45 C.F.R. §§ 46.101 et seq.Google Scholar

See, e.g., National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants: Volume I, Report and Recommendations of the National Bioethics Advisory Commission (Bethesda, MD: National Bioethics Advisory Commission, 2001); Pettit, P., ℌInstituting a Research Ethic: Chilling and Cautionary Tales,” in Rules, Reasons, and Norms (Oxford: Oxford University Press, 2002): 378–401; Slater, E. E., “IRB Reform,” New England Journal of Medicine, 346 (2001): 1402–1404; Turnberg, L., “Common Sense and Common Consent in Communicable Disease Surveillance,” Journal of Medical Ethics, 29 (2003): 27–29; Ilgen, D. R. Bell, B. S., “Informed Consent and Dual Purpose Research,” American Psychologist, 56 (2001): 1177; Panel on Institutional Review Boards Surveys and Social Science Research and National Research Council, Protecting Participants and Facilitating Social and Behavioral Sciences Research (Washington, D.C.: National Academy Press, 2003).Google Scholar

Centers for Disease Control and Prevention, Guidelines for Defining Public Health Research and Public Health Non-Research, available at <http://www.cdc.gov/od/ads/opspoll1.htm> (last visited October 28, 2003).+(last+visited+October+28,+2003).>Google Scholar

Anonymous, “Code of Ethics for Public Health,” Public Health Reports, 116 (2001): 270–271; Thomas, J. C. Sage, M. Dillenberg, J. Guillory, V. J., “A Code of Ethics for Public Health,” American Journal of Public Health, 92 (2002): 1057–1059; Kass, N. E., “An Ethics Framework for Public Health,” American Journal of Public Health, 91 (2001): 1776–1782; Childress, J. F. Faden, R. R. Gaare, R. D. Gostin, L. O. Kahn, J. Bonnie, R. J. Kass, N. E. Mastroianni, A. C. Moreno, J. D. Nieburg, P., “Public Health Ethics: Mapping the Terrain,” Journal of Law, Medicine & Ethics, 30 (2002): 170–178; Roberts, M. J. Reich, M. R., “Ethical Analysis in Public Health,” Lancet, 359 (2002): 1055–1059; Schabas, R., “Is Public Health Ethical?,” Canadian Journal of Public Health. Revue Canadienne de Sante Publique, 93 (2002): 98–100; Weed, D. L., “Towards a Philosophy of Public Health,” Journal of Epidemiology & Community Health, 53 (1999): 99–104; Callahan, D. Jennings, B., “Ethics and Public Health: Forging a Strong Relationship,” American Journal of Public Health, 92 (2002): 169–176, Steinberg, K. K., “Ethical Challenges at the Beginning of the Millennium,” Statistics in Medicine, 20 (2001): 1415–1419; Mann, J. M., “Medicine and Public Health, Ethics and Human Rights,” Hastings Center Report, 27 (1997): 6–13; Gruskin, S., “Ethics, Human Rights, and Public Health,” American Journal of Public Health, 92 (2002): 698–699; Gostin, L. O., “Public Health, Ethics, and Human Rights: A Tribute to the Late Jonathan Mann,” Journal of Law, Medicine & Ethics, 29 (2001): 121–130; Burris, S. Gostin, L. O. Tress, D., “Public Health Surveillance of Genetic Information: Ethical and Legal Responses to Social Risk,” in Khoury, M. Burke, W. Thomson, E., eds, Genetics and Public Health in the 21st Century: Using Genetic Information to Improve Health and Prevent Disease (New York and Oxford: Oxford University Press, 2000): 527–548.Google Scholar

National Bioethics Advisory Commission, supra note 2, at 35–36.Google Scholar

.*? .*? in National Bioethics Advisory Commission, eds, Ethical and Policy Issues in Research Involving Human Participants: Commissioned Papers and Staff Analysis (Bethesda, MD: National Bioethics Advisory Commission, 2001): J1–J33 at J-23 Table 3.Google Scholar

See Amoroso, P. J. Middaugh, J. P., “Research Versus Public Health Practice: When Does a Study Require IRB Review,” Preventive Medicine, 36 (2003): 250–253; Council of State and Territorial Epidemiologists, CSTE Position Statement 1996–8: Definition of Public Health Research, available at <http://www.cste.org/ps/1996/1996–08.htm> (last visited October 28, 2003); Centers for Disease Control and Prevention, supra note 3.CrossRefGoogle Scholar

See, e.g., Callahan, Jennings, , supra note 4; Steinberg, , supra note 4; Amoroso, Middaugh, , supra note 7.Google Scholar

45 C.F.R. §46.102(d) (emphasis added).Google Scholar

See Centers for Disease Control and Prevention, supra note 3; accord Council of State and Territorial Epidemiologists, supra note 7.Google Scholar

See Amoroso, Middaugh, , supra note 7, at 251.Google Scholar

McWilliams, R. Hoover-Fong, J. Hamosh, A. Beaty, B.S.T. Beaty, G. C., “Problematic Variation in Local Institutional Review of a Multicenter Genetic Epidemiology Study,” JAMA, 290 (2003): 360–366; Hirshon, J. M. Krugman, S. D. Witting, M. D. Furuno, J. P. Limcangco, M. R. Perisse, A. R. Rasch, E. K., “Variability in Institutional Review Board Assessment of Minimal-Risk Research,” Academic Emergency Medicine, 9 (2002): 1417–1420; Stair, T. Reed, C. Radeos, M. Koski, G. Camargo, C., “Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Clinical Trial,” Academic Emergency Medicine, 8 (2001): 636–641; Silverman, H. Hull, S. C. Sugarman, J., “Variability among Institutional Review Boards' Decisions within the Context of a Multicenter Trial,” Critical Care Medicine, 29 (2001): 235–241.CrossRefGoogle Scholar

See Wedeen, R. P., “Consent in Epidemiology: Implications of History for Public Policy,” Archives of Environmental Health, 55 (2000): 231–239; Wedeen, R. P., “Ethics in Public Health Institutions,” American Journal of Public Health, 92 (2002): 1884–1885.CrossRefGoogle Scholar

National Bioethics Advisory Commission, supra note 2, at 36.Google Scholar

Id. at 35–36.Google Scholar

Burris, S. Gable, L. Stone, L. Lazzarini, Z., “The Role of State Law Protection for Human Research Subjects in Public Health” Journal of Law, Medicine and Ethics 31 (2003): 654–662.CrossRefGoogle Scholar

Health Insurance Portability and Accountability Act of 1996, Public Law 104–191.Google Scholar

VA ST. § 32.1–162.17.Google Scholar

Id. § 32.1–39.Google Scholar

See the papers by Weeden, supra note 13.Google Scholar

See, e.g., Roggin, K. K. Chwals, W. J. Tracy, T. F., “Institutional Review Board Approval for Prospective Experimental Studies on Infants and Children,” Journal of Pediatric Surgery, 36 (2001): 205–208.CrossRefGoogle Scholar

Amoroso, Middaugh, , supra note 7, at 250.Google Scholar

Callahan, Jennings, , supra note 4, at 171 (emphasis added).Google Scholar

See, e.g., Angell, M., “The Ethics of Clinical Research in the Third World,” New England Journal of Medicine, 337 (1997): 847–849.CrossRefGoogle Scholar

VA ST § 32.1–40.Google Scholar

KY ST § 211.005.Google Scholar

CA HEALTH & SAFETY § 100325; accord, e.g., id § 100335; MA ST 111 § 5.Google Scholar

Gostin, L. O., Public Health Law: Power, Duty, Restraint (Berkeley: University of California Press, 2000): 4.Google Scholar

Id. at 5–9; Gostin, , supra note 4, at 123.Google Scholar

See Callahan, Jennings, , supra note 4, at 169; Kass, , supra note 4, at 1776–77; O'Neill, O., “Public Health or Clinical Ethics: Thinking Beyond Borders,” Ethics and International Affairs, 16 (2002): 35–45, at 35–36.Google Scholar

See sources cited supra note 4.Google Scholar

See, e.g., Childress, et al, supra note 4, at 170Google Scholar

Rose, G., “Sick Individuals and Sick Populations,” International Journal of Epidemiology, 14 (1985): 32–38.Google Scholar

See, e.g., Blankenship, K. M. Bray, S. Merson, M., “Structural Interventions in Public Health,” AIDS, 14 Suppl 1 (2000): S11–21; Burris, S., “Introduction: Merging Law, Human Rights and Social Epidemiology,” Journal of Law, Medicines Ethics, 30 (2002): 498–509; Sumartojo, E., “Structural Factors in HIV Prevention: Concepts, Examples, and Implications for Research,” AIDS, 14 Suppl 1 (2000): S3–10.CrossRefGoogle Scholar

See, e.g., O’Neill, O., supra note 31, at 36.Google Scholar

Cf. Burris, , supra note 35.Google Scholar

Gostin, , supra note 4, at 122.Google Scholar

See, e.g., Childress, et al., supra note 4, at 170.Google Scholar

See, e.g., Schabas, , supra note 11, at 98.Google Scholar

Upshur, R. E., “Principles for the Justification of Public Health Intervention,” Canadian Journal of Public Health, 93 (2002): 101–103, at 101.CrossRefGoogle Scholar

See, e.g., Gostin, L. O. Burris, S. Lazzarini, Z., “The Law and the Public’s Health: A Study of Infectious Disease Law in the United States,” Columbia Law Review, 99 (1999): 59–128; Gostin, , supra note 4, at 122.Google Scholar

Callahan, Jennings, , supra note 4, at 170; accord O'Neill, , supra note 31, at 36–37.Google Scholar

O’Neill, , supra note 31, at 37.Google Scholar

Accord Callahan, Jennings, supra note 4, at 170; see also Weed, , supra note 4, at 100.Google Scholar

See Callahan, Jennings, , supra note 4, at 169.Google Scholar

Kass, , supra note 4, at 1777.Google Scholar

See Wedeen, , “Consent in Epidemiology,” supra note 13, at 232.Google Scholar

Callahan, Jennings, , supra note 4, at 170.Google Scholar

Callahan, Jennings, , supra note 4, 173.CrossRefGoogle Scholar

See, e.g., Commonwealth v. Alger, 61 Mass. (7 Cush.) 53, 61 (1851).Google Scholar

Jacobson v. Commonwealth of Massachusetts, 197 U.S. 1, 25–28 (1905). Accord, e.g., People v. Budd, 22 N.E. 670 (N.Y. 1889); People ex rel. Schulz v. Hamilton, 161 N.Y.S. 425 (N.Y.Sup. 1916).Google Scholar

See generally Gostin, L.O. Lazzarini, Z., Human Rights and Public Health in the AIDS Pandemic (1997).Google Scholar

See, e.g., Burris, S. Kawachi, I. Sarat, A., “Integrating Law and Social Epidemiology,” Journal of Law, Medicine & Ethics, 30 (2002): 510–521.CrossRefGoogle Scholar

Cf. O’Neill, O., “Practical Principles and Practical Judgment,” Hastings Center Report, 31 (2001): 15–23.CrossRefGoogle Scholar

See, e.g., Pressman, J. L. Wildavsky, J., Implementation (Berkeley, CA: University of California Press, 1973); Bardach, E., The Implementation Game (Berkeley, CA: University of California Press, 1977).Google Scholar

Kass, , supra note 4, at 1777.Google Scholar

National Bioethics Advisory Commission, supra note 2; Silverman, , supra, note 12.Google Scholar

The empirical data on this point are quite limited. See Ilgen, D. R. Bell, B. S., “Conducting Industrial and Organizational Psychological Research: Institutional Review of Research in Work Organizations,” Ethics & Behavior, 11 (2001): 395–412.CrossRefGoogle Scholar

Cf. Thomas, et al, supra note 4, at 1057; Kass, , supra note 4, at 1777.Google Scholar

See sources cited supra note 4.Google Scholar

O’Neill, , supra, note 31, at 40.Google Scholar

See, e.g., Upshur, , supra note 41, at 101; Callahan, Jennings, , supra note 4, at 173–74; Childress, et al., supra note 4, at 173.Google Scholar

See Steinberg, , supra note 4.Google Scholar

See, e.g., Institute of Medicine, Responsible Research: A Systems Approach to Protecting Research Participants 2 (2002). For a clear explication of the standard history, see Wedeen, , “Consent in Epidemiology,” supra note 13, at 232–33.Google Scholar

See, e.g., Alcaraz, R. Klonoff, E. A. Landrine, H., “The Effects on Children of Participating in Studies of Minors' Access to Tobacco,” Preventive Medicine, 26 (1997): 236–240; Cardon, P. V. Dommel, F. W., “Injuries to Research Subjects: A Survey of Investigators,” New England Journal of Medicine, 295 (1976): 650–654; Beecher, H. K., “Ethics and Clinical Research,” New England Journal of Medicine, 274 (1966): 1354–1360; Pappworth, M. H., Human Guinea Pigs; Experimentation on Man. (London: Routledge & Paul, 1967); Gray, B. H., Human Subjects in Medical Experimentation: A Sociological Study of the Conduct and Regulation of Clinical Research. (New Haven: Wiley Interscience, 1975); Barber, B. Lally, J. J. Makarushka, J. L. Sullivan, D., Research on Human Subjects: Problems of Social Control in Medical Experimentation. (New Brunswick: Transaction Books, 1978).Google Scholar

This point is made and explicated in Chalmers, D. Pettit, P., “Towards a Consensual Culture in the Ethical Review of Research,” Medical Journal of Australia, 169 (1998): 79–82. For a more detailed discussion of this argument, see Pettit, , supra note 2.CrossRefGoogle Scholar

See, e.g., McNeill, Paul M., The Ethics and Politics of Human Experimentation (1993); Institute of Medicine, supra note 6; Department of Health and Human Services, Office of Inspector General, Institutional Review Boards: A Time for Reform (OEI-01-97-00193, 1998).Google Scholar

See, e.g., McNeill, , supra note 68.Google Scholar

See Institute of Medicine, supra note 65, at 5 n.4.Google Scholar

The data are very sparse. See, e.g., Wagner, T. H. Bhandari, A. Chadwick, G. L. Nelson, D. K., “The Cost of Operating Institutional Review Boards (IRBs),” Academic Medicine, 78 (2003): 638–644.CrossRefGoogle Scholar

The data are sparse, and a review is beyond the scope of this paper. For some discussion, see, e.g., Nelson, K. Garcia, R. E. Brown, J. Mangione, C. M. Louis, T. A. Keeler, E. Cretin, S., “Do Patient Consent Procedures Affect Participation Rates in Health Services Research?,” Medical Care, 40 (2002): 283–288; McCarthy, D. B. Shatin, D. Drinkard, C. R. Kleinman, J. H. Gardner, J. S., “Medical Records and Privacy: Empirical Effects of Legislation,” Health Services Research, 34 (1999): 417–425; Yawn, B. P. Yawn, R. A. Geier, G. R. Xia, Z. Jacobsen, S. J., “The Impact of Requiring Patient Authorization for Use of Data in Medical Records Research,” Journal of Family Practice, 47 (1998): 361–365; Alcaraz, R. Klonoff, E. A. Landrine, H., supra note 66.CrossRefGoogle Scholar

See, e.g, Cassell, J. Young, A., “Why We Should Not Seek Individual Informed Consent for Participation in Health Services Research,” Journal of Medical Ethics, 28 (2002): 313–317; Mammel, K. A. Kaplan, D. W., “Research Consent by Adolescent Minors and Institutional Review Boards,” Journal of Adolescent Health, 17 (1995): 323–330.CrossRefGoogle Scholar

See Kahn, J. P. Mastroianni, A. C., “Moving from Compliance to Conscience: Why We Can and Should Improve on the Ethics of Clinical Research,” Archives of Internal Medicine, 161 (2001): 925–928; London, L., “Ethical Oversight of Public Health Research: Can Rules and IRBs Make a Difference in Developing Countries?,” American Journal of Public Health, 92 (2002): 1079–1084.CrossRefGoogle Scholar

Kahn, Mastroianni, , supra note 74.Google Scholar

Teubner, G., “Juridification: Concepts, Aspects, Limits, Solutions,” in Juridification of Social Spheres: A Comparative Analysis in the Areas of Labour, Corporate, Antitrust and Social and Welfare Law(Berlin and New York: De Gruyter, 1987): 389–435.CrossRefGoogle Scholar

Braithwaite, J., “Rules and Principles: A Theory of Legal Certainty,” Australian Journal of Legal Philosophy, 27 (2002): 47–82.Google Scholar

Murray, A. Scott, C., “Controlling the New Media: Hybrid Responses to New Forms of Power,” Modern Law Review, 65 (2002): 491–516: 504 fig. 1.CrossRefGoogle Scholar

Institute of Medicine, supra note 65, at 6.Google Scholar

Chalmers & Pettit, supra note 70, at 80.Google Scholar

See 45 C.F.R. §46.111.CrossRefGoogle Scholar

See Amoroso, Middaugh, , supra note 7, at 253.Google Scholar

See Turning Point Collaborative, “Model State Public Health Act,” § 5–101 (Draft January 31, 2003) available at <http://www.hss.state.ak.us/dph/deu/turningpoint/PDF%27s/MSPHact.pdf> (last visited October 28, 2003).+(last+visited+October+28,+2003).>Google Scholar

DeRenzo, E. G. Bonkovsky, F. O., “Bioethics Consultants to the National Institutes of Health’s Intramural IRB System: The Continuing Evolution,” IRB: A Review of Human Subjects Research, 15 (1993): 9–10.CrossRefGoogle Scholar

See, e.g., Bauchner, H. Sharfstein, J., “Failure to Report Ethical Approval in Child Health Research: Review of Published Papers,” British Medical Journal, 323 (2001): 318–319CrossRefGoogle Scholar

See sources cited supra note 12.Google Scholar

See, e.g., Black, J., “Proceduralizing Regulation: Part I,” Oxford Journal of Legal Studies, 20 (2000): 597–614J; Black, , “Proceduralizing Regulation: Part II,” Oxford Journal of Legal Studies, 21 (2001): 33–58; Callahan, Jennings, , supra, note 4, at 173–74 (describing importance of politics, law and democratic deliberation to public health); Childress et al., supra, note 4, at 173 (discussing need for “public justification” of decisions). But see Juengst, E. T., “Commentary: What ‘Community Review’ Can and Cannot Do,” Journal of Law, Medicine & Ethics, 28 (2000): 52–55.CrossRefGoogle Scholar

Schwartz, J., “Oversight of Human Subject Research: The Role of the States,” in National Bioethics Advisory Commission, eds, Ethical and Policy Issues in Research Involving Human Participants: Commissioned Papers and Staff Analysis (Bethesda, MD: National Bioethics Advisory Commission, 2001): M1–M20.Google Scholar