An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical/scientific professionals and non-medical / non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in biomedical research and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favourable opinion on the research protocol, the suitability of the investigator(s)/researchers, facilities, and the methods and material to be used in obtaining and documenting informed consent of the research subjects.
Published in Chapter:
Social and Ethical Aspects of Biomedical Research
Gerrhard Fortwengel (University for Health Sciences, Medical Informatics and Technology, Austria)
Copyright: © 2009
|Pages: 19
DOI: 10.4018/978-1-60566-022-6.ch009
Abstract
At the beginning of this section the authors provide a definition of biomedical research and an interpretation of the meaning of ethics and social values of research. They continue with the introduction of the risk-benefit approach as basic requirement for any biomedical research involving human subjects and illustrate the need for uniformity with respect to social and ethical issues. The differences and similarities between social and ethical research are described in the core section; social and ethical aspects are presented according to central and peripheral dimensions. In reference to specific areas of research in biomedical science it is exemplary shown that more general principles are not sufficient to cover all types of research, and that depending on research characteristics, the techniques used and the purpose of the research, other specific aspects might need to be considered as well. The chapter ends with a short conclusion calling for continued reflection and review of social and ethical issues speeding an age of fast changes in science and technologies to thereby ensure proper protection of the individual and the best future for society.