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The central, though not only, federal regulation is the Common Rule, found at 45 C.F.R. pt. 42 (2003).Google Scholar

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See, e.g., Schneider, C.E., The Practice of Autonomy: Patients, Doctors and Medical Decisions (New York: Oxford University Press, 1998).Google Scholar

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Recent litigation prompted by human subjects research is altering the mix of legal tools in play. See, e.g., Grimes v. Kennedy Krieger Inst., 782 A.2d 807 (Md. 2001).Google Scholar

On the federal regulation in play, see supra note 8 regarding the Common Rule. Additional important regulation protecting human subjects includes that of the FDA. See 21 C.F.R. pts. 50–56 (2003). On the relevant state law, see, e.g., CAL. HEALTH & SAFETY CODE JS 24170–24179.5 (West 1978 & Supp. 2003); VA. CODE ANN. tit. 32.1 § 162.16–20 (Michie 1979 & Supp. 2003); WASH. REV. CODE ANN. §§ 42.48.010–900 (West 1985 & Supp. 2003).Google Scholar

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See, e.g., “Symposium: Research with Children: The New Legal and Policy landscape,” Journal of Health Care Law & Policy 6 (2002): 1–193; Wolf, Kahn, Wagner, , supra note 31.Google Scholar

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See National Institutes of Health (NTH), Department of Health and Human Services, “Guidelines for Research Involving Recombinant DNA Molecules,” Appendix M, “Points to Consider in the Design and Submission of Protocols for the Transfer of Recombinant DNA Molecules into One or More Human Research Participants (Points to Consider),” available at <www4.od.nih.gov/oba/rac/guidelines_02/Appendix_M.htm> (last visited April 26, 2004); King, N.M.P., “RAC Oversight of Gene Transfer Research: A Model Worth Extending?” Journal of Law, Medicine & Ethics 30 (2002): 381 –86; Anderson, W.F., “Big Changes at the RAC!” Human Gene Therapy 5 (1998): 1309–10.+(last+visited+April+26,+2004);+King,+N.M.P.,+“RAC+Oversight+of+Gene+Transfer+Research:+A+Model+Worth+Extending?”+Journal+of+Law,+Medicine+&+Ethics+30+(2002):+381+–86;+Anderson,+W.F.,+“Big+Changes+at+the+RAC!”+Human+Gene+Therapy+5+(1998):+1309–10.>Google Scholar

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To tap into the sizeable literature critiquing use of grand narrative, see, e.g., Guinier, L. Torres, G., The Miner’s Canary: Enlisting Race, Resisting Power, Transforming Democracy (Cambridge, MA: Harvard University Press, 2002): 34–38; Ewick, P. Silbey, S.S., “Subversive Stories and Hegemonic Tales: Toward a Sociology of Narrative,” Law & Society Review 29 (1995): 197–226; Coombs, M.I., “Outsider Scholarship: The Law Review Stories,” University of Colorado Law Review 63 (1992): 683–716; Abrams, K., “Hearing the Call of Stories,” California Law Review 79 (1991): 971–1052.Google Scholar

The completed reports of the President’s Council are: President’s Council on Bioethics, Reproduction and Responsibility, supra note 40; President’s Council on Bioethics, Monitoring Stem Cell Research (Washington, DC: 2004); President’s Council on Bioethics, Beyond Therapy: Biotechnology and the Pursuit of Happiness (Washington, DC: 2003); President’s Council on Bioethics, Human Cloning, supra note 13. I do not include an anthology of readings also issued by the Council without normative recommendations. President’s Council on Bioethics, Being Human: Readings from the President’s Council on Bioethics (Washington, DC: 2003). On the work of the President’s Council, see <www.bioethics.gov> (last visited May 18, 2004).+(last+visited+May+18,+2004).>Google Scholar

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See Human Cloning Ban and Stem Cell Research Protection Act of 2003, S. 303, 108^th Cong. (2003); Human Cloning Prohibition Act of 2003, H.R. 534, 108^th Cong. (2003); Human Cloning Prohibition Act of 2003, S. 245, 108^th Cong. (2003), Human Cloning Prohibition Act of 2003, H.R. 234, 108^th Cong. (2003); Cloning Prohibition Act of 2003, H.R. 801, 108^th Cong. (2003).Google Scholar

President’s Council on Bioethics, Reproduction and Responsibility, supra note 40. Council recommendations are in chapter 10.Google Scholar

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Id. at 220. The eight practices that the Council recommends for Congressional prohibition are: Transferring a human embryo into a non-human, mixing human and non-human gametes to produce an embryo, transferring a human embryo to a woman’s uterus for any purpose other than producing a baby, trying to conceive a child by means other than joining egg and sperm, using gametes from a human fetus or stems cells from a human embryo to try to conceive a child, fusing blastomeres from two or more embryos to attempt human conception, conducting research on human embryos beyond 10–14 days after fertilization, and buying or selling human embryos. Id. at 220–27.Google Scholar

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See Annas, G.J., “The Nuremberg Code in U.S. Courts: Ethics versus Expediency,” in Annas, G.J. Grodin, M.A., eds., The Nazi Doctors and the Nuremberg Code (New York: Oxford University Press, 1992): 201–22.Google Scholar

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See Frase, R.S., “Criminalization and Decriminalization,” in Bernard, T.J. et al. , eds., Encyclopedia of Crime & Justice (New York: Macmillan, 2d ed. 2001): vol. 1 at 347–61, 358 (quoting, at 358, James Fitzjames Stephen).Google Scholar

Cf. Robertson, , “Wrongful Life,” supra note 89, at 80 (“There is an important question of federalism here. Even if criminal sanctions were warranted, it does not follow that the federal government should enact them. We generally leave matters of family, procreation, and protection of children to the states.”).Google Scholar

See, e.g., Zimring, F.E. Hawkins, G., “Legislating Federal Crime and Its Consequences,” Annals of the American Academy of Political and Social Science 543 (1996): 15–26; Ehrlich, S.A., “The Increasing Federalization of Crime,” Arizona State Law Journal 32 (2000): 825–42. See also American Bar Association, Task Force on the Federalization of Criminal Law, The Federalization of Criminal Law (Washington, DC: 1998).CrossRefGoogle Scholar

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Alta Charo has explored related terrain in trying to develop a bioethics of public policy. See Charo, R.A., “Dealing with Dolly: Cloning and the National Bioethics Advisory Commission” Jurimetrics Journal 38 (Fall 1997): 11–22; Charo, R.A., “The Hunting of the Snark: The Moral Status of Embryos, Right-to-Lifers, and Third World Women,” Stanford Law & Policy Review 6 (1995): 11–27.Google Scholar

See Administrative Procedure Act, 5 U.S.C. §§ 551 et seq. (2000); Federal Advisory Committee Act, 5 U.S.C. Appendix 2 (2000).Google Scholar

See Wolf, S.M., “Ethics Committees and Due Process: Nesting Rights in a Community of Caring,” Maryland Law Review 50 (1991): 798–858; Wolf, S.M., “Toward a Theory of Process,” Law, Medicine & Health Care 20 (1993): 278 – 90.Google Scholar

See Blackburn, E., “Bioethics and the Political Distortion of Biomedical Science,” New England Journal of Medicine 350 (2004): 1379–80; Caplan, A.L. et al. , “Petition Sponsored by Arthur Caplan, PhD.,” Mar. 3, 2004 (e-mail, on file with the author).CrossRefGoogle Scholar

Cf. Union of Concerned Scientists, “Restoring Scientific Integrity in Policy-making,” available at <www.ucsusa.org/global_environment/rsi/signon.html> (last visited April 26, 2004) (letter from 60 prominent scientists accusing the current Bush administration of misusing science); Glanz, J., “Scientists Say Administration Distorts Facts,” New York Times, Feb. 19, 2004, at A18. On problems of fair representation, see also Callahan, , supra note 90, at chapter 7; Spielman, B., “Should Consensus Be ‘The Commission Method’ in the US? The Perspective of the Federal Advisory Committee Act, Regulations, and Case Law,” Bioethics 17 (2003): 341–56.+(last+visited+April+26,+2004)+(letter+from+60+prominent+scientists+accusing+the+current+Bush+administration+of+misusing+science);+Glanz,+J.,+“Scientists+Say+Administration+Distorts+Facts,”+New+York+Times,+Feb.+19,+2004,+at+A18.+On+problems+of+fair+representation,+see+also+Callahan,+,+supra+note+90,+at+chapter+7;+Spielman,+B.,+“Should+Consensus+Be+‘The+Commission+Method’+in+the+US?+The+Perspective+of+the+Federal+Advisory+Committee+Act,+Regulations,+and+Case+Law,”+Bioethics+17+(2003):+341–56.>Google Scholar

Bethany Spielman offers a model of such scholarship in her work on what law has to teach bioethics on the desirability of consensus within federal commissions. See Spielman, , supra note 101.Google Scholar

See, e.g., Symposium, “The Legal Construction of Norms,” Virginia Law Review 86 (2000): 1577–2021; Symposium, “Social Norms, Social Meaning, and the Economic Analysis of Law,” Journal of Legal Studies 27 (1998): 537–823; Symposium, “Normative Failure Theory of Law,” Cornell Law Review 82 (1997): 947–79; McAdams, R.H., “The Origin, Development, and Regulation of Norms,”Michigan Law Review 96 (1997): 338–433; Sunstein, C., “Social Norms and Social Roles,”Columbia Law Review 96 (1996): 903–68; Lessig, L., “The Regulation of Social Meaning,” University of Chicago Law Review 62 (1995): 943–1045.Google Scholar

Scholars beginning to explore the implications of work on law and norms for problems in bioethics include Gail Agrawal and Arti Rai. See Agrawal, G.B., “Resuscitating Professionalism: Self-Regulation in the Medical Marketplace,” Missouri Law Review 66 (2001): 341–411; Rai, A.K., “Regulating Scientific Research: Intellectual Property Rights and the Norms of Science,” Northwestern University Law Review 94 (1999): 77–152.Google Scholar

On litigation against bioethicists and their potential liability, individually and as committee members, see, e.g., Sontag, D.N., “Are Clinical Ethics Consultants in Danger? An Analysis of the Potential Legal Liability of Individual Clinical Ethicists,” University of Pennsylvania Law Review 151 (2002): 667–705 (discussing the Gelsinger, Robertson, and older Bouvia cases); Merritt, A.L., “The Tort Liability of Hospital Ethics Committees”, Southern California Law Review 60 (1987): 1239–97.CrossRefGoogle Scholar

See, e.g., Bosk, C., “The Licensing and Certification of Ethics Consultants: What Part of ‘No!’ Was So Hard to Understand?” in Aulisio, M.P. Arnold, R.M. Youngner, S.J., eds., Ethics Consultation: From Theory to Practice (Baltimore: Johns Hopkins University Press, 2003): 147–63; Churchill, L.R., “Are We Professionals? A Critical Look at the Social Role of Bioethicists,” Daedalus128, no. 4 (1999): 253–74; Shalit, R., “When We Were Philosopher Kings,” New Republic 216, no. 17 (1997): 24– 28; Baylis, F.E., ed., The Health Care Ethics Consultant (Totowa, NJ: Humana Press, 1994); Scofield, G.R., “Here Come the Ethicists!” Trends in Health Care, Law & Ethics, 8 no. 4 (1993): 19–22; Scofield, G.R., “Ethics Consultation: The Least Dangerous Profession?” Cambridge Quarterly of Healthcare Ethics 2 (1993): 417–25. There is a closely related debate over whether bioethicists can claim a genuine expertise. See, e.g., Pellegrino, E.D., “Clinical Ethics Consultations: Some Reflection on the Report of the SHHV-SBC,” Journal of Clinical Ethics 10, no. 1 (1999): 5–12; Casarett, D.J. Daskal, F. Lantos, J., “Experts in Ethics? The Authority of the Clinical Ethicist,”Hastings Center Report28, no. 6(1998): 6–11; Caplan, A.L., “Moral Experts and Moral Expertise: Do Either Exist?” in Hoffmaster, B. Freedman, B. Fraser, G., eds., Clinical Ethics: Theory and Practice (Clifton, NJ: Humana Press, 1989): 59–87. Related to that has been a further debate on the role of the bioethicist as expert witness in court. See, e.g., Spielman, B. Agich, G., “The Future of Bioethics Testimony: Guidelines for Determining Qualifications, Reliability, and Helpfulness,” San Diego Law Review 36 (1999): 1043–7; Delgado and McAllen, supra note 55.Google Scholar

American Society for Bioethics and Humanities, Core Competencies for Health Care Ethics Consultation: The Report of the American Society for Bioethics and Humanities (Glenview, IL: 1998) [hereinafter “Core Competencies”]. For recent debate on what standards should guide private bioethics consultation, see Brody, B. et al. , “Bioethics Consultation in the Private Sector”, Hastings Center Report 32, no. 3 (2002): 14–20; Youngner, S.J. Arnold, R., “Who Will Watch the Watchers?” Hastings Center Reports, no. 3 (2002): 21–22; Brody, B. et al. , “The Task Force Responds,” Hastings Center Report 32, no. 3 (2002): 22–23.Google Scholar

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