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Trust-based Obligations of the State and Physician-researchers to Patient-subjects
Journal of Medical Ethics (2006)
  • Paul B. Miller, University of Toronto
  • Charles Weijer, The University of Western Ontario

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.

  • Research Ethics,
  • Moral Obligations,
  • Research Subjects,
  • Researcher-Subject Relations
Publication Date
September, 2006
Citation Information
Paul B. Miller and Charles Weijer. "Trust-based Obligations of the State and Physician-researchers to Patient-subjects" Journal of Medical Ethics Vol. 32 Iss. 9 (2006)
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