(in The Future of Human Subjects Research, Cambridge: The MIT Press, 2014, Forthcoming)
27 Pages Posted: 15 Oct 2012 Last revised: 16 Oct 2012
Date Written: October 14, 2012
Critics of Institutional Review Board practices often base their charges on the claim that IRB review began with and is premised upon a "medical model" of research, and hence a "medical model" of risk. Based on this claim, they charge that IRB review, especially in the social and behavioral sciences, has experienced "mission creep". This paper argues that this line of critique is fundamentally misguided. While it remains unclear what critics mean by "medical model", the point of contemporary human research subjects regulation remains the same across all domains of research. That point is to protect the autonomy of human subjects, primarily through the use of informed consent. In fields as different as biomedical self-experimentation and ethnography there is the danger of losing sight of subjects' autonomy. Critiques of the so-called medical model are sometimes libertarian and sometimes utilitarian in spirit. Either way, such critiques have not yet demonstrated that these philosophical schools of thought have the resources to guard against the potential risk of harm that lexically prioritizing the autonomy of human subjects does. Precisely because IRB review recognizes that human subjects research occurs in different fields using different research methods, IRB review requires researchers to explain their particular methods, the particular risks of harm created by these methods, and the implementation of procedures by which subjects may autonomously consent to precisely those risks.
Keywords: Institutional Review Board, IRB, The Common Rule, autonomy, human rights, utilitarianism, libertarianism, medical research, ethnography, Nuremberg Trials
Suggested Citation: Suggested Citation
Feldman, Heidi Li, What's Right about the Medical Model in Human Subjects Research Regulation (October 14, 2012). (in The Future of Human Subjects Research, Cambridge: The MIT Press, 2014, Forthcoming); Georgetown Public Law Research Paper No. 12-151. Available at SSRN: https://ssrn.com/abstract=2161624