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其他書名
Draft Document
出版Medical Research Council of Canada, 1996
ISBN066224432X9780662244325
URLhttp://books.google.com.hk/books?id=DKSaNAAACAAJ&hl=&source=gbs_api
註釋This draft code has been written to meet the varied needs of researchers, members of Research Ethics Boards (REBs), and administrators of institutions where research with humans is conducted. The first section establishes a philosophical approach within which to begin consideration of research ethics, and the second section establishes a framework of ethical principles considered as fundamental to the ethical conduct of research. The two subsequent sections prescribe minimal standards for the composition and operation of REBs. Sections 5 to 11 give practical guidance concerning a number of matters common to all research protocols, informed consent, privacy and confidentiality, access to personal records, continuing ethical review, conflict of interest, incentives for participation, and responsibility for adverse outcomes. Sections 12 and 13 highlight two high-priority issues: research with populations at risk of exploitation in research and research with collectivities. Section 14 reviews research outside Canada and sections 15 to 17 address human genetic research, research on human reproduction, and the use of human tissue. The final two sections provide material specific to clinical trials and quality assurance. The appendix includes sample consent forms.