Protection of human subjects in medical research: from the viewpoint of historical development of ethical regulations
Nihon ishigaku zasshi. [Journal of Japanese history of medicine] 2011 Mar; 57(1): 63-70
Recent clinical research is conducted based on bioethical consideration of human subjects. The Ethical Guidelines for Clinical Studies (EGCS) form the standard for this 'subject protection'. In current clinical research, consideration of subject rights and life is held more important than the scientific and social value of the research. We describe herein the major revisions and history of ethical considerations leading up to implementation of the revised EGCS on April 1, 2009. The obligations of clinical researchers regarding ethical studies and training and enrollment in insurance for subject compensation have been added to these latest guidelines. The role of ethics review boards, which supervise whether clinical researchers are actively performing subject protection, is also becoming extremely important.
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United States Regulatory Requirements for Research Involving Human Subjects Includes Appendix 1: The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research; Appendix 2: World Medical Association Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects Unknown creator (1998-12)
Exemption of Certain Research and Demonstration Projects From Regulations for Protection of Human Research Subjects Unknown creator (United States. Department of Health and Human Services. Office of the Secretary, 1982-03-22)
Exemption of Certain Research and Demonstration Projects From Regulations for Protection of Human Research Subjects: Final Rule Unknown creator (United States. Department of Health and Human Services. Office of the Secretary, 1983-03-04)