Developing capacity for ethical review: minutes of the TDR Planning Meeting*

Abstract

The TDR Planning Meeting on Developing Capacity for Ethical Review was opened by Dr H. Engers, Co-ordinator for Research Capacity Strengthening Plus, TDR/WHO on behalf of Dr C. Morel, Director, TDR, followed by welcome remarks from Dr T. Pang, Director, Research Policy Evidence, WHO, and Dr John Bryant, President, CIOMS. Professor R. Lie, Bergen University, presented the objectives of the meeting. He indicated that the meeting would describe the work accomplished in capacity-building for ethical review of biomedical research and examine a way forward through partnership. Professor K. Hirayama of Japan then gave a presentation on the ‘The Local and National Need to Develop Ethical Review in an International Framework’, emphasizing the role of regional Fora for Ethics Committees in responding to the need for competent ethical review of research proposals. Professor F. Crawley, EFGCP, discussed the development of the Operational Guidelines for Ethics Committees That Review Biomedical Research and the resulting establishment of FERCAP, the Forum for Ethical Review Committees in Asia and Western Pacific Regions. He presented the ongoing regional development of capacity-building in ethical review as it is being undertaken through the establishment of fora in the regions of Latin America, Africa, the Caribbean, the Mediterranean, and Russia/NIS. These fora provide essential platforms for regional, national, and local ethics committees to develop SOPs, national guidelines and legislation, networking, GCP, bioethics education, and act as a voice for persons in developing countries in the international discussion on research. The meeting participants discussed the experience to date and the ongoing activities in the various regions. Nine months have elapsed since the formation of FERCAP, and the participants were interested to examined the lessons learned during this process. Dr V. Muthuswamy, ICMR and FERCAP, and Dr J. Karbwang, TDR, informed the participants that the project had demonstrated that a greater number of individuals can be involved in this exercise, especially those involved in community health actions and those involved in national policy development. Further, it will be beneficial to involve the various international research and sponsoring partners from the very beginning because of the common interests in this area. It was also felt necessary to develop within this framework more tools for the training programmes and training the trainers that would also increase participation at all levels. Dr E. Esber, FDA, suggested that the project also should consider developing Good Ethics Review Practices to complement the Operational Guidelines. The participants then discussed the role of the pharmaceutical industry and other sponsoring agencies with regard to the possibility for conflict of interest in supporting the development of ethical review committees. Dr B. Haumann of Glaxo Wellcome suggested that sponsors contributing funds to the development of particular ethics committees might give rise to a conflict of interest. However, by pooling the funding for a common project, conflict of interest would be avoided. Dr M. Salvi of the European Commission suggested that there could be a conflict of interest if the industry did not contribute to capacitybuilding in ethical review! Further, it was recognized that this is also a potential issue for all types of funders. There was consensus that conflict of interest could be avoided. The discussion also pointed out that if international agencies such as WHO, UNAIDS, and UNESCO, take a leading role and assist countries with taking up capacity-building in ethical review as a priority, the response will be stronger and the results more efficiently realized. In this context a proposal was made that the Advisory Committee on Health Research (ACHR) of WHO could take this matter to the Executive Board of WHO which could lead to a resolution for consideration by the World Health Assembly. If that were to happen, representatives of every nation would learn of the importance of capacity-building for ethical review. It was further suggested that an international