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

Journal of Medical Ethics 32 (9):542-547 (2006)
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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

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Charles Weijer
University of Western Ontario

Citations of this work

Scientific Research and the Public Trust.David B. Resnik - 2011 - Science and Engineering Ethics 17 (3):399-409.
Fiduciary Obligation in Clinical Research.Paul B. Miller & Charles Weijer - 2006 - Journal of Law, Medicine and Ethics 34 (2):424-440.
Government Policy Experiments and the Ethics of Randomization.Douglas MacKay - 2020 - Philosophy and Public Affairs 48 (4):319-352.
Fiduciary Obligation in Clinical Research.Paul B. Miller & Charles Weijer - 2006 - Journal of Law, Medicine and Ethics 34 (2):424-440.

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