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).
Highlights
Stem cell science is a controversial field of research with a huge potential market for therapeutic applications on a global scale (Department of Business Innovation &Skills, 2011)
National home-keeping policies use regulation to enable translational stem cell applications despite the existence of international authorities such as the International Society for Stem Cell Research (ISSCR)
The concept calls for attention to how countries formulate stem cell policies through locally available political and regulatory mechanisms to articulate circumstances at home with global regulatory trends: governments can alter the status of national and local regulation; use various kinds of permissions for stem cell studies, trials, and provision; create regulatory clauses to make spaces for experimentation; allow hidden deployment of unauthorised therapies, and accelerate pathways to the marketing of stem cell products
Summary
Comparing National Home-Keeping and the Regulation of Translational Stem Cell Applications: An International Perspective. Received Date: 30 March 2015 Revised Date: 23 January 2016 Accepted Date: 25 January 2016. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain
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