MU Law Professor Contrasts Medical Research and Patient Care Ethics

November 2nd, 2010

The views and opinions expressed in this “for expert comment” release are based on research and/or opinions of the researcher(s) and/or faculty member(s) and do not reflect the University’s official stance.

COLUMBIA, Mo. ­­­– When doctors practice medicine in clinical settings, they are bound by the Hippocratic duty of loyalty to act in the medical best interests of each patient. Thus, when doctors prescribe a treatment, the potential benefits must outweigh the potential risks for each patient. But in medical research, subjects are often asked to assume a reasonable amount of risk to benefit others.

Paul Litton, associate professor in the University of Missouri School of Law and an expert in the ethics and law of human subjects research, recently argued in a medical journal article that the Hippocratic duty of loyalty to a patient’s best interest fails to characterize accurately the moral obligations owed by physicians to research participants. The distinct purpose of research requires and justifies a different set of extensive obligations.

“The purpose of research is not to maximize the best interests of research subjects,” Litton said. “It’s to produce scientifically valid results, generalizable knowledge that we can use to improve the health of future patients. Physicians conducting research must protect the welfare of participants, but many accepted aspects of research are incompatible with the Hippocratic ideal because they involve risk for the good of others.”

Enrolling in a research trial is often the best option for patients. For example, a patient with a life-threatening illness may have no real option in the medical care setting, and research could be their best hope. Nevertheless, even in such research situations, physicians often ask participants to assume some risks that are inconsistent with the Hippocratic duty of loyalty.

“For example, while a doctor in a clinical setting may tailor treatment to each individual patient, research requires controlled experimentation, which may require limiting treatments by experimental trial groups,” Litton said.

In addition, Litton and co-author Franklin G. Miller cite that research participants may be asked to assume the risk of physically invasive interventions, such as biopsies or imaging procedures, even though the interventions would not advance their best personal interests.

“While the Hippocratic duty of loyalty does not and should not apply to medical research, researchers do have extensive, substantial obligations to research participants,” Litton said. “Among other duties, physicians and researchers must not expose participants to unreasonable or unnecessary risks, exploit vulnerabilities and must monitor their well-being and respect their autonomy.”

Litton says that the federal regulations allow institutional review boards to approve research that exposes participants to some risk that is not in their individual best interest but is good for medical knowledge.

Litton’s article, “What Physician-Investigators Owe Patients Who Participate in Research”, was published in the Journal of the American Medical Association.