Rehabilitating Equipoise

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 p...

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Bibliographic Details
Published in:Kennedy Institute of Ethics journal 2003-06, Vol.13 (2), p.93-118
Main Authors: Miller, Paul B, Weijer, Charles
Format: Article
Language:English
Subjects:
Bioethics
Clinical medicine
Clinical trials
Dissent and Disputes
Ethics
Ethics Committees, Research
Ethics, Medical
Ethics, Research
Experimentation on humans
Humans
Informed consent
Medical research
Medical sector
Patient Selection - ethics
Patients
Personal grooming
Physician and patient
Physician-Patient Relations
Physicians
Placebos
Randomized Controlled Trials as Topic - ethics
Research Design
Research ethics
Uncertainty
United States
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Summary: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 this way, FE and CE are not necessarily competing notions, but rather address complementary moral concerns.
ISSN:1054-6863
1086-3249
1086-3249
DOI:10.1353/ken.2003.0014