Consider this seemingly innocent, straightforward question: “Would you be interested in participating in a clinical trial?” Now consider the ethical implications if a surgeon asks his or her own patient the same question.
Timothy M. Pawlik, MD, PhD, MPH, co-authored ethical guidance for surgeons who also are clinical researchers.1 “As surgeons get more involved in clinical trials, it’s helpful to be familiar with the various ethical considerations,” says Pawlik, chair of the department of surgery at The Ohio State University Wexner Medical Center.
One ethical issue involves the study itself. “We want to be asking robust, worthwhile questions, where there is equipoise in the medical community, which have real implications to potentially improve the care provided to patients,” Pawlik says.
Surgeons may believe Treatment A is a little better than Treatment B. However, in the medical community overall, there may be uncertainty on which therapy is best, so the question is important enough to study. How to approach the patient is another ethical consideration. “It can be a tricky business,” Pawlik admits.
Clinicians’ primary obligation is the patient’s well-being. If the surgeon also is a researcher, the patient’s care “must always come first,” Pawlik stresses.
Just as with any clinical trial, patients have the right to fully understand the purpose of the study, any potential risks and benefits, that they can discontinue participation at any time, and whether there is any possibility of personal benefit. However, those informed consent discussions are more ethically challenging if the surgeon is directly involved in the trial. “You can have consent that is not well-informed — or you can have a very informed patient who doesn’t consent,” Pawlik explains.
For the surgeon/researcher, the focus should be more on fully informing the patient, and less on whether consent is ultimately obtained. Discussions should reassure the patient there will be no adverse effects on care or the relationship with the surgeon. “That takes a lot of work and effort,” Pawlik acknowledges.
Ideally, the surgeon is not the one asking for consent, since some patients might agree just to please their provider.
“Having a third party who’s knowledgeable about the trial be the one to obtain consent can maintain objectivity,” Pawlik says.
Surgeons should not be involved personally in enrolling patients into a clinical research study, according to Christian J. Vercler, MD, co-chief of the clinical ethics service at the University of Michigan Center for Bioethics and Social Services in Medicine. “The surgeon/patient relationship is fiduciary, and it needs to be, in order to account for the inherent power imbalance between patient and surgeon,” Vercler explains.2
It is the surgeon’s responsibility to put the interests of the patient ahead of other interests, including recruiting people for a clinical trial. “The goal of research is to create generalizable knowledge, and the goal of an operation is to improve the patient’s condition,” Vercler says.
The patient must trust the surgeon, and that trust is warranted when the surgeon maintains the prioritization of the patient over other competing interests. “The patient’s trust of the surgeon to competently perform an operation may be —inappropriately — projected onto the research endeavor,” Vercler explains.
Patients might feel unable to decline the request to consent to a clinical trial if their surgeon asks, someone they trusted to operate on them. “For surgeons to personally ask their patients to participate in a clinical trial would be coercive,” Vercler argues.
The ethical solution, says Vercler, is to separate the consent processes for the operation and for the clinical trial. Research personnel can secure consent for the clinical trial instead of the surgeon. “Even the presence of the surgeon in the room during the consent for research participation could be unduly influential,” Vercler warns.
To fully respect the patient’s autonomy, surgeons should avoid interactions that could be considered coercive. “Improvisation and innovation in surgery that occur on an ad hoc basis is still aimed to satisfy the best interests of the patient,” Vercler notes.
In contrast, clinical research is conducted when equipoise exists and further data are needed to answer a clinical question. Patients cannot be expected to sort all this out and understand the goals of surgeon-as-researcher are different than the goals of the surgeon who is providing clinical care. “This is why it is essential to disentangle the roles of the surgeon in each situation,” Vercler offers.
REFERENCES
1. Pawlik TM, Schwartz TA, Itani KMF. Practical guide to ethical considerations in clinical trials in surgery. JAMA Surg 2022; Oct 26. doi: 10.1001/jamasurg.2022.4895. [Online ahead of print].
2. Vercler CJ. Surgical ethics: surgical virtue and more. Narrat Inq Bioeth 2015;5:45-51.
Consider this seemingly innocent, straightforward question: “Would you be interested in participating in a clinical trial?” Now consider the ethical implications if a surgeon asks his or her own patient the same question.
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