Stem Cell Reviews and Reports

, Volume 5, Issue 2, pp 82–88 | Cite as

The Stem Cell Research Environment: A Patchwork of Patchworks

  • Timothy CaulfieldEmail author
  • Amy Zarzeczny
  • Jennifer McCormick
  • Tania Bubela
  • Christine Critchley
  • Edna Einsiedel
  • Jacques Galipeau
  • Shawn Harmon
  • Michael Huynh
  • Insoo Hyun
  • Judy Illes
  • Rosario Isasi
  • Yann Joly
  • Graeme Laurie
  • Geoff Lomax
  • Holly Longstaff
  • Michael McDonald
  • Charles Murdoch
  • Ubaka Ogbogu
  • Jason Owen-Smith
  • Shaun Pattinson
  • Shainur Premji
  • Barbara von Tigerstrom
  • David E. Winickoff


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.


Stem cell research Policy Regulation International Collaboration Harmonization 



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.


  1. 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.CrossRefGoogle Scholar
  2. 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. 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.PubMedCrossRefGoogle Scholar
  4. 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.PubMedGoogle Scholar
  5. 5.
    Pollack, A. (2009). F. D. A. Approves a stem cell trial. New York Times January 23, 2009. Accessed January 26, 2009 at
  6. 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.PubMedCrossRefGoogle Scholar
  7. 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.CrossRefGoogle Scholar
  8. 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. 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. 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.CrossRefGoogle Scholar
  11. 11.
    Javitt, G., Suthers, K., & Hudson, K. (2005). Cloning: A policy analysis. Washington DC: Genetics and public policy center.Google Scholar
  12. 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.PubMedCrossRefGoogle Scholar
  13. 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.CrossRefGoogle Scholar
  14. 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. 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.PubMedCrossRefGoogle Scholar
  16. 16.
    Downey, R., & Geransar, R. (2008). Stem cell research, publics, and stakeholder views. Health Law Review, 16(2), 70–85.Google Scholar
  17. 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.PubMedGoogle Scholar
  18. 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
  19. 19.
    Heller, M., & Eisenberg, R. (1998). Can patents deter innovation? The anticommons in biomedical research. Science, 280, 698–701.PubMedCrossRefGoogle Scholar
  20. 20.
    Organization for Economic Co-operation and Development (2004). Patents and innovation: Trends and policy challenges. Accessed January 23, 2009 at
  21. 21.
    Crovitz, G. (2008). Patent gridlock surpasses innovation. The Wall Street Journal July 14, 2008. Accessed January 23, 2009 at
  22. 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. 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
  24. 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
  25. 25.
    European Patent Office (2009). Case number G 0002/06, decision of the enlarged board of appeal. Accessed January 23, 2009 at$FILE/G0002_06_en.pdf.
  26. 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.PubMedCrossRefGoogle Scholar
  27. 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.PubMedCrossRefGoogle Scholar
  28. 28.
    Caulfield, T., et al. (2007). Stem cell research ethics: consensus statement on emerging issues. Journal of Obstetrics and Gynaecology Canada, 29, 843–8.PubMedGoogle Scholar
  29. 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. 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.PubMedCrossRefGoogle Scholar
  31. 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.PubMedCrossRefGoogle Scholar
  32. 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.PubMedCrossRefGoogle Scholar
  33. 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.PubMedCrossRefGoogle Scholar
  34. 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.PubMedCrossRefGoogle Scholar
  35. 35.
    Gold, R., et al. (2004). The unexamined assumptions of intellectual property. Public Affairs Quarterly, 18, 299–344.PubMedGoogle Scholar
  36. 36.
    Scherer, F. (2002). The economics of human gene patents. Academic Medicine, 77, 1348–67. doi: 10.1097/00001888-200212001-00006.PubMedCrossRefGoogle Scholar
  37. 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.PubMedCrossRefGoogle Scholar
  38. 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.CrossRefGoogle Scholar
  39. 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.CrossRefGoogle Scholar
  40. 40.
    International Society for Stem Cell Research (2008). Guidelines for the clinical translation of stem cells. Accessed January 21, 2009 at
  41. 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.PubMedCrossRefGoogle Scholar
  42. 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.PubMedCrossRefGoogle Scholar
  43. 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. 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.PubMedCrossRefGoogle Scholar
  45. 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.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science + Business Media 2009

Authors and Affiliations

  • Timothy Caulfield
    • 1
    Email author
  • Amy Zarzeczny
    • 1
  • Jennifer McCormick
    • 2
  • Tania Bubela
    • 3
  • Christine Critchley
    • 4
  • Edna Einsiedel
    • 5
  • Jacques Galipeau
    • 6
  • Shawn Harmon
    • 7
  • Michael Huynh
    • 8
  • Insoo Hyun
    • 9
  • Judy Illes
    • 10
  • Rosario Isasi
    • 11
  • Yann Joly
    • 11
  • Graeme Laurie
    • 12
  • Geoff Lomax
    • 13
  • Holly Longstaff
    • 14
  • Michael McDonald
    • 14
  • Charles Murdoch
    • 16
  • Ubaka Ogbogu
    • 15
    • 16
  • Jason Owen-Smith
    • 17
  • Shaun Pattinson
    • 18
  • Shainur Premji
    • 19
  • Barbara von Tigerstrom
    • 20
  • David E. Winickoff
    • 21
  1. 1.Health Law Institute, Faculty of LawUniversity of AlbertaEdmontonCanada
  2. 2.Department of Medicine, Program in Professionalism and BioethicsMayo Clinic and College of MedicineRochesterUSA
  3. 3.Health Law Institute, School of Public HealthUniversity of AlbertaEdmontonCanada
  4. 4.Swinburne UniversityMelbourneAustralia
  5. 5.Faculty of Communication and CultureUniversity of CalgaryCalgaryCanada
  6. 6.Lady Davis Institute for Medical Research, Sir Mortimer B. Davis Jewish HospitalMcGill UniversityMontrealCanada
  7. 7.ESRC InnoGen and AHRC SCRIPTUniversity of EdinburghEdinburghUK
  8. 8.McGill UniversityMontrealCanada
  9. 9.Case Western Reserve UniversityClevelandUSA
  10. 10.National Core for Neuroethics, Department of Medicine, Division of NeurologyUniversity of British ColumbiaVancouverCanada
  11. 11.Centre de recherche en droit publicUniversité de MontréalMontrealCanada
  12. 12.School of LawUniversity of EdinburghEdinburghUK
  13. 13.California Institute for Regenerative MedicineSan FranciscoUSA
  14. 14.The W. Maurice Young Centre for Applied EthicsUniversity of British ColumbiaVancouverCanada
  15. 15.Faculty of LawUniversity of TorontoTorontoCanada
  16. 16.Health Law InstituteUniversity of AlbertaEdmontonCanada
  17. 17.University of MichiganAnn ArborUSA
  18. 18.Department of LawDurham UniversityDurhamUK
  19. 19.Department of Community Health SciencesUniversity of CalgaryCalgaryCanada
  20. 20.College of Law and School of Public HealthUniversity of SaskatchewanSaskatoonCanada
  21. 21.University of CaliforniaBerkeleyUSA

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