Bioethics Blogs

IRB Chair: "Nobody Really Knows" If IRBs Do Any Good

A former chair of the University of Wisconsin-Madison Education and Social/Behavioral Science IRB guesses that IRB review “most likely” protects subjects from harm, but concedes that “nobody really knows.” He also notes that that it consumes tens of thousands of hours of work, mostly by researchers, at his university each year.

[Kenneth R. Mayer, “Working through the Unworkable? The View from Inside an Institutional Review Board,” PS: Political Science & Politics 49, no. 02 (April 2016): 289–93, doi:10.1017/S1049096516000226.]

Real Questions

Kenneth Mayer raises some significant methodological and ethical challenges facing social scientists. For instance,

A PI proposed a study involving interviews with people who have been charged with a crime or are the target of a criminal investigation to discuss the activities that led to the charges or investigations. Should the IRB be concerned about the risk that participants could be subject to prosecution or hurt their ability to defend themselves if a district attorney demands the researcher’s notes? Is informed consent sufficient to address these risks?

and

How should we evaluate risks in a project that studies attitudes toward government in a country with an authoritarian regime? Can we rely on the proposition that people in those regimes understand the risks of criticizing their government and that those risks are therefore (in the Common Rule definition) “not greater in and of themselves than those ordinarily encountered in daily life” (45 CFR 102(j))?

Fake Answers

Unfortunately, Mayer’s IRB was not able to give clear answers to such questions. Rather, it offered its best guess about what to do, while acknowledging that “another IRB, quite reasonably, may have come to different conclusions.”

This practice marks Mayer and his colleagues as among those “well-meaning amateurs” identified by John Lantos, whose idiosyncratic decisions endanger research participants and research alike.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.