Using Preimplantation Genetic Diagnosis to Create a Stem Cell Donor: Issues,Guidelines & Limits

Handyside A.H. , “Biopsy of Human Preimplantation Embryos and Sexing by DNA Amplification,” Lancet, (1989): 347–49.

American Society for Reproductive Medicine, “A Practice Committee Report: Preimplantation Genetic Diagnosis,” June 2001, available at <www.asrm.org/Media/Practice/preimplantation.pdf>.

See Ethics Committee of the American Society for Reproductive Medicine, “Sex Selection and Preimplantation Genetic Diagnosis,” Fertility & Sterility, 72 (1999): 595–98; ESHRE PGD Consortium Steering Committee, “ESHRE Preimplantation Genetic Diagnosis (PGD) Consortium: Data Collection III (May 2001),” Human Reproduction, 17 (2002): 233–46.

On PGD for susceptibility to disease and for late-onset disorders, see Robertson J.A. , “Extending Preimplantation Genetic Diagnosis: The Ethical Debate,” Human Reproduction, 18 (2003): 465–71; Verlinsky Y. , “Preimplantation Diagnosis for Early-Onset Alzheimer Disease Caused by V717L Mutation,” JAMA, 287 (2002): 1018–21; Towner D. Loewy R.S. , “Ethics of Preimplantation Diagnosis for a Woman Destined to Develop Early-Onset Alzheimer Disease,” JAMA, 287 (2002): 1038–40; De Wert G.M.W.R. , “Non-Disclosure Preimplantation Genetic Diagnosis for Huntington's Disease: Practical and Ethical Dilemmas,” Prenatal Diagnosis, 18 (1998): 1422–26.

See ESHRE Ethics Task Force, Shenfield R. , “Taskforce 5: Preimplantation Genetic Diagnosis,” Human Reproduction, 18 (2003): 649–51; Robertson , supra note 4; Verlinsky , supra note 4; Pennings G. Schots R. Liebaers I. , “Ethical Considerations on Preimplantation Genetic Diagnosis for HLA Typing to Match a Future Child as a Donor of Haematopoietic Stem Cells to a Sibling,” Human Reproduction, 17 (2002): 534–38; Robertson J.A. Kahn J.P. Wagner J.E. , “Conception to Obtain Hematopoietic Stem Cells,” Hastings Center Report, 32, no. 3 (2002): 34–40; Murray T.H. , “What Are Families For? Getting to an Ethics of Reproductive Technology, Hastings Center Report , 32, no. 3 (2002): 41–45; Verlinsky Y. , “Preimplantation Diagnosis for Fanconi Anemia Combined with HLA Matching,” JAMA, 285 (2001): 3130–33; Damewood M.D. , “Ethical Implications of a New Application of Preimplantation Diagnosis,” JAMA, 285 (2001): 3143–44; Belkin L. , “The Made-to-Order Savior,” New York Times Magazine, July 1, 2001, at 36–42, 48, 62–63; Boyle R.J. Savulescu J. , “Ethics of Using Preimplantation Genetic Diagnosis to Select a Stem Cell Donor for an Existing Person,” British Medical Journal, 323 (2001): 1240–43; Human Fertilisation and Embryology Authority and Advisory Committee on Genetic Testing, “Consultation Document on Preimplantation Genetic Diagnosis,” Nov. 1999, available at <www.hfea.gov.uk/AboutHFEA/Consultations/PGD%20document.pdf>; Human Fertilisation and Embryology Authority and Human Genetics Commission, “Outcome of the Public Consultation on Preimplantation Genetic Diagnosis,” Nov. 2001, available at <www.hfea.gov.uk/AboutHFEA/Consultations/PGD%20outcome.pdf>; Burgio G.R. Locatelli F. , “Ethics of Creating Programmed Stem-Cell Donors,” Lancet, (2000): 1868–69; Green R.M. Fibison W.J. Hughes M.R. , “Planned Parenthood: Case Commentary,” Cambridge Quarterly of Healthcare Ethics, 6 (1997): 100–05; Colen B.D. , “Conception for Fertility Raises Moral, Ethical Stakes & the Travis Dilemma: Doctors Denied Couple Chance to Have Son,” Newsday, Mar. 11, 1990, at 22–25. Additional debate concerns PGD for carrier status and to select nonmedical traits. See ESHRE Ethics Task Force, supra, Robertson , supra note 4.

See Verlinsky (2001), supra note 5; Belkin , supra note 5; Grewal S.S. , “Successful Hematopoietic Stem Cell Transplant for Fanconi Anemia from an Uneffected HLA Genotypically-Identical Sibling Using Preimplantation Genetic Diagnosis,” Blood, (forthcoming).

On procreative liberty generally, see Robertson J.A. , Children of Choice: Freedom and the New Reproductive Technologies (Princeton, NJ: Princeton University Press, 1994): 22–24. Note that Robertson argues not for an absolute commitment to procreative liberty, but rather a strong presumption. He maintains that a demonstration of harm can justify limits. Id. at 16–18.

Compare New York State Task Force on life and the Law, Assisted Reproductive Technologies: Analysis and Recommendations (1998): 202–03 (“In deciding whether to provide assisted reproductive services to a prospective patient, physicians are entitled to consider the welfare of any child who might be born as a result of the procedure.”).

See Murray , supra note 5. See also Annas G.J. , “Human Cloning: A Choice or an Echo?” University of Dayton Law Review, 23 (1998): 247–75, at 261–63.

Verlinsky (2001), supra note 5; Verlinsky Y. Kuliev A. , An Atlas of Preimplantation Genetic Diagnosis (New York, NY: Parthenon, 2000).

See, e.g., Wagner J.E. Davies S.M. Auerbach A.D. , “Hematopoietic Cell Transplantation in the Treatment of Fanconi Anemia,” in Thomas E.D. Blume K.G. Forman S.J. , eds., Hematopoietic Cell Transplantation (Malden, MA: Blackwell Science, 1999): 1204–19.

Auerbach A.D. , “Prenatal Identification of Potential Donors for Umbilical Cord Transplantation for Fanconi Anemia,” Transfusion, 30 (1990): 682–87; Ferrell v. Rosenbaum, 691 A.2d 641 (D.C. Ct. App. 1997).

Auerbach A. Sagi M. Adler B. , “Fanconi Anemia: Prenatal Diagnosis of 30 Fetuses at Risk,” Pediatrics, 76 (1985): 794–800.

Auerbach , supra note 12.

Auerbach A.D. , “Umbilical Cord Transplants for Genetic Disease: Diagnostic and Ethical Issues in Fetal Studies,” Blood Cells, 20 (1994): 303–09.

See Belkin , supra note 5.

Verlinsky (2001), supra note 5.

See Davies J.A. , “Couple Permitted to Create ‘Designer’ Baby,” The Age, Mar. 12, 2003, 2003 WL 14778731; Davies J.A. , “Epworth Hit over Donor Delay,” The Age, Mar. 13, 2003, 2003 WL 14778863; Kennedy E. , ‘“Designer Babies’ May be Available in New Zealand,” The Dominion , Jan. 14, 2002, 2002 Westlaw 7524275; Dyer C. , “Watchdog Approves Embryo Selection to Heal 3 Year Old Child,” British Medical Journal, 324 (2002): 503; “Couple Fight On for Genetically Selected Baby,” BBC News, Aug. 2, 2002, available at <news.bbc.co.uk/2/low/programmes/breakfast/2167608.stm>; “Special Delivery,” Guardian Unlimited, Oct. 15, 2001, available at <www.guardian.co.uk/genes/article/0,2763,574283,00.html>.

See Davies (Mar. 12, 2003), supra note 18; Davies (Mar. 13, 2003), supra note 18; Spriggs M. Savulescu J. , “‘Savior Siblings,’” Journal of Medical Ethics, 28 (2002): 289.

See Dyer , supra note 18; “Couple Fight On for Genetically Selected Baby,” supra note 18; “Special Delivery,” supra note 18; Human Fertilisation and Embryology Authority, “PGD and Tissue Typing,” press releases Dec. 2001 – Apr. 2003, available at <www.hfea.gov.uk/PressOffice/PressReleasesbysubject/PGDandtissuetyping>; Quintaville v. Human Fertilisation and Embryology Authority, case no. C1/2003/0101, no. [2003] EWCA Civ 667 (C.A. May 16, 2003), available at <www.bailii.org/ew/cases/EWCA/Civ/2003/667.html> (Eng.).

See also “Doctor Plans UK ‘Designer Baby’ Clinic,” BBC News, Dec. 11, 2001, available at <news.bbc.co.uk/2/low/health/1702854.stm>; Kolata G. , “More Babies Being Born to be Donors of Tissue,” New York Times, June 4, 1991, at A-1.

American Society for Reproductive Medicine, supra note 2.

Ethics Committee of the American Society for Reproductive Medicine, supra note 3; Robertson J.A. , “Sex Selection for Gender Variety by Preimplantation Genetic Diagnosis,” Fertility & Sterility, 78 (2002): 463.

Ethics Committee of the American Society of Reproductive Medicine, supra note 3.

Robertson , supra note 23.

American Medical Association, Council on Ethical and Judicial Affairs, Code of Medical Ethics: Current Opinions with Annotations, § 2.12, Genetic Counseling (Chicago, IL: AMA Press, 2002): 37–38.

See Viville S. Pergament D. , “Results of a Survey of the Legal Status and Attitudes Towards Preimplantation Genetic Diagnosis Conducted in 13 Different Countries,” Prenatal Diagnosis, 18 (1998): 1374–80. Note that UNESCO's International Bioethics Committee issued a draft policy in late 2002. UNESCO, International Bioethics Committee (IBC), Working Group of the IBC on Pre-implantation Genetic Diagnosis and Germ-line Intervention, “Draft Report on Pre-implantation Genetic Diagnosis and Germ-line intervention,” Paris, Sept. 30, 2002, no. SHS/EST/02/CIB-9/2.

See Annas G.J. , “The Shadowlands: Secrets, Lies, and Assisted Reproduction,” N. Eng. J. Med., 399 (1998): 935–39; President's Council on Bioethics, Human Cloning and Human Dignity: The Report of the President's Council on Bioethics (New York, NY: Public Affairs, 2002): 238–40.

Human Fertilisation and Embryology Act, 1990, ch. 37, sec. 8 (Eng.).

Human Fertilisation and Embryology Authority and Human Genetics Commission, supra note 5; Ethics Committee of the Human Fertilization and Embryology Authority, “Ethical Issues in the Creation and Selection of Preimplantation Embryos to Produce Tissue Donors,” Nov. 22, 2001, formerly at <www.hfea.gov.uk> (on file with the authors); Yeandel J. , “HFEA to Allow Tissue Typing in Conjunction with Preimplantation Genetic Diagnosis,” Dec. 13, 2001, available at <www.hfea.gov.uk/PressOffice/Archive/HFEAtoallowtissuetypinginconjunctionwithpreimplantationgeneticdiagnosis>.

See Dyer , supra note 18; Human Fertilisation and Embryology Authority, supra note 20.

Ethics Committee of the Human Fertilisation and Embryology Authority, supra note 31.

Infertility Treatment Authority, “Tissue Typing in Conjunction with Preimplantation Genetic Diagnosis,” 2003, available at <http://www.ita.org.au/_documents/policies/Policy_PGD_HLA_Matching.pdf>.

See Dyer , supra note 18.

Human Fertilisation and Embryology Authority, supra note 20 (“One of the [HFEA's] criteria [for approving PGD to create a donor] is that: ‘the embryos conceived in the course of this treatment should themselves be at risk from the condition by which the existing child is affected.”’). The couple subsequently underwent IVF and PGD for HLA matching in the U.S., resulting in a child born in June 2003. See ‘”Designer Baby’ Born to UK Couple,” BBC News, June 19, 2003, available at <news.bbc.co.uk/2/hi/health/3002610.stm>.

See Human Fertilisation and Embryology Authority, supra note 20.

See ESHRE Task Force, supra note 5; Robertson , supra note 4; Pennings Schots Liebaers , supra note 5; Robertson Kahn Wagner , supra note 5; Murray , supra note 5; Damewood , supra note 5; Boyle Savulescu , supra note 5; Burgio Locatelli , supra note 5; Green Fibison Hughes , supra note 5.

Robertson Kahn Wagner , supra note 5.

Pennings Schots Liebaers , supra note 5.

45 C.F.R. pt. 46 (2002) (HHS); 21 C.F.R. pts. 50–56 (2002) (FDA).

See New York State Task Force on Life and the Law, supra note 8, at 161–75; Butler D. , “Spermatid Injection Fertilizes Ethics Debate,” Nature, 377 (1995): 277. Indeed, the New York State Task Force (at 174) recommends that “[n]ew assisted reproductive procedures of unproven safety and efficacy should generally be introduced through a formal research protocol, with the review and approval of an IRB.”

Ethics Committee, American Fertility Society, “Ethical Considerations of Assisted Reproductive Technologies,” Fertility & Sterility, 62, Supp. 1 (1994): 66S.

See Pergamet E. Bonnicksen A. , “Preimplantation Genetics: A Case for Prospective Action,” American Journal of Medical Genetics, 52 (1994): 151–57; Robertson J.A. , “Ethical and Legal Issues in Preimplantation Genetic Screening,” Fertility & Sterility, 57 (1992): 1–11.

See American Society for Reproductive Medicine, supra note 2; ESHRE PGD Consortium Steering Committee, supra note 3.

See Christian M.C. , “A Central Institutional Review Board for Multi-Institutional Trials,” N. Eng. J. Med., 346 (2002): 1405–08.

See 45 C.F.R. pt. 42 (HHS); 21 C.F.R. pts. 50–56 (FDA).

45 C.F.R. pt. 46 subpt. B (HHS).

45 C.F.R. pt. 46 subpt. D (HHS); 21 C.F.R. pt. 50 subpt. D (FDA).

See subparts cited in note 51, supra.

45 C.F.R. § 46.404 (HHS); 21 C.F.R. §50.51 (FDA).

45 C.F.R. § 46.102(i) (HHS); 21 C.F.R. §50.3(k) (FDA).

Gordon B. Prentice E. Reitemeier P. , “The Use of Normal Children as Participants in Research on Therapy,” IRB, 18, no. 3 (1996): 5–8.

45 C.F.R. §46.406 (HHS); 21 C.F.R. §50.53 (FDA).

45 C.F.R. §46.407 (HHS); 21 C.F.R. §50.54 (FDA).

45 C.F.R. §46.405 (HHS); 21 C.F.R. §50.52 (FDA).

Gordon Prentice Reitemeier , supra note 56.

See sections cited in note 59, supra.

See Kolata , supra note 21; Burgio G.R. , “Programming of Bone Marrow Donor for a Leukaemic Sibling,” Lancet, (1987): 1484–85; “Making Babies to Save a Life,” Sunday Age, Jan. 6, 2002, 2002 WL 7828726.

See, e.g., Boyle Savulescu , supra note 5, at 1242 (“psychological harm …, even if it did occur, [is] unlikely to be so severe that it would be tetter for that particular child never to have existed”). See generally Robertson , Children of Choice, supra note 7, at 75–76.

See generally Parfit D. , Reasons and Persons (Oxford: Clarendon, 1984): 351–441.

Id. at 378; Parfit D. , “Future Generations: Further Problems,” Philosophy and Public Affairs, 11, no. 2(1982): 113–72.

See, e.g., Roberts M. , Child versus Child-maker: Future Persons and Present Duties in Ethics and Law (Lanham, MD: Rowman & Littlefield, 1998); Steinbock B. , Life Before Birth: The Moral and Legal Status of Embryos and Fetuses (New York, NY: Oxford University Press, 1992); Feinberg J. , Freedom and Fulfillment (Princeton, NJ: Princeton University Press, 1992): 33; New York State Task Force on Life and the Law, supra note 8, at 102–04; Brock D.W. , “The Non-identity Problem and Genetic Harms: The Case of Wrongful Handicaps,” Bioethics, 9, nos. 3–4 (1995): 269–75; Cohen C.B. , “Give Me Children or I Shall Die! New Reproductive Technologies and Harm to Children,” Hastings Center Report, 26, no. 2 (1996): 19–27.

For the argument that doing wrong is still wrong even if it is not person affecting, see, e.g., Buchanan A. , From Chance to Choice: Genetics and Justice (Cambridge: Cambridge University Press, 2000): 246–57.

Murray Compare , supra note 5, at 45 (asking whether PGD to create a donor “support[s] or undermine[s] the values central to parents and children?”).

See id.

Human Fertilization and Embryology Authority and Human Genetics Commssion, supra note 20.

45 C.F.R. §46.405 (HHS); 21 C.F.R. §50.52 (FDA).

See Kim F.T.H. , “Association of Stress During Delivery with Increased Numbers of Nucleated Cells and Hematopoietic Progenitor Cells in Umbilical Cord Blood,” American Journal of Obstetrics and Gynecology, 183 (2000): 1144–51.

See American Academy of Pediatrics, “Informed Consent, Parental Permission, and Assent in Pediatric Practice,” Pediatrics, 95 (1995): 314–17.

45 C.F.R. §46.408 (HHS); 21 C.F.R. §50.55 (FDA).

45 C.F.R. §46.405 (HHS); 21 C.F.R. §50.52 (FDA).

Human Fertilisation and Embryology Authority and Human Genetics Commission, supra note 5.

Nelson Compare L. Milliken N. , “Compelled Medical Treatment of Pregnant Women: Life, Liberty, and Law in Conflict, JAMA, 259 (1988): 1060–66 (on the ethical hazards of legally forcing unwanted treatment on pregnant women).

See Baron C.H. Botsford M. Cole G.F. , “Live Organ and Tissue Transplants from Minor Donors in Massachusetts,” Boston University Law Review, 55 (1975): 159–93.

See Strunk v. Strunk, 445 S.W.2d 145 (Ky. 1969); Hart v. Brown, 289 A.2d 386 (Conn. Super. Ct. 1972); Little v. Little, 576 S.W.2d 493 (Tex. Civ. App. 1979).

See In re Richardson, 284 So.2d 185 (La. Ct. App. 1973); In re Pescinski, 226 N.W.2d 180 (Wis. 1975).

Strunk, 445 S.W.2d 145.

Hart, 289 A.2d 386.

See Little, 576 S.W.2d 493; Pescinski, 226 N.W.2d 180; Curran v. Bosze, 566 N.E.2d 1319 (Ill. 1990); American Medical Association, Council on Ethical and Judicial Affairs, Code of Medical Ethics: Current Opinions with Annotations , 2002–2003 ed., §2.167, The Use of Minors as Organ and Tissue Donors (Chicago, IL: AMA Press, 2002): 58–59.

See Chan K.W. , “Use of Minors as Bone Marrow Donors: Current Attitude and Management: A Survey of 56 Pediatric Transplant Centers,” Journal of Pediatrics, 128 (1996): 644–48; Hill H.F. , “Assessment and Management of Donor Pain Following Marrow Harvest for Allogenic Bone Marrow Transplantation,” Bone Marrow Transplantation, 4 (1989): 157–61; Bortin M.M. Berckuer C.D. , “Major Complications of Marrow Harvesting for Transplantation,” Experimental Hematology, 11 (1983): 916–21.

See Packman W.L. , “Psychosocial Impact of Pediatric BMT on Siblings,” Bone Marrow Transplantation, 24 (1999): 701–06; Shama W.I. , “The Experience and Preparation of Pediatric Sibling Bone Marrow Donors,” Social Work in Health Care, 27 (1998): 89–99; Packman W.L. , “Siblings' Perception of the Bone Marrow Transplantation Process,” Journal of Psychosocial Oncology, 15 (1997): 81–105; Rappaport B.S. , “Evolution of Consultation-Liason Services in Bone Marrow Transplantation,” General Hospital Psychiatry, 10 (1988): 346–51; Patemaude A.F. Szymanski L. Rappaport J. , “Psychosocial Costs of Bone Marrow Transplantation in Children,” American Journal of Orthopsychiatry, 49 (1979): 409–13.

Curran, 566 N.E.2d 1319.

See Chan , supra note 84.

West's Wisconsin Statutes Annotated §146.34 (2002).

See 45 C.F.R. pt. 46 (HHS); 21 C.F.R. pt. 50–56 (FDA).

See Code of Alabama §22-8-9 (2002); Revised Code of Washington §70.54.305 (2002).

West's Wisconsin Statutes Annotated §146.34 (2002).