Regulation and Education: The Role of the Institutional Review Board in Social Science Research

Abstract

Since its origin in the policy and regulation of the Department df Health, Education and Welfare (subsequently renamed the Department of Health and Human Services), the Institutional Review Board (IRB) has made consideration of the interests of human subjects an important and formal stage of social scientific research. 1 Social scientists are directly affected by the IRB in their roles as (1) investigators who must obtain IRB approval of research projects; and (2) potential IRB members who must review the research of professional colleagues. In this chapter, we discuss three major tasks confronting IRB members as they review research proposals: (1) identifying and evaluating risks to subject interests; (2) ensuring that subjects give their informed consent to research participation; and (3) structuring the review process to focus scarce IRB resources on the review and monitoring of proposals presenting the greatest risk. Then, we discuss the interaction between the IRB and the research community. We suggest several ways in which social scientists, as IRB members and as investigators, can improve the review process through more effective communication. Finally, we stress the importance of a vitalized educational role for the IRB. We focus on broad general problems of IRB functioning rather than on specific current regulatory or ethical issues such as those raised by the IRB recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 2 (1978) or by the 1981 Health and Human Services (HHS) regulations for IRBs, which deregu-lated certain kinds of social science research.