Conflicts of Interest and Recommendations for Clinical Treatments That Benefit Researchers

While financial conflicts of interest in both research and clinical care have received substantial attention, including recommendations for disclosure and management, they are not the only conflicts that are important to consider. Clinicians commonly balance conflicts in the practice of medicine—for example, balancing their commitment to their patients and obligations to their families as they make decisions about how much time to devote to clinical care. In a fee-for-service health system, clinicians also face conflicts when recommending medical interventions for patients. Researchers face conflicts when reviewing grant applications and manuscripts, as explicit and implicit biases can influence evaluations. More importantly, researchers’ own appraisals of data interpretation or their approach to enrolling participants can be motivated by self-interest. These conflicts are typically managed by a combination of disclosures, self-reflection, and oversight, which can mitigate but not eliminate the conflicts.

The conflicts become more complex when the roles of clinician and researcher intersect. Clinicians may design and conduct research to develop and improve clinical strategies with their own patients (such as COVID research in the intensive care unit), and in this context clinical care and research are inextricably intertwined. Oncology and surgery are two areas that have grappled with this dual-role conflict of provider and investigator for generations. This practice has subsequently improved clinical outcomes, but has not been without stories of exploitation and harm to patient-participants. The case described next takes place in a surgical oncology context, where the recommendation to proceed with a surgical procedure may be influenced by the surgeon’s interest in obtaining biospecimens for his or her research study. Marie E. Nicolini and Dave Wendler from the National Institutes of Health Clinical Center argue for careful oversight by institutional review boards (IRBs) to minimize these conflicts. The other two commentaries agree that oversight should play a role but articulate the importance of researchers being permitted to provide clinical care simultaneously. Daniel J. Benedetti and Alexander Langerman from Vanderbilt University emphasize the value to both current and future patients in allowing researchers to also provide clinical care. Raymond J. Hutchinson from the University of Michigan emphasizes the limitations of oversight and suggests that it is necessary to rely on the integrity and virtue of the clinician to navigate this conflict, to best serve patients’ interests.

CASE SUMMARY

A 70-year-old woman with advanced cancer meets with a surgeon to discuss a standard but risky surgery. The surgeon is also a researcher who is very interested in obtaining samples of the woman’s rare tumor for future studies. Previously, the woman consulted two other surgeons who advised against the surgery on the grounds that the potential benefits to her did not justify the high risks. However, this surgeon-researcher believes the surgery is indicated for the woman. He also explains that he hopes to retain samples of her tumor for future research. Based on the surgeon-researcher’s clinical recommendation, the woman decides to undergo the surgery and the surgeon-researcher obtains her informed consent.

The woman experiences some complications post surgery and a staff member calls an ethics consultation to discuss her case. The staff member wonders whether it is appropriate for clinical recommendations to be provided by individuals who have a research interest in the patient’s choice.

SPECIFIC QUESTIONS

Is it appropriate for researchers to obtain consent for their own studies?

Is this surgeon’s conflict of interest between pursuing his research and providing clinical advice to patients different from similar conflicts that arise in other studies?

Is this different from the conflicts of interest that arise in standard clinical care?

Should the institution take steps to try to mitigate this potential conflict of interest?