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The Council for International Organizations and Medical Sciences (CIOMS) Guidelines on Ethics of Clinical Trials

¹ Pediatric Intensive Care Unit, Royal Brompton Hospital, London, United Kingdom

Correspondence and requests for reprints should be addressed to Duncan J. Macrae, M.B. Ch.B., F.R.C.A., F.R.C.P.C.H., Royal Brompton Hospital, London SW3 6NP, UK. E-mail: d.macrae{at}rbht.nhs.uk

ABSTRACT

Numerous bodies from many countries, including governments, government regulatory departments, research organizations, medical professional bodies, and health care providers, have issued guidance or legislation on the ethical conduct of clinical trials. It is possible to trace the development of current guidelines back to the post–World War II Nuremburg war crimes trials, more specifically the "Doctors' Trial." From that trial emerged the Nuremburg Code, which set out basic principles to be observed when conducting research involving human subjects and which subsequently formed the basis for comprehensive international guidelines on medical research, such as the Declaration of Helsinki. Most recently, the Council for International Organizations and Medical Sciences (CIOMS) produced detailed guidelines (originally published in 1993 and updated in 2002) on the implementation of the principles outlined in the Declaration of Helsinki. The CIOMS guidelines set in an appropriate context the challenges of present-day clinical research, by addressing complex issues including HIV/AIDS research, availability of study treatments after a study ends, women as research subjects, safeguarding confidentiality, compensation for adverse events, as well guidelines on consent.

Key Words: ethics • health policy • clinical trial • guidelines