While innovation in surgery takes many forms—from novel devices to new approaches in treatment—there are common ethical considerations that should inform how these advances are introduced into patient care.
In yesterday’s Ethics of Surgical Innovation session, panelists discussed the complex ethical issues regarding xenotransplantation and best practices for managing the challenges related to conflicts of interest in other areas of notable advancements in surgery.
“There are a number of ethical issues that arise in xenotransplantation,” said Douglas W. Hanto, MD, PhD, FACS, co-chair of the Surgical Ethics Working Group at Harvard Medical School Center for Bioethics in Boston, Massachusetts. “Is it acceptable for humans to use other animals as a source of organs for transplantation? And how do we address the disagreement within segments of our population?”
Other ethical considerations tethered to these procedures include public health concerns (risk of transmission of animal infections); patient selection (who will be selected and by whom?); and informed consent.
Informed consent for these procedures must comprise the elements of disclosure, understanding, voluntariness, competence, and written consent.
“One area of informed consent that creates unique conflicts for xenograft recipients is voluntariness, [which typically states that] consent must be voluntary, free of coercion, free of any promises of benefits unlikely to result from participation, and the ability to withdraw from the study without penalty at any time,” explained Dr. Hanto.
James D. Geiger, MD, FACS, professor of surgery at Nationwide Children’s Hospital in Toledo, Ohio, presented the inventor’s perspective regarding conflicts of interest. “Conflicts of interest policies should optimize innovation. We should avoid reactionary rules based on one bad actor,” said Dr. Geiger, calling for increased support for inventors rather than “policing” them.
He said “full transparency is critical” regarding potential conflicts of interest, and he called for a change in terminology to avoid negative implications. “There's been some talk by institutions of medicine and others to use a term like ‘confluence.’ I'm not sure what the proper terminology is—but I think we have to watch this.”
Panelists also outlined foundational principles for biomedical ethics, including respect for autonomy, beneficence, nonmaleficence, and justice.
“Where does justice fit in all of this?” asked Richard I. Whyte, MD, MBA, vice-chair of the Department of Surgery at Beth Israel Deaconess Medical Center and professor of surgery at Harvard Medical School, both in Boston, Massachusetts. “Because what is fair to one person may not be fair to another…given the uneven access to healthcare in the US and unequal levels of trust in the medical establishment.”
Clinical investigators should continue to monitor the ongoing evolution of ethical considerations within the domain of innovation, according to session panelists, but resist losing sight of the importance of this work.
“It’s a noble cause, and the path can be difficult—but there’s plenty of joy along the way,” noted Dr. Geiger.
