The Stem Cell Research Environment: A Patchwork of Patchworks
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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.
KeywordsStem 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.
- 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
- 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.
- 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
- 11.Javitt, G., Suthers, K., & Hudson, K. (2005). Cloning: A policy analysis. Washington DC: Genetics and public policy center.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
- 16.Downey, R., & Geransar, R. (2008). Stem cell research, publics, and stakeholder views. Health Law Review, 16(2), 70–85.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.
- 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.
- 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
- 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
- 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.
- 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