Strategic Communications and Marketing News Bureau

Guidelines governing human-subject research deterring scholars, expert says

CHAMPAIGN, 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 their research.

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.”

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