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Guidelines governing human-subject
research deterring scholars, expert says
Business & Law Editor
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of I. Photo
Gunsalus, an adjunct professor at the Illinois College
of Law, calls the extension of the biomedical model of
human-subject review into such fields as anthropology and
history “overreaching” and calls on campus Institutional
Review Boards (IRBs) to re-examine the growing panoply of
rules and restrictions governing
Ill. — Social science research on university campuses is being stifled by “hyperzealous”
rules that bear little relation to the goal of protecting human subjects
from unethical or unprofessional behavior, an expert from the University
of Illinois at Urbana-Champaign writes.
C.K. Gunsalus, an adjunct professor at the Illinois College
of Law, calls the extension of the biomedical model of human-subject
review into such fields as anthropology and history “overreaching”
and calls on campus Institutional Review Boards (IRBs) to re-examine
the growing panoply of rules and restrictions governing scholarly research.
IRBs grew out of several major scandals involving harmful human experimentation
funded by federal dollars dating back to the Tuskegee syphilis experiments
conducted by the U.S. Public Health Service between 1932 and 1972.
Most universities now require researchers in the humanities and social
sciences to obtain informed consent and prepare detailed analyses before
undertaking any research that involves human subjects.
Too much of the time, Gunsalus writes in an upcoming paper in the journal
Ethics and Behavior, IRBs focus on “form over substance,”
which can delay research and impair the integrity of research designs
without improving ethics.
Most activities within disciplines, such as oral history, journalism
and English, do not belong within the scope of IRB jurisdiction, she
wrote. Other fields, such as survey research, informational interviews
and informal interactions, are better left to department-based oversight
rather than centralized review.
To protect subjects and deal with improper behavior, Gunsalus proposes
the establishment of an effective complaint system.
“Few would deny the need for IRBs in biomedical or behavioral
research, or the important role they play in protecting vulnerable populations
from exploitation,” she wrote, but applying the same rules to
the social sciences and humanities raises serious issues of academic
freedom and First Amendment guarantees.
She cites instances where a historian interviewing participants of the
civil rights movement and an English professor writing an autobiographical
account were investigated for not seeking IRB approval before conducting
Ironically, she notes, there are many research activities outside the
bounds of the university that pose much greater risks to human subjects.
Doctors experimenting with new surgical devices, genetic tests conducted
by biotechnology companies and corporations requiring the employees
to undergo severe forms of “team building” are not regulated.
“We need to find ways to increase effective regulatory coverage
in the areas of greatest risk for harm and withdraw gracefully from
the ‘mission creep’ that has caused IRBs to require review
and approval for extremely low-risk areas of human interactions,”
she concluded in her essay.
Her paper, slated for the December 2004 issue of Ethics and Behavior,
is titled, “The Nanny State Meets the Inner Lawyer: Over-Regulating
While Under-Protecting Human Subjects of Research.”