Revolution or Reform in Human Subjects Research Oversight

Emanuel E. J. Grady C. , and Crouch R. A. , eds., Oxford Textbook of Clinical Research Ethics (New York: Oxford University Press, 2008); Beecher H. K. , “Ethics and Clinical Research,” New England Journal of Medicine 274, no. 24 (1966):1354–1360.

McCarthy C. R. , “The Origins and Policies that Govern Institutional Review Boards,” in Emanuel E. J. Grady C. , and Crouch R. A. , eds., Oxford Textbook of Clinical Research Ethics (New York: Oxford University Press, 2008): 541–551.

Carpenter D. P. , Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton: Princeton University Press, 2010).

World Medical Association, Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, 1975, available at <http://ethics.iit.edu/indexOfCodes-2.php?key=24_552_1129> (last visited December 7, 2012). Principle 1.2 reads, “The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted to a specially appointed independent committee for consideration, comment and guidance.”

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Biomedical and Behavioral Research, (Washington, D.C.: U.S. Government Printing Office, 1979).

See McCarthy , supra note 3.

Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Participants in Human Subjects Research, December 2011: at 42.

Stewart D. J. Whitney S. N. , and Kurzrock R. , “Equipoise Lost: Ethics, Costs, and the Regulation of Cancer Clinical Research,” Journal of Clinical Oncology 28, no. 17 (2010): 2925–2935; Whitney S. N. and Schneider C. E. , “Viewpoint: A Method to Estimate the Cost in Lives of Ethics Board Review of Biomedical Research,” Journal of Internal Medicine 269, no. 4 (2011): 396–402; Silberman G. and Kahn K. L. , “Burdens on Research Imposed by Institutional Review Boards: The State of the Evidence and Its Implications for Regulatory Reform,” Milbank Quarterly 89, no. 4 (2011): 599–627; Infectious Diseases Society of America, “Grinding to a Halt: The Effects of the Increasing Regulatory Burden on Research and Quality Improvement Eforts,” Clinical Infectious Diseases 49, no. 3 (2009): 328–335.

See Silberman and Kahn , supra note 9; Burman W. J. Reves R. R. Cohn D. L. , and Schooley R. T. , “Breaking the Camel's Back: Multicenter Clinical Trials and Local Institutional Review Boards,” Annals of Internal Medicine 134, no. 2 (2001): 152–157; Gold J. L. and Dewa C. S. , “Institutional Review Boards and Multisite Studies in Health Services Research: Is There a Better Way?” Health Services Research 40, no. 1 (2005): 291–307; Vick C. C. Finan K. R. Kiefe C. Neumayer L. , and Hawn M. T. , “Variation in Institutional Review Processes for a Multisite Observational Study,” American Journal of Surgery 190, no. 5 (2005): 805–809; Humphreys K. Trafton J. , and Wagner T. H. , “The Cost of Institutional Review Board Procedures in Multicenter Observational Research,” Annals of Internal Medicine 139, no. 1 (2003): 77.

See Gold and Dewa , supra note 10.; McWilliams R. Hoover-Fong J. , and Hamosh A. , “Problematic Variation in Local Institutional Review of a Multicenter Genetic Epidemiology Study,” JAMA 290, no. 3 (2003): 360–366; Rogers A. S. Schwartz D. F. Weissman G. , and English A. , “A Case Study in Adolescent Participation in Clinical Research: Eleven Clinical Sites, One Common Protocol, and Eleven IRBs,” IRB: Ethics and Human Research 21, no. 1 (1999): 6–10; Stair T. O. Reed C. R. Radeos M. S. Koski G. , and Camargo C. A. , “Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Clinical Trial,” Academic Emergency Medicine 8, no. 6 (2001): 636–641; Stark A. R. Tyson J. E. , and Hibberd P. L. , “Variation Among Institutional Review Boards in Evaluating the Design of a Multicenter Randomized Trial,” Journal of Perinatology 30, no. 3 (2010): 163–169; Finch S. A. Barkin S. L. , and Wasserman R. C. , “Effects of Local Institutional Review Board Review on Participation in National Practice-based Research Network Studies,” Archives of Pediatric & Adolescent Medicine 163, no. 12 (2009): 1130–1134; Silverman H. Hull S. C. , and Sugarman J. , “Variability Among Institutional Review Boards' Decisions Within the Context of a Multicenter Trial,” Critical Care Medicine 29, no. 2 (2001): 235–241; Burman W. Breese P. , and Weis S. , “The Effects of Local Review on Informed Consent Documents from a Multicenter Clinical Trials Consortium,” Controlled Clinical Trials 24, no. 3 (2003): 245–255; Mansbach J. Acholonu U. Clark S. , and Camargo C. , “Variation in Institutional Review Board Responses to a Standard, Observational, Pediatric Research Protocol,” Academic Emergency Medicine 14, no. 4 (2007): 377–380; Kimberly M. B. Hoehn K. S. Feudtner C. Nelson R. M. , and Schreiner M. , “Variation in Standards of Research Compensation and Child Assent Practices: A Comparison of 69 Institutional Review Board-Approved Informed Permission and Assent Forms for 3 Multicenter Pediatric Clinical Trials,” Pediatrics 117, no. 5 (2006): 1706–1711.

Christopher P. P. Foti M. E. Roy-Bujnowski K. , and Appelbaum P. S. , “Consent Form Readability and Educational Levels of Potential Participants in Mental Health Research,” Psychiatric Services 58, no. 2 (2007): 27–232; Sharp S. M. , “Consent Documents for Oncology Trials: Does Anybody Read These Things?” American Journal of Clinical Oncology 27, no. 6 (2004): 570–575; Schneider C. E. , “The Hydra,” Hastings Center Report 40, no. 4 (2010): 9–11.

See Burman , supra note 11; Paasche-Orlow M. K. Taylor H. A. , and Brancati F. L. , “Readability Standards for Informed-Consent Forms as Compared with Actual Readability,” New England Journal of Medicine 348, no. 8 (2003): 721–726.

Gunsalus C. K. Bruner E. M. , and Burbules N. C. , “Mission Creep in the IRB World,” Science 312, no. 5779 (2006): 1441.

See Silberman and Kahn , supra note 9; See Humphreys , supra note 10; Sugarman J. Getz K. , and Speckman J. L. , “The Cost of Institutional Review Boards in Academic Medical Centers,” New England Journal of Medicine 352, no. 17 (2005): 1825–1827; Emanuel E. J. Schnipper L. E. Kamin D. Y. Levinson J. , and Lichter A. S. , “The Costs of Conducting Clinical Research,” Journal of Clinical Oncology 21, no. 22 (2003): 4145–4150; Wagner T. H. Bhandari A. Chadwick G. L. , and Nelson D. K. , “The Cost of Operating Institutional Review Boards (IRBs),” Academic Medicine 78, no. 6 (2003): 638–644.

Jonas H. , “Philosophical Refections on Experimenting with Human Subjects,” Daedalus 98, no. 2 (1969): 219–247; Joffe S. and Miller F. G. , “Bench to Bedside: Mapping the Moral Terrain of Clinical Research,” Hastings Center Report 32, no. 2 (2008): 30–42.

Tu J. V. Willison D. J. , and Silver F. L. , “Impracticability of Informed Consent in the Registry of the Canadian Stroke Network,” N. Engl. J. Med. 350, no. 14 (2004): 1414–1421; Forsberg Stjernschantz J. Hansson M. G. , and Eriksson S. , “Biobank Research: Who Benefits from Individual Consent?” British Medical Journal 343 (2011): D5647.

Kuehn B. M. , “DHHS Halts Quality Improvement Study: Policy May Hamper Tests of Methods to Improve Care,” JAMA 299, no. 9 (2008): 1005–1006.

Ness R. B. , “Influence of the HIPAA Privacy Rule on Health Research,” JAMA 298, no. 18 (2007): 2164–2170.

Fost N. and Levine R. J. , “The Dysregulation of Human Subjects Research,” JAMA 298, no. 18 (2007): 2196–2198.

Emanuel E. J. and Menikofff J. , “Reforming the Regulations Governing Research with Human Subjects,” N. Engl. J. Med. 365, no. 12 (2011): 1145–1150; Department of Health and Human Services, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” Federal Register 76, no. 143 (2011): 44512–44531.

See Emanuel and Menikofff , supra note 21.

Kim S. Ubel P. , and De Vries R. , “Pruning the Regulatory Tree,” Nature 457, no. 7229 (2009): 534–535.

Whitney S. N. and Schneider C. E. , “Was the Institutional Review Board System a Mistake?” Clinical Infectious Diseases 49, no. 12 (2009): 1957; Burman W. and Daum R. , “Reply to Whitney and Schneider,” Clinical Infectious Diseases 49, no. 12 (2009): 1957–1958.

Hamburger P. , “Getting Permission,” Northwestern University Law Review 101, no. 2 (2007): 405–492.

Emanuel E. J. Wendler D. , and Grady C. , “What Makes Clinical Research Ethical?” JAMA 283, no. 20 (2000): 2701–2711.

Id.; World Medical Association, Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, 2008, available at <http://www.wma.net/en/30publications/10policies/b3/index.html> (last visited December 7, 2012).

See Beecher , supra note 2.

Miller F. G. and Wertheimer A. , “Facing Up to Paternalism in Research Ethics,” Hastings Center Report 37, no. 3 (2007): 24–34.

Glickman S. W. McHutchison J. G. , and Peterson E. D. , “Ethical and Scientific Implications of the Globalization of Clinical Research,” New England Journal of Medicine 360, no. 8 (2009): 816–823.

See Presidential Commission, supra note 8.

Epstein R. A. , “Defanging IRBs: Replacing Coercion with Information,” Northwestern University Law Review 101, no. 2 (2007): 735–748.

See Miller and Wertheimer , supra note 29.

See National Commission, supra note 5.

See Miller and Wertheimer , supra note 29, at 24.

See Emanuel and Menikofff , supra note 21; Institute of Medicine, Responsible Research: A Systems Approach to Protecting Research Participants (Washington, D.C.: National Academies Press, 2002).

See Kim , supra note 23.

See Emanuel and Menikoff , supra note 21; See Department of Health and Human Services, supra note 21.

Stroustrup A. Kornetsky S. , and Joffe S. , “Knowledge of Regulations Governing Pediatric Research: A Pilot Study,” IRB: Ethics and Human Research 30, no. 5 (2008): 1–7.

See Institute of Medicine, supra note 37: at 90–91.

See Department of Health and Human Services, supra note 21.

Taylor H. A. , “Moving Beyond Compliance: Measuring Ethical Quality to Enhance the Oversight of Human Subjects Research,” IRB 29, no. 5 (2007): 9–14; Coleman C. and Bouësseau M. , “How Do We Know that Research Ethics Committees Are Really Working? The Neglected Role of Outcomes Assessment in Research Ethics Review,” BMC Medical Ethics 9, no. 1 (2008): 6.