This Guide is intended to be used as a tool for research ethics committee (REC) members.

The text has been elaborated by the Group of Specialists on Biomedical Research (CDBI-CO-GT2) working under the authority of the Steering Committee on Bioethics (CDBI) of the Council of Europe. The Guide does not provide new principles, but highlights the ethical basis for the principles laid down in the European instruments covering biomedical research and indicates operational procedures to facilitate their implementation.

At its 37th plenary meeting, the CDBI decided to declassify the draft Guide for consultation. The consultation took place from 8 December 2009 to 31 March 2010. The Guide was revised taking into account all the comments received during the consultation process. The revised version of the Guide was adopted by the Steering Committee on Bioethics on 3 December 2010.