Applying the Common Rule to Public Health Agencies: Questions and Tentative Answers about a Separate Regulatory Regime

45 C.F.R. §§ 46.101 et seq.

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. , “Instituting 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).

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).

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.

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

See Institute of Medicine, The Future of Public Health (Washington, DC: National Academy Press, 1988); Institute of Medicine, The Future of the Public's Health in the 21st Century (Washington, D.C.: National Academies Press, 2003); National Bioethics Advisory Commission, “Federal Agency Survey on Policies and Procedures for the Protection of Human Subjects in Research,” 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.

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.

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

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

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

See Amoroso Middaugh , supra note 7, at 251.

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.

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.

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

Id. at 35–36.

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.

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

VA ST. § 32.1–162.17.

Id. § 32.1–39.

See the papers by Weeden, supra note 13.

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.

Amoroso Middaugh , supra note 7, at 250.

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

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

VA ST § 32.1–40.

KY ST § 211.005.

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

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

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

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.

See sources cited supra note 4.

See, e.g., Childress , supra note 4, at 170

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

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.

See, e.g., O'Neill O. , supra note 31, at 36.

Cf. Burris , supra note 35.

Gostin , supra note 4, at 122.

See, e.g., Childress , supra note 4, at 170.

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

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

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.

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

O'Neill , supra note 31, at 37.

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

See Callahan Jennings , supra note 4, at 169.

Kass , supra note 4, at 1777.

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

Callahan Jennings , supra note 4, at 170.

Callahan Jennings , supra note 4, 173.

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

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).

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

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

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

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).

Kass , supra note 4, at 1777.

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

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.

Cf. Thomas , supra note 4, at 1057; Kass , supra note 4, at 1777.

See sources cited supra note 4.

O'Neill , supra, note 31, at 40.

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

See Steinberg , supra note 4.

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.

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).

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.

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).

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

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

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.

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.

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.

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.

Kahn Mastroianni , supra note 74.

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.

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

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.

Institute of Medicine, supra note 65, at 6.

Chalmers & Pettit, supra note 70, at 80.

See 45 C.F.R. §46.111.

See Amoroso Middaugh , supra note 7, at 253.

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).

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.

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): 318–319

See sources cited supra note 12.

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.

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.