Declaration of Helsinki should be strengthened

doi:10.1136/bmj.322.7281.299/a

BMJ 2001;322:299 ( 3 February )

Letters

Declaration of Helsinki should be strengthened

Equipoise is essential principle of human experimentation

All countries must have common standards for international research ethics

Authors' reply

Equipoise is essential principle of human experimentation

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

EDITOR $---$ We wish to join in the debate about the next revision of the Declaration of Helsinki and to address some of the argumentsput forward by Rothman et al.¹

We agree with Rothman and Michels that equipoise ("the uncertainty principle"²) is an essential ingredient of an ethicalexperiment and that the declaration should be amended to say so.We recently argued that extraordinary care should be given tounderstand and protect this fundamental principle, on which nearlythe 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 thatpatients who participate in trials are asked to make a sacrificefor the good of others. This concern, however, is alleviated byexplicitly invoking equipoise as the principle on which randomisedcontrolled trials are based. The uncertainty principle statesthat a patient should . . . [Full text of this article]

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For and against: Declaration of Helsinki should be strengthened • FOR • AGAINST • Rothman and Michels' riposte: Kenneth J Rothman, Karin B Michels, and Michael Baum
BMJ 2000 321: 442-445. [Extract] [Full Text] [PDF]