Guide for Research Ethics Committee Members Steering Committee on Bioethics Guide for Research Ethics Committee Members Steering Committee on Bioethics This document is intended to be used as a tool for research ethics committee (REC) mem- bers. 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 consult- ation. 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. French edition: Guide à l’intention des membres des comités d’éhique de la recherche All other correspondence concerning this document should be addressed to Human Rights Directorate – Bioethics Department. Layout: SPDP, Council of Europe © Council of Europe, April 2012 Table of contents 1. The guide: a tool for Research Ethics Committee (REC) Members .........................................7 2. Introduction ..................................................................................................................................................8 3. Ethical principles .........................................................................................................................................9 3.A Аutonomy ........................................................................................................................................................9 3.B Beneficence and non-maleficence ...................................................................................................... 10 3.C Justice ............................................................................................................................................................ 11 3.D Ensuring respect for ethical principles: independent scientific and ethical evaluation ............................................................................................................................. 11 4. Legal aspects .............................................................................................................................................. 12 4.A Introduction ................................................................................................................................................ 12 4.B Sources .......................................................................................................................................................... 12 4.B.1 Non legally binding instruments ...................................................................................... 12 4.B.2 Legally binding instruments ............................................................................................... 13 5. Research Ethics Committees (RECs) ................................................................................................. 15 5.A REC – Description ...................................................................................................................................... 15 5.A.1 Roles and activities of RECs in the research process .................................................. 15 5.A.2 Composition of RECs ............................................................................................................. 19 5.A.3 REC appointment and renewal process ......................................................................... 21 5.A.4 Initial and continuing training of REC members ......................................................... 21 5.A.5 Confidentiality ......................................................................................................................... 21 5.A.6 Accountability of RECs .......................................................................................................... 22 5.B Method of Working ................................................................................................................................... 22 5.B.1 Statutes ...................................................................................................................................... 22 5.B.2 Rules of Procedure ................................................................................................................. 23 5.B.3 Follow up of an ongoing research project .................................................................... 24 5.B.4 REC self-evaluation tools ..................................................................................................... 24 5.B.5 Exchange with other bodies ............................................................................................... 25 5.C Independent audit of REC functioning ............................................................................................. 25 6. Independent REC examination of a research project ............................................................... 27 6.A General .......................................................................................................................................................... 27 6.B Application process .................................................................................................................................. 27 6.C Information to be provided to and examined by the REC ......................................................... 27 6.C.1 Description of the project ................................................................................................... 29 6.C.2 Justification for involving human beings in the research ........................................ 29 6.C.3 Inclusion and exclusion criteria ......................................................................................... 30 3 Table of contents 6.C.4 Healthy volunteers ................................................................................................................. 30 6.C.5 Justification for control groups .......................................................................................... 30 6.C.6 Use of placebo ......................................................................................................................... 31 6.C.7 Benefits and risks .................................................................................................................... 31 6.C.8 Recruitment arrangements ................................................................................................. 32 6.C.9 Information for potential participants ............................................................................ 32 6.C.10 Potential undue influence ................................................................................................... 33 6.C.11 Informed consent ................................................................................................................... 34 6.C.12 Documenting consent/authorisation ............................................................................. 34 6.C.13 Arrangements for seeking consent .................................................................................. 34 6.C.14 Scope of the consent ............................................................................................................. 34 6.C.15 Safety and supervision ......................................................................................................... 35 6.C.16 Information for the REC during the conduct of research ......................................... 35 6.C.17 New information and protection of research participants ...................................... 36 6.C.18 Confidentiality and right to information ........................................................................ 36 6.C.19 Duty of care............................................................................................................................... 37 6.C.20 Availability of research results ........................................................................................... 37 6.C.21 Circumstances that might lead to conflict of interest affecting the independent judgement of researchers................................................................. 38 6.C.22 Payments and rewards to be made in the context of the research ...................... 39 6.C.23 Foreseen potential further uses, including commercial uses, of the research results, data, or biological materials ................................................. 39 6.C.24 Arrangements for compensation for damage ............................................................. 39 7. Persons not able to consent ................................................................................................................ 40 8. Research in specific situations ............................................................................................................ 43 8.A Clinical emergencies ................................................................................................................................ 43 8. A.1 Protective conditions ...........................................................................................................