Global regulatory developments for clinical stem cell research: diversification and challenges to collaborations.
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.
Centre for Education Studies, Faculty of Social Sciences, University of Warwick, Coventry, CV4 7AL, UK.|Centre for Bionetworking, School of Global Studies, University of Sussex, Brighton, BN1 9SJ, UK.
Achim
A
Rosemann
Institute of Science & Technology Studies, National University of Quilmes (IESCT-UNQ), Roque S. Peña 352, (1876) Bernal, Buenos Aires, Argentina.|National Council of Scientific & Technical Research (CONICET), Godoy Cruz 2290, C1425FQB Buenos Aires, Argentina.
Gabriela
G
Bortz
Institute of Science & Technology Studies, National University of Quilmes (IESCT-UNQ), Roque S. Peña 352, (1876) Bernal, Buenos Aires, Argentina.|Institute of Social Research, National Autonomous University of Mexico, Circuito Mario de la Cueva s/n, Ciudad Universitaria, Coyoacán, 04510 Ciudad de México, México.
Federico
F
Vasen
Centre for Bionetworking, School of Global Studies, University of Sussex, Brighton, BN1 9SJ, UK.|Department of Anthropology, University of Sussex, Arts C 206, Brighton, BN1 9SJ, UK.
Margaret
M
Sleeboom-Faulkner
D035843:Biomedical Research / Q000331:legislation & jurisprudence* / Q000592:standards*; D014943:Global Health; D006801:Humans; D007391:International Cooperation; D057905:Stem Cell Research / Q000331:legislation & jurisprudence*
clinical stem cell research; evidence-based medicine; international harmonization; multicountry trials; research regulation