Exploring the complexity of protecting human subjects in social and behavioral research

by David R. Van Houten, MS, research integrity advocate

During PRIM&R’s Best Practices for Assessing Risk in Social and Behavioral Research webinar, Jeffrey M. Cohen, PhD, CIP, CEO of HRP Consulting Group, Inc., discussed challenges for institutional review boards (IRBs) charged with reviewing social and behavioral research.

While human research protections is complicated across all areas of research, the presentation served to illuminate the complexities associated with protecting human subjects in social and behavioral studies. In his presentation, Dr. Cohen pointed out that IRB responsibilities include identifying and assessing risk to human subjects—an area he feels is often misunderstood. Drawing upon his own experience in the field, he shared an organized and clear approach to understanding and assessing risk to human subjects.

The webinar also emphasized that it is important to understand that risk is not the same as harm, but rather it is the possibility of harm. Risk has two components: (1) the probability or likelihood that harm will occur and (2) the magnitude of the potential harm. For instance, the risk to subjects may be higher in a study where harm of low magnitude is very likely to occur than in a study where the potential harm is of greater magnitude but less likely to occur. There is no specific formula for assessing these components, especially in social and behavioral research, but it is the IRB’s responsibility to ask about both the magnitude and likelihood of possible harms.

Dr. Cohen continued by applying this framework to the protection of subjects in a social and behavioral research study. The case study that he presented—a survey of youth on the street—provided an on-target example for those with little experience in social and behavioral research. In this instance, the IRB must consider that the study population faces a great deal of risk throughout their day-to-day lives, and ask how much their participation in the research might increase the existing risks they face, in order to determine if the study is minimal risk.

The webinar also highlighted the fact that few social and behavioral research studies include risks of physical harm. Thus, the IRB is compelled to identify the risk of psychological harm. Psychological harm can often manifest itself months or years after participating in research. This can present a challenge and require specific knowledge of social and psychological risk on the IRB, which are more subjective and come with less empirical evidence than those encountered in biomedical research. In order to assess this type of research, the IRB should include among its members specialists with training and experience in the area of psychological harm.

Considering that social and behavioral research can also be an important component of biomedical research protocols, this webinar is a valuable resource for all professionals involved with human subjects research.

Interested in checking out this webinar? The archive for Best Practices for Assessing Risk in Social and Behavioral Research is available for purchase.