Fresh thinking about the Declaration of Helsinki

doi:10.1136/bmj.a2128

Published 17 October 2008, doi:10.1136/bmj.a2128
Cite this as: BMJ 2008;337:a2128

Editorials

Fresh thinking about the Declaration of Helsinki

A comprehensive approach to ethical research

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

The Declaration of Helsinki is the cornerstone of research ethics.¹Its periodic revision provides an opportunity for debate aboutits purpose and effectiveness.² The sixth revision, being consideredby the World Medical Association (WMA; www.wma.net/e/ethicsunit/helsinki.htm)this October, follows extensive consultation.¹ ² However, debateabout the operational details often loses sight of the objectivesand principles.² Much has changed in the nature of researchand bioethical thinking since the declaration was conceived.¹² ³ Public confidence in research is at an all time low, andthe current model and traditional ethical tools seem to be failingto meet their objectives. It is time for fresh thinking.

The declaration’s objectives were framed, in responseto past abuses, to protect human subjects in research.² However,the framework put in place to protect subjects has been criticisedas paternalistic and for failing to address the full scope ofethically responsible research.¹

We propose an alternative comprehensive . . . [Full text of this article]

Michael D E Goodyear, assistant professor of medicine¹, Lisa A Eckenwiler, associate professor of philosophy, director of health care ethics², Carolyn Ells, associate professor of medicine³

¹ Dalhousie University, Halifax, NS, Canada B3H 2Y9, ² Department of Philosophy, Center for Health Policy Research and Ethics, George Mason University, Fairfax, VA 22030, USA, ³ Biomedical Ethics Unit, McGill University, Montreal, QC, Canada H3A 1X1

mgoodyear@dal.ca

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