Ethics committees and achievement of good clinical practice

Abstract

Local ethics committees (institutional review boards, or similar bodies) were established during the last decades at (bio)medical research institutions worldwide to serve as review bodies of the proposed research projects (inclusive protocols of clinical trials), and also to monitor if the ethical principles, including the requirements of good practice (clinical, laboratory, and scientific) are respected and fulfilled during the conduct of research projects. Existing pluralism of the philosophical background on which contemporary bioethics theories are developed is questioning seriously the ancient traditions of Hippocratic, non-utilitarian medical ethics, trying to promote more utilitarian and secular approaches. Individual physicians, or researchers, as well as the ethics committee itself, are faced today with complicated ethical dilemmas, that frequently have to be solved in the atmosphere of considerable social, collegiate, economical, and time pressures, and sometimes without helpful guidance of appropriate legislation. An interesting possibility of how to overcome some of the pitfalls of the ethics review process is to express a common ethical responsibility for the research project or trial protocol in a statement of most (or all) parties involved (such as the principal investigator, sponsor, ethics committee, the patient, "society'). Such an approach has proven helpful in enhancing concrete deliberations of ethics committees-established in Slovakia since 1991 according to the requirements of the national guidelines issued by the Slovak Ministry of Health.