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Global regulatory developments for clinical stem cell research : diversification and challenges to collaborations
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Rosemann, Achim, Bortz, Gaby, Vasen, Federico and Sleeboom-Faulkner, Margaret (2016) Global regulatory developments for clinical stem cell research : diversification and challenges to collaborations. Regenerative Medicine, 11 (7). pp. 647-657. doi:10.2217/rme-2016-0072 ISSN 1746-0751.
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Official URL: http://doi.org/10.2217/rme-2016-0072
Abstract
In this article, we explore regulatory developments in stem cell medicine in seven jurisdictions: Japan, China, India, Argentina, Brazil, the USA and the EU. We will show that the research methods, ethical standards and approval procedures for the market use of clinical stem cell interventions are undergoing an important process of global diversification. We will discuss the implications of this process for international harmonization and the conduct of multicountry clinical research collaborations. It will become clear that the increasing heterogeneity of research standards and regulations in the stem cell field presents a significant challenge to international clinical trial partnerships, especially with countries that diverge from the regulatory models that have been developed in the USA and the EU.
Item Type: | Journal Article | ||||||||
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Subjects: | H Social Sciences > H Social Sciences (General) Q Science > QH Natural history R Medicine > RA Public aspects of medicine |
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Divisions: | Faculty of Social Sciences > Centre for Education Studies (2013- ) | ||||||||
Library of Congress Subject Headings (LCSH): | Stem cells--Research , Evidence-based medicine | ||||||||
Journal or Publication Title: | Regenerative Medicine | ||||||||
Publisher: | Future Medicine | ||||||||
ISSN: | 1746-0751 | ||||||||
Official Date: | October 2016 | ||||||||
Dates: |
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Volume: | 11 | ||||||||
Number: | 7 | ||||||||
Page Range: | pp. 647-657 | ||||||||
DOI: | 10.2217/rme-2016-0072 | ||||||||
Status: | Peer Reviewed | ||||||||
Publication Status: | Published | ||||||||
Access rights to Published version: | Restricted or Subscription Access | ||||||||
Date of first compliant deposit: | 16 August 2016 | ||||||||
Date of first compliant Open Access: | 1 November 2017 | ||||||||
Funder: | European Research Council (ERC), Economic and Social Research Council (Great Britain) (ESRC) | ||||||||
Grant number: | ERC (283219); ESRC (ES/I018107/1) | ||||||||
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