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KMID : 1011120140080010057
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Bioethics Policy Studies
2014 Volume.8 No. 1 p.57 ~ p.79
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A Study on the Regulation for Protecting Human Subjects in Stem Cell Research and TranslationalResearch
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Park Soo-Hun
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Abstract
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NAS and ISSCR have enacted two guidelines focusing regulatory models for protecting human subjects in stem cell research and stem cell translational research. Especially, 2008 ISSCR Guidelines would be the subject and be examined for protecting human subjects in stem cell translational research in this article. In order to provide regulatory models for protecting human subjects in the stem cell research, 2005 NAS Guidelines has required independent ESCRO Committee as a duty of the institutions for establishing and use of human embryonic stem cell lines. However, 2007 NAS Guidelines has reduced this strict obligation by using another institution’s ESCRO Committees. On the part of 2006 ISSCR Guidelines, it was not required as a duty of institution for establishing ESCRO Committee. Instead, this guideline provided that special SCRO Procedure not ESCRO Committee was enough to give approval to the stem cell research. In regard to stem cell translational research, stepwise process is assumed and based on the traditional research ethics paradigms. 2008 ISSCR Guidelines suggested that stem cell specific experts could review stem cell research protocols. And, in pre-clinical trials for stem cell translational research, the use of independent peer review was stressed. In addition, informed consent and long-term monitoring to the patients should be obtained and taken in order to resolve uncertainties in the embryonic stem cell. Thus, 2008 ISSCR Guidelines has to play an important role as starting point balancing treatment and innovation.
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KEYWORD
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ESCRO Committee, Protection of Human Subjects, Regulation of Stem Cell Research, Stem Cell Research, Stem Cell Translational Research, SCRO Procedure
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