Science and Engineering Ethics

, Volume 11, Issue 4, pp 589–616 | Cite as

The gap between law and ethics in human embryonic stem cell research: Overcoming the effect of U.S. Federal policy on research advances and public benefit



Key ethical issues arise in association with the conduct of stem cell research by research institutions in the United States. These ethical issues, summarized in detail, receive no adequate translation into federal laws or regulations, also described in this article. U.S. Federal policy takes a passive approach to these ethical issues, translating them simply into limitations on taxpayer funding, and foregoes scientific and ethical leadership while protecting intellectual property interests through a laissez faire approach to stem cell patents and licenses. Those patents and licenses, far from being scientifically and ethically neutral in effect, virtually prohibit commercially sponsored research that could otherwise be a realistic alternative to the federal funding gap. The lack of federal funding and related data-sharing principles, combined with the effect of U.S. patent policy, the lack of key agency guidance, and the proliferation of divergent state laws arising from the lack of Federal leadership, significantly impede ethical stem cell research in the United States, without coherently supporting any consensus ethical vision. Research institutions must themselves implement steps, described in the article, to integrate addressing ethical review with the many legal compliance issues U.S. federal and state laws create.


stem cells patents intellectual property U.S. policy ethics laws 


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Rideout W M., Hochedlinger K., Kyba M., Daley G.Q., Jaenisch R. (2002) Correction of a genetic defect by nuclear transplantation and combined cell and gene therapy. Cell;109: 17–27.CrossRefGoogle Scholar
  2. 2.
    Fischbach G D & Fischbach R L. (2004) Stem cells: science, policy and ethics. Journal of Clinical Investigation.; 114: 1364–1370.CrossRefGoogle Scholar
  3. 3.
    Originally in the Balanced Budget Downpayment Act, 110 Stat. 26, 34 (1996), subsequently reenacted as Public Law 106-554, Sec. 510.Google Scholar
  4. 4.
    National Bioethics Advisory Commission. (1997). Cloning Human Beings. Rockville, MD.Google Scholar
  5. 5.
    “Rendering legal opinion regarding federal funding for research involving human pluripotent stem cells,” Memo from Harriet S. Rabb, General Counsel of the Department of Health and Human Services to Harold Varmus, Director of the National Institutes of Health, January 15, 1999.Google Scholar
  6. 6.
    National Bioethics Advisory Commission. (2000), Ethical Issues in Human Stem Cell Research. Rockville, MD.Google Scholar
  7. 7.
    President’s Council on Bioethics. (2002). Human Cloning and Human Dignity: the Report of the President’s Council on Bioethics. New York: Public Affairs. available at, accessed October 2005.Google Scholar
  8. 8.
    Towns C R & Jones D G. (2004) Stem cells, embryos, and the environment: a context for both science and ethics. Journal of Medical Ethics. 30: 410–413.CrossRefGoogle Scholar
  9. 9.
    McGee, Kaplan A L. (1999), What’s in the Dish? Hastings CenterRreporter 29:36–37.CrossRefGoogle Scholar
  10. 10.
    Meyer M J., Nelson L J. (2001) Respecting what we destroy — reflections on human embryo research. Hastings Center report 31: 16–23.CrossRefGoogle Scholar
  11. 11.
    Green R M. (2002) Determining moral status. American Journal of Bioethics. 2: 20–30.CrossRefGoogle Scholar
  12. 12.
    Doerflinger R M. (2002) Ditching Religion and Reality. American Journal of Bioethics 2: 31–32.CrossRefGoogle Scholar
  13. 13.
    Hansen J-E S. (2004) Embryonic stem cell production through therapeutic cloning has fewer ethical problems than stem cell harvest from surplus IVF embryos. Journal of Medical Ethics 28: 86–88.CrossRefGoogle Scholar
  14. 14.
    deWert G et al.. (2003) Human embryonic stem cells: Research ethics and policy. Human Reproduction. 18: 672–682.CrossRefGoogle Scholar
  15. 15.
    McHugh P R. (2004) Zygote and clonote — The ethical use of embryonic stem cells. N.Engl. J. Med. 351: 209–211.CrossRefGoogle Scholar
  16. 16.
    Sylvester KG., Longaker M T. (2004) Stem cells: review and update. Archives of Surgery. 139: 93–99.CrossRefGoogle Scholar
  17. 17.
    McLean M R. (2002) What’s in a Name? “Nuclear Transplantation” and the Ethics of Stem Cell Research. Hastings L. J. 53: 1017.Google Scholar
  18. 18.
    Lo B., Chou V., et al. (2004) Informed consent in human oocyte, embryo, and embryonic stem cell research. Fertility and Sterility 82: 559–563.CrossRefGoogle Scholar
  19. 19.
    Childress J F. (2004) Human stem cell research: some controversies in bioethics and public policy. Blood cells, Molecules and Diseases 32: 100–105.CrossRefGoogle Scholar
  20. 20.
    Kuhn V T. (2002) Stem cells: equity or ownership? American Journal of Bioethics. 2: 1–2.CrossRefGoogle Scholar
  21. 21.
    Sandel M J. (2004) Embryo Ethics — The Moral Logic of Stem Cell Research. N. Engl. J. Med. 351: 207–209.CrossRefGoogle Scholar
  22. 22.
    Tauer C A. (2004) International policy failures: cloning and stem cell research. Lancet. 364: 209–214.CrossRefGoogle Scholar
  23. 23.
    Pasquale F. (2002) Two Concepts of Immortality: Reframing Public Debate on Stem Cell Research. Yale Journ. Law & the Humanities 14: 73–121.Google Scholar
  24. 24.
    Wertz D C. (2002) Embryos and Stem Cell Research in the United States: History and Politics. Gene Therapy. 9: 674–678.CrossRefGoogle Scholar
  25. 25.
    Lauritzen P. (2005) Stem cells, biotechnology and human rights: implications for a post-human future. The Hastings CenterReport. 35(2): 25–33.CrossRefGoogle Scholar
  26. 26.
    Kopinski N E. (2004) Human-Non-Human Chimeras: A Regulatory Proposal on the Blurring on Species Lines. B.C.L. Rev. 45: 619.Google Scholar
  27. 27.
    Green M., Schill K., Takahashi S., Bateman-House A., Beauchamp T., Bok H., Cheney D., Coyle J., Deacon T., Dennett D., Donovan P., Flanagan O., Goldman S., Greely H., Martin L., Miller E., Mueller D., Siegel A., Solter D., Gearhart J., McKhann G., Faden R. (2005) Moral issues of nonhuman primate neural grafting. Science. 309: 385–386.CrossRefGoogle Scholar
  28. 28.
    Heng BC, Hong YH, Cao T. (2005) Modulating gene expression in stem cells without recombinant DNA and permanent genetic modification. Cell and Tissue Research. 321(2): 147–150.CrossRefGoogle Scholar
  29. 29.
  30. 30.
    Halliday S. (2004) A Comparative Approach to the Regulation of Human Embryonic Stem Cells Research in Europe. Med. Law Rev. 2004; 12: 40–69.CrossRefGoogle Scholar
  31. 31. (accessed October 2005).Google Scholar
  32. 32.
    See NIH Stem Cell Information — Frequently Asked Questions, Finding questions 3–4, 6–8 ( (accessed October 2005))Google Scholar
  33. 33.
    Office for Human Research Protections, Department of Health and Human Services, Guidance for Investigators and Institutional Review Boards regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Stem Cell-derived Test Articles. March 19, 2002., accessed October 2005.Google Scholar
  34. 34.
    21 C.F.R. Parts 50 and 56.Google Scholar
  35. 35.
    U.S. Food and Drug Administration, Cellular Therapy: Potential for Treating Heart Disease. June 21, 2004 (accessed October 2005 at: Scholar
  36. 36.
    U.S. Food and Drug Administration. Proposed Approach to Regulation of cellular and Tissue-based Products. February 1997 (accessed October 2005 at: Scholar
  37. 37.
    Auerbach S A (Comments). (2002) Taking Another Look at the Definition of an Embryo: President Bush’s Criteria, and the Problematic Application of Federal Regulations to Human Embyonic Stem Cells. Emery Law Journal 51: 1557.Google Scholar
  38. 38.
    21 C.F.R 1271.3(e).Google Scholar
  39. 39.
    66 FR 5447 (2001); 66 Fed. Reg. 1508 (2000); 64 FR 52696; and 68 FR 2689 (2003).Google Scholar
  40. 40.
    U.S.Patent Nos. 5843780 and 6200806.Google Scholar
  41. 41.
    WiCell website,, (accessed October 2005)Google Scholar
  42. 42.
    307 F.3d 1331, 64 U.S.P.Q 2d 1737 (Fed. Cir. 2002).Google Scholar
  43. 43.
    __ U.S. ___ (No. 03-1237, decided June 13, 2005)Google Scholar
  44. 44.
    See, e.g., the material transfer agreement used for the transfer of the new stem cell lines created by Howard Hughes Medical Institute investigator Douglas Melton at Harvard University, available through, accessed March 2005.Google Scholar
  45. 45.
    Licensing fees slow advance of stem cells. Nature. 2005;435(7040): 272–273.Google Scholar
  46. 46.
    See, e.g., the Solicitor General’s amicus brief in response to the petition for the grant of certiorari in Duke University v. John M. J. Madey (No.02-1007), accessed in December 2004 at Scholar
  47. 47.
    See, e.g., Hella M T, Eisenberg R S. (1998) Can Patents Deter Innovation? The Anticommons in Biomedical Research. 1998; 280: 698.Google Scholar
  48. 48.
    NIH Grants Policy, Part II Subpart A, Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Biomedical Research Resources, accessed at. (accessed October 2005)Google Scholar
  49. 49.
    NIH Final NIH Statement on Sharing Research Data, NOT-OD-03-032 (February 26, 2003).Google Scholar
  50. 50.
    Report of the National Institutes of Health (NIH) Working Group on Research Tools, Presented to the Advisory Committee to the Director, June 4, 1998. (accessed October 2005)Google Scholar
  51. 51.
    NIH. Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, 64 Fed. Reg. 72090 (Dec. 23, 1999).Google Scholar
  52. 52.
    Rai A K., Eisenberg R S. (2003) Bayh-Dole Reform and the Progress of Biomedicine. Law & Contemporary Problems. 66: 289.Google Scholar
  53. 53.
    Mikhail P. (2000) Hopkins v. CellPro: An Illustration that Patenting and Exclusive Licensing of Fundamental Science is Not Always in the Public Interest. Harvard Journal of Law and Technology 13: 375–394.Google Scholar
  54. 54.
    Bagley M A. (2003) Patent First, Ask Questions Later: Morality and Biotechnology in Patent Law. Wm. & Mary Law Review. 45: 469.Google Scholar
  55. 55.
    Diamond v. Chakrabarty, 447 U.S. 303 (1980).Google Scholar
  56. 56.
    Juicy Whip v. Orange Bang, 185 F.3d 1364, 1367 (Fed.Cir 1999).Google Scholar
  57. 57.
    Committee on Guidelines for Human Embryonic Stem Cell Research, National Research Council and Institute of Medicine of the National Academies. (2005) “Guidelines for Human Embryonic Stem Cell Research.” (National Academies Press 2005).Google Scholar
  58. 58.
    Holmes O W. (1897) The Path of the Law. Harvard Law Review. 10: 457.CrossRefGoogle Scholar
  59. 59.
    Zoloth L. (2002) Jordan’s Banks, A View from the First Years of Human Embryonic Stem cell Research. American Journal of Bioethics 2: 3–11.CrossRefGoogle Scholar
  60. 60.
    21 C.F.R. 56.111(a)(2); 45 C.F.R. 46.111 (a)(2).Google Scholar

Copyright information

© Opragen Publications 2005

Authors and Affiliations

  1. 1.Harvard Medical School, Deputy General Counsel and Chief Counsel, Research AffairsChildren’s Hospital BostonBostonUSA

Personalised recommendations