Role Synergy Versus Role Conflict in Dual-Role Consent in Usual Care Trials

Abstract

The Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979) clearly differentiates research from clinical care, and provides the foundation for today’s human subjects research regulations. The basis of this distinction is the fundamental difference in goals of the two endeavors. Research is conducted to create generalizable knowledge for the benefit of future patients and society, whereas clinical care is practiced for the benefit of current, individual patients. Over the past decade, however, learning health systems have begun to blur the boundary between research and clinical care, turning to comparative effectiveness research in order to generate useful data about how well medical interventions work in a real-world setting. But existing regulations were not designed to address this type of research, and recent discussions highlight the need for an altered approach. One aspect of human subjects research regulations that is under evaluation for revision in comparative effectiveness research is the informed consent process. Modified methods for obtaining informed consent for comparative effectiveness studies have been proposed previously. Faden et al. (2014) suggested that in some such studies, patient consent should not be required. Kim and Miller (2014) recommended using a brief verbal consent, termed “integrated consent.” Wendler (2015) proposed a “targeted” consent process that supplements consent for standard care with information that highlights the differences between the standard care and the research. Dual-role consent, the focus of the article by Morain and colleagues (Morain et al. 2019), is a concept with unique ethical considerations. According to the Institute of Medicine (2009), dual-role consent is an example of a conflict of obligations wherein there is a tension between two competing primary obligations with equivalent weight (patient welfare and scientific truth). Others have argued that these competing obligations should have different weights, contending that a physician’s fiduciary obligation to his or her patient requires a hierarchical approach, where patient welfare trumps other values, including the scientific truth sought from clinical research (Kitsis 2009; Pellegrino 1992). When viewed from this perspective, in dual-role consent, the physician-investigator should consider the patient’s welfare as paramount. The authors propose that the more closely a clinical trial resembles usual care, the more acceptable or preferable it is to use dual-role consent. The term “usual care” trials encompasses a wide range of studies that fall under the umbrella of comparative effectiveness research. The assumption is that in usual care trials, clinical equipoise exists and there is lack of consensus among the professional community on whether one treatment is better than another (Freedman 1987). But usual care does not necessarily mean optimal care or even standard of care. Enrolling a patient in a study with a suboptimal usual care arm is ethically problematic. A survey of 34 stakeholders about the ethical challenges of pragmatic clinical trials reported a concern that the use of a suboptimal usual care comparator could compromise clinical equipoise (Kalkman et al. 2016). Morain and colleagues suggest that when clinical research approximates usual care, it is permissible or preferable for treating physicians to manage this internal tension, and to obtain consent for their own patients to participate in the research, asserting that role synergy better enables a physician investigator to obtain dual-role consent in usual care studies because this physician is more knowledgeable about a patient’s case. The example given is a trial comparing commonly used Food and Drug Administration (FDA)-approved antibiotics for the treatment of urinary tract infections, and the authors state that “patients are unlikely to have any preferences between the two treatment options.” However, this is a