PubMed · 7110341
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J Wynn. 1982-09-16. Trials ahead.. https://doi.org/10.1038/299198b0
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This essay explores some concerns about the quality of informed consent in patients whose autonomy is diminished by fatal illness. It argues that patients with diminished autonomy cannot give free and voluntary consent, and that recruitment of such patients as subjects in human experimentation exploits their vulnerability in a morally objectionable way. Two options are given to overcome this objection: (i) recruit only those patients who desire to contribute to medical knowledge, rather than gain access to experimental treatment, or (ii) provide prospective subjects the choice to participate in standard double-blind study or receive the experimental treatment. Either option would guarantee that patients in desperate conditions are given a more meaningful choice and a richer freedom, and thus a higher quality of informed consent, than under standard randomized trials.
The randomization ingredient in double-blind controlled experiments may be objectionable to patients who, in their desperation, come to such trials seeking a last chance of cure. Minogue et al., who view such a situation as inherently exploitive and undermining of patient autonomy, propose that such "desperate volunteers" instead be enrolled in the active arm, while other patients, less desperate and more committed to medical progress, continue to be randomized. Their view is critiqued as destructive of medical progress, inappropriate in its lack of clinical response to such patients, and fatally flawed by unrealistic notions of autonomy and voluntariness.