The revised Declaration of Helsinki: interpreting and implementing ethical principles in biomedical research

Abstract

This 2-day international conference* was held at the Council for Scientific and Industrial Research (CSIR) Conference Centre, Pretoria, South Africa on 27–28 March 2001. The World Medical Association (WMA), the University of Pretoria School of Health Systems and Public Health (SHSPH) and the European Forum for Good Clinical Practice (EFGCP) hosted it. There were nearly 80 speakers and delegates from a wide range of developed and developing countries. The conference gave the first opportunity for delegates from many organizations to discuss together the implications of the recent revision of the Declaration of Helsinki, adopted at the 52nd WMA General Assembly held in Edinburgh, Scotland in October 2000. Many of them had been involved in the lengthy consultative process beforehand. Some delegates felt that this revision had resulted in uncertainties in both the interpretation and the implementation of the Declaration, which had already resulted in divergent opinions and practices [1,2]. The aim of the conference was to examine how the revised Declaration might best be interpreted and implemented.