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
: 17–27.CrossRefGoogle Scholar
Fischbach G D & Fischbach R L. (2004) Stem cells: science, policy and ethics. Journal of Clinical Investigation.
: 1364–1370.CrossRefGoogle Scholar
Originally in the Balanced Budget Downpayment Act, 110 Stat. 26, 34 (1996), subsequently reenacted as Public Law 106-554, Sec. 510.
National Bioethics Advisory Commission. (1997). Cloning Human Beings. Rockville, MD.
“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.
National Bioethics Advisory Commission. (2000), Ethical Issues in Human Stem Cell Research. Rockville, MD.
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 www.bioethics.gov/topics/cloning_index.html, accessed October 2005.
Towns C R & Jones D G. (2004) Stem cells, embryos, and the environment: a context for both science and ethics. Journal of Medical Ethics
: 410–413.CrossRefGoogle Scholar
McGee, Kaplan A L. (1999), What’s in the Dish? Hastings CenterRreporter
Meyer M J., Nelson L J. (2001) Respecting what we destroy — reflections on human embryo research. Hastings Center report
: 16–23.CrossRefGoogle Scholar
Green R M. (2002) Determining moral status. American Journal of Bioethics
: 20–30.CrossRefGoogle Scholar
Doerflinger R M. (2002) Ditching Religion and Reality. American Journal of Bioethics
: 31–32.CrossRefGoogle Scholar
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
: 86–88.CrossRefGoogle Scholar
deWert G et al.. (2003) Human embryonic stem cells: Research ethics and policy. Human Reproduction
: 672–682.CrossRefGoogle Scholar
McHugh P R. (2004) Zygote and clonote — The ethical use of embryonic stem cells. N.Engl. J. Med.
: 209–211.CrossRefGoogle Scholar
Sylvester KG., Longaker M T. (2004) Stem cells: review and update. Archives of Surgery
: 93–99.CrossRefGoogle Scholar
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
Lo B., Chou V., et al. (2004) Informed consent in human oocyte, embryo, and embryonic stem cell research. Fertility and Sterility
: 559–563.CrossRefGoogle Scholar
Childress J F. (2004) Human stem cell research: some controversies in bioethics and public policy. Blood cells, Molecules and Diseases
: 100–105.CrossRefGoogle Scholar
Kuhn V T. (2002) Stem cells: equity or ownership? American Journal of Bioethics
: 1–2.CrossRefGoogle Scholar
Sandel M J. (2004) Embryo Ethics — The Moral Logic of Stem Cell Research. N. Engl. J. Med.
: 207–209.CrossRefGoogle Scholar
Tauer C A. (2004) International policy failures: cloning and stem cell research. Lancet
: 209–214.CrossRefGoogle Scholar
Pasquale F. (2002) Two Concepts of Immortality: Reframing Public Debate on Stem Cell Research. Yale Journ. Law & the Humanities
: 73–121.Google Scholar
Wertz D C. (2002) Embryos and Stem Cell Research in the United States: History and Politics. Gene Therapy
: 674–678.CrossRefGoogle Scholar
Lauritzen P. (2005) Stem cells, biotechnology and human rights: implications for a post-human future. The Hastings CenterReport
(2): 25–33.CrossRefGoogle Scholar
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
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
: 385–386.CrossRefGoogle Scholar
Heng BC, Hong YH, Cao T. (2005) Modulating gene expression in stem cells without recombinant DNA and permanent genetic modification. Cell and Tissue Research
(2): 147–150.CrossRefGoogle Scholar
NOTICE OF CRITERIA FOR FEDERAL FUNDING OF RESEARCH ON EXISTING HUMAN EMBRYONIC STEM CELLS AND ESTABLISHMENT OF NIH HUMAN EMBRYONIC STEM CELL REGISTRY, NOT-OD-02-005 (November 7, 2001), http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html (accessed October 2005).
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
http://stemcells.nih.gov/. (accessed October 2005).
See NIH Stem Cell Information — Frequently Asked Questions, Finding questions 3–4, 6–8 (http://stemcells.nih.gov/info/faqs.asp#notlisted (accessed October 2005))
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. www.hhs.gov/ohrp/humansubjects/guidance/stemcell.pdf, accessed October 2005.
21 C.F.R. Parts 50 and 56.
U.S. Food and Drug Administration, Cellular Therapy: Potential for Treating Heart Disease. June 21, 2004 (accessed October 2005 at: www.fda.gov/cber/genetherapy/celltherapyheart.htm.
U.S. Food and Drug Administration. Proposed Approach to Regulation of cellular and Tissue-based Products. February 1997 (accessed October 2005 at: www.fda.gov/cber/gdlns/celltissue.pdf).
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
21 C.F.R 1271.3(e).
66 FR 5447 (2001); 66 Fed. Reg. 1508 (2000); 64 FR 52696; and 68 FR 2689 (2003).
U.S.Patent Nos. 5843780 and 6200806.
WiCell website, www.Wicell.org, (accessed October 2005)
307 F.3d 1331, 64 U.S.P.Q 2d 1737 (Fed. Cir. 2002).
__ U.S. ___ (No. 03-1237, decided June 13, 2005)
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 http://www.meb.harvard.edu/melton/hues/HUES_MTA.html, accessed March 2005.
Licensing fees slow advance of stem cells. Nature. 2005;435(7040): 272–273.
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 http://www.usdoj.gov/osg/briefs/2002/2pet/6invit/2002-1007.pet.ami.inv.html
See, e.g., Hella M T, Eisenberg R S. (1998) Can Patents Deter Innovation? The Anticommons in Biomedical Research. 1998; 280: 698.
NIH Grants Policy, Part II Subpart A, Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Biomedical Research Resources, accessed at. http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131 (accessed October 2005)
NIH Final NIH Statement on Sharing Research Data, NOT-OD-03-032 (February 26, 2003).
Report of the National Institutes of Health (NIH) Working Group on Research Tools, Presented to the Advisory Committee to the Director, June 4, 1998. http://www.nih.gov/news/researchtools/index.htm (accessed October 2005)
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).
Rai A K., Eisenberg R S. (2003) Bayh-Dole Reform and the Progress of Biomedicine. Law & Contemporary Problems
: 289.Google Scholar
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
Bagley M A. (2003) Patent First, Ask Questions Later: Morality and Biotechnology in Patent Law. Wm. & Mary Law Review
: 469.Google Scholar
Diamond v. Chakrabarty, 447 U.S. 303 (1980).
Juicy Whip v. Orange Bang, 185 F.3d 1364, 1367 (Fed.Cir 1999).
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).
Holmes O W. (1897) The Path of the Law. Harvard Law Review
. 10: 457.CrossRefGoogle Scholar
Zoloth L. (2002) Jordan’s Banks, A View from the First Years of Human Embryonic Stem cell Research
. American Journal of Bioethics
: 3–11.CrossRefGoogle Scholar
21 C.F.R. 56.111(a)(2); 45 C.F.R. 46.111 (a)(2).