Individual Autonomy and the Double-Blind Controlled Experiment: The Case of Desperate Volunteers

Abstract

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 ethics of randomised controlled trials from the perspectives of patients, the public, and healthcare professionals

“…Even when the patients were not desperate, they preferred a three way choice—that is, treatment A, treatment B, or trial of A versus B (J Marsden et al, unpublished data). The preference for wide availability even before licensing has been taken up by Minogue, who argued that by offering potentially lifesaving treatments only within the confines of a trial, patient autonomy is infringed and it is desperation that compels them to “consent.”32Logue, on the other hand, argued that although there are fewer options (either enter a trial or not), patient autonomy is not infringed, for limited choice is an inevitable part of everyday life 33…”

Transcranial magnetic stimulation: a historical evaluation and future prognosis of therapeutically relevant ethical concerns

“…As such, for many patients, rTMS became a ‘last hope’ intervention, which raises an ethical issue relevant to many young technologies: when a treatment population consists of desperate individuals willing to endure potentially unsafe procedures to obtain relief, an objective focus on potential signs of diminished autonomy as a result of neuropsychiatric illness, desperation or both, becomes doubly important. This is especially true when obtaining informed consent 24 25. This problem may be further aggravated by patients seeking and receiving misleading information via secondary sources such as the internet.…”

AIDS: Bioethics and public policy

“…Sharing of the active drug took place, the trial results arguably became less useful than they would have been, had patients not thought they were given a coercive offer. Philosophers have argued for (Minogue et al, 1995) and against (Arras, 1990) this interpretation, and depending on one's concept of justice one can take legitimately different views on this matter. With the relative success of anti-HIV medications in the last decade, this particular point may have become moot.…”