For and against: Clinical equipoise and not the uncertainty principle is the moral underpinning of the randomised controlled trial  FOR  AGAINST

doi:10.1136/bmj.321.7263.756

BMJ 2000;321:756-758 ( 23 September )

Education and debate

For and against

Clinical equipoise and not the uncertainty principle is the moral underpinning of the randomised controlled trial

FOR

AGAINST

Clinical equipoise and not the uncertainty principle is the moral underpinning of the randomised controlled trial

The first 150 words of the full text of this article appear below.

The ethical basis for entering patients in randomised controlled trials is under debate. Some doctors espouse the uncertaintyprinciple whereby randomisation to treatment is acceptable whenan individual doctor is genuinely unsure which treatment is bestfor a patient. Others believe that clinical equipoise, reflectingcollective professional uncertainty over treatment, is the soundestethical criterion. Here doctors from two Canadian centres discusstheirpositions.

Charles Weijer, assistant professor of medicine, ^a Stanley H Shapiro, professor, ^b Kathleen Cranley Glass, assistant professor. ^c

^a Department of Bioethics, Dalhousie University, Halifax, NS B3H 4H7, Canada, ^b Department of Epidemiology and Biostatistics, McGill University, Montreal H3A 1A2, Canada, ^c Biomedical Ethics Unit, Department of Human Genetics and Department of Pediatrics, McGill University

Correspondence to: C Weijer charles.weijer@dal.ca

On what ethical grounds may a physician offer trial participation to his or her patient? The answer seems to depend greatlyon which side of the Atlantic you reside. In the United Kingdom,the uncertainty principle is widely endorsed. ¹ ² However,in North America, clinical equipoise $---$ reflecting collective uncertainty $---$ isthe dominant ethical basis.³ Which of these principles offersthe preferred moral underpinning for the randomised controlledtrial?

It is widely acknowledged that physicians have a primary duty to promote their patients' welfare. When physicians become investigators,. . . [Full text of this article]

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Rapid Responses:

Read all Rapid Responses

The Patient's Role: Ellen Hodnett
bmj.com, 22 Sep 2000 [Full text]
Equipoise and "the uncertainty principle" are not two mutually exclusive concepts: R J Lilford, et al.
bmj.com, 25 Sep 2000 [Full text]
Uncertainty principle and principle of uncertainty, not synonyms.: G R Howarth
bmj.com, 27 Sep 2000 [Full text]
For another exchange on equipoise and uncertainty: David Sackett
bmj.com, 5 Oct 2000 [Full text]
Simple 'uncertainty' is the bedrock of the ethics of clinical research: Graham Wylie
bmj.com, 11 Oct 2000 [Full text]
Uncertainty about clinical equipoise: Fred Gifford
bmj.com, 4 Nov 2000 [Full text]
Uncertainty principle versus lack of knowledge: Ivan Berlin
bmj.com, 21 Nov 2000 [Full text]