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Regulatory Aspects of Embryo Testing: An American View

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Screening the Single Euploid Embryo

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References

  1. Fauser B, Devroey P. Baby-making: what the new reproductive treatments mean for families and society. New York: Oxford University Press; 2011.

    Google Scholar 

  2. Capalbo A, Rienzi L, Cimadomo D, et al. Correlation between standard blastocyst morphology, euploidy and implantation: an observational study in two centers involving 956 screen blastocysts. Hum Reprod. 2014;29:1173–81.

    Article  PubMed  Google Scholar 

  3. Delhanty JDA. Is the polar body approach best for pre-implantation genetic screening? Placenta. 2011;32(Suppl):S268–70.

    Article  PubMed  Google Scholar 

  4. Buxton J. Unforeseen uses of preimplantation genetic diagnosis—ethical and legal issues. In: Horsey K, Biggs H, editors. Human fertilisation and embryology: reproducing regulation. New York: Routledge-Cavendish; 2007.

    Google Scholar 

  5. Verlinksy Y, Kuliev A. Practical preimplantation genetic diagnosis. London: Springer; 2005.

    Google Scholar 

  6. Forman EJ, Hong KH, Ferry KM, et al. In vitro fertilization with single euploid blastocyst transfer: a randomized controlled trial. Fertil Steril. 2013;100:100–7.

    Article  PubMed  Google Scholar 

  7. Nielsen L. Legal consensus and divergence in Europe in the area of assisted conception—room for harmonisation? In: Evans D, editor. Creating the child: the ethics, law and practice of assisted procreation. Boston: Martinus Nijhoff; 1996.

    Google Scholar 

  8. Gurmankin AD, Caplan A, Braverman AM. Screening practices and beliefs of assisted reproductive technology programs. Fertil Steril. 2005;83:61–7.

    Article  PubMed  Google Scholar 

  9. Cameron v Board of Education of Hillsboro, Ohio. No. C-1-90-291. U.S. Dist. Ct. (Ohio) 1991.

    Google Scholar 

  10. Lifchez v Hartigan. No. 82 C 4324. U.S. Dist. Ct. (Ill.) 1990.

  11. See, for example, Minn. Stat. § 145.422 subds. 1, 2.

    Google Scholar 

  12. SenGupta SB, Delhanty JDA. Preimplantation genetic diagnosis: recent triumphs and remaining challenges. Rev Mol Diagn. 2012;12:585–92.

    Article  CAS  Google Scholar 

  13. 42 United States Code § 263a-1.

    Google Scholar 

  14. 21 Code of Federal Regulations §§ 1270, 1271.

    Google Scholar 

  15. United States Food and Drug Administration. Tissue and tissue product questions and answers. http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/QuestionsaboutTissues/ucm101559.htm.

  16. 21 Code of Federal Regulations § 1271.1(a).

    Google Scholar 

  17. 21 Code of Federal Regulations § 1271.90(a)(2).

    Google Scholar 

  18. Preimplantation genetic diagnosis: a discussion of challenges, concerns, and preliminary options related to the genetic testing of human embryos. Genetic & Public Policy Center;2004.

    Google Scholar 

  19. Draft guidance for industry, clinical laboratories, and FDA staff: in vitro multivariate index assays. United States Food and Drug Administration;2007.

    Google Scholar 

  20. Good laboratory practices for molecular genetic testing for heritable diseases and conditions. Morb Mortal Wkly Rep. 2009;58(RR-06):1–29.

    Google Scholar 

  21. N.Y. Pub. Health Law § 5-574.

    Google Scholar 

  22. N.Y. Comp. Codes R. & Regs. tit. 10 § 58-1.10(g).

    Google Scholar 

  23. Definition and scope of certificate of qualification categories. New York State Department of Health. 2014;DOH-238(i).

    Google Scholar 

  24. Clinical laboratory evaluation program guide. New York State Department of Health;2013.

    Google Scholar 

  25. Management of NPL requests. New York State Department of Health;2012.

    Google Scholar 

  26. See, for example, Del. Code Ann. tit. 24 § 1799J; N.M. Stat. Ann. § 16.10.21.8(D); Okla. Stat. tit. 63 § 1-564(A)(4); Utah Code Ann. § 58-75-301(1)(e)(i)-(ii).

    Google Scholar 

  27. See, for example, 225 Ill. Comp. Stat. 135/15(i) (due to sunset January 1, 2015).

    Google Scholar 

  28. See, for example, Ind. Code § 25-17.3-4-4.

    Google Scholar 

  29. Good laboratory practices. Centers for Disease Control;2012.

    Google Scholar 

  30. See, for example, Wash. Rev. Code § 70.02.010.

    Google Scholar 

  31. See, for example, Alaska Stat. § 18.13.010(a)(2); Colo. Rev. Stat. § 10-3-1104.7(1)(a); Fla. Stat. § 760.40(2)(a); Ga. Code Ann. § 33-54-1(1); La. Rev. Stat. Ann. § 22:213.7(E)(1).

    Google Scholar 

  32. 42 United States Code § 1320d-5; 42 United States Code § 1320d-6; Alaska Stat. §§ 18.13.020, 18.13.030; Mass. Gen. Laws § 111.70G(d).

    Google Scholar 

  33. 42 United States Code § 2000ff.

    Google Scholar 

  34. 29 Code of Federal Regulations § 1635.3(f)(2)(v).

    Google Scholar 

  35. 26 Code of Federal Regulations §§ 54.9802-3T(a)(3)(iii)(B), 2590.702-1(a)(3)(iii); 45 Code of Federal Regulations § 146.122 (a)(3)(iii).

    Google Scholar 

  36. 63 Okla. Stat. § 1-728c(3).

    Google Scholar 

  37. North Coast Women’s Care Group v Superior Court. No. S142892. Calif. Supreme Ct. 2008.

    Google Scholar 

  38. Fortado L. Genetic testing maps new legal turf: doctors’ liability grows as tests are more widely used. N J Law J. 2004;177:1063.

    Google Scholar 

  39. See, for example, Fla. Stat. § 766.102, La. Rev. Stat. Ann. § 9:2794(A)(1).

    Google Scholar 

  40. See, for example, Fla. Admin. Code Ann. r.64B8-9.014.

    Google Scholar 

  41. See, for example, Ariz. Rev. Stat. Ann. § 36-2153.

    Google Scholar 

  42. See, for example, Cal. Health & Safety Code § 1644.6(d).

    Google Scholar 

  43. Kindregan CP, McBrien M. Assisted reproductive technology: a lawyer’s guide to emerging law and science. Chicago: American Bar Association; 2011.

    Google Scholar 

  44. See, for example, Stiver v Parker. No. 90-1624. U.S. Ct. of Appeals (Mich.) 1992.

    Google Scholar 

  45. Paretta v Medical Offices for Human Reproduction. No. 0122555/2000. N.Y. Supreme Ct. 2003.

    Google Scholar 

  46. Donovan v Idant Laboratories. No. 08-4075. U.S. Dist. Ct. (Pa.) 2009.

    Google Scholar 

  47. Amagwula T, Chang P, Hossain A, et al. Preimplantation genetic diagnosis: a systematic review of litigation in the face of new technology. Fertil Steril. 2012;98:1277–82.

    Article  PubMed  Google Scholar 

  48. Crockin SL, Jones HW. Legal conceptions: the evolving law and policy of assisted reproductive technologies. Baltimore: Johns Hopkins; 2010.

    Google Scholar 

  49. Desmyttere S, Bonduelle M, Nekkebroeck J, Roelants M, Liebaers I, De Schepper J. Growth and health outcome of 102 2-year-old children conceived after preimplantation genetic diagnosis or screening. Early Hum Dev. 2009;85:755–9.

    Article  PubMed  Google Scholar 

  50. Harney on medical malpractice. Matthew Bender; 2013.

    Google Scholar 

  51. See, in this connection, Jeter v. Mayo Clinic Arizona. No. 1-CA-CV 04-0048. Ariz. Ct. App. 2005.

    Google Scholar 

  52. Keye WR, Bradshaw KD. A survey of the practices and opinions of the domestic members of the American Society for Reproductive Medicine. Fertil Steril. 2004;82:536–42.

    Article  PubMed  Google Scholar 

  53. Baruch S, Kauman D, Hudson K. Genetic testing of embryos: practices and perspectives of US in vitro fertilization clinics. Fertil Steril. 2008;89:1053–8.

    Article  PubMed  Google Scholar 

  54. Adamson D. Regulation of assisted reproductive technologies in the United States. Fertil Steril. 2002;78:932–42.

    Article  PubMed  Google Scholar 

  55. Preimplantation genetic testing: a practice committee opinion. Fertil Steril 2008;90(Suppl 3):S136–44.

    Google Scholar 

  56. Ethics Committee of the American Society for Reproductive Medicine. Sex selection and preimplantation genetic diagnosis. Fertil Steril. 1999;72:595–8.

    Article  Google Scholar 

  57. Ethics Committee of the American Society for Reproductive Medicine. Preconception gender selection for nonmedical reasons. Fertil Steril. 2001;75:861–63.

    Article  Google Scholar 

  58. Revised minimum standards for practices offering assisted reproductive technologies: a committee opinion. Fertil Steril 2014;102:682–86.

    Google Scholar 

  59. Use of preimplantation genetic diagnosis for serious adult onset conditions: a committee opinion. Fertil Steril 2013;100:54–7.

    Google Scholar 

  60. Davis LB, Champion SJ, Fair SO, Baker VL, Garber AM. A cost-benefit analysis of preimplantation genetic diagnosis for carrier couples of cystic fibrosis. Fertil Steril. 2010;93:1793–804.

    Article  PubMed  Google Scholar 

  61. Tur-Kapasa I, Rechitsky S, Aljadeff G, Grotjan E, Verlinsky Y. Preimplantation genetic diagnosis (PGD) for all cystic fibrosis (CF) carrier couples: strategy and cost analysis [abstract]. Fertil Steril. 2006;86:S59.

    Article  Google Scholar 

  62. Oversight of assisted reproductive technology. ASRM: 2010.

    Google Scholar 

  63. Klitzman R. Anticipating issues related to increasing preimplantation genetic diagnosis use: a research agenda. Reprod Biomed Online. 2008;17(Suppl):33–42.

    Article  PubMed  Google Scholar 

  64. See, for example, Ariz. Rev. Stat. Ann. § 13-3603.02(A)(1); 720 Ill. Comp. Stat. 510/6(8); Kan. Stat. Ann. § 67-6726; N.C. Gen. Stat. § 90-21.121; N.D. Cent. Code §14-02-1-04.1(1)(a); 18 Pa. Cons. Stat. § 3204(c); Okla. Stat. tit. 63, § 1-731.2(B).

    Google Scholar 

  65. Kirby M. New frontier: regulating technology by law and ‘code’. In: Brownsword R, Yeung K, editors. Regulating technologies: legal futures, regulatory frames and technologies fixes. Oxford: Hart; 2008. p. 370.

    Google Scholar 

  66. Varone F, Rothmayr C, Montpetit E. Comparing biotechnology policy in Europe and North America: a theoretical framework. In: Montpetit E, Rothmayr C, Varone F, editors. The politics of biotechnology in North America and Europe: policy networks, institutions, and internationalization. New York: Rowman & Littlefield; 2007.

    Google Scholar 

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  1. School of Law, City University of New York, Long Island City, NY, 11101, USA

    Richard F. Storrow

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  1. Richard F. Storrow
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  1. Center for Advanced Genetics, Reproductive Research Section, Carlsbad, California, USA

    E Scott Sills

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Storrow, R.F. (2015). Regulatory Aspects of Embryo Testing: An American View. In: Sills, E. (eds) Screening the Single Euploid Embryo. Springer, Cham. https://doi.org/10.1007/978-3-319-16892-0_25

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  • DOI: https://doi.org/10.1007/978-3-319-16892-0_25

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