Rules on protecting people in social and behavioral studies need to be revised, says US panel

BMJ 2014; 348 doi: (Published 10 January 2014) Cite this as: BMJ 2014;348:g147
  1. Michael McCarthy
  1. 1Seattle

Current rules governing research involving human participants in the United States should be revised to take into account the differences between risks posed by biomedical research and those posed by most social and behavioral research studies, says an expert panel convened by the National Research Council.

The council commissioned the panel to advise the Department of Health and Human Services, which is currently updating the Federal Policy for the Protection of Human Subjects, the regulation that governs human research in the US and that is often referred to as the “Common Rule.”

The revisions suggested by the panel would cover research typically conducted in such fields as anthropology, cognitive sciences, political science, psychology, social work, and health services research.

The study was supported by the Bill and Melinda Gates Foundation, the Alfred P Sloan Foundation, and the National Academy of Education. Susan Fiske, professor of psychology and public affairs at Princeton University, chaired the panel.

Unlike biomedical research, which can often pose a risk of physical harm to study participants, social and behavioral studies, although they may pose a risk of psychological harm or harm resulting from the release of damaging information, rarely pose a risk of physical harm, the panel noted. Nevertheless, current regulations demand the same standard of review and regulatory oversight for social and behavioral sciences, posing a substantial and unnecessary burden to researchers in these fields, the panel said.

In its report the panel called on the Department of Health and Human Services to redefine “human subjects research” as research involving “direct interaction or intervention with a living individual or that involves obtaining identifiable private information about an individual.”1

Only research that fitted that definition should be regulated by the Common Rule and be subject to oversight by an institutional review board, the panel said.

Research that was based on “publicly available information, information in the public domain, or information that can be observed in public contexts . . . whether or not the information is identifiable, as long as individuals whose information is obtained have no reasonable expectation of privacy” should not be considered human subjects research under this new definition, the panel said.

Social or behavioral research that did fall under the new definition should be put into one of three categories: excused research, expedited review, or full review, the panel said.

Research would qualify as “excused” if the only risk it posed was that personally identifiable information might be disclosed and the risk of harm from the disclosure would be minimal. Minimal risks would be defined as those in which “the probability and magnitude of physical or psychological harm does not exceed that which is ordinarily encountered in daily life or in the routine medical, psychological, or educational examinations, tests, or procedures of the general population,” the panel said.

“For example, a community-based translational study examining the efficacy of two standard grief counseling techniques for elderly widows and widowers may pose no greater risks than procedures currently available to this population and should be classified as minimal risk,” the panel said.

Because most social and behavioral research posed such minimal risks, most studies in these fields would fall into the category of “excused” research and would not require approval by an institutional review board, the panel said.

Investigators conducting such studies would be required only to register with an institutional review board, to describe the study consent procedures, and to submit a data protection plan. A random sample of excused studies would be routinely audited to assure compliance.

Studies that had greater potential for causing harm but whose risk could be minimized by adopting additional procedures should qualify for “expedited” review by an institutional review board that should take no more than two weeks, the panel said.

In the “rare instances” when social or behavioral research posed a greater than minimal risk, such as when an intervention might exacerbate symptoms in people with serious mental health disorders—for example, exposure therapy for patients with severe phobias—full review should be required, the panel said.

The panel also called for changes in the requirements for informed consent that would “emphasize the consent process over documentation.” These changes would include greater flexibility in the wording of consent documents that would be more appropriate for social and behavioral research.

The panel wrote, “Given the diversity of participants with respect to cultural, educational, and mental health, and developmental levels, a standard informed consent form seems unlikely to improve participant comprehension of consent in practice. Social and behavioral research involves many research contexts and many different populations—and therefore many different specific requirements for informed consent.”

Researchers should also be given greater latitude to explain studies to participants orally and obtain their oral consent. Such flexibility would be appropriate when working with people with limited reading ability, those for whom English was a second language, those with minor cognitive deficits, or those who lived in dangerous environments where documentation of their participation might put them in physical danger, the panel said.


Cite this as: BMJ 2014;348:g147


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