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Protecting Participants and Facilitating Social and Behavioral Sciences Research
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THE U.S. SYSTEM for protecting people who volunteer to partic- ipate in research is widely perceived to need improvement. A major concern is that the linchpins of the protection system— institutional review boards (IRBs)—are overloaded and underfunded and so may not be able to adequately protect participants from harm in high-risk research, such as clinical trials of experimental drugs. Three other concerns—often voiced about research in the social, behavioral, and economic sciences (SBES), but generally applicable to human participant protection—are important. The first is that the re- view process too often focuses on documenting consent to participate in research so as to satisfy the letter of federal requirements, when IRBs and researchers instead need to focus on developing the most effective processes for helping individuals reach an informed, volun- tary decision about participation. The second concern is that IRBs, re- searchers, and the entire human participant protection system may pay too little attention to the challenge of countering increasing threats to the confidentiality of research data because of technological and other changes, such as the ability to readily access and link large databases through the Internet. The third concern is that the review process may delay research or impair the integrity of research designs, without nec- essarily improving participant protection, because the type of review is not commensurate with risk—for example, full board review for minimal-risk research that uses such methods as surveys, structured interviews, participant observation, laboratory experiments, and analyses of existing data.
Constance F. Citro, Daniel R. Ilgen, and Cora B. Marret - Personal Name
0-309-51136-4
NONE
Management
English
2003
1-277
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