Gender Identity Politics, Human Subjects Issues, and the “Law of Unintended Consequences”
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Among the many fascinating aspects of her excellent historical study of the Conway-Bailey affair, Dreger provides a succinct and accurate overview of how human research protection programs are operated at universities and research institutes. The key element in all such programs is the research ethics committee for that institution, generically known as the Institutional Review Board (IRB). It is the IRB and its accompanying administrative office and staff that are responsible for approval and oversight of research involving human subjects.
One of the main charges against Bailey was that his book (TMWWBQ) was a research project involving unconsented subjects and research data gathered without a priori IRB review and approval. As Dreger accurately analyzed and concluded, this is an empty accusation without foundation or merit. First, Dreger outlines the various practical and regulatory considerations demonstrating that the Bailey book was notresearch (that is, not a systematic...
KeywordsOral History Human Subject Research Regulatory Oversight Human Research Protection Institutional Review Board Review
- Gunsalus, C. K., Bruner, E., Burbules, N., Dash, L. D., Finkin, M. W., Goldberg, J., et al. (2006). The Illinois white paper—improving the system for protecting human subjects: Counteracting IRB mission creep. University of Illinois Law & Economics Research Paper No. LE06-016. Available at SSRN: http://ssrn.com/abstract=902995.