Literature DB >> 26921839

Comparing national home-keeping and the regulation of translational stem cell applications: An international perspective.

Margaret Sleeboom-Faulkner1, Choon Key Chekar2, Alex Faulkner3, Carolyn Heitmeyer4, Marina Marouda4, Achim Rosemann5, Nattaka Chaisinthop4, Hung-Chieh Jessica Chang6, Adrian Ely4, Masae Kato7, Prasanna K Patra8, Yeyang Su4, Suli Sui9, Wakana Suzuki10, Xinqing Zhang11.   

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).
Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Keywords:  Asia; Europe; International science community; National home-keeping; Research regulation; Standards; Translational stem cell research; USA

Mesh:

Year:  2016        PMID: 26921839     DOI: 10.1016/j.socscimed.2016.01.047

Source DB:  PubMed          Journal:  Soc Sci Med        ISSN: 0277-9536            Impact factor:   4.634


  6 in total

1.  The Shortage of Malaysian Stem Cell Ethics in Mainstream Database: a Preliminary Study.

Authors:  Gopalan Nishakanthi
Journal:  Asian Bioeth Rev       Date:  2019-11-28

2.  Systematic review assessing the evidence for the use of stem cells in fracture healing.

Authors:  Andrew Mott; Alex Mitchell; Catriona McDaid; Melissa Harden; Rachael Grupping; Alexandra Dean; Ailish Byrne; Laura Doherty; Hemant Sharma
Journal:  Bone Jt Open       Date:  2020-10-06

Review 3.  Overcoming barriers to facilitate the regulation of multi-centre regenerative medicine clinical trials.

Authors:  Erika Kleiderman; Audrey Boily; Craig Hasilo; Bartha Maria Knoppers
Journal:  Stem Cell Res Ther       Date:  2018-11-08       Impact factor: 6.832

4.  Regulatory brokerage: Competitive advantage and regulation in the field of regenerative medicine.

Authors:  Margaret Sleeboom-Faulkner
Journal:  Soc Stud Sci       Date:  2019-06       Impact factor: 3.885

Review 5.  Reflection on the enactment and impact of safety laws for regenerative medicine in Japan.

Authors:  Kayo Takashima; Michael Morrison; Jusaku Minari
Journal:  Stem Cell Reports       Date:  2021-05-20       Impact factor: 7.765

6.  Current and emerging global themes in the bioethics of regenerative medicine: the tangled web of stem cell translation.

Authors:  Sarah Chan
Journal:  Regen Med       Date:  2017-11-09       Impact factor: 3.806

  6 in total

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