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Justifying Investigator/Clinician Consent When The Physician-Patient Relationship Can Support Better Research Decision-Making

Morain, Joffe, and Largent offer a compelling analysis supported by the limited existing empirical data to argue that, in some circumstances, it is ethical for physicianinvestigators to seek consent from patients for whom they are providing clinical care (Morain, Joffe, and Largent 2019). They note limitations to the three primary concerns of creating role conflict, compromising voluntariness, and promoting the therapeutic misconception and suggest that consent by physician-investigators for their own patients can be acceptable in some circumstances. We find their thoughtful analysis compelling, as it is consistent with our view that precluding consent by clinicians who are both the treating physician and the investigator is an outdated shibboleth (Shah et al. 2015). Our view is motivated by data about patient preferences to have their physician facilitate decision making about research participation, based on their trust in their physician and the physician’s familiarity with their medical and personal narrative (Cho et al. 2015; Kelley et al. 2015; Kraft et al. 2017a). Morain, Joffe, and Largent also offer pragmatic suggestions to mitigate ethical concerns by using approaches developed for addressing conflicts of interest, including having (1) a “cooling off” period, (2) access to a neutral third party, and (3) a different team member obtaining the signature. When feasible in a particular clinical and research context, these are very good suggestions, especially when there are significant concerns about comprehension and voluntariness, even if these three approaches are not necessary in all circumstances of investigator/clinician consent. Morain, Joffe, and Largent label the challenge created by the consenting individual being both a treating physician and an investigator as a problem of “dual-role consent.” While this descriptive label makes intuitive sense in the context of a focused discussion of this issue, the label itself is vague and offers little information by itself. It is not clear which roles are being referred to, just that there are two roles. Further, this label can evoke thoughts of “dual-use” research, which is also vague and is a label that aims to problematize the duality between altruistic and malicious use of knowledge and research materials (National Academies of Sciences, Engineering, and Medicine 2017). We therefore use our preferred term of investigator/clinician consent. More deliberation on the label may be warranted, but investigator/clinician consent provides additional clarity about the roles at issue and allows for better understanding by those not embedded in the field of informed consent. Further, while this is framed as a consent issue, as the authors acknowledge, the process extends from recruitment to enrollment, which may or may not even include using a consent form. In the comments that follow, we use consent to refer to the process from initial recruitment to enrollment. While we concur with the overall analysis by Morain, Joffe, and Largent, we conclude that investigator/clinician consent may even be acceptable, if not preferable, when trials appear to deviate from clinical care. The relationship between an investigator/clinician and a patient may support improved research-related decision making. All individuals, regardless of their role, must consider how best to leverage those trusting and respectful relationships to promote comprehension and voluntariness.