By Rosamond Rhodes Pages: 19-36
Contemporary research ethics policies started with reflection on the
atrocities perpetrated upon concentration camp inmates by Nazi doctors.
Apparently, as a consequence of that experience, the policies that now
guide human subject research focus on the protection of human subjects
by making informed consent the centerpiece of regulatory attention. I
take the choice of context for policy design, the initial prioritization
of informed consent, and several associated conceptual missteps, to
have set research ethics off in the wrong direction. The aim of this
paper is to sort out these confusions and their implications and to
offer instead a straightforward framework for considering the ethical
conduct of human subject research. In the course of this discussion I
clarify different senses of autonomy that have been confounded and
present more intelligible justifications for informed consent. I also
take issue with several of the now accepted dogmas that govern research
ethics. These include: the primacy of informed consent, the protection
of the vulnerable, the substitution of beneficence for research’s social
purpose, and the introduction of an untenable distinction between
innovation and research.
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