REVIEW – September 2006

A general ethical framework for biomedical research involving human subjects


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An important factor for the progress of medicine is the increasing amount and quality of data from biomedical research. Biomedical research is in a complicated ethical situation in a sense that science by itself is clearly a social activity which has according to R.K. Merton its own scientific ethos and in many cases of biomedical research researchers must also follow norms and principles of medical ethics. Since Nuremberg trial the biomedical research ethics has developed both on international and national level with high speeds and currently contains elaborated social structure and ethical regulations to perform ethically correct scientific research on human beings. We can call such social network as a general bioethical framework for biomedical research which should be followed by any respective biomedical research project or trial. The bioethical framework for modern human biomedical research is described here in terms of history, development, structure, and functioning. Main issues of the framework presented in this paper are typology of biomedical research; autonomy of research subjects and informed consent; ethical justification of biomedical research; possible ethical outcomes of study design; and role of research ethics committees (RECs). Despite of being society in a phase of transition, the Estonian biomedical research ethics environment has most important structural components and is generally functioning in appropriate and stable way. At the same time we clearly need more public debate on hot bioethical issues and more research ethics education for our researchers.