I will review the major changes introduced into the CIOMS International Guidelines at their present stage of development. These cannot be considered final until approved by CIOMS. The distinction between therapeutic (clinical) and nontherapeutic (nonclinical) research has been removed; this facilitates the development of more logical and consistent guidelines. The highly controversial requirement of earlier documents -- that each subject is entitled to receive 'the best proven therapeutic method' -- has been replaced with a requirement that each research subject is to be assured the 'highest attainable and sustainable therapeutic method'; this has important implications with regard to justification of placebo controls in randomized clinical trials. The requirement that therapeutic products developed in the course of research carried out in 'resource poor' countries or communities be made 'reasonably available' to the residents of such countries or communities is being refined and clarified. The excessively paternalistic position taken in the 1993 Guidelines with regard to the 'resource poor' countries is being replaced with a combination of more acceptable safeguards against exploitation and an acknowledgement that such countries are generally entitled to determine which research projects may be carried out within their borders. There are new guidelines on genetics and reproductive biology; other new topics will also be addressed. Finally, the Guidelines recommend establishment of an international agency to provide authoritative interpretation of the Guidelines when there are disputes or uncertainties about their meaning and to monitor developments in the field of research ethics for timely identification of needs for amendments.
Learning Objectives: N/A
Keywords: Ethics, International
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: N/A
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.