Intended for healthcare professionals


Fresh thinking about the Declaration of Helsinki

BMJ 2008; 337 doi: (Published 17 October 2008) Cite this as: BMJ 2008;337:a2128
  1. Michael D E Goodyear, assistant professor of medicine1,
  2. Lisa A Eckenwiler, associate professor of philosophy, director of health care ethics2,
  3. Carolyn Ells, associate professor of medicine3
  1. 1Dalhousie University, Halifax, NS, Canada B3H 2Y9
  2. 2Department of Philosophy, Center for Health Policy Research and Ethics, George Mason University, Fairfax, VA 22030, USA
  3. 3Biomedical Ethics Unit, McGill University, Montreal, QC, Canada H3A 1X1
  1. mgoodyear{at}

    A comprehensive approach to ethical research

    The Declaration of Helsinki is the cornerstone of research ethics.1 Its periodic revision provides an opportunity for debate about its purpose and effectiveness.2 The sixth revision, being considered by the World Medical Association (WMA; this October, follows extensive consultation.1 2 However, debate about the operational details often loses sight of the objectives and principles.2 Much has changed in the nature of research and bioethical thinking since the declaration was conceived.1 2 3 Public confidence in research is at an all time low, and the current model and traditional ethical tools seem to be failing to meet their objectives. It is time for fresh thinking.

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

    We propose an alternative comprehensive framework in which basic ethical principles collectively inform, support, and direct all aspects of research—from the design of the research agenda and research questions, through the process of evaluation and execution, to the dissemination of results and distribution of benefits. This would broaden the scope of ethical research beyond that of the behaviour of the …

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