I am a surgeon, mother, daughter, researcher, and ethicist. These multiple roles dancing together to a more discordant tune amid this unprecedented time. The “daughter” has managed to convince her ageing parents that they really ought to not leave the house and that she will step in to accommodate their needs. Simultaneously, the “surgeon” is surprised when her 80-year-old mother, Layla, relays that she received a phone call telling her she needs to present to the hospital for some tests. Those tests, the “ethicist” realized were actually additional screening bloodwork for a study Layla was being enrolled in regarding an anti-amyloid agent for mild cognitive dysfunction. “This must be a misunderstanding” the “researcher” thought, as hospital directives have halted all non-essential research, as evident in her own hospital. Either way the “daughter” says: “No way. You are not going and how are you supposed to get there?” Layla had been told that in an effort to limit contact with the public, she should take an Uber. After clarifying with the study coordinator it was concluded that the request to present at the hospital to engage in the continuation of a clinical trial was not a mistake. As a surgeon, mother, daughter, researcher, and ethicist, I’m tasked with navigating this unchartered territory.
The recently published JAMA article “Preserving Clinical Trial Integrity During the Coronavirus Pandemic” addresses many issues of importance regarding research, which is being threatened by the pandemic. The authors share the benefits of continuing clinical trials, including: preservation of invested resources, the devoted effort and time of participants, the potential to help numerous individuals, and the integral role of research in improving health and preventing disability. The authors balance the risks and benefits of continuing clinical trials. The idea that “ongoing trials have potential to benefit millions of people with debilitating chronic diseases long after the coronavirus pandemic has ended” resonates strongly. Thus, unintended consequences of actions that arise during the pandemic require consideration, including the risks of altering or halting research.
I can’t sleep. I’m upset that the timelines for this study have not changed and I worry about my obligation to inform others. While managing obligations to my work and my now daycareless children, I have the additional difficult task of undoing the blasé suggestion to my parents by a medical professional, that taking an Uber is safe. Despite the fact that I engage in research, which inherently involves potential unknown risks, I’m disappointed that those in charge of the study feel that any degree of risk is acceptable for my family. Moreover, if my mother is no longer allowed in the trial because I have questioned these things, she has no chance of getting the promising study drug. Might I be the cause of her future demise, or have to trade in her present safety?
Even Drs. McDermott and Newman advance their reasoning with the comment that trials may “provide [the patient’s] only hope of survival.” However, the authors’ reasoning illustrates that acting with the interests of a clinician while simultaneously acting with the interests of a researcher leads to role conflict. The goal of clinical medicine is to treat, to cure, and to attain goals of care. Conversely, the goal of research is not treatment, but rather the generation of knowledge. Failure to appreciate this difference is deemed therapeutic misconception. When clinical equipoise exists, participants should not be enrolled in trials with an expectation, by patient or researcher, of a therapeutic outcome. Furthermore, truly informed research participants understand and accept the known and unknown risks of participation, even if they remain optimistic about a particular therapy. So, while the continuation of clinical trials may be crucial amidst the pandemic, it is flawed to justify continuation on the grounds that a study may be a patient’s last treatment option. Therapeutic misconception lies at the heart of role conflict, leading to a deficiency in the professional responsibility of researchers.
I call a friend. He has more objectivity by being removed from the study subject. He reminds me that research is not meant to be for the study participant. He reminds me research is supposed to be on hold right now. He reminds me that I’m only trying to protect my parents and that staying at home is the best way to do so. He reminds me that she may not get the drug of interest in a randomized control trial. So the solution becomes clear. As a surgeon, mother, daughter, researcher, and ethicist, I withdraw her from the study.
Engaging in multiple roles has value. The daughter-clinician can empathize better with a daughter caring for her elderly parent. The ethicist-clinician can share an honest lens towards the provision of equitable care. The researcher-clinician can understand the impact of research on clinical medicine with a passionate foundation. Multiple roles that each of us hold make us better, more successful, and compassionate physicians. The goal should not be to hang these hats on the top shelf of a dusty closet, but rather to be aware of biases we hold, whether they are neutral, negative, or positive. Amid this pandemic, as treatments and elective surgeries are curtailed, individuals might feel obliged to turn to clinical trials to obtain treatment. It is a physician’s duty, now more than ever, to make the morally obligatory distinction between care and research, and to first, do no harm.
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