title: Comparing national home-keeping and the regulation of translational stem cell applications: An international perspective.
abstract: A very large grey area exists between translational stem cell research and applications that comply with the ideals of randomised control trials and good laboratory and clinical practice and what is often referred to as snake-oil trade. We identify a discrepancy between international research and ethics regulation and the ways in which regulatory instruments in the stem cell field are developed in practice. We examine this discrepancy using the notion of 'national home-keeping', referring to the way governments articulate international standards and regulation with conflicting demands on local players at home. Identifying particular dimensions of regulatory tools - authority, permissions, space and acceleration - as crucial to national home-keeping in Asia, Europe and the USA, we show how local regulation works to enable development of the field, notwithstanding international (i.e. principally 'western') regulation. Triangulating regulation with empirical data and archival research between 2012 and 2015 has helped us to shed light on how countries and organisations adapt and resist internationally dominant regulation through the manipulation of regulatory tools (contingent upon country size, the state's ability to accumulate resources, healthcare demands, established traditions of scientific governance, and economic and scientific ambitions).
authors.affiliation: University of Sussex Centre for Bionetworking, Anthropology, Arts C209, Falmer BN1 9SJ, UK. Electronic address: m.sleeboom-faulkner@sussex.ac.uk.
authors.forename: Margaret
authors.initials: M
authors.lastname: Sleeboom-Faulkner
authors.affiliation: University of Sussex Centre for Bionetworking, Anthropology, Arts C208, Falmer BN1 9SJ, UK. Electronic address: choonkey.chekar@gmail.com.
authors.forename: Choon Key
authors.initials: CK
authors.lastname: Chekar
authors.affiliation: University of Sussex, International Relations, Arts C306, Falmer BN1 9SJ, UK. Electronic address: A.Faulkner@sussex.ac.uk.
authors.forename: Alex
authors.initials: A
authors.lastname: Faulkner
authors.affiliation: University of Sussex Centre for Bionetworking, Anthropology, Arts C208, Falmer BN1 9SJ, UK.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Heitmeyer
authors.affiliation: University of Sussex Centre for Bionetworking, Anthropology, Arts C208, Falmer BN1 9SJ, UK.
authors.forename: Marina
authors.initials: M
authors.lastname: Marouda
authors.affiliation: University of Sussex Centre for Bionetworking, Anthropology, Arts C208, Falmer BN1 9SJ, UK. Electronic address: A.Rosemann@warwick.ac.uk.
authors.forename: Achim
authors.initials: A
authors.lastname: Rosemann
authors.affiliation: University of Sussex Centre for Bionetworking, Anthropology, Arts C208, Falmer BN1 9SJ, UK.
authors.forename: Nattaka
authors.initials: N
authors.lastname: Chaisinthop
authors.affiliation: University of Sussex Centre for Bionetworking, Anthropology, Arts C208, Falmer BN1 9SJ, UK; Chinese Medical University, Taiwan, ROC. Electronic address: chcjessica@gmail.com.
authors.forename: Hung-Chieh Jessica
authors.initials: HC
authors.lastname: Chang
authors.affiliation: University of Sussex Centre for Bionetworking, Anthropology, Arts C208, Falmer BN1 9SJ, UK.
authors.forename: Adrian
authors.initials: A
authors.lastname: Ely
authors.affiliation: University of Sussex Centre for Bionetworking, Anthropology, Arts C208, Falmer BN1 9SJ, UK. Electronic address: katomasae@hotmail.com.
authors.forename: Masae
authors.initials: M
authors.lastname: Kato
authors.affiliation: University of Sussex Centre for Bionetworking, Anthropology, Arts C208, Falmer BN1 9SJ, UK. Electronic address: pkpatra@rediffmail.com.
authors.forename: Prasanna K
authors.initials: PK
authors.lastname: Patra
authors.affiliation: University of Sussex Centre for Bionetworking, Anthropology, Arts C208, Falmer BN1 9SJ, UK.
authors.forename: Yeyang
authors.initials: Y
authors.lastname: Su
authors.affiliation: Center for Bioethics, Chinese Academy of Medical Sciences & Peking Union Medical College, 5 Dong Dan San Tiao, Beijing 100005, PR China. Electronic address: suisuli@hotmail.com.
authors.forename: Suli
authors.initials: S
authors.lastname: Sui
authors.affiliation: University of Sussex Centre for Bionetworking, Anthropology, Arts C208, Falmer BN1 9SJ, UK; Kyoto University, Yohida-honmachi, Sakyo-ku, Kyoto 606-8501, Japan. Electronic address: wakana.s.kyoto@gmail.com.
authors.forename: Wakana
authors.initials: W
authors.lastname: Suzuki
authors.affiliation: Center for Bioethics, Peking Union Medical College, Beijing 100005, PR China.
authors.forename: Xinqing
authors.initials: X
authors.lastname: Zhang
mesh_terms: D001208:Asia; D005060:Europe; D033161:Government Regulation; D006801:Humans; D038622:Internationality / Q000331:legislation & jurisprudence*; D057905:Stem Cell Research / Q000331:legislation & jurisprudence*; D057170:Translational Research, Biomedical / Q000331:legislation & jurisprudence*; D014481:United States
keywords: Asia; Europe; International science community; National home-keeping; Research regulation; Standards; Translational stem cell research; USA