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Contemporary Ethical Issues in Stem Cell Research

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Abstract

Recent advancements in stem cell technologies bring the promise of finding treatments and cures to a wide range of conditions and diseases but also considerable ethical concerns. This chapter focuses on contemporary bioethical issues central to individuals’ participation in stem cell research as “human subjects.” It explores how the core ethical principles of beneficence, respect for persons, and justice may be implicated in research requiring donation of gametes, embryos, and somatic cells and in clinical trials or innovative stem cell therapies. The first section addresses certain rights of individuals who donate biological materials for the purposes of human embryonic stem cell research, including the necessity of providing voluntary informed consent and how compensation for participation may affect the voluntariness of such consent. The second section evaluates ethical issues relating to the testing and using novel stem cell therapies in humans.

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References

  1. Thomson JA, Itskkovitz-Eldor J, Shapiro SS, Waknitz MA, Swiergiel JJ, Marshall VS, Jones JM. Embryonic stem cell lines derived from human blastocysts. Science. 1998;282(5391):1145–7.

    Article  PubMed  CAS  Google Scholar 

  2. Lo B, Parham L. Ethical issues in stem cell research. Endocr Rev. 2009;30(3):204–13.

    Article  PubMed  Google Scholar 

  3. Steinbock B. Moral status and human embryos. 2006. http://dspace.sunyconnect.suny.edu/bitstream/handle/1951/52173/Moral%20Status,%20Moral%20Value,%20and%20Human%20Embryos.pdf?sequence=1. Accessed 11 May 2012.

  4. International Society for Stem Cell Research. Guidelines for the conduct of human embryonic stem cell research. 2006. http://www.isscr.org/docs/default-source/hesc-guidelines/isscrhescguidelines2006.pdf. Accessed 11 May 2012.

  5. National Institutes of Health. NIH guidelines for human stem cell research. 2009. http://stemcells.nih.gov/policy/pages/2009guidelines.aspx. Accessed 11 May 2012.

  6. National Academy of Sciences. Amendments to the guidelines for embryonic stem cell research. 2010. http://www.nap.edu/catalog.php?record_id=12923. Accessed 11 May 2012.

  7. Egli D, Chen A, Saphier G, Powers D, Alper M, Katz K, Berger B, Goland R, Leibel RL, Melton DA, Eggan K. Impracticality of egg donor recruitment in the absence of compensation. Cell Stem Cell. 2011;9(4):293–4.

    Article  PubMed  CAS  Google Scholar 

  8. Hyun I. Moving human SCNT research forward ethically. Cell Stem Cell. 2011;9(4):295–7.

    Article  PubMed  CAS  Google Scholar 

  9. Roxland B. New York State’s landmark policies on oversight and compensation for egg donation to stem cell research. Regen Med. 2012;7(3):397–408.

    Article  PubMed  CAS  Google Scholar 

  10. Streiffer R. At the edge of humanity: human stem cells, chimeras, and moral status. Kennedy Inst Ethics J. 2005;15(4):347–70.

    Article  PubMed  Google Scholar 

  11. Ryan K, Brady J, Cooke R, Height DI, Jonsen AR, King P, Lebacqz K, Louisell D, Seldin D, Stellar E, Turtle R. The Belmont Report. National Commission for the Protection of Human Subjects of Behavioral and Biomedical Research (“Belmont Report”); 1979 http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html.

  12. Korenman SG. Teaching the responsible conduct of research in humans. University of California Regents; 2006. http://ori.hhs.gov/education/products/ucla/default.htm.

  13. NYSTEM. ESSCB model informed consent forms. 2012. http://stemcell.ny.gov/esscb-forms. Accessed 23 Sept 2012.

  14. Rothenberg KH, Ulrich MR. NIH guidelines on human embryonic stem cell research in context: clarity or confusion? World Stem Cell Report; 2010. p. 89–98.

    Google Scholar 

  15. NYSTEM. Awardee requirements—appendix A-2. 2010. http://stemcell.ny.gov/sites/default/files/documents/files/NYSTEM_Appendix_A-2_03-10.pdf. Accessed 23 Sept 2012.

  16. Hug K. Banks, repositories and registries of stem cell lines in Europe: regulatory and ethical aspects. Stem Cell Rev. 2009;5:18–35.

    Article  PubMed  Google Scholar 

  17. Schaefer GO, Wertheimer A. The right to withdraw from research. Kennedy Inst Ethics J. 2010;20(4):329–52.

    PubMed  Google Scholar 

  18. Nuremberg C. Trials of war criminals before the Nuremberg military tribunals under control council law No. 10, vol. 2. Washington, DC: U.S. Government Printing Office; 1949. p. 181–2.

    Google Scholar 

  19. Wendler D. One time general consent for research on biological samples. BMJ. 2006;332(7540):544–7.

    Article  PubMed  Google Scholar 

  20. Kapp MB. Ethical and legal issues in research involving human subjects: do you want a piece of me? J Clin Pathol. 2006;59:335–9.

    Article  PubMed  CAS  Google Scholar 

  21. Evans BJ, Meslin EM. Encouraging translational research through harmonization of FDA and common rule informed consent requirements for research with banked specimens. J Leg Med. 2006;27(2):119–66.

    Article  PubMed  Google Scholar 

  22. Magnus D, Cho MK. Issues in oocyte donation for stem cell research. Science. 2005;308(5729):1747–8.

    Article  PubMed  CAS  Google Scholar 

  23. Lomax GP, Peckman SR. Stem cell policy exceptionalism: proceed with caution. Stem Cell Rev. 2011;8:299–304.

    Article  Google Scholar 

  24. Hakimian R, Korn D. Ownership and use of tissue specimens for research. JAMA. 2004;292(20):2500–5.

    Article  PubMed  CAS  Google Scholar 

  25. Isasi RM, Knoppers BM, Andrews PW, Bredenoord A, Colman A, Hin LE, Hull H, Kim O, Lomax G, Morris C, Sipp D, Stacey G, Wahlstrom J, Zeng F. Disclosure and management of research findings in stem cell research and banking: policy statement. Regen Med. 2012;7(3):439.

    Article  PubMed  CAS  Google Scholar 

  26. Renegar G, Webster CJ, Stuerzebecher S, Harty L, Ide SE, Balkite B, Rogalski-Salter TA, Cohen N, Spear BB, Barnes DM, Brazell C. Returning genetic research results to individuals: points-to-consider. Bioethics. 2006;20(1):24–36.

    Article  PubMed  Google Scholar 

  27. Dickert N, Grady C. What’s the price of a research subject? Approaches to payment for research participation. N Engl J Med. 1999;341:198–203.

    Article  PubMed  CAS  Google Scholar 

  28. Althuis MD, Moghissi KS, Westhoff CL, Scoccia B, Lamb EJ, Lubin JH, Brinton LA. Uterine cancer after use of clomiphene citrate to induce ovulation. Am J Epidemiol. 2005;161(7):607–15.

    Article  PubMed  Google Scholar 

  29. Brinton LA. Long-term effects of ovulation-stimulating drugs on cancer risk. Reprod Biomed Online. 2007;15(1):38–44.

    Article  PubMed  Google Scholar 

  30. Ellison B, Meliker J. Assessing the risk of ovarian hyperstimulation syndrome in egg donation: implications for human embryonic stem cell research. Am J Bioeth. 2011;11(9):22–30.

    Article  PubMed  Google Scholar 

  31. Wertheimer A, Miller F. Payment for research participation: a coercive offer? J Med Ethics. 2008;34:389–92.

    Article  PubMed  CAS  Google Scholar 

  32. Rao R. Coercion, commercialization, and commodification: the ethics of compensation for egg donors in stem cell research. Berkeley Tech Law J. 2006;21(3):1055–66.

    Google Scholar 

  33. Halpern SD, Karlawish JH, Casarett D, Berlin JA, Asch DA. Empirical assessment of whether moderate payments are undue or unjust inducement for participation in clinical trials. Arch Intern Med. 2004;164(7):801–3.

    Article  PubMed  Google Scholar 

  34. Klitzman R, Sauer MV. Payment of egg donors in stem cell research in the USA. Reprod Biomed Online. 2009;18(5):603–8.

    Article  PubMed  Google Scholar 

  35. Hyun I. Fair payment or undue inducement? Nature. 2006;442(7103):629–30.

    Article  PubMed  CAS  Google Scholar 

  36. Robertson JA. Compensation and egg donation for research. Fertil Steril. 2006;86(6):1573–5.

    Article  PubMed  Google Scholar 

  37. Dickenson D. Commodification of human tissue: implications for feminist and development ethics. Dev World Bioeth. 2002;2(1):55–63.

    Article  PubMed  Google Scholar 

  38. Baum K. Golden eggs: toward the rational regulation of oocyte donation. Brigh Young Univ Law Rev. 2001;1:107–66.

    PubMed  CAS  Google Scholar 

  39. American Society of Reproductive Medicine (ASRM) Ethics Committee. Financial compensation of oocyte donors. Fertil Steril. 2006;88(2):305–9.

    Google Scholar 

  40. Crockin SL. A legal defense for compensating research egg donors. Cell Stem Cell. 2010;6(2):99–102.

    Article  PubMed  CAS  Google Scholar 

  41. NYSTEM. Resolution of the funding committee regarding recommended standards for the compensation of women donating oocytes solely for research purposes. 2009. http://stemcell.ny.gov/sites/default/files/documents/files/Compensation%20of%20Gamete%20Donors%20resolution%20of%20Funding%20Committee%20June%2011%2C%201009.pdf. Accessed 23 Sept 2012.

  42. Trounson A. New perspectives in human stem cell therapeutic research. BMC Med. 2009;7(29):1–5.

    Google Scholar 

  43. Mathews DJH, et al. Cell-based interventions for neurologic conditions: ethical challenges for early human trials. Neurology. 2008;71:288–93.

    Article  PubMed  CAS  Google Scholar 

  44. McKernan R, McNeish J, Smith D. Pharma’s developing interest in stem cells. Cell Stem Cell. 2010;6(6):517–20.

    Article  PubMed  CAS  Google Scholar 

  45. Trounson A, Thakar R, Lomax G, Gibbons D. Clinical trials for stem cell therapies. BMC Med. 2011;9:52–9.

    Article  PubMed  Google Scholar 

  46. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987;317(3):141–5.

    Article  PubMed  CAS  Google Scholar 

  47. Master Z, McLeod M, Mendez I. Benefits, risks and ethical considerations in translation of stem cell research to clinical applications in Parkinson’s disease. J Med Ethics. 2007;33(3):169–73.

    Article  PubMed  Google Scholar 

  48. Miller FG, Rosenstein DL. The therapeutic orientation to clinical trials. N Engl J Med. 2003;384(14):1383–6.

    Article  Google Scholar 

  49. Taylor PL. The embryonic stem cell controversy: overseeing innovative therapy without mistaking it for research: a function-based model based on old truths, new capacities, and lessons from stem cells. J Law Med Ethics. 2010;38(2):286–302.

    Article  PubMed  Google Scholar 

  50. Sugarman J, Slip D. Ethical aspects of stem cell-based clinical translation: research, innovation and delivering unproven interventions. In: Hug K, Hermerén G, editors. Translational stem cell research: issues beyond the moral status of the human embryo. New York, NY: Humana Press; 2011.

    Google Scholar 

  51. Magnus D. Translating stem cell research: issues at the research frontier. J Law Med Ethics. 2010;38(2):267–77.

    Article  PubMed  Google Scholar 

  52. Moore FD. Ethical problems special to surgery: surgical teaching, surgical innovation and the surgeon in managed care. Arch Surg. 2000;135:14–6.

    Article  PubMed  CAS  Google Scholar 

  53. Lindvall O, Hyun I. Medical innovation versus stem cell tourism. Science. 2009;324:1664.

    Article  PubMed  CAS  Google Scholar 

  54. International Society for Stem Cell Research. Guidelines for the clinical translation of stem cells. 2008. http://www.isscr.org. Accessed 11 May 2012.

  55. Dresser R. Stem cell research as innovation: expanding the ethical and policy conversation. J Med Ethics. 2010;38(2):332–41.

    Article  Google Scholar 

  56. Murdoch CE, Scott CT. Stem cell tourism and the power of hope. Am J Bioeth. 2010;10(5):16–23.

    Article  PubMed  Google Scholar 

  57. Regenberg A, Hutchinson L, Schanker B, Mathews D. Medicine on the fringe: stem cell-based interventions in advance of evidence. Stem Cells. 2009;27:2312–9.

    Article  PubMed  Google Scholar 

  58. Eisenstein M. Stem cells: don’t believe the hype. Nature. 2012;484:S5.

    Article  PubMed  Google Scholar 

  59. Hyun I. Allowing innovative stem-cell based therapies outside of clinical trials. J Law Med Ethics. 2010;38(2):277–86.

    Article  PubMed  Google Scholar 

  60. Kiatpongsan S, Sipp D. Monitoring and regulating offshore stem cell clinics. Science. 2009;323:1564–5.

    Article  PubMed  CAS  Google Scholar 

  61. International Society for Stem Cell Research. Patients beware: commercialized stem cell treatments on the web. Cell Stem Cell. 2010;7:43–9.

    Article  Google Scholar 

  62. Master Z, Resnik DB. Stem cell tourism and scientific responsibility. EMBO Rep. 2011;12:992–5.

    Article  PubMed  CAS  Google Scholar 

  63. Hess P. Risk of tumorigenesis in first-in-human trials of embryonic stem cell neural derivatives: ethics in the face of long-term uncertainty. Account Res. 2009;16:175–98.

    PubMed  Google Scholar 

  64. Herberts CA, Kwa MSG, Hermsen HPH. Risk factors in the development of stem cell therapy. J Transl Med. 2011;9:29.

    Article  PubMed  Google Scholar 

  65. Sugarman J. Reflections on governance models for the clinical translation of stem cells. J Law Med Ethics. 2010;38(2):251–6.

    Article  PubMed  Google Scholar 

  66. Lo B, Kriegstein A, Grady D. Clinical trials in stem cell transplantation: guidelines for scientific and ethical review. Clin Trials. 2008;5(5):517–22.

    Article  PubMed  Google Scholar 

  67. Hyun I, et al. New ISSCR guidelines underscore major principles for responsible translational stem cell research. Cell Stem Cell. 2008;3:607–9.

    Article  PubMed  CAS  Google Scholar 

  68. Appelbaum PS, Lidz CW, Grisso T. Therapeutic misconception in clinical research: frequency and risk factors. IRB. 2004;26(2):1–8.

    Article  PubMed  Google Scholar 

  69. Levine AD, Wolf LE. The roles and responsibilities of physicians in patients’ decisions about unproven stem cell therapies. J Law Med Ethics. 2012;40(1):122–34.

    Article  PubMed  Google Scholar 

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Disclaimer

The views expressed in this chapter are solely those of the authors and do not necessarily represent those of the Empire State Stem Cell Board, the New York State Task Force on Life and the Law, the New York State Department of Health, Health Research, Inc., or the New York State Government.

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Authors and Affiliations

  1. New York State Task Force on Life and the Law, Chicago Kent College of Law, 90 Church Street, 4th Floor, New York, NY, 10007, USA

    Valerie Gutmann Koch J.D.

  2. NYU School of Law, 40 Washington Sq., S., New York, NY, USA

    Beth E. Roxland J.D.

  3. New York University, Center for Bioethics, 285 Mercer Street, 9th Floor, New York, NY, 10003, USA

    Barbara Pohl M.A.

  4. Columbia University Mailman School of Public Health, 722 West 168th Street, New York, NY, 10032, USA

    Sarah K. Keech J.D.

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  1. Valerie Gutmann Koch J.D.
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  2. Beth E. Roxland J.D.
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  4. Sarah K. Keech J.D.
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Correspondence to Valerie Gutmann Koch J.D. .

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  1. New York State Health Department Wadsworth Center, Albany, New York, USA

    Stewart Sell

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Koch, V.G., Roxland, B.E., Pohl, B., Keech, S.K. (2013). Contemporary Ethical Issues in Stem Cell Research. In: Sell, S. (eds) Stem Cells Handbook. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4614-7696-2_2

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