Trust based obligations of the state and physician-researchers to patient-subjects

• Published in: Journal of medical ethics Vol. 32; no. 9; pp. 542 - 547
• Main Authors: Miller, P B, Weijer, C
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group Ltd and Institute of Medical Ethics 01.09.2006; BMJ Publishing Group; BMJ Publishing Group Ltd; BMJ Publishing Group LTD; BMJ Group
• Subjects: Behavior; Beneficence; Clinical judgment; Clinical medicine; Clinical research; Clinical trials; Duty of care; Ethical aspects; Ethics; Ethics Committees, Research; Ethics, Research; Government Regulation; Humans; Judgment; Medical practice; Medical research; Medical treatment; Medicine, Experimental; Moral Obligations; Morality; Norms; Participation; Patient Advocacy - ethics; Patient Selection - ethics; Physician and patient; Physician-patient relations; Physicians; Preferences; Public good; randomised controlled trial; Randomized Controlled Trials as Topic - ethics; Randomized Controlled Trials as Topic - standards; RCT; REC; Research Ethics; research ethics committee; Research Personnel - ethics; Researcher-Subject Relations; Researchers; Studies; Trust; United States
• ISSN: 0306-6800; 1473-4257
• DOI: 10.1136/jme.2005.014670

When may a physician enroll a patient in clinical research? An adequate answer to this question requires clarification of trust-based obligations of the state and the physician-researcher respectively to the patient-subject. The state relies on the voluntarism of patient-subjects to advance the public interest in science. Accordingly, it is obligated to protect the agent-neutral interests of patient-subjects through promulgating standards that secure these interests. Component analysis is the only comprehensive and systematic specification of regulatory standards for benefit-harm evaluation by research ethics committees (RECs). Clinical equipoise, a standard in component analysis, ensures the treatment arms of a randomised control trial are consistent with competent medical care. It thus serves to protect agent-neutral welfare interests of the patient-subject. But REC review occurs prior to enrolment, highlighting the independent responsibility of the physician-researcher to protect the agent-relative welfare interests of the patient-subject. In a novel interpretation of the duty of care, we argue for a “clinical judgment principle” which requires the physician-researcher to exercise judgment in the interests of the patient-subject taking into account evidence on treatments and the patient-subject‘s circumstances.