This letter is written to provide input to your committee for use in your final report. It comments on issues of human participant protection in research in the domain of the social, behavioral, and economic sciences (SBES) and outside the domain of biomedical research. In fact, research methods are rarely unique to either domain, although some methods, such as interviews, are more typically used in SBES research than in biomedical research, while the reverse is true for other methods, such as double-blind experiments.3 Some of the differences between the two domains in research methods and in the frequency and nature of their use create issues of human participant protection for one domain that may receive less emphasis in the other. This letter provides an SBES perspective—on the assumption that your committee by design is more concerned with biomedical research.

In the letter we primarily address field, laboratory, and archival research conducted by such typical SBES methods as mail, telephone, and in-person surveys, structured interviews, participant observation, laboratory research, and other methods that ordinarily pose low risk to participants. By “low risk” we refer to the definition in federal regulations, namely, that a study has a low probability of causing physical, psychological, or economic harm to participants and that the nature of the harm is minimal and no more than is normally encountered in daily life (see the Common Rule, Title 45, Code of Federal Regulations (CFR), subpart A, sec 46.102i, revised June 18, 1991).

We focus on low-risk SBES research for two reasons. First, as your committee and our panel deliberated, it became clear that your group’s primary focus is on high-risk research, regardless of domain. Second, many of the concerns raised about the protection of human participants in SBES research relate to low-risk research. We do not imply thereby that SBES research is always low risk, nor that biomedical research is always—or even often—high risk. Studies of IRB operations report that high percentages of all types of research—biomedical, social, and psychological—are deemed to be low risk (Gray, Cooke, and Tannenbaum, 1978:1096; Bell, Whiton, and Connelly, 1998:20).

The final report at the conclusion of our work (planned for fall 2002) will discuss in more detail issues of defining risk and other aspects of ethical review of SBES research for a broad audience of IRBs, researchers, and

3  

For example, 49 percent and 59 percent of SBES research reviewed by a sample of university IRBs involved interviews or self-administered questionnaires, respectively, compared with 23 percent and 21 percent, respectively, of biomedical research. In contrast, 27 percent, 25 percent, and 21 percent of biomedical research involved invasive procedures, double-blind experiments, and placebo administration, respectively, compared with 3 percent, 3 percent, and 1 percent, respectively, of SBES research (Bell, Whiton, and Connelly, 1998:Fig. 8).



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