Global regulatory developments for clinical stem cell research: diversification and challenges to collaborations

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. ISSN 1746-0751

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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: Article
Schools and Departments: School of Global Studies > Anthropology
Subjects: H Social Sciences
R Medicine
R Medicine > RA Public aspects of medicine
Depositing User: Achim Rosemann
Date Deposited: 15 Aug 2016 14:39
Last Modified: 02 Oct 2017 01:00
URI: http://sro.sussex.ac.uk/id/eprint/62396

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Project NameSussex Project NumberFunderFunder Ref
Bionetworking in Asia - A social science approach to international collaboration, informal exchanges, and responsible innovation in the life sciencesG0812EUROPEAN UNION283219
Bionetworking in Asia - International collaboration, exchange, and responsible innovation in the life sciencesG0750ESRC-ECONOMIC & SOCIAL RESEARCH COUNCILES/I018107/1