Stem Cell Reviews and Reports

, Volume 5, Issue 2, pp 108–115 | Cite as

Policy Interoperability in Stem Cell Research: Demystifying Harmonization

Hypothesis and Commentary


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.


Stem cells Ethics Policy Legislation Harmonization Transfer hESC lines Cross-border research International research Law reform Policy convergence Stem cell tourism Stem cell banks 



The author would like to thank the Canadian Stem Cell Network, the International Regulome Consortium and the International Stem Cell Forum for their funding support. The author would also thanks Professors Bartha M. Knoppers and Timothy Caulfield for their comments and thoughtful suggestions on an earlier version of the present article. The opinions are those of the author alone.


  1. 1.
    Matthews, D. J., Donovan, P., Harris, J., et al. (2006). Integrity in International Stem Cell Research Collaborations. Science., 313, 921–2. doi: 10.1126/science.1127990.CrossRefGoogle Scholar
  2. 2.
    Boodman, M. (1991). The Myth of Harmonization of Laws. Am J Contemp Law., 39, 699–724. doi: 10.2307/840738.CrossRefGoogle Scholar
  3. 3.
    Oxford University Press. Oxford English Dictionary 2008.Google Scholar
  4. 4.
    Isasi RM, Knoppers BM. (a). Mind the Gap: Policy Approaches to Embryonic Stem Cell and Cloning Research in 50 countries. Eur J Health Law. 2006;13(1):9–25. doi: 10.1163/157180906777036328
  5. 5.
    Isasi, R. M., & Knoppers, B. M. (2007). c. Monetary payments for the procurement of oocytes for stem cell research: In search of ethical and political consistency. Stem Cell Rev., 1, 37–44. doi: 10.1016/j.scr.2007.09.003.Google Scholar
  6. 6.
    Lomax G, Stayn S. Similarities and Differences Among Stem Cell Research Policies: Opportunities for Policymakers, Patients and Researchers. Medical Research Law & Policy 2008 7(21): 695-698.Google Scholar
  7. 7.
    McCormick JB, Owen-Smith J, Scott CT. Distribution of Human Embryonic Stem Cell Lines: Who, When, and Where. Cell Stem Cell. 2009;4(2):107–10. doi: 10.1016/j.stem.2009.01.002
  8. 8.
    Lo, B., Parham, L., Broom, C., et al. (2009). Importing Human Pluripotent Stem Cell Lines Derived at Another Institution: Tailoring Review to Ethical Concerns. Cell Stem Cell., 4, 115–23. doi: 10.1016/j.stem.2009.01.013.PubMedCrossRefGoogle Scholar
  9. 9.
    O’Rourke, P. P., Abelman, M., & Heffernan, K. G. (2008). Centralized Banks for Human Embryonic Stem Cells: A Worthwhile Challenge. Cell Stem Cell., 2, 307–12. doi: 10.1016/j.stem.2008.03.018.PubMedCrossRefGoogle Scholar
  10. 10.
    Elstner A, Damaschum A, Kurtz G, et al. The Changing Landscape of European and International Regulation on Embryonic Stem Cell Research. Stem Cell Rev. 2008; In press.Google Scholar
  11. 11.
    Bovenberg, J. A. (2007). Legal Pathways for Cross-Border Research: Building a Legal Platform for Biomedical Academia. Eur J Hum Genet., 15, 522–4. doi: 10.1038/sj.ejhg.5201792.PubMedCrossRefGoogle Scholar
  12. 12.
    Committee on Guidelines for Human Embryonic Stem Cell Research, National Research Council National Academies of Science. Guidelines for Human Embryonic Stem Cell Research 2007, 2008 Amendments.Google Scholar
  13. 13.
    Sugarman, J., & Siegel, A. (2008). How to Determine Whether Existing Human Embryonic Stem Cell Lines Can be Used Ethically. Cell Stem Cell., 3, 238–9. doi: 10.1016/j.stem.2008.08.012.PubMedCrossRefGoogle Scholar
  14. 14.
    Lomax, G., & Mc Nab, A. (2008). Harmonizing Standards and Coding for hESC Research. Cell Stem Cell., 2, 201–2. doi: 10.1016/j.stem.2008.02.002.PubMedCrossRefGoogle Scholar
  15. 15.
    Hyun I, Lindvall O, Ahrlund-Richter L, et al. New ISSCR guidelines Underscore Major Principles for Responsible Translational Stem Cell Research. Cell Stem Cell. 2008;3(6):607–9. doi: 10.1016/j.stem.2008.11.009
  16. 16.
    Mauron A, Jacone ME. Stem Cell Science: Current Ethical and Policy Issues. Clin Pharmacol Ther. 2007;82(3):330–3. doi: 10.1038/sj.clpt.6100295
  17. 17.
    Isasi RM, Annas GJ. To clone alone: the United Nations' Human Cloning Declaration. Law Hum Genome Rev 2006; Jan-Jul (24): 13-26.Google Scholar

Copyright information

© Springer Science + Business Media 2009

Authors and Affiliations

  1. 1.CRDPUniversité de MontréalMontréalCanada

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