Behavioral Science Working Group Looks at IRB Regulations

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

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

THIRD PARTIES

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.