Informed consent and federal funding for stem cell research

Hastings Center Report

Volumn 38, Issue 3, 2008, Pages 40-47

  Streiffer, Robert ^a  

^a UNIVERSITY OF WISCONSIN MADISON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANIMAL; ECONOMICS; EMBRYO RESEARCH; ETHICS; FINANCIAL MANAGEMENT; GOVERNMENT; HEALTH CARE ORGANIZATION; HUMAN; INFORMED CONSENT; ORGANIZATION; REVIEW; STEM CELL; STEM CELL TRANSPLANTATION; UNITED STATES;

ANIMALS; CONSENT FORMS; EMBRYO RESEARCH; FEDERAL GOVERNMENT; FINANCING, GOVERNMENT; HUMANS; INFORMED CONSENT; NATIONAL ACADEMY OF SCIENCES (U.S.); NATIONAL INSTITUTES OF HEALTH (U.S.); STEM CELL TRANSPLANTATION; STEM CELLS; UNITED STATES;

EID: 44849105161     PISSN: 00930334     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (39)

1. M.J. Martin et al., "Human Embryonic Stem Cells Express an Immunogenic Nonhuman Sialic Acid," Nature Medicine 11 (2005): 228-32;
2. T.E. Ludwig et al., "Derivation of Human Embryonic Stem Cells in Defined Conditions," Nature Biotechnology 24 (2006): 185-87.
3. Ludwig et al., "Derivation of Human Embryonic Stem Cells in Defined Conditions"; J. Lauerman and R. Waters, "Harvard Stem Cells Favored Over Those Produced with U.S. Funds," Bloomberg News, July 13, 2006, at http://www.bloomberg.com/apps/news?pid=20601103&sid= aeyb8GOm8Md8&refer=us;
4. A. Abbott et al., "The Lure of Stem Cells," Nature 27 (2006): 336-37.
5. Lauerman and Waters, "Harvard Stem Cells"; S. Bhattacharya, "Human Stem Cell Bank Doubles Its Lines," NewScientist.com, February 15, 2005, at http://www.newscientist.com/channel/health/dn7019-human- stem-cell-bank-doubles-its-lines.html;
6. Ludwig et al., "Derivation of Human Embryonic Stem Cells in Defined Conditions."
7. Abbott et al., "The Lure of Stem Cells"; Ludwig et al., "Derivation of Human Embryonic Stem Cells in Defined Conditions";
8. A. Zimm and N. Roland, "Bush Stem Cell Limits Should Be Eased, NIH Chief Says," Bloomberg News, March 19, 2007, at http://www. bloomberg.com/apps/news?pid=20601103&sid=aMuYISbI-hbQ4&refer=us;
9. R. Weiss, "Stem Cell Policy Hampering Research, NIH Official Says," Washington Post, January 20, 2007.
10. National Institutes of Health, Report of the Human Embryo Research Panel, vol. I (Bethesda, Md.: National Institutes of Health, 1994), at 53.
11. American Society for Reproductive Medicine, "Informed Consent in the Use of Gametes and Embryos for Research," Fertility and Sterility 68 (1997): 780-81.
12. National Bioethics Advisory Commission, Ethical Issues in Human Stem Cell Research, vol. I: Report and Recommendations of the National Bioethics Advisory Commission (Rockville, Md.: National Bioethics Advisory Commission, 1999), at vi.
13. Ibid.
14. 64 Federal Register 67576 (1999);
15. 65 Federal Register 51976 (2000), respectively.
16. Cited in D. Duffy, Congressional Research Service, "Background and Legal Issues Related to Stem Cell Research," Almanac of Policy Issues, June 12, 2002, at http://www.policyalmanac.org/health/archive/ crs_stem_cell.shtml.
17. R. Levine, Ethics and Regulation of Clinical Research (London, U.K.: Yale University Press, 1986), at 95-153.
18. For ES Cell International, BresaGen, and WARF, there was one form each. The forms for UCSF included two copies of a research subject consent form that were identical except for different dates of institutional review board approval, an embryo and gamete donation consent form, and an "Experimental Subject's Bill of Rights." From Cellartis and the Technion-Israel Institute of Technology, there was an English form for each and a form in Swedish and Hebrew, respectively.
19. Domestic Policy Council, The White House, "Advancing Stem Cell Science without Destroying Human Life," April 2007, at http://www. whitehouse.gov/dpc/stemcell/2007/index.html, at 18-19.
20. R. Streiffer, "At the Edge of Humanity: Human Stem Cells, Chimeras, and Moral Status," Kennedy Institute of Ethics Journal 15 (2005): 347-70.
21. J. Shreeve, "The Other Stem Cell Debate," The New York Times Magazine, April 10, 2005, 42-47.
22. R. Streiffer and A. Rubel, "Democratic Principles and Mandatory Labeling of Genetically Engineered Food," Public Affairs Quarterly 18 (2004): 223-48;
23. R. Streiffer and A. Rubel, "Genetically Engineered Animals and the Ethics of Food Labeling," The Labeling of Genetically Modified Foods, ed. P. Weirich (Oxford, U.K.: Oxford University Press, 2007): 63-87.
24. R. Streiffer and T. Hedemann, "The Political Import of Intrinsic Objections to Genetically Engineered Food," Journal of Agricultural and Environmental Ethics 18 (2005): 191-210;
25. Streiffer and Rubel, "Democratic Principles"; Streiffer and Rubel, "Genetically Engineered Animals."
26. National Institutes of Health, Report of the Human Embryo Research Panel, at 82.
27. R.S. Goldstein et al., "Integration and Differentiation of Human Embryonic Stem Cells Transplanted to the Chick Embryo," Developmental Dynamics 225 (2002): 80-86.
28. A. Muotri et al., "Development of Functional Human Embryonic Stem Cell-Derived Neurons in Mouse Brain," Proceedings of the National Academy of Sciences 102 (2005): 18644-48.
29. D. James et al., "Contribution of Human Embryonic Stem Cells to Mouse Blastocysts," Developmental Biology 295 (2006): 90-102.
30. J. Thomson and E. Zanjani, American Society of Hematology Abstracts 104 (2004): Abstract 2685.
31. ALS Association, "Update on Stem Cell Research and Potential Treatments for ALS," August 6, 2004, at http://www.alsa.org/news/article. cfm?id=455.
32. Going back to the original donors and asking them to sign improved consent forms would also eliminate these problems but would pose severe logistical difficulties and would itself constitute a serious invasion of the embryo donors' privacy.
33. Committee on Guidelines for Human Embryonic Stem Cell Research, Institute of Medicine and National Research Council, Guidelines for Human Embryonic Stem Cell Research (Washington, D.C.: National Academies Press, 2005).
34. S. Mitchell, "Stem Cell Lines May Not Meet Guidelines," United Press International, May 3, 2005, archived at http://www. partkinsons-information-exchange-network-online.com/parkmail1.12005b/msg00462. html.
35. Human Embryonic Stem Cell Research Advisory Committee, 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research (Washington, D.C.: National Academies Press, 2007), at 4.
36. Ibid.
37. Levine, Ethics and Regulation of Clinical Research, at 95-153.
38. National Institutes of Health, Report of the Human Embryo Research Panel, at xiii.
39. Committee on Guidelines for Human Embryonic Stem Cell Research, Guidelines for Human Embryonic Stem Cell Research, at 105.