Final published version
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Research output: Contribution to Journal/Magazine › Journal article › peer-review
Research output: Contribution to Journal/Magazine › Journal article › peer-review
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TY - JOUR
T1 - Comparing national home-keeping and the regulation of translational stem cell applications
T2 - An international perspective
AU - Sleeboom-Faulkner, Margaret
AU - Chekar, Choon Key
AU - Faulkner, Alex
AU - Heitmeyer, Carolyn
AU - Marouda, Marina
AU - Rosemann, Achim
AU - Chaisinthop, Nattaka
AU - Chang, Hung-Chieh Jessica
AU - Ely, Adrian
AU - Kato, Masae
AU - Patra, Prasanna K
AU - Su, Yeyang
AU - Sui, Suli
AU - Suzuki, Wakana
AU - Zhang, Xinqing
N1 - Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.
PY - 2016/3/31
Y1 - 2016/3/31
N2 - 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).
AB - 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).
KW - Asia
KW - Europe
KW - Government Regulation
KW - Humans
KW - Internationality/legislation & jurisprudence
KW - Stem Cell Research/legislation & jurisprudence
KW - Translational Medical Research/legislation & jurisprudence
KW - United States
U2 - 10.1016/j.socscimed.2016.01.047
DO - 10.1016/j.socscimed.2016.01.047
M3 - Journal article
C2 - 26921839
VL - 153
SP - 240
EP - 249
JO - Social Science and Medicine
JF - Social Science and Medicine
SN - 0277-9536
ER -