Cioms' Placebo Rule and the Promotion of Negligent Medical Practice
22 Pages Posted: 2 Nov 2004
Guideline 11 of the 2002 version of the Council of International Organizations of Medical Sciences' International Ethical Guidelines for Biomedical Research Involving Human Subjects supports the use of placebo controls in clinical trials even when an established effective intervention exist. A note of clarification added to the new World Medical Association's Declaration of Helsinki goes in the same direction, even though this note clearly contradicts other provisions in the Declaration. The article highlights how this approach to placebo controlled trials constitutes an endorsement of the violation of well-established legal obligations, related to the primacy of the human subject and physicians' duty of care. The authors analyse the legal standards of four national jurisdictions to support this view. The CIOMS rule thus exposes researchers, research ethics committees and institutions to legal liability under national law. Surprisingly, nothing in the CIOMS guideline gives any indication of legal duties of researchers under national law. The authors call for an explicit recognition by CIOMS and the World Medical Association of the binding nature of national law. They invite national regulatory agencies and other legal scholars to clarify the legal standards in their jurisdiction and to improve awareness of the existence of legal obligations in the context of research.
Keywords: Research regulation, human subjects research, research ethics, duty of care, negligence, placebo control, Declaration of Helsinki, CIOMS
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