Ethical approval for health research in central and eastern Europe: an international survey

Research ethics committees in central and eastern Europe are increasing in importance as institutions in this region host a growing and more diverse r ange and volume of health-related research, with funding from an increasing ly wide variety of sources. Aim: To describe the arrangements for ethical supervision of research in el even countries of central and eastern Europe, so as to identify examples of good practice and areas of weakness. Methods: A questionnaire was sent to key informants known to be active in h ealth-related research in Albania, Bulgaria, Croatia, Czech central and eas tern Republic, Estonia, Hungary, Lithuania, Poland, Romania, Russia, and Uk raine in October 2000. It sought information on the composition and functio ning of ethics committees, their training and any public concerns about the ethics of health-related research. Results: All countries except Ukraine confirmed that decision-making commit tee structures operate to oversee the ethics of research on human subjects. In all countries except Albania committees are comprised of medical and no nmedical members. Members received specific training in bioethics in Estoni a, Hungary, and Lithuania. Countries had made different degrees of progress in implementing arrangements for coordinating multi-site research and for monitoring research once it had commenced. Public concern about ethical iss ues arising from health-related research was rare. Conclusion: The development of ethical supervision of health-related resear ch in central and eastern Europe varies considerably. In some countries the re are significant weaknesses that should be addressed. Other countries cou ld serve as examples of good practice in the region. A major challenge is h ow the public can be involved in this process.