Phase 1 drug trials-first-in-human tests of new pharmaceuticals- are necessary for FDA approval, and healthy volunteers are necessary to conduct those trials. Bioethicists are rightly concerned with the morally problematic aspects of these trials: Are risks and benefits balanced? Are would-be volunteers sufficiently informed, and have they given proper consent? But these are not the only, or even the most worrisome, ethical problems with Phase 1 research. In Adverse Events (2020), Jill Fisher looks beyond these ordinary bioethical concerns to the moral complications associated with the motivations of healthy volunteers and the demands of the everyday work of running those trials. Her work is the latest example of a much needed "second bioethics." Unlike the "first bioethics," this approach views health-care institutions from the outside, examining the structural and organizational sources that generate the ethical quandaries bioethicists are called upon to mediate and the ethical problems they often fail to see. Adverse Events makes clear that the moral problems of medicine can only be addressed by supporting bioethics of both types-the first and the second.
Citation
Raymond De Vries. A Tale of Two Bioethics. Perspectives in biology and medicine. 2022;65(1):133-142
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PMID: 35307706
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