APS Observer

These phrases, uttered recently in Washington, DC, could be referring to a number of things: the latest in summer blockbuster movies, the 107th Congress, the upcoming football season.

Yet they refer to something far more important in the day-to-day work of a research psychologist: Institutional Review Boards, better known as IRBs. The current state of confusion and frustration that surrounds IRBs is cause for concern among scientists from all disciplines nationwide. While behavioral and social scientists share in those frustrations, they have a few more that are unique to the field.

At a recent meeting of the National Academy of Science's Panel on Institutional Review Boards, Surveys, and Social Science Research, the discussion reflected a growing concern over IRBs. The panel was formed by the Committee on National Statistics (CNSTAT) in collaboration with the Board on Behavioral, Cognitive and Sensory Sciences, and coordinating with the Institute of Medicine (IOM).

The panel is conducting an 18-month study, during which time it will review current and proposed methods of human subjects protection in social science data collection. The chief concern of the study is the structure, function, and performance of the IRB system that was put in place by the Department of Health and Human Service, largely to guide biomedical and clinical research, but that also affects social science researchers.

While IRBs play a pivotal role in the research process, many researchers would like to see them function more efficiently and more economically. For example, many propose a sort of "triage" system in which research proposals that include greater risk to participants are more closely scrutinized, and research involving little to no risk are handled more quickly. Also, an important aspect in IRB reform is avoiding the "pendulum effect," which occurs when all researchers end up in a sense being punished for the transgressions of others. For example, IRBs may become overly cautious when an experiment, even one at another institution, results in harm to a subject. Extreme situations produce reactions which can adversely affect a wide spectrum of research.

According to Barbara A. Spellman, APS Secretary and a research psychologist at the University of Virginia, there is a "climate of fear" when it comes to dealing with IRBs. Many APS members engage in minimal risk research, and accordingly, have cause for concern over the directions in which IRB review is moving.

Minimal risk research occurs, as defined by the Code of Federal Regulations (45 CFR 46.102(i)), when the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life, or during the performance of routine physical or psychological examinations. Of course, not all psychologists are engaged in minimal risk research. But if the simplest, full adult-consent, minimal-risk research cannot go forward smoothly with a green light from an IRB, says Spellman, what will happen to more complex proposals involving more sensitive topics?

Spellman also points out that although risk is generally different in psychological experiments than in biomedical experiments, many IRBs are not familiar with what constitutes risk in psychology. She is concerned that IRBs might apply the most onerous of standards of review to even the most innocuous of experiments, out of a disproportionate fear that their institution's research might be shut down as a result of the IRB's lapses. If this occurs, says Spellman, then their evaluations are not true to science and not true to the researcher. It is easy to see, given that no one on an IRB wants to be accused of being the least ethical member, how each evaluator can become more stringent than the previous, until nothing passes muster.

Of course, IRBs do not have the sole responsibility when it comes to protecting research subjects. In fact, investigators have the central role. But it is clear that the education of both investigators and IRB members is necessary if the two wish to function harmoniously. Psychologists' unique concerns stem from the fact that IRBs continue to use guidelines that were written with biomedical research in mind while reviewing experiments concerning behavioral science. APS is working to make sure that these concerns are addressed and to find ways to ensure that IRBs conduct appropriate review of behavioral and social science research.