Commentary | Published:

Stem cell research policy and iPS cells

Nature Methods volume 7, pages 2833 (2010) | Download Citation


The field of induced pluripotent stem cells (iPSCs) will be subject to a wide range of laws and research ethics policies, many of which exist as a result of the controversies associated with research on human embryonic stem cells. Understanding this potentially complex regulatory environment will help iPSC research move forward and will inform future policy.

Access optionsAccess options

Rent or Buy article

Get time limited or full article access on ReadCube.


All prices are NET prices.


  1. 1.

    Nature 458, 962–965 (2009).

  2. 2.

    Cell Stem Cell 2, 529–533 (2008).

  3. 3.

    , & PLoS Biol. 7, e1000042 (2009).

  4. 4.

    , & CMAJ 176, 1722–1725 (2007).

  5. 5.

    et al. Cell Stem Cell 5, 11–14 (2009).

  6. 6.

    Canada's Assisted Human Reproduction Act, S.C. 2004, c. 2 (2004).

  7. 7.

    Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Tri-council policy statement: ethical conduct for research involving humans. (2005).

  8. 8.

    Canadian Institutes of Health Research. Updated guidelines for human pluripotent stem cell research. (2007).

  9. 9.

    US National Institutes of Health. Guidelines on human stem cell research. (2009).

  10. 10.

    US Office for Human Research Protections. Federal Policy for the Protection of Human Subjects (the “Common Rule”). Subpart A of 45 CFR 46 (56 FR 28003). Statutory authority for the HHS Human Subject Protection Regulations (45 CFR 46) derives from 5 U.S.C. 301; 42 U.S.C. 300v-1(b); and 42 U.S.C. 289. (2005).

  11. 11.

    US National Research Council and Institute of Medicine of the National Academies. 2008 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research (National Academies Press, Washington, DC, 2008).

  12. 12.

    US Title 45 Code of Federal Regulations, Part 46, Protection of Human Subjects (45 CFR Part 46). (2005).

  13. 13.

    Proposed amendments to the California Institute for Regenerative Medicine Medical and Ethical Standards Regulations. (2009).

  14. 14.

    Proposed amendments to the California Department of Public Health Guidelines for Human Stem Cell Research pursuant to Health and Safety Code §125118. (2009).

  15. 15.

    California Senate Bill 1260 Ch. 483 (2006).

  16. 16.

    Japan's Ministry of Education, Culture, Sports, Science and Technology. Guidelines for derivation and utilization of human ES cells. (2001).

  17. 17.

    Japan's Ministry of Education, Culture, Sports, Science and Technology. Guidelines for derivation and distribution of human ES cells [in Japanese]. (2009).

  18. 18.

    Japan's Ministry of Education, Culture, Sports, Science and Technology. Guidelines for utilization of human ES cells [in Japanese]. (2009).

  19. 19.

    Japan's Ministry of Health, Labour and Welfare. Guidelines for the clinical research using human stem cells [in Japanese]. (2006).

  20. 20.

    UK Human Fertilisation and Embryology Act 1990 Ch. 37, as amended by the Human Fertilisation and Embryology Act 2008 Ch. 22 (2008).

  21. 21.

    UK Human Tissue Act Ch. 30 (2004).

  22. 22.

    International Society for Stem Cell Research. Guidelines for the conduct of human embryonic stem cell research. (2006).

  23. 23.

    & Am. J. Bioeth. 7, 51–71 (2007).

  24. 24.

    & Eur. J. Health Law 13, 9–26 (2006).

  25. 25.

    & N. Engl. J. Med. 355, 1730–1735 (2006).

Download references


The authors wish to thank G. Lomax, S. Pattinson, U. Ogbogu and T. Camm for their review of and comments on an earlier draft, as well as Canada's Stem Cell Network and the Leading Project of the MEXT, Japan (to K.K.) for funding.

Author information


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

    • Timothy Caulfield
  2. Center for Biomedical Ethics, Stanford University, Stanford, California, USA.

    • Christopher Scott
  3. Department of Bioethics, School of Medicine, Case Western Reserve University, Cleveland, Ohio, USA.

    • Insoo Hyun
  4. Medical Research Council National Institute for Medical Research, London, UK.

    • Robin Lovell-Badge
  5. Institute for Research in Humanities, Graduate School of Biostudies, Institute for Integrated Cell-Material Sciences, Kyoto University, Kyoto, Japan.

    • Kazuto Kato
  6. Health Law Institute, University of Alberta, Edmonton, Alberta, Canada.

    • Amy Zarzeczny


  1. Search for Timothy Caulfield in:

  2. Search for Christopher Scott in:

  3. Search for Insoo Hyun in:

  4. Search for Robin Lovell-Badge in:

  5. Search for Kazuto Kato in:

  6. Search for Amy Zarzeczny in:

Corresponding author

Correspondence to Timothy Caulfield.

About this article

Publication history



Further reading

Newsletter Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing