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Commentary 2: Therapeutic Mis-Estimation and Fulfilling the Obligation to Treat Research Subjects with Respect

The authors present four important ethical issues arising from their social science research focusing on informed consent during a study of “personalized” (precision) medicine: the patient did not understand the aims of the clinical research; the patient had high hopes of direct benefit; he viewed the authors as providing a counseling function; and the patient seemed to not want to exercise his right to selfdetermination. Let me address each issue in turn. First, the patient did not understand the aims insofar as he appeared to view the study as involving personal medical care, and thus was subject to a therapeutic misconception. The previous commentary describes well the general problem of a therapeutic misconception. Notably, when steps to more clearly separate the medical care team from the research team are taken, they are likely to decrease the problem of therapeutic misconception (Henderson et al., 2007; Jefford & Moore, 2008; Kim et al., 2015). However, while therapeutic misconception can be reduced, a more pernicious and difficult to solve problem is that of therapeutic misestimation in which the patient understands that he is in a study that does not aim to provide him a personal medical benefit but still has high hopes that he will incidentally benefit (Horng & Grady, 2003). Mr. Keller, as the authors state as their second ethical problem, had high hopes for personal medical benefit (therapeutic misestimation). Even when steps such as those recommended by the first commentary are taken, such as having a well-trained third party carefully review the consent forms with research participants, the incidence of therapeutic misestimation stays high, in the range of 65% to 95% for participants (Pentz et al., 2012). This problem has been viewed as a result of cognitive biases that accompany unrealistic hope and other desperate emotional states common among patients who are seriously ill (Halpern, 2012). To address this recalcitrant problem, we recently held a national clinical trial leadership panel at the leading American research ethics conference “Public Responsibility in Medicine and Research [PRIMR]” in 2018. The five members included the former head of the U.S. President’s Commission on Bioethics, the current head of Clinical Trials Operations of the National Cancer Institute, the Director of Ethical and Regulatory Affairs of the National Cancer Institute, and two others. All five panel members agreed that we need a foundational change in the approach to informed consent with patients with serious cancers. One example of this change is that when people with advanced cancers are enrolled in phase 1/2 clinical trials they should be offered palliative care concurrently alongside the trial intervention. Note that in nonresearch settings life-extending medical treatment (such as the surgery Mr. Keller received for his cancer) and palliative care are increasingly offered concurrently. In the United States palliative care no longer implies that a person is dying, but rather that they need a team for support and comfort. The new recommendation generated by the PRIMR panel is that patients enrolled in phase 1/2 oncology trials should be offered concurrent palliative care. The question this raises in Mr. Keller’s case is that even though he was not even receiving an experimental treatment, but only donating tissue, does the research team have any responsibility to offer him some form of support to address his counseling needs? This question links to the third ethical issue the authors raise, which is that the patient sought support/counseling from them. This put the social science researchers in a very difficult position. On one hand, they felt empathy for this patient’s need for support given the difficulty of his treatment and of course of his underlying illness and serious prognosis. On the other hand, they define their study as nonparticipant research on patient–clinical researcher relationships, clearly conveying their obligation to not disturb those relationships to study them. They also have responsibilities to both treat the patient with respect and yet to work within the parameters set by the clinical research team. Given these tensions, the availability of a third party to provide Mr. Keller with counseling to help guide him through the medical maze would have been beneficial to both the patient and the researchers. 831589 JREXXX10.1177/1556264619831589bJournal of Empirical Research on Human Research EthicsHalpern research-article2019