Protecting Human Beings: Institutional Review Boards and Social Science Research
This report was prepared by the staff of the Association following meetings in November 1999 and May 2000 with representatives of the American Anthropological Association, the American Historical Association, the American Political Science Association, the American Sociological Association, the Oral History Association, and the Organization of American Historians to consider the experiences of social scientists and scholars in other academic disciplines whose research is subject to the government's rules for protecting human beings. The AAUP's Committee A on Academic Freedom and Tenure has approved publication of the report with an invitation for comments.
This report is about the government's rules for protecting human beings who are the subjects of social science research.1 These rules and the mechanisms for implementing them have been in place, in one form or another, for more than thirty years. They are a permanent feature of research institutions in the United States, and there are clear signs that their influence is expanding.
The government's system for regulating research involving human subjects was born out of fear that researchers might, whether wittingly or not, physically or mentally injure the human beings that they study. The government's system is meant, therefore, to limit professional choice insofar as it might otherwise result in harm to human subjects. In pursuit of this aim, the government imposes a regulatory burden on research institutions and their individual researchers. Whether the burden is reasonable depends upon several considerations, not the least of which is the application of the government's rules to disparate academic fields of study, each with its own concepts and methods of research and standards of professional responsibility.
The report is addressed both to researchers in the social sciences and to those individuals in research institutions who are responsible for implementing the government's regulations. To some degree these categories overlap, most clearly when researchers serve on local committees that determine if a proposed project satisfies the government's requirements. The report rests on the assumption that researchers in their several capacities and administrative officers can benefit from more and better information about the government's evolving regulations and the challenge of applying them fairly and effectively to the social sciences.
This report is in four parts. Part I, an overview of concerns about the government's regulations, describes the concerns of social scientists that institutional review boards (IRBs) go too far in regulating their research, but also draws attention to the concerns of those critics of IRBs who believe that their authority must be expanded.
Part II, a preliminary section on IRBs and academic freedom, considers whether the government's system for regulating human-subject research itself violates the freedom of researchers to plan and carry out their projects as they deem appropriate.
Part III, the longest section of the report, describes and evaluates the government's regulations for protecting the human subjects of research and how they have been applied to the work of social scientists. The section includes comment on what needs to be done to improve the functioning of campus IRBs with respect to social science research.
Part IV draws conclusions and offers them in the form of recommendations. The report's central conclusion is that IRBs, in carrying out their responsibilities, too often mistakenly apply standards of clinical and biomedical research to social science research, to the detriment of the latter; its central recommendation is that IRBs can and should do more to take into account the pluralistic nature of academic research that is subject to their review.
I. Concerns About IRBs
In 1991, the U.S. Department of Health and Human Services (HHS) issued a set of revised regulations for protecting the rights and welfare of human-research subjects. …