When may a physician legitimately offer enrollment in
a randomized clinical trial (RCT) to her patient? Two answers to
this question have had a profound impact on the research ethics
literature. Equipoise, as originated by Charles Fried, which we term
Fried's equipoise (FE), stipulates that a physician may offer trial
enrollment to her patient only when the physician is genuinely uncertain
as to the preferred treatment. Clinical equipoise (CE), originated
by Benjamin Freedman, requires that there exist a state of honest,
professional disagreement in the community of expert practitioners as to
the preferred treatment. FE and CE are widely understood as competing
concepts. We argue that FE and CE offer separable and, in themselves,
incomplete justifications for the conduct of clinical trials. FE
articulates conditions under which the fiduciary duties of physician to
patient may be upheld in the conduct of research. CE sets out a standard
for the social approval of research by institutional review boards. Viewed
in this way, FE and CE are not necessarily competing notions, but rather
address complementary moral concerns.
Heated debate surrounds the question whether the relationship between physician‐researcher and patient‐subject is governed by a duty of care. Miller and Weijer argue that fiduciary law provides a strong legal foundation for this duty, and for articulating the terms of the relationship between physician‐researcher and patient‐subject.
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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