the
risk of cancer research is death,
and the benefit is protection or
cure from cancer, which the human
subject may receive. Similarly, the
risk in an anorexia study is depression and the benefit is the psychotherapy, which the human subject
is likely to receive. Additionally,
it is suggested that the bulk of
social-science research offers little
individual benefit to the human
subjects who participate in the
research. For instance, a study of
how people use technology will
generate knowledge about new
ideas for products and services,
which is a long-term benefit and
may or may not be directly beneficial to human subjects who are
participating in the research.
Federal regulations require IRBs
to approve the informed consent
form, which is the voluntary consent
of human subjects to participate in
a study. Each human subject must
sign this form before research is conducted. Scholars have argued that the
nature of informed consent causes
some challenges in social-science
research compared to biomedical and
behavioral research. For instance,

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WINTER 2014

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