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KMID : 1172020170180010063
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Journal of Korean Bioethics Association
2017 Volume.18 No. 1 p.63 ~ p.82
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Reformed U.S. Common Rule and Current Trends in Human Subject Protection Policy
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Jung Jun-Ho
Kim Ock-Joo
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Abstract
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Fully revised and updated U.S. Common Rule (Federal Policy for the Protection of Human Subject) will come into effect from January 19, 2018. Updated Common Rule reflects the changes in research landscape, as well as public view of human subject research. Purpose of the revision is to modernize, strengthen, and make more effective policy. It is intended to facilitate valuable research, reduce burden, delay, and ambiguity for investigator while better protecting human subject involved in research. Changes in its scope and definitions of Common Rule suggest that Bioethics and Safety Act in Korea may also need substantial revision which can reflect the current shifts in research enterprise. This study focuses on historical development of the Common Rule, and significant changes from pre-2018 rule in the final rule (2017) of the Common Rule which shows changing concept of human research protection. This will help to understand the context of development process of Common Rule that had substantial influence on Korea’s Bioethics and Safety Act.
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KEYWORD
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Human Subject Research, Human Research Protection, Common Rule, Institutional Review Board, Informed Consent, Biospecimen
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