Author Affiliations: University of Missouri School of Law, Columbia (Dr Litton); and National Institutes of Health, Bethesda, Maryland (Dr Miller).
Evidence-based medicine prescribes that clinical practice should be guided by the results of rigorous research. The close connection between clinical research and patient care, coupled with the need for research to be conducted by physician-investigators with patients who participate in research (patient-participants), makes it difficult to appreciate how the ethical obligation of investigators differ from those of physicians. Moreover, clinical research creates ethical tensions by exposing patient-participants to risks of harm for the sake of generating scientific knowledge. This has been obscured and assuaged by the prominent tendency to view the ethics of clinical research through the lens of the patient-physician relationship.1 According to this therapeutic orientation, physician-investigators retain a fiduciary duty of loyalty to the medical best interests of patients, characteristic of clinical practice, in the context of conducting clinical research. In contrast, this fiduciary loyalty does not cohere with the socially valuable enterprise of clinical research. To be sure, researchers owe significant and extensive ethical obligation to patient-participants. However, the ethics of clinical practice does not provide an accurate account of the dual obligations of investigators to promote valuable science and protect human research participants.
Litton P, Miller FG. What Physician-Investigators Owe Patients Who Participate in Research. JAMA. 2010;304(13):1491-1492. doi:10.1001/jama.2010.1409