1 See THE PRESIDENT's COUNCIL ON BIOETHICS, REPRODUCTION AND RESPONSIBILITY: THE REGULATION OF NEW TECHNOLOGIES, at ch. 9-10 (2004), available at http://www.bioethics.gov/reports/reproductionandresponsibility/index.html (criticizing patchwork framework for regulation of ART in U.S. and suggesting comprehensive regulation, including permanent monitoring and oversight arrangements); Erik Parens & Lori Knowles, Reprogenetics and Public Policy: Reflections & Recommendations, HASTINGS CTR. RPT. (Supp. Jul. - Aug. 2003), available at http://www.thehastingscenter.org/publications/reports.asp (advising creation of commission, Reprogenetics Technology Advisory Committee, to propose legislation to Congress). See, e.g., Andrews, Lori, et al., Cloning Position Paper of the IIT Institute for Science, Law, and Technology Working Group On Reproductive Technologies, 8 S. CAL. INTERDISC. L.J. 87, 99 (1998)Google Scholar (advocating the U.S. ban human cloning and explaining that the loss of possible benefits of cloning as a result of such a ban could be avoided by crafting legislation similar to that of the United Kingdom's licensing of clinics involved in reproductive technologies); Childress, James F., An Ethical Defense of Federal Funding for Human Embryonic Stem Cell Research, 2 YALE J. HEALTH POL’Y L. & ETHICS 157, 163 (2001)Google ScholarPubMed (stating that a public body similar to that used in the U.K. may be needed in the U.S. for regulating embryonic stem cell research); Cohen, Cynthia B., Unmanaged Care: The Need to Regulate New Reproductive Technologies in the United States, 11 BIOETHICS 348 (1997)CrossRefGoogle ScholarPubMed; Havins, Weldon E. & Dalessio, James J., The Ever-Widening Gap Between the Science of Artificial Reproductive Technology and the Laws Which Govern that Technology, 48 DEPAUL L. REV. 825 (1999)Google ScholarPubMed; Stenger, Robert L., The Law and Assisted Reproduction in the United Kingdom and the United States, 9 J.L. & HEALTH 135, 159 (1994–1995)Google Scholar (arguing that Britain's Human Fertilization and Embryology Act of 1990 can offer guidance to states within the U.S. in their attempts to formulate legislation on assisted reproductive technology); Belew, Kara L., Comment, Stem Cell Division: Abortion Law and its Influence on the Adoption of Radically Different Embryonic Stem Cell Legislation in the United States, the United Kingdom, and Germany, 39 TEX. INT’L L.J. 479, 519 (2004)Google ScholarPubMed (stating that the U.S. and Germany will have to change their laws and regulations concerning stem cell research to something similar to the U.K. framework if either country wants “to stay on the forefront of biomedical technology.”); Burchell, Melissa S., Note, America's Struggle to Develop a Consistent Legal Approach To Controversial Human Embryonic Stem Cell Research and Therapeutic Cloning: Are the Politics Getting in the Way of Hope?, 32 SYRACUSE J. INT’L L. & COM. 133, 158-61 (2004)Google Scholar (arguing that the U.S. should revise its regulations on stem cell research and therapeutic cloning, modeling them after the U.K.’s); Jayson, Sherri A., Comment, “Loving Infertile Couple Seeks Woman Age 18–31 to Help Have Baby. 6,500 Plus Expenses and a Gift”: Should We Regulate the Use of Assisted Reproductive Technologies by Older Women?, 11 ALB. L.J. SCI. & TECH. 287, 311 (2001)Google Scholar (discussing legislation regulating age of women undergoing ART). Compare Rhodes, Suzanne H., Comments, The Difficulty of Regulating Reproductive and Therapeutic Cloning: Can the United States Learn Anything From the Laws of Other Countries?, 21 PENN. ST. INT’L L. REV. 341, 355 (2003)Google Scholar (recommending that the U.S. “follow the lead” of the U.K. and other countries and place a ban on reproductive cloning), with D’Andrea, Arthur C., Note, Federalizing Bioethics, 83 TEX. L. REV. 1663 (2005)Google Scholar (arguing that regulation of human cloning should be done on a state, not national level).

2 The publication of the reports is considerably delayed. The 2002 data was not published until 2004. See DIV. OF REPROD. HEALTH, CTRS. FOR DISEASE CONTROL & PREVENTION, & SOC’Y FOR ASSISTED REPROD. TECH., AM. SOC’Y FOR REPROD. MED., 2002 ASSISTED REPRODUCTIVE TECHNOLOGY SUCCESS RATES: NATIONAL SUMMARY AND FERTILITY CLINIC REPORTS (2004), available at http://www.cdc.gov/ART/ART02/index.htm [hereinafter 2002 ART RATES].

3 The existing federal regulation limits federal funding for embryo research. On August 9, 2001, President Bush announced that federal funds for human embryonic stem cell research would be limited to 64 stem cell lines that were in existence as of the date of the announcement. In May 2005, The U.S. House of Representative approved a bill to expand federal financing for embryonic stem cell research to permit financing studies involving human embryos in frozen storage at fertility clinics if they would otherwise be discarded. To date, the Senate has not passed comparable legislation. The States have been more active in regulating assisted reproduction. In particular, fourteen states have laws pertaining to human cloning. See National Conference of State Legislatures, State Human Cloning Laws, (2005), available at http://www.ncsl.org/programs/health/genetics/rt-shcl.htm (charting state laws regulating the cloning of human embryos as of June 21, 2005). Legislation that would regulate ART and the use of frozen embryos has been introduced in ten states. See National Conference of State Legislatures, Genetics Legislation Database, available at http://www.ncsl.org/programs/health/genetics/geneticsDB.cfm (last visited Oct. 26, 2005).

4 See 2002 ART RATES, supra note 2, at 5-6 (stating that clinics known to be in existence without reporting success rate data were merely listed as nonreporters, in compliance with U.S. law).

5 The Human Fertilisation and Embryology Authority, About the Human Fertilisation and Embryology Authority, http://www.hfea.gov.uk/AboutHFEA (last visited Oct. 23, 2005).

6 See Human Fertilisation and Embryology Act, 1990, c. 37, § 11, sched. 2 (Eng.), available at http://www.opsi.gov.uk/acts/acts1990/Ukpga_19900037_en_1.htm#end (Select “Schedule 2” link).

7 White, Gladys B., Crisis in Assisted Conception: The British Approach to an American Dilemma, 7 J. WOMEN's HEALTH 321, 327 (1998).CrossRefGoogle Scholar

8 On file with author (Glenn McGee).

9 See generally Human Fertilisation and Embryology Act, 1990, c. 37 (Eng.).

10 Id. §§ 3–15.

11 HUMAN FERTILISATION & EMBRYOLOGY AUTH., FACING UP TO THE CHALLENGE: HFEA ANNUAL REPORT 2003/04 (Thirteenth Annual Report) at 5 (2004), available at http://www.hfea.gov.uk/HFEAPublications/AnnualReport [hereinafter FACING UP TO THE CHALLENGE] .

12 Id.

13 HUMAN FERTILISATION AND EMBRYOLOGY AUTH. CODE OF PRACTICE 6TH EDITION (2003), available at http://www.hfea.gov.uk/HFEAPublications/CodeofPractice.

14 The Human Fertilisation and Embryology Authority, supra note 5.

15 Id.

16 See, e.g., Burchell, supra note 1, at 139-42 (describing federal regulation of embryonic stem cell research in the U.S. as inconsistent and contradictory); Childress, supra note 1, at 162–63 (contrasting the U.K.'s “strict regulation of reproductive technologies” with the “limited and uneven” regulation in the U.S.). But see PRESIDENT's COUNCIL ON BIOETHICS, supra note 1, at 47–50 (discussing extensively current regulation of ART).

17 Fertility Clinic Success Rate and Certification Act of 1992, Pub. L. No. 102-493, 106 Stat. 3146 (codified at 42 U.S.C. §§ 263a-1 to a-7 (2000)).

18 42 U.S.C. §§ 263a-1 to a-5 (2000).

19 Id. §§ 263a-2(a)(1), 263a-5(1)(A).

20 See PRESIDENT's COUNCIL ON BIOETHICS, supra note 1, at 50.

21 For a list of state laws regulating the cloning of human embryos, see NATIONAL CONFERENCE OF STATE LEGISLATURES, STATE HUMAN CLONING LAWS (2005), http://www.ncsl.org/programs/health/genetics/rt-shcl.htm (charting state laws regulating the cloning of human embryos as of June 21, 2005). Legislation that would regulate ART and the use of frozen embryos has been introduced in nine states. See NATIONAL CONFERENCE OF STATE LEGISLATURES, GENETICS LEGISLATION DATABASE, http://www.ncsl.org/programs/health/genetics/geneticsDB.cfm (select “ART/Frozen Embryos”; then enter search) (last visited Oct. 26, 2005).

22 See PRESIDENT's COUNCIL ON BIOETHICS, supra note 1, at 51-54 (outlining state regulation of ART and concluding that “There are few state laws that bear directly on assisted reproduction.”).

23 FACING UP TO THE CHALLENGE, supra note 11, at 12, 41.

24 Twelfth Annual Report And Accounts 2002/03, 2003 HUMAN FERTILISATION AND EMBRYOLOGY AUTH. 16, http://www.hfea.gov.uk/HFEAPublications/AnnualReport/Twelfth%20HFEA%20Annual%20Report.pdf [hereinafter Twelfth Annual Report].

25 FACING UP TO THE CHALLENGE, supra note 11, at 5.

26 Human Fertilisation and Embryology Auth., http://www.hfea.gov.uk (last visited Oct. 20, 2005).

27 Eleventh Annual Report And Accounts 2002, 2002 HUMAN FERTILISATION AND EMBRYOLOGY AUTH. 7, http://www.hfea.gov.uk/HFEAPublications/AnnualReport/2002%20HFEA%20Annual%20Report.pdf [hereinafter Eleventh Annual Report].

28 Id.

29 FACING UP TO THE CHALLENGE, supra note 11, at 9.

30 Eleventh Annual Report, supra note 27, at 18.

31 Id.

32 FACING UP TO THE CHALLENGE, supra note 11, at 9.

33 Id.

34 Id.

35 Id.

36 42 U.S.C. § 263a-1 (2005).

37 The homepage for SART is located at http://www.sart.org/home.html.

38 ASRM is a professional society. The homepage for the ASRM is located at http://www.asrm.org.

39 Med. Research Int’l, In vitro Fertilization/Embryo Transfer in the United States: 1985 and 1986 Results from the National IVF/ET Registry, 49 FERTILITY & STERILITY 212 (1988).

40 See generally Centers for Disease Control and Prevention, Assisted Reproductive Technology: All Reports, at http://www.cdc.gov/ART/ARTReports.htm (showing links to published ART reports beginning with the 1995 ART report through the 2002 ART report).

41 See American Society for Reproductive Medicine, The ASRM Invites You To Apply For Membership, http://www.asrm.org/Professionals/Membership/member.html (showing that affiliations with like organizations is a benefit of membership in ASRM); American Society for Reproductive Medicine, Specialty Societies, http://www.asrm.org/Professionals/Membership/member.html (showing that SART is affiliated with ASRM). See also Society for Assisted Reproductive Technology, What Does Sart Do Anyway?, at http://sart.org/whatis.html (demonstrating close affiliation with ASRM).

42 E-mail communication from Joyce Zeitz to author Alicia Ouellette (October 5, 2005) (on file with author).

43 Society for Assisted Reproductive Technology, supra note 41 (last visited Sept. 23, 2005).

44 Id. SART requires all its member laboratories to be accredited by a SART approved program. All laboratory accreditation programs approved by SART follow the Clinical Laboratory Amendments of 1988 (CLIA). CLIA requires certification at least every two years. BROOKS A. KEEL & TAMMIE K. SCHALUE, Quality Control and Accreditation, in A COLOR ATLAS FOR HUMAN ASSISTED REPRODUCTION 277–78 (Pasquale Patrizio et al. eds., 2003); Clinical Laboratory Amendments of 1988, 100 Pub. L. No. 578, 102 Stat. 2903 (1988) (codified at 42 U.S.C. § 263(a)).

45 Reporting of Pregnancy Success Rates From Assisted Reproductive Technology Programs, 70 Fed. Reg. 5187, 5188 (Feb. 1, 2005).

46 Angenlique Lopez, RLT PG Representative to SART, REPRODUCTIVE TECHNOLOGIST PROFESSIONAL GROUP NEWSLETTER (American Society of Reproductive Medicine), Summer 2005 at 3, available at http://www.asrm.org/Professionals/PG-SIGAffiliated_Soc/rltpg/rltpg_summer2005_newsletter.pdf.

47 Id.

48 2002 ART RATES, supra note 2, at 4.

49 Victoria Clay Wright, et al., Assisted Reproductive Surveillance – United States 2001, MORBIDITY AND MORTALITY WEEKLY REPORT (April 30, 2004), at http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5301a1.htm. See also PRESIDENT's COUNCIL ON BIOETHICS, supra note 1, at 47–50.

50 Soc’y for Assisted Reprod. Tech. & The Am. Soc’y for Reprod. Med., Assisted Reproductive Technology in the United States: 1999 Results Generated from the American Society for Reproductive Medicine/Society for Assisted Reproductive Technology Registry, 78 FERTILITY & STERILITY 918, 919 (2002).Google Scholar

51 Interview with Joyce Zeitz, Executive Administrator, Society for Assisted Reproductive Technology (June 25, 2003); E-mail communication from Joyce Zeitz to author Ouellette dated October 5, 2005 (on file with author).

52 Reporting of Pregnancy Success Rates From Assisted Reproductive Technology Programs, 65 Fed. Reg. 53,310, 53,311 (Sept. 1, 2000).

53 Id.

54 See Reporting of Pregnancy Success Rates From Assisted Reproductive Technology Programs, 70 Fed. Reg. 5187, 5188 (Feb. 1, 2005).

55 Soc’y for Assisted Reprod. Tech. & The Am. Soc’y for Reprod. Med., Assisted Reproductive Technology in the United States and Canada: 1995 Results Generated from the American Society for Reproductive Medicine/Society for Assisted Reproductive Technology Registry, 69 FERTILITY & STERILITY 389 (1998).CrossRefGoogle Scholar

56 DIV. OF REPROD. HEALTH, CTRS. FOR DISEASE CONTROL & PREVENTION ET AL, 2000 ASSISTED REPRODUCTIVE TECHNOLOGY SUCCESS RATES: NATIONAL SUMMARY AND FERTILITY CLINIC REPORTS 71 (2002), available at http://www.cdc.gov/reproductivehealth/ART/ARTReports.htm [hereinafter 2000 RATES].

57 2002 ART RATES, supra note 2, at 69.

58 See, e.g., 2002 ART RATES, supra note 2, at 71, 509–510. Out of 428 total listed clinics, approximately 91% of them submitted data.

59 See Reporting of Pregnancy Success Rates From Assisted Reproductive Technology Programs, supra note 52, at 53,312-13.

60 DIV. OF REPROD. HEALTH, CTRS. FOR DISEASE CONTROL & PREVENTION ET AL, 1999 ASSISTED REPRODUCTIVE TECHNOLOGY SUCCESS RATES: NATIONAL SUMMARY AND FERTILITY CLINIC REPORTS 6, 469–70 (2001), available at http://www.cdc.gov/reproductivehealth/ART/ARTReports.htm [hereinafter 1999 RATES].

61 DIV. OF REPROD. HEALTH, CTRS. FOR DISEASE CONTROL & PREVENTION ET AL, 1998 ASSISTED REPRODUCTIVE TECHNOLOGY SUCCESS RATES: NATIONAL SUMMARY AND FERTILITY CLINIC REPORTS 5, 445–46 (2000), available at http://www.cdc.gov/reproductivehealth/ART/ARTReports.htm [hereinafter 1998 RATES].

62 1999 RATES, supra note 60, at 6, 469–70.

63 2000 RATES, supra note 56, at 6, 501–02.

64 1999 RATES, supra note 60, at 469–70.

65 1998 RATES, supra note 61, at 445–46.

66 DIV. OF REPROD. HEALTH, CTRS. FOR DISEASE CONTROL & PREVENTION ET AL, 1997 ASSISTED REPRODUCTIVE TECHNOLOGY SUCCESS RATES: NATIONAL SUMMARY AND FERTILITY CLINIC REPORTS 404–05 (1999), available at http://www.cdc.gov/reproductivehealth/ART/ARTReports.htm [hereinafter 1997 RATES].

67 2000 RATES, supra note 56, at 501–02.

68 1999 RATES, supra note 60, at 469–70.

69 DIV. OF REPROD. HEALTH, CTRS. FOR DISEASE CONTROL & PREVENTION ET AL, 1996 ASSISTED REPRODUCTIVE TECHNOLOGY SUCCESS RATES: NATIONAL SUMMARY AND FERTILITY CLINIC REPORTS 359 (1998), available at http://www.cdc.gov/reproductivehealth/ART/ARTReports.htm.

70 1997 RATES, supra note 66, at 405.

71 1998 RATES, supra note 61, at 446.

72 1999 RATES, supra note 60, at 470.

73 2000 RATES, supra note 56, at 502.

74 Gina Kolata, Researchers Report Success in Method to Pick Baby's Sex, N.Y. TIMES, Sept. 9, 1998, at A1.

75 See Claudia Kalb & Karen Springen, Brave New Babies, NEWSWEEK, Jan. 26, 2004, at 45.

76 Interview with Richard J. Sherins, M.D., Director of the GIVF Division of Andrology, The Genetics & IVF Institute (April 2003).

77 SART members may lose their membership, but SART is “not a punitive society.” See Sandra Carson, President ASRM, Keynote Address at the Meeting of the President's Council on Bioethics (March 7, 2005), available at http://www.bioethics.gov/transcripts/march03/mar7full.html.

78 See, e.g., 2002 ART RATES, supra note 2, at 5–6.

79 Id. at 5.

80 Compare 2002 ART RATES, supra note 2, at 509–510 (listing 37 non-reporting clinics), with 2000 RATES, supra note 56, at 501–502 (listing 25 non-reporting clinics).

81 Human Fertilisation and Embryology Act, 1990, c. 37, § 11(1)(b) (Eng.), available at http://www.opsi.gov.uk/acts/acts1990.htm.

82 Id. sched. 2.

83 Id.

84 Id. §§ 39–40.

85 ELEVENTH ANNUAL REPORT, supra note 27, at 6–7.

86 Human Fertilisation and Embryology Act, 1990, c. 37, § 41(1) (Eng.), available at http://www.opsi.gov.uk/acts/acts1990.htm.

87 Id. §§ 12–13.

88 Id. §§ 23-24.

89 New Embryo Research Regulations, HUMAN FERTILISATION AND EMBRYOLOGY AUTHORITY UPDATE (London), Feb. 2001, at 2, available at http://www.hfea.gov.uk/HFEAPublications/HFEAUpdate.

90 HUMAN FERTILISATION AND EMBRYOLOGY AUTH., NINTH ANNUAL REPORT AND ACCOUNTS 2000 25 (2000), available at http://www.hfea.gov.uk/HFEAPublications/AnnualReport [hereinafter NINTH ANNUAL REPORT].

91 New Embryo Research Regulations, supra note 89, at 2.

92 Andy Coghlan & Emma Young, Landmark vote clears the way for stem cell research in Britain, NEW SCIENTIST, Jan. 6 2001, at 99.

93 HUMAN FERTILISATION AND EMBRYOLOGY AUTH., supra note 13, § 10.6, at 93.

94 FACING UP TO THE CHALLENGE, supra note 11, at 13.

95 HUMAN FERTILISATION AND EMBRYOLOGY AUTH., supra note 13, § 10.10, at 94.

96 ELEVENTH ANNUAL REPORT, supra note 27, at 11.

97 FACING UP TO THE CHALLENGE, supra note 11, 20 apps. 4-5.

98 Id. at 14.

99 See Id.

100 Human Fertilisation and Embryology Act, 1990, c. 37, §§ 2–3, sched. 2 (Eng.), available at http://www.opsi.gov.uk/acts/acts1990.htm.

101 ELEVENTH ANNUAL REPORT, supra note 27, at 6.

102 Interview with Joyce Zeitz, Executive Administrator, Society for Assisted Reproductive Technology (June 25, 2003).

103 Society for Assisted Reproductive Technology, supra note 43, at ¶ 9.

104 Fertility Clinic Success Rate and Certification Act of 1992, 42 U.S.C. § 263a-2(a) to (b) (2005).

105 Implementation of the Fertility Clinic Success Rate and Certification Act of 1992: A Model Program for the Certification of Embryo Laboratories, 64 Fed. Reg. 39,374, 39,386 (July 21, 1999).

106 The President's Council on Bioethics, Discussion Document, U.S. Public Policy and the Biotechnologies that Touch the Beginnings of Human Life: A Detailed Overview, at text accompanying notes 85-86 (June 3, 2003), available at http://www.bioethics.gov/background/biotechnology.html.

107 See 2002 ART RATES, supra note 2, at 69. See also THE NEW YORK STATE TASK FORCE ON LIFE AND THE LAW, EXECUTIVE SUMMARY OF ASSISTED REPRODUCTIVE TECHNOLOGIES: ANALYSIS AND RECOMMENDATIONS FOR PUBLIC POLICY, at Certification and Licensure (Oct. 2001), http://www.health.state.ny.us/nysdoh/taskfce/execsum.htm.

108 2002 ART RATES, supra note 2, at 69–70.

109 2002 ART RATES, supra note 2, at 69–70; Society for Assisted Reproductive Technology, supra note 43, at ¶9.

110 2002 ART RATES, supra note 2, at 71.

111 1998 RATES, supra note 61, at 47.

112 White, supra note 7, at 323.

113 Press Release, Society for Assisted Reproductive Technology, Society for Assisted Reproductive Technology Embarks on New, Aggressive Campaign Aimed at Setting Higher Standards, Greater Awareness of Reproductive Medicine (Oct. 25, 2000) (on file with authors), available at http://www.obgyn.net/infertility/infertility.asp?page=/infertility/articles/sart.

114 Society for Assisted Reproductive Technology, supra note 43, at ¶ 9.

115 See COLL. OF AM PATHOLOGISTS, STANDARDS FOR LABORATORY ACCREDITATION (2000), available at http://www.cap.org/apps/docs/laboratory_accreditation/lapstandards.pdf.

116 Id. at 1-3.

117 Id.

118 Id. at 5.

119 Id.

120 Id. at 4–5.

121 See FACING UP TO THE CHALLENGE, supra note 11, at 7.

122 See HUMAN FERTILISATION AND EMBRYOLOGY AUTH., supra note 13, at 9–10; Human Fertilisation and Embryology Act, 1990, c. 37, § 3(1) (Eng.), available at http://www.opsi.gov.uk/acts/acts1990.htm.

123 See HUMAN FERTILISATION AND EMBRYOLOGY AUTH., supra note 13, at 9–10.

124 See Id. at 10.

125 The HFEA maintains all six editions of the Code of Practice on its website. HFEA, http://www.hfea.gov.uk/HFEAPublications/Codeof Practice (last visited October 26, 2005).

126 Human Fertilisation and Embryology Act, 1990, c.37, § 11, sched. 2 (Eng.), available at http://www.opsi.gov.uk/acts/acts1990.htm.

127 See ELEVENTH ANNUAL REPORT, supra note 27, at 16–17.

128 See FACING UP TO THE CHALLENGE, supra note 11, at 15.

129 See id. at 19.

130 K.C. Zoon, Human Cells Used in Therapy Involving the Transfer of Genetic Material, FDA Center for Biologics Evaluation and Research Letter to Sponsors/Researchers (July 6, 2001), available at http://www.fda.gov/cber/ltr/cytotrans070601.htm.

131 42 U.S.C. §§263a-1—263a-5.

132 See, e.g., Katherine Seligman, License Revoked for Embryo Mix-Up, S.F. CHRON., March 3, 2005, at B4 (reporting that the Medical Board of California revoked the license of San Franciscobased fertility specialist Dr. Steven Katz, who implanted the wrong embryo in a patient and failed to inform her of the mistake until more than two years later).

133 See Lorio, Kathryn Venturatos, The Process of Regulating Assisted Reproductive Technologies: What We Can Learn from Our Neighbors—What Translates and What Does Not, 45 LOY. L. REV. 247, 266 (1999).Google ScholarPubMed

134 Rosato, Jennifer L., The Children of ART (Assisted Reproductive Technology): Should the Law Protect them From Harm?, 2004 UTAH L. REV. 57, 73-74 (2004)Google ScholarPubMed (arguing that the politics of abortion preclude meaningful regulation of ART in the United States).

135 See D’Andrea, supra note 1, at 1698 (noting that devolving law making powers to the states recognizes “the tension between the principle of one law for all’ and the need to accommodate a bewildering variety of religious and belief systems.’”).

136 See, e.g., Havins & Dalessio, supra note 1.

137 Havins & Dalessio, supra note 1, at 828–31; R. Alta Charo, Children by Choice: Reproductive Technologies and the Boundaries of Personal Autonomy, NATURE CELL BIOLOGY & NATURE MEDICINE (Fertility Supp. 2002), available at www.nature.com/fertility.

138 LA. REV. STAT. ANN. § 9:129 (1991); Havins & Dalessio, supra note 1, at 837-38.

139 Sandra Carson, President, American Society for Reproductive Medicine, Chief, Baylor University Assisted Reproductive Technology Program,. Remarks at the Meeting of the President's Council on Bioethics (March 7, 2003), available at http://www.bioethics.gov/transcripts/march03/mar7full.html.

140 See http://www.sart.org (The Benefits of Membership).

141 See generally ASRM/SART Statement on Responsibility and Reproduction, March 30, 2004, available at http://www.asrm.org/Washington/Bulletins/vol6no22.html.

142 See Mark.S. Frankel & Parisa Morris, A View From the Field on Food and Drug Administration Regulation: Report of a 2002 Survey of U.S. Fertility Clinics, 79 FERTILITY & STERILITY 1060 (2003).

143 Id. at 1061.

144 Id.

145 See Carson, supra note 139.

146 Interview with Joyce Zeitz, Executive Administrator, Society for Assisted Reproductive Technology (Aug. 7, 2001).

147 Lorio, supra note 133, at 248.

148 See generally PCBE: Monitoring Stem Cell Research: Chapter 2 “Current Federal Law and Policy” (January 2004), THE PRESIDENT's COUNSEL ON BIOETHICS, available at http://www.bioethics.gov/reports/stemcell/chapter2.html (describing a history of federal policy in this area).

149 See, e.g., Rick Weiss, Bill Renews Fight on Stem Cells; House, Senate Measures Would Loosen Bush's Research Curbs, WASH. POST, Feb. 17, 2005, at A6; Rick Weiss, Approved Stem Cells’Potential Questioned, WASH. POST, October 29, 2004, at A3; Ceci Connolly, 2 GOP Senators Defend Bush on Stem Cell Research, WASH. POST, August 13, 2004, at A2; CNN.com Specials, The Stem Cell Debate, http://www.cnn.com/SPECIALS/2001/stemcell/ (last visited Oct. 26, 2005).

150 The original amendment can be found in Section 128 of P.L. 104-99; it affected NIH funding for FY1996 contained in P.L. 104-91. For subsequent fiscal years, the rider is found in Title V, General Provisions, of the Labor, HHS and Education appropriations acts in the following public laws: FY1997,P.L. 104-208; FY1998, P.L. 105-78; FY1999, P.L. 105-277; FY2000, P.L. 106-113; FY2001, P.L. 106-554; FY2002, P.L. 107-116; FY2003, P.L. 108-7; FY2004, P.L. 108-199; and, FY2005, P.L. 108-447. See CRS Report for Congress, Stem Cell Research, n.19, available at http://fpc.state.gov/documents/organization/51131.pdf . The amendment states:

• (a) None of the funds made available in this Act may be used for — (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).

• (b) For purposes of this section, the term human embryo or embryos’ includes any organism, not protected as a human subject under 45 CFR 46 [the Human Subject Protection regulations] as of the date of enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes [sperm or egg] or human diploid cells [cells that have two sets of chromosomes, such as somatic cells].

151 See, e.g., JUDITH A. JOHNSON & ERIN D. WILLIAMS, CONG. RES. SERV., STEM CELL RESEARCH 8 (2005), available at http://fpc.state.gov/documents/organization/51131.pdf; Daley, George Q., Missed opportunities in Embryonic Stem-Cell Research, 351 NEW ENG. J. MED. 627 (2004)CrossRefGoogle ScholarPubMed; NAT’L BIOETHICS ADVISORY COMM’N, ETHICAL ISSUES IN HUMAN STEM CELL RESEARCH 35 (1999), available at http://www.georgetown.edu/research/nrcbl/nbac/stemcell.pdf.

152 See Clinton Administration NIH Guidelines for Embryonic Stem Cell Funding, 65 Fed. Reg. 51,975, (Aug. 25, 2000), reprinted in President's Council on Bioethics, Monitoring Stem Cell Research, Appendix D, available at http://www.bioethics.gov/reports/stemcell/appendix_d.html; NAT’L BIOETHICS ADVISORY COMM’N, supra note 151, at 35.

153 Roger Noll, The Politics and Economics of Implementing State-Sponsored Embryonic Stem-Cell Research 21, http://siepr.stanford.edu/papers/pdf/04-28.pdf, (June 2005)(Stanford Institute for Economic Policy Research Discussion Paper 04-2820).

154 Sheryl Gay Stolberg, Senate's Leader Veers from Bush Over Stem Cells, N.Y. TIMES, July 29, 2005, at A6.

155 Ceci Connolly, Frist Breaks with Bush on Stem Cell Research, WASH. POST, July 30, 2005, at A1.

156 Senate Lacks Vote for Stem Cell Override, (August 1, 2005), available at http://www.boston.com/news/nation/washington/articles/2005/08/01/senate_lacks_votes_for_stem_cell_override?mode=PF (last visited Oct. 26, 2005).

157 Address to the Nation on Stem Cell Research, 37 PUB. PAPERS 32 (Aug. 13, 2001).

158 See generally Noll, supra note 153.

159 See National Council of State Legislatures, supra note 3, for an inventory of state legislative activities.

160 Id. For analyses of state legislation and subsequent court action, see Lori B. Andrews, Legislators as Lobbyists: Proposed State Regulation of Embryonic Stem Cell Research, Therapeutic Cloning, and Reproductive Cloning, available at http://www.bioethics.gov/reports/stemcell/appendix_e_html; Havens & Dalessio, supra note 1.

161 The State Science and Technology Institute publishes weekly digests of State funded technology initiatives on its website, http://www.ssti.org/Digest/Indices/indexstate.htm.

162 California Gives Go-Ahead to Stem Cell Research, http://www.msnbc.msn.com/id/6384390/ (last visited Oct. 27, 2005).

163 For descriptions of state initiatives, see What's New in State Stem Cell Legislation and Funding, http://www.grassrootsconnection.com/state_stem_cell_resources.htm (last visited Oct. 27, 2005).

164 Letter from James Thomson, Professor, University of Wisconsin-Madison Medical School, to Rep. Steve Kestell, Representative, Wisconsin State Assembly, June 28, 2005, available at www.wisbusiness.com/1008/large/050627thomson.pdf .

165 California Gives Go-Ahead to Stem Cell Research, supra note 162.

166 Illinois Regenerative Medicine Institute Act, H. B. 3815, 94th Gen. Assemb. (Ill. 2005).

167 Stem Cell Research Bond Act, Assemb. B. 4013, 211th Leg., 2d Reg. Sess. (N.J. 2005).

168 Stem Cell Research Act, H. B. 864, 189th Gen. Assemb. (Pa. 2005); Amy Worden, Spotlights on Biology and God, PHILA. ENQUIRER, Jun. 21, 2005, http://www.philly.com/mld/inquirer/news/local/states/pennsylvania/11943819.htm.

169 Jeana Anderson, Gov. Unveils 375m Stem-Cell Initiative, THE DAILY CARDINAL, Nov. 18, 2004, http://www.dailycardinal.com/article.php?storyid=809385 .

170 An Act Permitting Stem Cell Research and Banning the Cloning of Human Beings, S. B. 934, 2005 Gen. Assem., Jan. Sess. (Conn. 2005) (enacted), 2005 Conn. Act. 05-149.

171 The argument in this paragraph is largely drawn from Noll, supra note 153.

172 Id.

173 See Andrews, supra note 8.

174 See Jessica Reaves, The Great Debate Over Stem Cell Research, TIME ONLINE, July 11, 2001, http://www.time.com/time/health/article/0,8599,167245,00.html; J.C. Wilke, I’m Pro-Life and Oppose Embryonic Stem Cell Research, CULTURE OF LIFE FOUNDATION & INSTITUTE, June 27, 2001, http://sites.silaspartners.com/partner/Article_Display_Page/0,,PTID4211|CHID102753|CIID578206,00.html.

175 See Noll, supra note 153.

176 For coverage of the implementation of the California initiative, see David Jensen, California Stem Cell Report, http://www.californiastemcellreport.blogspot.com/ (last visited Oct. 26, 2005). For a description of the most recent suit filed against the stem cell program, see Terri Somers, Group Files Lawsuit to Halt Research at Stem Cell Institute, S.D. UNION TRIB., Aug. 6, 2005, at A4.

177 See Tina Kelley, In Race Toward Stem Cell Research Institute, New Jersey Stalls, N.Y. TIMES, July 31, 2005, at 25, §1, col. 2.

178 See id.

179 The Human Fertilisation and Embryology Authority, Patients’ Guides are available as pdf files at http://www.hfea.gov.uk/HFEAPublications/PatientsGuides.

180 HUMAN FERTILISATION AND EMBRYOLOGY AUTH., NINTH ANNUAL REPORT & ACCOUNTS 2000 14 (2000), available at http://www.hfea.gov.uk/HFEAPublications/AnnualReport; ELEVENTH ANNUAL REPORT, supra note 27, at 13.

181 Fertility Watchdog “incompetent”, BBC NEWS (Dec. 10 2004), http://news.bbc.co.uk/1/hi/health/4084365.stm; Mark Henderson, An Embryo That Went on Growing, TIMES ONLINE, http://timesonline.co.uk/printFriendly/0,,1-210-1524515-355,00.html.

182 See generally Havins & Dalessio, supra note 1.

183 See Jayson, supra note 1, at 299–302.

184 See generally Cohen, supra note 1, at 353.

185 Willgoos, Christine, Comment, FDA Regulation: An Answer to the Questions of Human Cloning and Germline Gene Therapy, 27 AM. J.L. & MED. 101 (2001)Google Scholar.

186 Lorio, supra note 133, at 253.

187 Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing, 66 Fed. Reg. 5447 (Jan. 19, 2001) (codified at 21 C.F.R. pts. 207, 807, 1271).

188 See generally Willgoos, supra note 185, at 122.

189 21 C.F.R. § 1271.1 (2005).

190 Id. § 1271.3.

191 Id. pt. 1271, subpt. C.

192 Id. pt. 1271, subpt. B.

193 66 Fed. Reg. 5447 (Jan. 19, 2001) (codified at 21 C.F.R. pts. 207, 807, & 1271).

194 Id. pt. 1271, subpt. D.

195 Id. at 29949.

196 Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling, 70 Fed. Reg. 29949, 29949–29950 (May 25, 2005) (codified at 21 C.F.R. pt. 1271).

197 See Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products, 66 Fed. Reg. 5447, 5448 (Jan. 19, 2001).

198 Id.

199 Id. at 5549.

200 Public Health Service Act, 42 U.S.C. § 264 (2005); see also 21 C.F.R. § 1271.1 (2005).

201 Interview with Joyce Zeitz, Executive Administrator, Society for Assisted Reproductive Technology (August 8, 2001).

202 Id.

203 Id.

204 Id.

205 Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments: Inspection and Enforcement, 69 Fed. Reg. 68,612, 68,654 (Nov. 24, 2004).

206 66 Fed. Reg. 1507, 1544 (January 8, 2001).

207 69 Fed. Reg. 68,612.

208 See ELEVENTH ANNUAL REPORT, supra note 27, at 13.

209 Centers for Disease Control and Prevention, Contribution of Assisted Reproductive Technology and Ovulation-Inducing Drugs to Triplet and Higher-Order Multiple Births--United States, 1980-1997, 49 MORBIDITY & MORTALITY WKLY. REP. 535, 535, (June 23, 2000).

210 See Id. at 537.

211 Laura A. Scheive et al., Live-Birth Rates and Multiple-Birth Risk Using In-Vitro Fertilization, 282 JAMA 1832, 1832, 1837 (1999).

212 ELEVENTH ANNUAL REPORT, supra note 27, at 16–17.

213 HFEA CODE OF PRACTICE, supra note 13, at 84.

214 Press Release, Human Fertilisation & Embryology Auth., HFEA Strengthens Commitment to Reducing Multiple Births (Jan. 6, 2004), available at http://www.hfea.gov.uk/PressOffice/Archive/1073398264 (quoting Jane Denton, Director of The Multiple Births Foundation: “For some patients the prospect of twins or triplets may seem an ideal way to have the family they long for. But the reality can be very different. Multiple births are associated with premature and low birth-weight babies and the risk of death before birth or in the first week of life is significantly greater. Compared with one baby, long term disability like cerebral palsy is around five times higher for twins and 18 times higher for triplets.”)

215 See The Am. Soc’y for Reproductive Medicine, 2002 Guidelines for Gamete and Embryo Donation: A Practice Committee Report, 77 FERTILITY & STERILITY S1 (Supp. 5 June 2002).

216 The Practice Committee of the Soc’y for Assisted Reproductive Technology & the Am. Soc’y for Reproductive Medicine, Guidelines on the Number of Embryos Transferred, 82 FERTILITY & STERILITY 773 (2004)CrossRefGoogle Scholar [hereinafter SART & ASRM].

217 See id.

218 Id. at 773.

219 Id.

220 The guidelines recommended a maximum of three embryos for women 35-37, four for women 38-40, and five for women over 40. Id. at 773–774.

221 Id. at 774.

222 1998 RATES, supra note 61, at 18.

223 SART & ASRM, supra note 216, at 773.

224 James Meek, IVF Doctor Loses Bid to Change Embryo Rule, THE GUARDIAN, April 25, 2001, available at http://education.guardian.co.uk/news/story/0,5500,478170,00.html.

225 Rachel Ellis, Two-Embryo Limit For IVF as Triplet Births Soar, MAIL ON SUNDAY, July 8, 1996, available at 2001 WLNR 2726015; Robert Verkaik, Judge Turns Down Woman's Plea to Relax Embryo Limit, THE INDEPENDENT (London), Apr. 25, 2001, available at 2001 WLNR 6940416.

226 Meek, supra note 224.

227 Action to cut IVF multiple births, BBC NEWS, Aug. 7, 2001, http://news.bbc.co.uk/1/hi/health/1476646.stm.

228 NINTH ANNUAL REPORT, supra note 90, at 14.

229 The most recent analysis is reported in Soc’y for Assisted Reprod. Tech. & The Am. Soc’y for Reprod. Med., Assisted Reproductive Technology in the United States: 2000 Results Generated from the American Society for Reproductive Medicine/Society for Assisted Reproductive Technology Registry, 81 FERTILITY AND STERILITY 1 207-20 (2004).Google Scholar

230 Gatter, Robert, Faith, Confidence ,and Health Care: Fostering Trust in Medicine Through Law, 39 WAKE FOREST L. REV. 395, 424, 436–437(2004).Google ScholarPubMed

231 Id.

232 Human Fertilisation & Embryology Authority, Patients’ Guide to Infertility: Issues to Consider: Will I Get NHS Funding?, http://www.hfea.gov.uk/ForPatients/Archivedinformation/PatientsGuidetoInfertility/Issuestoconsider (last visited Sept. 26, 2005). “Multiple births are associated with premature birth, low birth weight babies, a higher rate of stillbirth and neonatal death, and long-term disability such as cerebral palsy . In addition to the health risks to the babies, there are also increased risks for the parents including complications at birth and the possible emotional strain of having to cope with more than one new baby in the family together with potential increased financial constraints.”

233 “[T]he vast majority of courts have denied the wrongful life cause of action by focusing on the element of harm and holding that life itself cannot constitute injury. Such a holding assumes that life is always preferable to non-life and/or that it is impossible for a trier of fact to measure damages for the harm of life compared to the utter void of nonexistence.’” Pollard, Deana A., Wrongful Analysis in Wrongful Life Jurisprudence, 55 ALA. L. REV. 327, 328 (2004).Google Scholar

234 Charo points out that determination of a court challenge to regulation of ART procedures will depend upon the U.S. Supreme Court's view of ART: is the creation of a fetus in a dish entitled to the same special protection from government intrusion as the creation of a fetus through sexual intercourse? If [the special protection afforded human reproduction is] associated with intimate marital relations, then technologies using third party gametes or hired surrogates may not be protected . If it is because the government ought not interfere with physical bodies and reproductive capabilities of its citizens, then there is a far weaker claim of any right to access medical services that depend on extra-uterine maintenance or diagnosis of embryos. But if it is because human reproduction is notable for the profound way in which it reflects individual choices, aspirations and self identity, then there may be a far broader range of reproductive decisions that are free from government intrusion. Charo, supra note 137, at 525.

235 Darren Shickle, “On a Supposed Right to Lie [to the Public] From Benevolent Motives”: Communicating Health Risks to the Public, 3 MED., HEALTH CARE & PHIL. 241 (2000).

236 Id. at 246-247.