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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 relevant federal agencies. In that report we will address all three basic principles of protection for human research participants, as articulated in the Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). These principles, which apply to all research domains and to low-risk as well as high-risk protocols, include respect for persons (respecting the choices of autonomous individuals and protecting those who are immature or incapacitated); beneficence (minimizing harm and maximizing benefits); and justice (fairness in the selection of research participants with regard to the distribution of the burdens and benefits of research).
This letter provides the panel’s initial recommendations on four topics: protection of confidentiality of information obtained from human research participants; requirements for informed consent, particularly for advance written consent; procedures for determination of exempt research and for expedited review of low-risk research; and system-level issues, such as training of researchers and accreditation. The recommendations were developed from an SBES perspective. Some of them may pertain to biomedical research, but we do not make that judgement. Many of the recommendations have benefited from the work of other groups that are active in considering the protection of human participants in SBES research, such as the Behavioral and Social Science Working Group of the National Human Research Protections Advisory Committee4 and the National Science Foundation’s Social, Behavioral, and Economic Subcommittee for Human Subjects.5
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).