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Financial Conflicts of Interest in Human Subjects Research: Proposals for a More Effective Regulatory Scheme Karen A

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Financial Conflicts of Interest in Human Subjects Research: Proposals for a More Effective Regulatory Scheme Karen A Washington and Lee Law Review Volume 60 | Issue 1 Article 3 Winter 1-1-2003 Financial Conflicts of Interest in Human Subjects Research: Proposals for a More Effective Regulatory Scheme Karen A. Jordan Follow this and additional works at: https://scholarlycommons.law.wlu.edu/wlulr Part of the Medical Jurisprudence Commons, and the Science and Technology Law Commons Recommended Citation Karen A. Jordan, Financial Conflicts of Interest in Human Subjects Research: Proposals for a More Effective Regulatory Scheme, 60 Wash. & Lee L. Rev. 15 (2003), https://scholarlycommons.law.wlu.edu/wlulr/vol60/iss1/3 This Article is brought to you for free and open access by the Washington and Lee Law Review at Washington & Lee University School of Law Scholarly Commons. It has been accepted for inclusion in Washington and Lee Law Review by an authorized editor of Washington & Lee University School of Law Scholarly Commons. For more information, please contact [email protected]. Financial Conflicts of Interest in Human Subjects Research: Proposals for a More Effective Regulatory Scheme Karen A. Jordan* Table of Contents I. Introduction ........................................ 17 II. The Shift to a More "Entrepreneurial" Research Environm ent ....................................... 20 A. Reasons Underlying the Changing Focus of Academic Research ............................... 20 B. The Resulting Financial Conflicts of Interest ............ 24 III. The Current Federal Regulatory Framework ............... 29 A. The Basic Federal Protections: IRB Review and Informed Consent ................................ 30 B. Current Safeguards Against Conflicts of Interest ......... 34 C. The Inadequacies of the Current Safeguards ............ 40 IV. Emerging Initiatives Relevant to Financial Conflicts of Interest ......................................... 42 A. Federal Regulatory Initiatives ....................... 42 1. The Recommendations of the Office of Inspector General: Help IRBs Do Their Job ................ 42 2. The HHS Initiatives ........................... 44 a. The Conference on Financial Conflicts of Interest: August 2000 ............................. 46 b. The HHS-OHRP Draft Interim Guidance: January 2001 ............................. 48 B. Private "Self-Regulatory" Initiatives .................. 51 1. Guidance by Premier Medical Schools: January 2001 ................................ 52 Professor of Law, Louis D. Brandeis School of Law at the University of Louisville. 60 WASH. &LEE L. REV 15 (2003) 2. Guidance by the Association of American Medical Colleges: December 2001 ...................... 54 C. Reprise of Key Deficiencies in the Recent Initiatives ...................................... 60 V. Proposals for a More Effective Regulatory System ........... 62 A. Deviate from the Traditional Model of Self-Regulation .................................. 62 B . Standards ...................................... 67 1. The Standard for Disclosure ..................... 67 a. The "Actual v. Potential" Issue ................ 67 b. More Encompassing Initial Disclosure Requirem ents ............................. 72 2. The Standard for Additional Regulatory Responses .................................. 75 C. The Additional Regulatory Response .................. 79 1. Prohibition .................................. 81 2. Prohibition as a Conflict Management Tool ......... 83 a. Commercial Sponsorship Should Not Be Prohibited ............................... 85 b. Prohibition on Participation in Research Is Appropriate ............................ 87 (1) More Effective and Less Costly Than Other Strategies ........................ 88 (2) Minimal Impact on Innovation ............. 89 (3) Minimal Impact on the Generation of Ideas and the Conduct of Research .............. 90 (4) The Potential for Profit Still Justifies the Capital Risk ........................ 95 3. Other Risk Management Techniques Are Not as Effective .................................... 97 a. Additional Disclosures ...................... 97 b. M onitoring ............................... 99 D. Structural Enhancements for Disclosure and M anagem ent ................................... 102 1. Disclosure to the "Office for Financial Conflict M anagem ent" ............................... 103 2. The Patient and Research Protection Comm ittee ................................. 104 3. Oversight by the OFCM and the PRPC ............ 106 4. Additional Enforcement Considerations: Monitoring Compliance and Sanctions ..................... 107 PROPOSALS FOR A MORE EFFECTIVEREGULATORY SCHEME 17 V I. Conclusion ....................................... 108 I. Introduction Human participants' need for protection in research received substantial attention in the late 1960s and early 1970s because of public disclosure of abuses in research.' After substantial study, the National Commission for Protection in Human Subjects of Biomedical and Behavioral Research (NCPHS) made numerous substantive and procedural recommendations for a process that would help ensure that research projects involving human partici- pants were appropriately designed and carried out.2 In response, the federal government enacted regulations that require institutions to assure federal agencies that their researchers will obtain both approval of research procedures by an institutional review board (IRB) before commencing the research project and written informed consent from research participants throughout the project.3 Those regulations were well received, and, as one commentator has noted, "everything seemed settled" by the 1980s." However, the environment for biomedical/biotechnology research involv- ing human participants has changed in the last two decades and the discussion of how to improve the process of protecting human research participants has again moved to the forefront of the debate.5 Indeed, a flurry of activity by 1. A well-known example is the Tuskegee syphilis experiment. See Kathryn A. Tuthill, Human Experimentation: Protecting PatientAutonomy Through Informed Consent, 18 J. LEGAL MED. 221, 231 n.71 (1997) (explaining that the United States Public Health Service studied hundreds of poor African American men in order to develop and understand the natural history of syphilis). Concerns also grew out of stories of abuse revealed during the Nuremberg trails, the promotional distribution of thalidomide resulting in numerous children born with birth defects, the administration of cancer cells to chronically ill and senile patients at a hospital in New York, and others. See Dep't of HHS, Office of Inspector General, InstitutionalReview Boards: Their Role in ReviewingApproved Research,Doc. No. OEI-01-97-00190, at 3 (June 1998) [hereinaf- ter IRB's Role] (describing roots of concern about the treatment of human subjects). 2. The Belmont Report: EthicalPrinciples and Guidelinesforthe Protectionof Human Participantsof Research (U.S. Government Printing Office, 1978), reprinted in 44 Fed. Reg. 23192 (Apr. 18, 1979) [hereinafterBelmont Report]. 3. Regulations for Protection of Human Subjects, 45 C.F.R. § 46 (1996). 4. See James F. Childress, The National Bioethics Advisory Commission: Bridging the Gaps in Human Research Protection, I J. HEALTH CARE L. & PoL'Y 105, 106 (1998) (noting that by the 1980s, the main focus of debate had switched to research on animals). 5. Additionally, numerous abuses to research subjects came to light in a recent examina- tion of the records of several thousand experiments funded and conducted, mostly in secret, by different branches of the federal government. See Childress, supra note 4, at 106 (describing 60 WASH. &LEE L. REV 15 (2003) federal regulators, the research community and scholars has recently taken place as concerns stemming from the changing research environment have come to light.6 The changes in the research environment include more compe- tition for research money and an increased commercialization of research. Together, the changes have resulted in a more entrepreneurial approach to research and development of innovative medical treatments, techniques, drugs, and devices such as surgical or diagnostic instruments. An entrepreneurial approach to research means that scientists conduct research with an emphasis on commercial applications and generating revenue for the institution as well as for individual researchers.7 Through cooperative arrangements with for-profit businesses and industries, university research is more quickly transferred into the private market, and institutions and research- ers share in the profits. The approach leads to an environment that is competi- tive, fast-paced, and laced with more tangible financial conflicts of interest arising at multiple points throughout the research process. The existence of financial conflicts of interest is not unique to the biomedical/biotechnology research arenas. But, because biomedical/biotechnology research more often involves human participants, financial conflicts of interest in this arena and the incentives they create must meet a higher level of scrutiny.8 Importantly, the entrepreneurial factor is present within the community of academic medical centers, where the majority of biomedical/biotechnology research has traditionally occurred, as well as in the growing for-profit experi- mentation industry. The for-profit experimentation industry, involving "human experimentation corporations" that aggressively recruit research participants and use independent for-profit IRBs, presents unique and pressing regulatory problems.9 However, this
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