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

UNLABELLED: Research ethics committees in central and eastern Europe are increasing in importance as institutions in this region host a growing and more diverse range and volume of health-related research, with funding from an increasingly wide variety of sources. AIM: To describe the arrangements for ethical supervision of research in eleven 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 health-related research in Albania, Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Lithuania, Poland, Romania, Russia, and Ukraine in October 2000. It sought information on the composition and functioning 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 committee structures operate to oversee the ethics of research on human subjects. In all countries except Albania committees are comprised of medical and non-medical members. Members received specific training in bioethics in Estonia, 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 issues arising from health-related research was rare. CONCLUSION: The development of ethical supervision of health-related research in central and eastern Europe varies considerably. In some countries there are significant weaknesses that should be addressed. Other countries could serve as examples of good practice in the region. A major challenge is how the public can be involved in this process.