Oct. 16, 2006

Research Review Boards Faulted

Institutional review boards — never designed for oversight of journalism programs or surveys by sociology majors — have gone way beyond their mandates and purpose, to the detriment of scholarship, says a new report from the American Association of University Professors.

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IRB’s serve an important purpose when people who are the subjects of research can face real harm, said David Hyman, an author of the report and a professor of law and medicine at the University of Illinois at Urbana-Champaign. But in cases where the chance for harm is quite low, the IRB process is not needed, he said. IRB review, he pointed out, has been required for projects such as journalism study, oral history research, and simple surveys of family members.

“That’s just nutty,” he said. “People talk to their parents and relatives all the time without IRB approval.”

The report recommends that IRB’s cease reviewing a number of projects where the chance for physical injury to a human subject is slim to nonexistent. When adults are the subject of surveys, interviews, or publicly observed, there is no need for an IRB process, said Jonathan Knight, the AAUP’s point person on academic freedom.

The report lists a number of “more or less familiar horror stories” to back up the claim that the process has gotten out of hand. In one case, a linguist had to get signed approval from the participants of a study who were not literate. In another, a white graduate student was told that he could not interview African-American students on career expectations because the interview might cause trauma.

Knight said that there is no systematic analysis of IRB’s to see how commonly such examples occur, but the stories pop up regularly.

Hyman added that IRB’s can have the effect of stifling research. Rejecting a study unfairly may lead to an upset researcher, while controversial research can result in lawsuits or a Congressional investigation. Simply weighing the costs on both sides causes institutions and administrators to err on the side of caution, he said.

— Paul D. Thacker

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Comments

Analysis of IRBs

It is probably true that there is no systematic analysis of IRBs. However, there is a special issue of the Journal of Applied Communication Research, volume 33, number 2, August 2005 dedicated to the topic of IRBs. It provides a useful starting point for further consideration of the problems of IRBs.

Michael W. Kramer, Professor and Chair at University of Missouri, at 11:00 am EDT on October 16, 2006

Empirical Research on IRBs

The well-founded call for empirical research has not gone unheeded. Recently, Joan Sieber, a well-known research ethics scholar, founded the Journal of Empirical Research on Human Research Ethics(see www.csueastbay.edu/JERHRE). With greater availability of empirical knowledge, perhaps IRBs will use that rather than regulatory power as a basis for developing procedures and reviews.

Karen A. Hegtvedt, Professor, Sociology at Emory University, at 12:50 pm EDT on October 16, 2006

IRB Creep

This is overdue attention to a serious problem. In addition to focusing on more examples of IRB behavior I would suggest focusing on the outcomes. All of those advocating continued IRB intrusion into research should be required to begin by answering Collins, Doll and Peto’s (1992) analysis. They stated regarding the UK/USA ISIS-2 trial:

“If the USA had recruited as fast as the UK then the trial would have ended six months earlier, and since the eventual ISIS-2 results have transformed medical practice. . . that six-month delay means that about 10,000 unnecessary deaths are directly due to whatever it was that slowed recruitment into ISIS-2 in the USA. Apart from consent procedures, all other aspects of the study were equivalent. It seems likely, therefore, that the US consent procedures were directly responsible for at least a few thousand unnecessary deaths, in the pursuit of “informed consent” that many doctors would consider inhumane” (p. 54)

My assumption is that this is but one of the negative outcomes caused by IRBs.

Collins, R., Doll, R., & Peto, R. (1992). Ethics of clinical trials. In C. J. Williams (Ed.), New treatments for cancer: Practical, ethical and legal problems. New York: John Wiley & Sons.

Gary Holden, at 12:55 pm EDT on October 16, 2006

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Research Review Boards Faulted

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Comments

Analysis of IRBs

Empirical Research on IRBs

IRB Creep

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