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& Treatment of Cancer, International Federation of Pharmaceutical Physicians, Foundation Marcel Mérieux, International Federation of Pharmaceutical Manufacturers’ Associations, International Conference on Harmonization, and European Forum for Good Clinical Practice. In addition, the draft text was widely distributed to organizations of ethics committees in Europe and the United States as well as to experts in the field of biomedical research ethics. On 2 January 2000 a new draft was prepared and distributed to the members of the Drafting Working Party, the Secretariat, and the Consultation Partners as well as to other parties who had commented or expressed an interest. Following on the reception of a wide range of detailed comments from around the world, the text was then widely discussed at a Meeting on Guidelines and Standard Operating Procedures for Ethical Review Committees held in Bangkok on 10-12 January 2000. Participants in this meeting were drawn from the regions of Africa, Asia, Latin America, North America, and Europe, from international organizations, (including WHO, UNAIDS, UNESCO, CIOMS, EFGCP, and IFPMA), and from universities and research institutions. A final deliberation took place at a Drafting Meeting held on 13 January 2000 in Bangkok. Following the Drafting Meeting a final set of comments were solicited and integrated into the final document. The purpose of this wide consultative process was to ensure extensive input while fostering the sharing of knowledge from developing and developed countries alongside organizations and institutions with varying degrees of experience and expertise. This process also help to prepare for the dissemination of the final text through an international process of capacity building that would strengthen national and local infrastructures for ethical review throughout the world. The Operational Guidelines for Ethics Committees That Review Biomedical Research are proposed by the WHO and CIOMS as a support for improving the organization, quality, and standards of 30
ethical review around the world. These Guidelines take into account current practices while suggesting guidance for a harmonized state-of-the-art approach. 31
Page 1 and 2: TDR/PRD/ETHICS/2000.1 Operational G
Page 3: TABLE OF CONTENTS PREFACE .........
Page 7 and 8: 1 OBJECTIVE The objective of these
Page 9 and 10: to ensure that their tasks can be e
Page 11 and 12: 4.4 Offices ECs should establish cl
Page 13 and 14: 5.2.3 the format for submission; 5.
Page 15 and 16: 5.3.13 a description of the arrange
Page 17 and 18: 6.2.2 Recruitment of Research Parti
Page 19 and 20: 6.2.5.5 the provisions made for rec
Page 21 and 22: 7.7 advice that is non-binding may
Page 23 and 24: 9.1 the quorum requirements, the re
Page 25: 10.10 all written documentation rec
Page 28 and 29: investigator A qualified scientist
Page 30 and 31: Assembly, Venice, Italy, October 19
Page 32 and 33: Secretariat Juntra Karbwang, TDR WH
Page 35: BACKGROUND The Operational Guidelin

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