Behavioral Science Working Group Looks at IRB Regulations

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A federal advisory group is examining issues relating to the protection of human subjects in behavioral and social science research in order to provide input to a broader assessment of institutional review boards (IRB) and other elements in the human research protection system. Psychologists and others from the behavioral and social sciences disciplines have long been concerned that the current system of regulatory protections do not adequately reflect the aspects of their research that are distinct from biomedical research involving human subjects.

Formed in April, the Social and Behavioral Science working group is co-chaired by APS Fellow and Charter Member Felice Levine, executive director of the American Sociological Association, and psychologist Jeffrey Cohen, Director of the Division of Education of the Office of Human Research Protection.

The working group is looking at issues in three areas: 1) Public Use Data Files, 2) Risk and Harm, and 3) Third Parties.

PUBLIC USE DATA FILES

Because the definition of “public use data files” is not clear in the “Common Rule” (45 CFR 46, the federal regulation that governs research with human subjects), the working group’s task is difficult. Issues of confidentiality and consent – and the scope of IRB responsibility – come into play when allowing access to data for secondary analysis. Over the past two years, an increasing number of IRBs have sought to review proposals involving such data. But a problem arises when there are no guidelines for the review of the analysis of this data by an IRB. Should it be subject to review at all? If so, what should the parameters be for such review?

The working group’s objectives on this topic include a clearer definition of the term “public use data file,” and more guidance for IRBs on this issue. The group’s recommendations would not necessarily require a change in the federal regulations; they are intended to educate IRBs and others regarding the applicability of the Common Rule to social and behavioral science research and to ensure uniformity among IRBs in determining whether a data file contains identifiable information.

RISK AND HARM

Currently, minimal risk is defined in the Common Rule as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life.” It is the goal of the working group to clarify for IRBs concepts of minimal risk in the context of behavioral and social science research and to help ensure that this standard is applied correctly in reviewing proposals from these fields. IRBs often do not have the necessary expertise in these areas, which in turn means they can’t adequately judge issues of risk in such research

THIRD PARTIES

Third parties in research are individuals who are not participants, but are associated with the research through information provided about them by the human subjects. Researchers currently are obligated to ensure the confidentiality and privacy of data pertaining to third parties. Yet should they be considered human subjects, and afforded the same protections? What about issues of informed consent?

The Common Rule does not address third parties. In fact, no formal policy exists on whether third parties should be considered human subjects. The working group would like to see more emphasis placed on privacy protection, rather than the broadening the definition of “human subject” to include third parties. There is concern that IRB workload will increase dramatically if every third party is deemed a human subject, in which case informed consent, or a waiver, would be needed. This could affect the progress of research significantly.

The working group operates under the auspices of the National Human Research Protection Advisory Committee (NHRPAC), which is the advisory group for the Office of Human Research Protection, the lead federal entity for human subjects protection. The group is charged with making recommendations to NHRPAC that will enhance the operations of IRBs and the human subject protection system as it relates to behavioral and social sciences.

Levine and Cohen both have indicated that professional societies such as APS have an important role to play in achieving progress on these issues. Last June, Cohen met with a group of leading psychology researchers at the APS annual convention in Toronto to get their views on problems with IRBs and other elements of the human research protection system. In addition to working with professional societies, the group also has worked closely with a National Science Foundation subcommittee on human subject protection in the behavioral and social sciences.

Observer Vol.14, No.10 December, 2001

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