Declaration of Helsinki should be strengthened. Equipoise is essential principle of human experimentation.
Year: 2001
Type: letter
Abstract: Editor—We wish to join in the debate about the next revision of the Declaration of Helsinki and to address some of the arguments put forward by Rothman et al.1
We agree with Rothman and Michels that equipoise (“the uncertainty principle”2) is an essential ingredient of an ethical experiment and that the declaration should be amended to say so. We recently argued that extraordinary care should be given to understand and protect this fundamental principle, on which nearly the entire system of human experimentation stands.3
Baum writes of “tensions between conduct of a trial and the autonomy of the individual.”1 This involves the notion that patients who participate in trials are asked to make a sacrifice for the good of others. This concern, however, is alleviated by explicitly invoking equipoise as the principle on which randomised controlled trials are based. The uncertainty principle states that a patient should be enrolled in a randomised controlled trial only if uncertainty about which of the trial treatments would benefit the patient most is so substantial that they are in equipoise or “indifferent” between treatment options.4,5
It follows that so long as we are substantially uncertain which treatment is superior, patients do not lose out prospectively and are not required to sacrifice themselves for the benefit of others.4 Thus, ethically, randomised controlled trials should be acceptable to both utilitarians (who seek to bring the greatest good to the greatest number of patients by ensuring scientifically robust results) and Kantians (who seek to protect and preserve patients' autonomy).4 The same principle applies to any randomised trial, whether it is placebo controlled or not; it is just that in placebo controlled trials we should be particularly vigilant about applying the uncertainty principle.3
In our opinion, the ethical dilemma expressed in Rothman et al's article is false—it has already been resolved. The question is now a technical one: how do we improve communication so that patients can really find out whether or not they are indifferent between treatment options?
Source: PubMed
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W55404791