Institutional Conflicts of Interest: Protecting Human Subjects,Scientific Integrity,and Institutional Accountability

Quick J. , “Maintaining the Integrity of the Clinical Evidence Base,” Bull World Health Organization 79, no.12 (2001): At 1093.

PhRMA, 2004 Pharmaceutical Industry Profile, Washington DC: Pharmaceutical Research and Manufacturers of America (2004).

Begin M. Erola J. Wells G. Potworoski J. , Accelerating Access for Patients to Best Medicine: The System and the Challenge (Ottawa: University of Ottawa, 2002).

Bodenheimer T. , “Uneasy Alliance – Clinical Investigators and the Pharmaceutical Industry,” New England Journal of Medicine 342, no. 20 (2000): 1539–1544.

Blumenthal D. Campbell E. G. Anderson M. S. Causino N. Louis K. S. , “Withholding Research Results in Academic Life Science: Evidence from a National Survey of Faculty,” Journal of the American Medical Association 277, no.15 (1997): 1224–1228.

Bayh-Dole Act, 35 USC 200–212; (1980).

DeAngelis C. D. , “Conflict of Interest and the Public Trust,” Journal of the American Medical Association 284, no. 7 (2000): At 2237–2238; Angell M. , “Is Academic Medicine For Sale?” New England Journal of Medicine 342, no. 20 (2000): 1516–1518.

Van Der Weyden M. B. , “Confronting Conflict of Interest in Research Organizations: Time for National Action,” Medical Journal of Australia 175, no. 8 (2001): 396–397.

Thompson D. F. , “Understanding Financial Conflicts of Interest,” New England Journal of Medicine 329, no. 8 (1993): 573–576.

See Thompson , supra note 9.

Martin J. B. Kasper D. L. , “In Whose Best Interest? Breaching the Academic-Industrial Wall,” New England Journal of Medicine 343, no. 22 (2000): 1646–1649.

Levinsky N. G. , “Nonfinancial Conflicts of Interest in Research,” New England Journal of Medicine 347, no. 10 (2002): 759–761.

See Thompson , supra note 9.

Task Force on Financial Conflicts of Interest in Clinical Research, Protecting Subjects, Preserving Trust, Promoting Progress II: Association of American Medical Colleges, (AAMC: Washington, D.C., 2002).

Task Force on Research and Accountability, Report on Individual and Institutional Financial Conflict of Interest, Washington, DC: Association of American Universities (2001).

Johns M. M. Barnes M. Florencio P. S. , “Restoring Balance to Industry-Academia Relationships in an Era of Institutional Financial Conflicts of Interest: Promoting Research While Maintaining Trust,” Journal of the American Medical Association 289, no. 6 (2003): 741–746.

Press E. Washburn J. , “The Kept University,” Atlantic Monthly 285 (2000): At 39–54.

Lewis S. Baird P. Evans R. G. , “Dancing with the Porcupine: Rules for Governing the University-Industry Relationship,” Canadian Medical Association Journal 165, no. 6 (2001): 783–785.

Collier J. Iheanacho I. , “The Pharmaceutical Industry as an Informant,” Lancet 360 no. 9343 (2002): 1405–1409.

See Angell , supra note 7.

OHRP, Financial Relationships in Clinical Research: Issues for Institutions, Clinical Investigators, and IRB's to Consider when Dealing with Issues of Financial Interests and Human Subject Protection, Washington, D.C.: Office of Human Research Protections (2001).

See Martin , supra note 11.

See Press, supra note 17.

See Van Der Weyden , supra note 8.

See Task Force on Financial Conflicts, supra note 14

See Press, Washburn , supra note 17.

Campbell E. G. Weissman J. S. Clarridge B. Yucel R. Causino N. Blumenthal D. , “Characteristics of Medical School Faculty Members Serving on Institutional Review Boards: Results of a National Survey”, Academic Medicine 78, no. 8, (2003): 831–836.

See Johns Barnes Floencio , supra note 16.

See OHRP, supra note 21.

Dukes M. N. , “Accountability of the Pharmaceutical Industry,” Lancet 360, no. 9346 (2002): 1682–1684; Pecoul B. Chirac P. Trouiller P. Pinel J. , Access to Essential Drugs in Poor Countries: A Lost Battle? Journal of the American Medical Association 281, no. 4 (1999): 361–367.

Angell M. Relman A. S. , “Prescription for Profit,” Washington Post, June 20, 2001, at A27.

Emanuel E. J. Teiner D. , “Institutional Conflict of Interest,” New England Journal of Medicine 332, no. 4 (1995): 262–267.

Shalala D. , “Protecting Research Subjects—What Must Be Done,” New England Journal of Medicine 343, no.11 (2000): 808–810.

See Martin , supra note 11.

Warning Letter from FDA, Center for Biologics Evaluation and Research to Dr. James Wilson, dated March 3, 2000, accessed at http://www.fda.gov/foi/warning_letters/m3435n.pdf on November 5, 2004.

See Shalala , supra note 33.

See Johns Barnes Floencio , supra note 16.

See OHRP, supra note 21.

See Johns Barnes Floencio , supra note 16.

Davidoff F. , “Between the Lines: Navigating the Uncharted Territory of Industry- Sponsored Research. A Former Medical Journal Editor Describes How and Why Staff Changed Their Policy on Disclosing Conflicts of Interest,” Health Affairs (Millwood) 21, no. 2 (2002): 235–242.

Davidson R. A. , “Source of Funding and Outcome of Clinical Trials,” Journal of General Internal Medicine 1, no. 3 (1986): 155–158: Friedberg M. Saffran B. Stinson T. J. Nelson W. Bennett C. L. , “Evaluation of Conflict of Interest in Economic Analyses of New Drugs Used in Oncology,” Journal of the American Medical Association 282, no. 15 (1999): 1453–1457; Lexchin J. Bero L. A. Djulbegovic B. Clark O. , “Pharmaceutical Industry Sponsorship and Research Outcome and Quality: Systematic Review,” British Medical Journal 326, no. 7400 (2003): 1167–1170; Cho M. K. Bero L. A. , “The Quality of Drug Studies Published in Symposium Proceedings,” Annals of Internal Medicine 124, no. 5 (1996): 485–489; Bhandari M. Busse J.W. Jackowski D. , “Association between Industry Funding and Statistically Significant Pro-Industry Findings in Medical and Surgical Randomized Trials,” Canadian Medical Association Journal 170, no. 4 (2004): 477–480.

Bero L. A. Rennie D. Influences on the Quality of Published Drug Studies, International Journal of Technology Assessment in Health Care 12, no.2 (1996): 209–237.

See Bero , supra note 42.

Safer D. J. , “Design and Reporting Modifications in Industry-Sponsored Comparative Psychopharmacology Trials,” Journal of Nervous and Mental Disease 190, no. 9 (2002): 583–592.

Rochon P. A. Gurwitz J. H. Simms R. W. , “A Study of Manufacturer-Supported Trials of Nonsteroidal Anti-Inflammatory Drugs in the Treatment of Arthritis,” Archives of Internal Medicine 154, no. 2 (1994): 157–163.

Montaner J.S. O'Shaughnessy M. V. Schechter M. T. , “Industry-Sponsored Clinical Research: A Double-Edged Sword,” Lancet 358, no. 9296 (2001): 1893–1895.

Ray W. A. Griffin M. R. Avorn J. , “Evaluating Drugs after their Approval for Clinical Use,” New England Journal of Medicine 329, no. 27 (1993): 2029–2032; see Rochon Gurwitz , and Simms , supra note 45

Marshall M. Lockwood A. Bradley C. Adams C. Joy C. Fenton M. , “Unpublished Rating Scales: A Major Source of Bias in Randomized Controlled Trials of Treatments for Schizophrenia,” British Journal of Psychiatry 176 (2000): 249–252.

Carpenter W. , “Industry Phase IV Trials are of Little or No Value: Pro,” Journal of Psychotic Disorders 5, no. 4 (2001): At 3 and 13.

Trivedi M. H. Rush A. J. Carmody T. J. , “Do Bupropion SR and Sertraline Differ in their Effects on Anxiety in Depressed Patients?” Journal of Clinical Psychiatry 62, no. 10 (2001): 776–781; Carpenter W. T. Jr. “From clinical trial to prescription,” Archives of General Psychiatry 59, no. 3 (2002): 282–285.

See Safer , supra note 44.

Lauritsen K. Havelund T. Laursen L. S. Rask-Madsen J. , “Withholding Unfavorable Results in Drug Company Sponsored Clinical Trials,” Lancet 1, no. 8541(1987): At 1091.

See Ray Griffin , supra note 47; Psaty B. M. Weiss N. S. Furberg C. D. , “Surrogate End Points, Health Outcomes, and the Drug-Approval Process for the Treatment of Risk Factors for Cardiovascular Disease,” Journal of the American Medical Association 282, no. 8 (1999): 786–790.

Kahn J. O. Cherng D. W. Mayer K. Murray H. Lagakos S. , “Evaluation of HIV-1 Immunogen, an Immunologic Modifier, Administered to Patients Infected with HIV Having 300 to 549 × 10(6)/4L CD4 Cell Counts: A randomized Controlled Trial,” Journal of the American Medical Association 284, no.17 (2000): 2193–2202.

Emanuel E. J. Wendler D. Grady C. , “What Makes Clinical Research Ethical?” Journal of the American Medical Association 283, no. 20 (2000): 2701–2711.

Editorial, “A Duty to Publish,” Nature Medicine (1998); 4(10): At 1089; Munro A.J. , “Publishing the Findings of Clinical Research,” British Medical Journal 307, no. 6915 (1993): 1340–1341.

Rosenberg S. A. , “Secrecy in Medical Research,” New England Journal of Medicine 334, no. 6 (1996): 392–394; Nadis S. , “US Concern Grows Over Secrecy Clauses,” Nature 398, no.6726 (1999): At 359.

Chalmers I. , “Underreporting Research is Scientific Misconduct,” Journal of the American Medical Association 263, no. 10 (1990): 1405–1408.

See Lexchin , supra note 41.

Rennie D. , “Thyroid storm,” Journal of the American Medical Association 277, no. 15 (1997): 1238–1243; See Blumenthal Champbell Anderson Causino Louis , supra note 5.

See Chalmers , supra note 58.

Kelch R. P. , “Maintaining the Public Trust in Clinical Research,” New England Journal of Medicine 346, no. 4 (2002): 285–287.

See Bodenheimer , supra note 4.

See Blumenthal Champbell Anderson Causino Louis , supra note 5.

Simonsen R. J. , “Corporate-Sponsored Research Contracts—an Ethical Minefield,” Quintessence International 27, no. 7 (1996): At 443; See Rennie , supra note 60.

Phillips R. A. Hoey J. , “Constraints of Interest: Lessons at the Hospital for Sick Children,” Canadian Medical Association 159, no. 8 (1998): 955–957.

Thompson J. Baird P. Downie J. , Report of the Committee of Inquiry on the Case Involving Dr. Nancy Olivieri, the Hospital for Sick Children, the University of Toronto, and Apotex Inc. (Toronto: Canadian Association of University Teachers, 2001).

See Angelis De , supra note 7.

See Task Force on Financial Conflicts, supra note 14.

Finkel M. J. , “Should Informed Consent Include Information on How Research is Funded?” Institutional Review Board 13, no. 5 (1991): 1–3.

Chaurette K. Jedrey C. , “Managing Conflicts of Interest in Human Subjects Research,” Medical Research Law & Policy Report 1, no. 14 (2002): 441–445.

McCrary S. V. Anderson C. B. Jakovljevic J. , “A National Survey of Policies on Disclosure of Conflicts of Interest in Biomedical Research,” New England Journal of Medicine 343, no. 22 (2000): 1621–1626.

Lo B. Wolf L. E. Berkeley A. , “Conflict-of-interest Policies for Investigators in Clinical Trials,” New England Journal of Medicine 343, no. 22 (2000): 1616–1620.

See OHRP, supra note 21.

See Task Force on Financial Conflicts, supra note 14

See OHRP, supra note 21.

See Task Force on Research, supra note 15.

See Task Force on Financial Conflicts, supra note 14.

See Task Force on Financial Conflicts, supra note 14.

See Emanuel Steiner , supra note 32.

See OHRP, supra note 21.

See, Chaurette Jedrey , supra note 71.

See Task Force on Financial Conflicts, supra note 14; See Task Force on Research, supra note 15.

van Gijn J. , “The Scribe of Stroke Trials,” European Neurology 49, no. 2 (2003): 125–127; Lees K. R. Orgogozo J. M. , “Acute Stroke: Trial by Jury. The Toothless Tiger (role of the principal investigator)” European Neurology 49, no. 2 (2003): 120–124.

Morse M. A. Califf R. M. Sugarman J. , “Monitoring and Ensuring Safety during Clinical Research,” Journal of the American Medical Association 285, no. 9 (2001): 1201–1205; Slutsky A. S. Lavery J. V. , “Data Safety and Monitoring Boards,” New England Journal Medicine 350, no. 11 (2004): 1143–1147

See Task Force on Financial Conflicts, supra note 14.

See OHRP, supra note 21.

American Association of Medical Colleges, Clinical Trial Contracts: A Discussion of Four Selected Provisions, Washington, DC (2004); DuVal G. , “Institutional Ethics Review of Clinical Study Agreements,” Journal of Medical Ethics 30, no. 1 (2004): 30–34.

See OHRP, supra note 21.