title: Trust based obligations of the state and physician-researchers to patient-subjects.
abstract: 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.
authors.affiliation: Department of Philosophy, University of Toronto, Ontario, Canada.
authors.forename: P B
authors.initials: PB
authors.lastname: Miller
authors.forename: C
authors.initials: C
authors.lastname: Weijer
mesh_terms: D026686:Beneficence; D028744:Ethics Committees, Research; D032984:Ethics, Research; D033161:Government Regulation; D006801:Humans; D007600:Judgment; D028681:Moral Obligations; D010344:Patient Advocacy / Q000941:ethics; D018579:Patient Selection / Q000941:ethics*; D016032:Randomized Controlled Trials as Topic / Q000941:ethics / Q000592:standards; D012108:Research Personnel / Q000941:ethics; D035844:Researcher-Subject Relations; D035502:Trust