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Boards that oversee human-subject research need overhaul

Mark Reutter, Business & Law Editor


CHAMPAIGN, Ill. — University Institutional Review Boards, which oversee research involving human subjects, need to be revamped to avoid the “mission creep” that is threatening academic freedom and restricting research on the nation’s campuses, according to a report by University of Illinois researchers and scholars.

The report, “Improving the System for Protecting Human Subjects: Counteracting IRB ‘Mission Creep,’ ” lays out recommendations to help IRBs better balance their mission.

A public discussion of the report will be held from 3 to 6 p.m. Nov. 17 (Thursday) at the Max L. Rowe Auditorium of the Law Building, 504 E. Pennsylvania Ave., Champaign. The discussion will feature a speech by Steven J. Breckler, executive director for science at the American Psychological Association.

Review boards were established in the 1960s to examine medical and biological research involving human subjects in the wake of several scandals involving unethical or harmful human experiments funded by federal dollars. The boards have since evolved into review mechanisms for nearly all research involving human subjects at educational and medical-research institutions.

Ironically, according to C.K. Gunsalus, an Illinois law and medicine professor who is the report’s main author, the red tape caused by some IRB panels has bred contempt among researchers rather than promote better understanding of the importance of ethical conduct.

The report calls upon universities and professional organizations to gather data on the effectiveness of IRBs, develop “best practices” standards for the boards and institute more flexible regulations for social science research.

IRB regulations originally were applied just to medical institutions that received federal research grants to study human subjects. Over time, universities have extended the rules to review research both financed and not financed by the taxpayer.

The “mission creep” encouraged by universities to avoid potential human-subject scandals or lawsuits has been the source of much consternation among researchers who sometimes must submit reams of paperwork in order to justify routine surveys and interviews.

“Too much time is spent on form over substance in the IRB process,” Gunsalus said, which delays research and can impair the integrity of study designs without any evidence of correcting possible abuse.

The report recommends that IRBs develop a priority system to concentrate on research that poses the greatest potential for human-subject harm. “It is important to focus IRB scrutiny and resources where they are most needed and where they are most appropriate,” the report noted. “We must abandon the ‘one-size-fits-all’ mindset for identifying and reviewing all covered research.”

Because of the biomedical roots of the oversight system, many campus IRBs apply medical protocols to social science disciplines where there is little risk that a poorly designed protocol could result in serious injury. Gunsalus cites the example of an English professor writing an autobiographical essay who was investigated for not seeking IRB approval before writing a memoir.

Another recommendation calls for journalism and oral history to be exempt from IRB regulations. “Such professional activities are quite distinct from biomedical research. Concerns about the conduct of these activities are better left to those bodies, such as department reviews, that are competent to judge them,” the report said.

In general, the report calls for a more commonsensical approach to proper ethical conduct and informed consent.

The report is the outgrowth of an April 2003 conference convened by the Illinois Center for Advanced Study, which gathered researchers to discuss human-subject research, academic freedom and IRB management.

In addition to Breckler’s presentation, the Nov. 17 public discussion will include comments by members of the report’s steering committee.

The steering committee includes Edward M. Bruner, professor of anthropology; Nicholas C. Burbules, professor of educational policy studies; Leon Dash, professor of Afro-American studies, of journalism and of law; Matthew W. Finkin, professor of law; Joseph P. Goldberg, professor of clinical medicine; William T. Greenough, professor of psychology and director of the Center for Advanced Study; Gregory A. Miller, professor of psychology; and Michael G. Pratt, professor of business administration.