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Welfare Versus Autonomy in Human Subjects Research

46 Pages Posted: 9 Jul 2009 Last revised: 9 Feb 2014

Mark S. Stein

affiliation not provided to SSRN

Julian Savulescu

University of Oxford - Uehiro Centre for Practical Ethics

Date Written: July 8, 2009


Autonomy is commonly seen as a fundamental value that should guide the federal regulation of human subjects research. In this article, we argue that autonomy is compromised, and should be compromised, for the sake of the welfare of research subjects and the welfare of people who stand to benefit from medical research. Such a compromise of autonomy is evident in exceptions to the requirement of informed consent, including the exceptions for emergency research and minimal-risk research. Less obviously, the blind clinical trial inherently represents a compromise of autonomy, as subjects are offered medical treatment on the condition that they give up (1) the right to know what treatment they are receiving, and (2) the right to participate in decision-making about their treatment. While such an offer of treatment conditioned on a waiver of informed-consent rights does not contravene the libertarian conception of autonomy, it does contravene the liberal conception of autonomy that is now dominant in bioethics. Autonomy is also compromised, on both the liberal and libertarian accounts, when access to experimental drugs is limited in order to channel people who are seeking those drugs into clinical trials.

We endorse most of the ways in which the regulation of human subjects research compromises autonomy for the sake of welfare. We also suggest some ways in which autonomy should be further subordinated to welfare, especially in the selection of research subjects. Researchers should select subjects who present a more favorable risk/benefit ratio, even if those subjects are less able to give autonomous consent. The necessity for this rule is illustrated by the Gelsinger case. In that case, researchers initially sought to test a gene-therapy treatment on terminal infants. They were persuaded instead to test the treatment on adults with a mild form of the disease, since those adults could give fully autonomous consent. One young adult subject died as a result; he would not have died if autonomy had been properly subordinated to welfare.

Keywords: human subjects research, welfare, autonomy, informed consent, bioethics

Suggested Citation

Stein, Mark S. and Savulescu, Julian, Welfare Versus Autonomy in Human Subjects Research (July 8, 2009). Florida State University Law Review, Forthcoming. Available at SSRN:

Mark S. Stein (Contact Author)

affiliation not provided to SSRN ( email )

No Address Available

Julian Savulescu

University of Oxford - Uehiro Centre for Practical Ethics ( email )

10 Merton Street
Oxford OX1 3JP
United Kingdom
+44 1865 276926 (Phone)
+44 1865 276932 (Fax)


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