Skip to main content
SpringerLink
Log in

Stem Cell Policy Exceptionalism: Proceed with Caution

  • Published:
Stem Cell Reviews and Reports Aims and scope Submit manuscript

Abstract

The term “stem cell exceptionalism” has been used to characterize the policy response to controversies surrounding human embryonic stem cell research. For example, governments and funding agencies have adopted policies governing the derivation and use of human embryonic stem cell lines. These policies have effectively served to fill gaps in existing guidelines and regulations and signal that scientists are committed to a responsible framework for the conduct of research involving human embryos. Recent publications discuss whether ethical and policy issues associated with induced pluripotent cells (iPSCs) from non-embryonic sources create a need for further policy intervention. We suggest many of the issues identified by commentators may be addressed through the application of established policy frameworks governing the use of tissue, human stem cells, and research participation by human research subjects. To the extent, iPSC research intersects with hESC research (e.g. the creation of human gametes and/or embryos), the policy framework governing hESC appears sufficiently robust at this time.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Snead, O. (2005). Preparing the groundwork for a responsible debate on stem cell research and human cloning. New England Law Review, 39, 479.

    Google Scholar 

  2. Stayn, S. (2006). A guide to state laws on hESC research and a call for interstate dialogue. Medical Research Law & Policy, 05(21), 718–725.

    Google Scholar 

  3. Sage, W. (2010). Will embryonic stem cells change health policy? Journal of Law, Medicine & Ethics, Law, Science and Innovation: The Embryonic Stem Cell Controversy, summer.

  4. NAS. (2005). Guidelines for human embryonic stem cell research. IOM National Research Council (U.S.). Committee on Guidelines for Human Embryonic Stem Cell Research. Washington: The National Academies Press.

    Google Scholar 

  5. Robertson, J. (2010). Embryo stem cell research: ten years of controversy. Journal of Law, Medicine & Ethics, Science and Innovation: The Embryonic Stem Cell Controversy, Summer.

  6. Lo, B., Parham, L., et al. (2010). Cloning mice and men: prohibiting the use of iPS cells for human reproductive cloning. Cell Stem Cell, 6(1), 16–20.

    Article  PubMed  CAS  Google Scholar 

  7. Caulfield, T., Scott, C., et al. (2010). Stem cell research policy and iPS cells. Nature Methods, 7(1), 28–33.

    Article  PubMed  CAS  Google Scholar 

  8. Aalto-Setala, K., Conklin, B. R., et al. (2009). Obtaining consent for future research with induced pluripotent cells: opportunities and challenges. PLoS Biology, 7(2), 204–208.

    Article  Google Scholar 

  9. Zarzeczny, A., Scott, C., et al. (2009). iPS cells: mapping the policy issues. Cell, 139(6), 1032–1037.

    Article  PubMed  CAS  Google Scholar 

  10. Sugarman, J. (2008). Human stem cell ethics: beyond the embryo. Cell Stem Cell, 2(6), 529–533.

    Article  PubMed  CAS  Google Scholar 

  11. Condic, M. L., & Rao, M. (2008). Regulatory issues for personalized pluripotent cells. Stem Cells, 26(11), 2753–2758.

    Article  PubMed  CAS  Google Scholar 

  12. Gunsalus, C. K., Bruner, E. M., et al. (2006). Mission creep and the IRB world. Science, 312(5779), 1441.

    Article  PubMed  CAS  Google Scholar 

  13. Kawakami, M., Sipp, D., & Kato, K. (2010). Regulatory impacts on stem cell research in Japan. Cell Stem Cell, 7:6(5), 415–418.

    Article  Google Scholar 

  14. Fink, D. W., Jr. (2009). FDA regulation of stem cell-based products. Science, 324(5935), 1662–1663.

    Article  PubMed  CAS  Google Scholar 

  15. Carpenter, M. K., Frey-Vasconcells, J., et al. (2009). Developing safe therapies from human pluripotent stem cells. Nature Biotechnology, 27(7), 606–613.

    Article  PubMed  CAS  Google Scholar 

  16. Rao, M., & Condic, M. L. (2009). Musings on genome medicine: is there hope for ethical and safe stem cell therapeutics? Genome Medicine, 1(7), 70.

    Article  PubMed  Google Scholar 

  17. Lau, D., et al. (2008). Stem cell clinics online: the direct-to-consumer portrayal of stem cell medicine. Cell Stem Cell, 3(6), 591–594.

    Article  PubMed  CAS  Google Scholar 

  18. CIRM (2011). Ethical and Policy Considerations for A Pluripotent Stem Cell Resource Center 2011 Update. Available at http://www.cirm.ca.gov/files/MeetingReports/SWG_April_2011_6_28_2011.pdf (accessed July 19, 2011).

  19. Mascalzoni, D., Hicks, A., et al. (2008). Informed consent in the genomics era. PLoS Medicine, 5(9), 1302–1305.

    Article  Google Scholar 

  20. Helft, P. R., Champion, V. L., et al. (2007). Cancer patients’ attitudes toward future research uses of stored human biological materials. Journal of Empirical Research on Human Research Ethics, 2(3), 15–22.

    Article  PubMed  Google Scholar 

  21. Malin, B., & Loukides, G. (2011). Identifiability in biobanks: models, measures, and mitigation strategies. Hum Genet. 2011 Jul 8. [Epub ahead of print].

  22. Baylis, F. (2008). Animal eggs for stem cell research: a path not worth taking. The American Journal of Bioethics, 8(12), 18–32.

    Article  PubMed  Google Scholar 

  23. Winickoff, D. E., & Winickoff, R. N. (2003). The charitable trust as a model for genomic biobanks. The New England Journal of Medicine, 349, 1180–1184.

    Article  PubMed  CAS  Google Scholar 

  24. Holm, S. (2006). Who should control the use of human embryonic stem cell lines: a defense of the donors’ ability to control. Bioethical Inquiry, 3, 55–68.

    Article  Google Scholar 

  25. Wendler, D. (2006). One-time general consent for research on biological samples. BMJ, 332(7540), 544–547.

    Article  PubMed  Google Scholar 

  26. Simon, C., & L’Heureux, J. (2011). Active choice but not too active: Public perspectives on biobank consent models. Genetics in Medicine, Published Ahead-of-Print.

  27. Caulfield, T. (2007). Biobanks and blanket consent: the proper place of the public good and public perception rationales. Kings Law Journal, 18, 209–226.

    Google Scholar 

  28. Presentation by Chris Hempel PRIM&R Advancing ethical research conference Tuesday December 7, 2010. Also, see http://addiandcassi.com/.

  29. UNESCO (2003) International declaration on human genetic data. United Nations Educational, Scientific, and Cultural Organization and ESHG. Eur J Hum Genet, 11(Suppl 2), S8–10.

    Google Scholar 

  30. National Cancer Institute. (2007). National Cancer Institute best practices for biospecimen resources.

  31. National Institutes of Health. (2009). National Institutes of Health guidelines on human stem cell research.

  32. Rothstein, M. A. (2007). Genetic exceptionalism and legislative pragmatism. The Journal of Law, Medicine & Ethics, 35(2 Suppl), 59–65.

    Article  Google Scholar 

  33. Caulfield, T., Zarzeczny, A., et al. (2009). The stem cell research environment: a patchwork of patchworks. Stem Cell Review and Reports, 5(2), 82–88.

    Article  Google Scholar 

Download references

Acknowledgments

The authors would like to acknowledge the time and effort taken by the reviewers to proved comprehensive comments.

Author information

Authors and Affiliations

  1. California Institute for Regenerative Medicine, 210 King Street, San Francisco, CA, 94107, USA

    Geoffrey P. Lomax

  2. Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research, University of California, Los Angeles, Box 957357, 477 (BSRB) Biomedical Sciences Research Building, Los Angeles, CA, 90095-7357, USA

    Steven R. Peckman

Authors
  1. Geoffrey P. Lomax
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Steven R. Peckman
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Geoffrey P. Lomax.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Lomax, G.P., Peckman, S.R. Stem Cell Policy Exceptionalism: Proceed with Caution. Stem Cell Rev and Rep 8, 299–304 (2012). https://doi.org/10.1007/s12015-011-9305-z

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12015-011-9305-z

Keywords

Search

Navigation