Literature DB >> 19521802

Policy interoperability in stem cell research: demystifying harmonization.

Rosario M Isasi1.   

Abstract

Scientific developments in the field of stem cell research continue to emerge at incredible speed and so too has the contentious debate surrounding their broad implications. Though economic, socio-ethical and legal concerns remain, at both national and international forums; we are witnessing a departure from an "embryo-centric" approach, to one that is focused on the globalization of research and to the ensuing need for policy interoperability. The common response to the challenges associated with the meaning, scope, and ethical significance of variance in national policies, is a call for the creation of uniform legal and ethical standards. However, this call towards policy convergence on the fundamental ethical and governance principles underpinning policies choices has led to confusion and to the mystification of the notion of harmonization. In this article we aim demystify the notion of policy harmonization in the context of stem cell research. We will do so by surveying the diverse elements to be harmonized. We will then present the problems of policy interoperability in the context of the globalization of SC research, in order to propose that the goal of harmonization in this field lies in the identification of prospective strategies to foster seamless cross-jurisdictional collaboration. Finally, policy interoperability will be analyzed through the lens of a range of policy approaches addressing the cross-jurisdictional transfer of hESC lines with the aim of demonstrating that the apparent ethical-political-legal divide in some contexts largely vanishes once we grasp the notion of harmonization and identify points of convergence.

Mesh:

Year:  2009        PMID: 19521802     DOI: 10.1007/s12015-009-9067-z

Source DB:  PubMed          Journal:  Stem Cell Rev Rep        ISSN: 2629-3277            Impact factor:   5.739


  13 in total

1.  Mind the gap: policy approaches to embryonic stem cell and cloning research in 50 countries.

Authors:  Rosario M Isasi; Bartha M Knoppers
Journal:  Eur J Health Law       Date:  2006-04

2.  Legal pathways for cross-border research: building a legal platform for biomedical academia.

Authors:  Jasper A Bovenberg
Journal:  Eur J Hum Genet       Date:  2007-02-28       Impact factor: 4.246

Review 3.  Stem cell science: current ethical and policy issues.

Authors:  A Mauron; M E Jaconi
Journal:  Clin Pharmacol Ther       Date:  2007-07-18       Impact factor: 6.875

Review 4.  New ISSCR guidelines underscore major principles for responsible translational stem cell research.

Authors:  Insoo Hyun; Olle Lindvall; Lars Ahrlund-Richter; Elena Cattaneo; Marina Cavazzana-Calvo; Giulio Cossu; Michele De Luca; Ira J Fox; Claude Gerstle; Robert A Goldstein; Göran Hermerén; Katherine A High; Hyun Ok Kim; Hin Peng Lee; Ephrat Levy-Lahad; Lingsong Li; Bernard Lo; Daniel R Marshak; Angela McNab; Megan Munsie; Hiromitsu Nakauchi; Mahendra Rao; Heather M Rooke; Carlos Simon Valles; Alok Srivastava; Jeremy Sugarman; Patrick L Taylor; Anna Veiga; Adrianne L Wong; Laurie Zoloth; George Q Daley
Journal:  Cell Stem Cell       Date:  2008-12-04       Impact factor: 24.633

5.  Importing human pluripotent stem cell lines derived at another institution: tailoring review to ethical concerns.

Authors:  Bernard Lo; Lindsay Parham; Christopher Broom; Marcelle Cedars; Elena Gates; Linda Giudice; Dina Gould Halme; William Hershon; Arnold Kriegstein; Pui-yan Kwok; Michelle Oberman; Clifford Roberts; Richard Wagner
Journal:  Cell Stem Cell       Date:  2009-02-06       Impact factor: 24.633

6.  How to determine whether existing human embryonic stem cell lines can be used ethically.

Authors:  Jeremy Sugarman; Andrew Siegel
Journal:  Cell Stem Cell       Date:  2008-09-11       Impact factor: 24.633

Review 7.  Harmonizing standards and coding for hESC research.

Authors:  Geoffrey Lomax; Angela McNab
Journal:  Cell Stem Cell       Date:  2008-03-06       Impact factor: 24.633

8.  To clone alone: the United Nations' Human Cloning Declaration.

Authors:  Rosario M Isasi; George J Annas
Journal:  Rev Derecho Genoma Hum       Date:  2006 Jan-Jul

9.  Distribution of human embryonic stem cell lines: who, when, and where.

Authors:  Jennifer B McCormick; Jason Owen-Smith; Christopher Thomas Scott
Journal:  Cell Stem Cell       Date:  2009-02-06       Impact factor: 24.633

10.  Science and law. Integrity in international stem cell research collaborations.

Authors:  Debra J H Mathews; Peter Donovan; John Harris; Robin Lovell-Badge; Julian Savulescu; Ruth Faden
Journal:  Science       Date:  2006-08-18       Impact factor: 47.728

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  9 in total

1.  Stem cell banking: between traceability and identifiability.

Authors:  Bartha M Knoppers; Rosario Isasi
Journal:  Genome Med       Date:  2010-10-05       Impact factor: 11.117

2.  Stem cell research in the Greater Middle East: the importance of establishing policy and ethics interoperability to foster international collaborations.

Authors:  Jesse M Flynn; Kirstin R W Matthews
Journal:  Stem Cell Rev Rep       Date:  2010-06       Impact factor: 5.739

Review 3.  Ethical Issues for Clinical Studies That use Human Embryonic Stem Cells: The 2014 Revisions to the Japanese Guidelines.

Authors:  Hiroshi Mizuno
Journal:  Stem Cell Rev Rep       Date:  2015-10       Impact factor: 5.739

Review 4.  Stem Cell-Based Therapies: What Interventional Radiologists Need to Know.

Authors:  Hyeon Yu; Clayton W Commander; Joseph M Stavas
Journal:  Semin Intervent Radiol       Date:  2021-11-24       Impact factor: 1.780

5.  From banking to international governance: fostering innovation in stem cell research.

Authors:  Rosario Isasi; Bartha M Knoppers
Journal:  Stem Cells Int       Date:  2011-09-05       Impact factor: 5.443

6.  Policy recommendations for addressing privacy challenges associated with cell-based research and interventions.

Authors:  Ubaka Ogbogu; Sarah Burningham; Adam Ollenberger; Kathryn Calder; Li Du; Khaled El Emam; Robyn Hyde-Lay; Rosario Isasi; Yann Joly; Ian Kerr; Bradley Malin; Michael McDonald; Steven Penney; Gayle Piat; Denis-Claude Roy; Jeremy Sugarman; Suzanne Vercauteren; Griet Verhenneman; Lori West; Timothy Caulfield
Journal:  BMC Med Ethics       Date:  2014-02-03       Impact factor: 2.652

7.  Uncertainty and innovation: Understanding the role of cell-based manufacturing facilities in shaping regulatory and commercialization environments.

Authors:  Rosario Isasi; Vasiliki Rahimzadeh; Kathleen Charlebois
Journal:  Appl Transl Genom       Date:  2016-11-11

8.  Considerations for an integrated population health databank in Africa: lessons from global best practices.

Authors:  Jude O Igumbor; Edna N Bosire; Marta Vicente-Crespo; Ehimario U Igumbor; Uthman A Olalekan; Tobias F Chirwa; Sam M Kinyanjui; Catherine Kyobutungi; Sharon Fonn
Journal:  Wellcome Open Res       Date:  2021-08-23

9.  Research Translation and Emerging Health Technologies: Synthetic Biology and Beyond.

Authors:  Sarah Chan
Journal:  Health Care Anal       Date:  2018-12
  9 in total

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