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The Stem Cell Research Environment: A Patchwork of Patchworks

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Abstract

Few areas of recent research have received as much focus or generated as much excitement and debate as stem cell research. Hope for the therapeutic promise of this field has been matched by social concern associated largely with the sources of stem cells and their uses. This interplay between promise and controversy has contributed to the enormous variation that exists among the environments in which stem cell research is conducted throughout the world. This variation is layered upon intra-jurisdictional policies that are also often complex and in flux, resulting in what we term a ‘patchwork of patchworks’. This patchwork of patchworks and its implications will become increasingly important as we enter this new era of stem cell research. The current progression towards translational and clinical research among international collaborators serves as a catalyst for identifying potential policy conflict and makes it imperative to address jurisdictional variability in stem cell research environments. The existing patchworks seen in contemporary stem cell research environments provide a valuable opportunity to consider how variations in regulations and policies across and within jurisdictions influence research efficiencies and directions. In one sense, the stem cell research context can be viewed as a living experiment occurring across the globe. The lessons to be gleaned from examining this field have great potential for broad-ranging general science policy application.

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Notes

  1. The international workshop, “Lay of the Land”, took place in Montreal, PC on January 15–16, 2009, as part of a Stem Cell Network funded project, “The Stem Cell Research Environment: Drawing the Evidence and Experience Together”.

  2. A condensed version of this article, entitled “International stem cell environments: a world of difference”, was published in Nature Reviews Stem Cells, online: 16 April 2009 | doi:10.1038/stemcells.2009.61.

References

  1. Ogbogu, U., & Rugg-Gunn, P. (2008). The legal status of novel stem cell technologies in Canada. Journal of International Biotechnology Law, 5, 186–99. doi:10.1515/JIBL.2008.32.

    Article  Google Scholar 

  2. Ogbogu, U., Caulfield, T., & Green, S. (2008). From human embryos to interspecies creations: ethical and legal uncertainties surrounding the creation of cytoplasmic hybrids for research. Medical Law International, 9, 227–44.

    Google Scholar 

  3. Hyun, I. (2008). Stem cells from skin cells: the ethical questions. Hastings Center Report, 38(1), 20–2. doi:10.1353/hcr.2008.0004.

    Article  PubMed  Google Scholar 

  4. Cohen, C. B., & Majmuder, M. (2009). Future directions for oversight of stem cell research in the United States. Kennedy Institute of Ethics Journal, 19(1), 79–100.

    PubMed  Google Scholar 

  5. Pollack, A. (2009). F. D. A. Approves a stem cell trial. New York Times January 23, 2009. Accessed January 26, 2009 at http://www.nytimes.com/2009/01/23/business/23stem.html?_r=1.

  6. Isasi, R., & Knoppers, B. (2006). Mind the gap: policy approaches to embryonic stem cell and cloning research in 50 countries. European Journal of Health Law, 13(1), 9–25. doi:10.1163/157180906777036328.

    Article  PubMed  Google Scholar 

  7. Isasi, R., & Knoppers, B. (2006). Beyond the permissibility of embryonic and stem cell research: substantive requirements and procedural safeguards. Human Reproduction, 21(10), 247481. doi:10.1093/humrep/del235.

    Article  Google Scholar 

  8. Stayn, S. (2006). A guide to state laws on hESC research and a call for interstate dialogue. Medical Research Law and Policy Report, 5, 718.

    Google Scholar 

  9. Cohen, C. B. (2007). Renewing the stuff of life: Stem cells, ethics, and public policy (pp. 139–165). New York and Oxford: Oxford University Press.

    Google Scholar 

  10. Pardo, R., & Calvo, F. (2008). Attitudes toward embryo research, worldviews, and the moral status of the embryo frame. Science Communication, 30(1), 8–47. doi:10.1177/1075547008319432.

    Article  Google Scholar 

  11. Javitt, G., Suthers, K., & Hudson, K. (2005). Cloning: A policy analysis. Washington DC: Genetics and public policy center.

    Google Scholar 

  12. Shepherd, R., et al. (2007). Towards an understanding of British public attitudes concerning human cloning. Social Science and Medicine, 65, 377–92. doi:10.1016/j.socscimed.2007.03.018.

    Article  PubMed  Google Scholar 

  13. Nisbet, M. (2005). The competition for worldviews: values, information, and public support for stem cell research. International Journal of Public Opinion Research, 17(1), 90–112. doi:10.1093/ijpor/edh058.

    Article  Google Scholar 

  14. Critchley, C., & Turney, L. (2004). Understanding Australians’ perceptions of controversial scientific research. Australian Journal of Emerging Technologies and Society, 2(2), 82–107.

    Google Scholar 

  15. Gaskell, G., Einsiedel, E., Hallman, W., Priest, S., Jackson, J., & Oolsthoorn, J. (2005). Social values and the governance of science. Science, 310, 1908–9. doi:10.1126/science.1119444.

    Article  PubMed  CAS  Google Scholar 

  16. Downey, R., & Geransar, R. (2008). Stem cell research, publics, and stakeholder views. Health Law Review, 16(2), 70–85.

    Google Scholar 

  17. Caulfield, T., & Bubela, T. (2007). Why a criminal ban? Analyzing the arguments against somatic cell nuclear transfer in the Canadian parliamentary debate. American Journal of Bioethics, 7, 51–71. doi:10.1080/15265160601109655.

    PubMed  Google Scholar 

  18. Human Fertilisation and Embryology Authority (2009). Hybrids and Chimeras; A consultation on the ethical and social implications of creating human/animal embryos in research. 2007. Accessed January 27, 2009 at http://www.hfea.gov.uk/docs/HFEA_Final.pdf.

  19. Heller, M., & Eisenberg, R. (1998). Can patents deter innovation? The anticommons in biomedical research. Science, 280, 698–701.

    Article  PubMed  CAS  Google Scholar 

  20. Organization for Economic Co-operation and Development (2004). Patents and innovation: Trends and policy challenges. Accessed January 23, 2009 at http://www.oecd.org/dataoecd/48/12/24508541.pdf.

  21. Crovitz, G. (2008). Patent gridlock surpasses innovation. The Wall Street Journal July 14, 2008. Accessed January 23, 2009 at http://online.wsj.com/article/SB121599469382949593.html.

  22. Harmon, S. (2007). Biotechnology innovation and patenting in the developing world: china—a giant among nations? Journal of Intellectual Property Rights, 12, 72–85.

    Google Scholar 

  23. World Intellectual Property Organization (2004). World intellectual property handbook: Policy, law and use, 2nd Ed. WIPO Publication No. 489(E). Accessed January 26, 2009 at http://www.wipo.int/about-ip/en/iprm/.

  24. Wisconsin Alumni Research Foundation (2008). U.S. patent office issues certificates to uphold WARF stem cell patents. June 26, 2008. Accessed January 23, 2009 at http://www.warf.org/news/news.jsp?news_id=234.

  25. European Patent Office (2009). Case number G 0002/06, decision of the enlarged board of appeal. Accessed January 23, 2009 at http://documents.epo.org/projects/babylon/eponet.nsf/0/428862B3DA9649A9C125750E002E8E94/$FILE/G0002_06_en.pdf.

  26. Longaker, M., Baker, L., & Greely, H. (2007). Proposition 71 and CIRM—assessing the return on investment. Nature Biotechnology, 25(15), 513–21. doi:10.1038/nbt0507-513.

    Article  PubMed  CAS  Google Scholar 

  27. Caulfield, T., Ogbogu, U., & Isasi, R. (2007). Informed consent in embryonic stem cell research: are we following basic principles? Canadian Medical Association Journal, 176, 1722–5. doi:10.1503/cmaj.061675.

    Article  PubMed  Google Scholar 

  28. Caulfield, T., et al. (2007). Stem cell research ethics: consensus statement on emerging issues. Journal of Obstetrics and Gynaecology Canada, 29, 843–8.

    PubMed  Google Scholar 

  29. Winickoff, D., Saha, K., & Graff, G. (2009). Opening stem cell research and development: a policy proposal for the management of data, intellectual property, and ethics. Yale Journal of Health Policy, Law and Ethics, 9, 52–127.

    Google Scholar 

  30. Sugarman, J., & Siegel, A. (2008). Research ethics: When embryonic stem cell lines fail to meet consent standards. Science, 322(5900), 379. doi:10.1126/science.1164441.

    Article  PubMed  CAS  Google Scholar 

  31. Isasi, R., & Knoppers, B. (2007). Monetary payments for the procurement of oocytes for stem cell research: In search of ethical and political consistency. Stem Cell Research, 1(1), 37–44. doi:10.1016/j.scr.2007.09.003.

    Article  PubMed  Google Scholar 

  32. Owen-Smith, J., & McCormick, J. (2006). An international gap in human ES cell research. Nature Biotechnology, 24(4), 391–2. doi:10.1038/nbt0406-391.

    Article  PubMed  CAS  Google Scholar 

  33. Levine, A. (2008). Identifying under-and overproducing countries in research related to human embryonic stem cells. Cell Stem Cell, 2, 521–4. doi:10.1016/j.stem.2008.05.008.

    Article  PubMed  CAS  Google Scholar 

  34. Caulfield, T., Ogbogu, U., Murdoch, C., & Einsiedel, E. (2008). Patents, commercialization and the Canadian stem cell community. Regenerative Medicine, 3(4), 483–96. doi:10.2217/17460751.3.4.483.

    Article  PubMed  Google Scholar 

  35. Gold, R., et al. (2004). The unexamined assumptions of intellectual property. Public Affairs Quarterly, 18, 299–344.

    PubMed  Google Scholar 

  36. Scherer, F. (2002). The economics of human gene patents. Academic Medicine, 77, 1348–67. doi:10.1097/00001888-200212001-00006.

    Article  PubMed  Google Scholar 

  37. Bergman, K., & Graff, G. (2007). The global stem cell patent landscape: implications for efficient technology transfer and commercial development. Nature Biotechnology, 25, 419–24. doi:10.1038/nbt0407-419.

    Article  PubMed  CAS  Google Scholar 

  38. Van Looy, B., Debackere, K., Callaert, J., Tijssen, R., & van Leeuwen, T. (2006). Scientific capabilities and technological performance of national innovation systems: An exploration of emerging industrial relevant research domains. Scientometrics, 66(2), 295–310. doi:10.1007/s11192-006-0030-3.

    Article  Google Scholar 

  39. Murray, F., & Stern, S. (2007). Do formal intellectual property rights hinder the free flow of scientific knowledge? An empirical test of the anti-commons hypothesis. Journal of Economic Behavior and Organization, 63(4), 648–87. doi:10.1016/j.jebo.2006.05.017.

    Article  Google Scholar 

  40. International Society for Stem Cell Research (2008). Guidelines for the clinical translation of stem cells. Accessed January 21, 2009 at http://www.isscr.org/clinical_trans/pdfs/ISSCRGLClinicalTrans.pdf.

  41. Lau, D., Ogbogu, U., Taylor, B., Stafinski, T., Menon, D., & Caulfield, T. (2008). Stem cell clinics online: the direct-to-consumer portrayal of stem cell medicine. Cell Stem Cell, 3, 591–4. doi:10.1016/j.stem.2008.11.001.

    Article  PubMed  CAS  Google Scholar 

  42. Levine, A. (2006). Research policy and the mobility of US stem cell scientists. Nature Biotechnology, 24(7), 865–6. doi:10.1038/nbt0706-865.

    Article  PubMed  CAS  Google Scholar 

  43. Winickoff, D., Saha, K., & Graff, G. (2009). Opening stem cell research and development: a policy proposal for the management of data, intellectual property, and ethics. Yale Journal of Health Policy, Law and Ethics, 9, 52–127. at 75–88.

    Google Scholar 

  44. McCormick, J., Owen-Smith, J., & Scott, C. (2009). Distribution of human embryonic stem cell lines: who, when, and where. Cell Stem Cell, 4(2), 107–10. doi:10.1016/j.stem.2009.01.002.

    Article  PubMed  CAS  Google Scholar 

  45. Lomax, G., & McNab, A. (2008). Harmonizing standards and coding for hESC research. Cell Stem Cell, 2, 201–2. doi:10.1016/j.stem.2008.02.002.

    Article  PubMed  CAS  Google Scholar 

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Acknowledgments

The authors would like to thank the Canadian Stem Cell Network for its funding support. Special thanks also go to Christopher Scott, Bartha Knoppers and Cynthia Cohen.

Author information

Authors and Affiliations

  1. Health Law Institute, Faculty of Law, University of Alberta, Edmonton, Canada

    Timothy Caulfield & Amy Zarzeczny

  2. Department of Medicine, Program in Professionalism and Bioethics, Mayo Clinic and College of Medicine, Rochester, USA

    Jennifer McCormick

  3. Health Law Institute, School of Public Health, University of Alberta, Edmonton, Canada

    Tania Bubela

  4. Swinburne University, Melbourne, Australia

    Christine Critchley

  5. Faculty of Communication and Culture, University of Calgary, Calgary, Canada

    Edna Einsiedel

  6. Lady Davis Institute for Medical Research, Sir Mortimer B. Davis Jewish Hospital, McGill University, Montreal, Canada

    Jacques Galipeau

  7. ESRC InnoGen and AHRC SCRIPT, University of Edinburgh, Edinburgh, UK

    Shawn Harmon

  8. McGill University, Montreal, Canada

    Michael Huynh

  9. Case Western Reserve University, Cleveland, USA

    Insoo Hyun

  10. National Core for Neuroethics, Department of Medicine, Division of Neurology, University of British Columbia, Vancouver, Canada

    Judy Illes

  11. Centre de recherche en droit public, Université de Montréal, Montreal, Canada

    Rosario Isasi & Yann Joly

  12. School of Law, University of Edinburgh, Edinburgh, UK

    Graeme Laurie

  13. California Institute for Regenerative Medicine, San Francisco, USA

    Geoff Lomax

  14. The W. Maurice Young Centre for Applied Ethics, University of British Columbia, Vancouver, Canada

    Holly Longstaff & Michael McDonald

  15. Faculty of Law, University of Toronto, Toronto, Canada

    Ubaka Ogbogu

  16. Health Law Institute, University of Alberta, Edmonton, Canada

    Charles Murdoch & Ubaka Ogbogu

  17. University of Michigan, Ann Arbor, USA

    Jason Owen-Smith

  18. Department of Law, Durham University, Durham, UK

    Shaun Pattinson

  19. Department of Community Health Sciences, University of Calgary, Calgary, Canada

    Shainur Premji

  20. College of Law and School of Public Health, University of Saskatchewan, Saskatoon, Canada

    Barbara von Tigerstrom

  21. University of California, Berkeley, USA

    David E. Winickoff

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  1. Timothy Caulfield
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  2. Amy Zarzeczny
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  16. Holly Longstaff
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  24. David E. Winickoff
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Correspondence to Timothy Caulfield.

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Caulfield, T., Zarzeczny, A., McCormick, J. et al. The Stem Cell Research Environment: A Patchwork of Patchworks. Stem Cell Rev and Rep 5, 82–88 (2009). https://doi.org/10.1007/s12015-009-9071-3

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