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Is it Really All about the Money? Reconsidering Non-Financial Interests in Medical Research

Published online by Cambridge University Press:  01 January 2021

Extract

Conflicts of interest have been reduced to financial conflicts. The National Institutes of Health’s (NIH) new rules for managing conflicts of interest in medical research, the first major change to the regulations in over 15 years, address only financial ties. Although several commentators urged that the regulations also cover non-financial interests, the Department of Health and Human Services declined to do so. Similarly, the Institute of Medicine’s (IOM) influential 2009 Conflict of Interest Report focuses almost exclusively on financial conflicts. Institutional policies at academic medical centers and guidance from professional bodies and medical journals also primarily emphasize financial ties. Even broadly worded rules are applied more readily to financial ties than non-financial interests, such as the regulations that restrict institutional review board (IRB) members with conflicting interests from participating in protocol reviews.

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Symposium
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Copyright © American Society of Law, Medicine and Ethics 2012

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References

Department of Health and Human Services, “Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors,” 76 Federal Register 53256 (August 25, 2011).Google Scholar
Id., at 53258.Google Scholar
Institute of Medicine, Conflict of Interest in Medical Research, Education, and Practice Washington, D.C.: National Academies Press, 2009) (hereinafter cited as IOM, Conflict of Interest Report).Google Scholar
See, e.g., Washington University School of Medicine Conflicts of Interest Policy Part I, §B.3, Part II, §D.1 (while the University's conflict of interest policy acknowledges that faculty and staff face many forms of competing interests, the Disclosure Review Committee addresses only financial conflicts), available at <http://medcoi.wustl.edu/medadmin/coisite.nsf/0ee53e934810efcd86256a94005e5f7d/1da8f38a49d1966786256c0d0055337e?OpenDocument>(last visited July 24, 2012); Mayo Clinic Conflict of Interest Policy §§I, II (recognizing that “conflict of interest” encompasses financial or other personal considerations but then defining conflicts of interest for purposes of institutional policy as situations where there may have been influence by “significant financial conflict of interest”), available at <https://secure.ethicspoint.com/domain/media/en/gui/23071/mcConfict_of_Interest_Policypdf>(last visited July 24, 2012); Report of the AAMC-AAU Advisory Committee on Financial Conflicts of Interest in Human Subjects Research, Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research (2008) (concentrating exclusively on financial conflicts); Blum, J. A. et al. , “Requirements and Definitions in Conflict of Interest Policies of Medical Journals,” JAMA 302, no. 20 (2009): 22302234 (most medical journals surveyed requested author disclosure of financial conflicts but only a minority requested disclosure of other potential conflicts such as personal relationships).CrossRefGoogle Scholar
The IRB regulations restrict IRB members with conflicting interests from participating in protocol reviews, but the rules do not specify what types of interests trigger the restrictions. See 45 C.F.R. §46.107(e); 21 C.F.R. § 56.107 (e). IRBs apply the rules more often to financial conflicts than non-financial interests. See Wolf, L.E. et al. , “Conflicts of Interest in Research: How IRBs Address Their Own Conflicts,” IRB: Ethics and Human Research 29, no. 1 (2007): 612 (70% of surveyed IRBs interpret conflict of interest for an IRB member as covering financial ties, but only 52% consider some relationships with study personnel to be a conflict). Among IRBs that consider non-financial ties, not all potentially conflicting relationships are consistently included. Id.Google Scholar
See Brody, H., “Clarifying Conflict of Interest,” American Journal of Bioethics 11, no. 1 (2011): 2328.CrossRefGoogle Scholar
See generally “Following the Money,” American Journal of Law and Medicine 36 (2010): 288–481 (symposium issue addressing the core theme of following the money in health care).CrossRefGoogle Scholar
See Shepherd, L. et al. , “In Plain Sight: A Simple Solution to a Fundamental Challenge in Human Research,” Journal of Law, Medicine and Ethics (forthcoming 2012); IOM, Conflict of Interest Report, supra note 3, at 97.Google Scholar
See DuVal, G., “Institutional Conflicts of Interest: Protecting Human Subjects, Scientific Integrity, and Institutional Accountability,” Journal of Law, Medicine & Ethics 32, no. 4 (2004): 613625.CrossRefGoogle Scholar
Sollitto, S. et al. , “Intrinsic Conflicts of Interest in Clinical Research: A Need for Disclosure,” Kennedy Institute of Ethics Journal 13, no. 2 (2003): 8391.CrossRefGoogle Scholar
Kassirer, J. P. et al. , “Financial Conflicts of Interest in Biomedical Research,” New England Journal of Medicine 329, no. 8 (1993): 570571.CrossRefGoogle Scholar
See Sage, W., “Some Principles Require Principals: Why Banning ‘Conflicts of Interest’ Won't Solve Incentive Problems in Biomedical Research,” Texas Law Review 85 (2007): 14131463.Google Scholar
See Fry-Revere, S. et al. , “More Regulation of Industry Supported Biomedical Research: Are We Asking the Right Questions?” Journal of Law, Medicine & Ethics 37, no. 3 (2009): 420430 (2009). Levinsky, N. G., “Nonfinancial Conflicts of Interest in Research,” New England. Journal of Medicine 347, no. 10 (2002): 759–761. Harrington, P. J., “Faculty Conflicts of Interest in an Age of Academic Entrepreneurialism: An Analysis of the Problem, the Law and Selected University Policies,” Journal of College and University Law 27, no. 4 (2001): 775–831.CrossRefGoogle Scholar
The PLoS Medicine Editors, “Making Sense of Non-Financial Competing Interests,” PLoS Medicine 5, no. 9 (2008): 12991301; International Committee of Medical Journal Editors, Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Ethical Considerations in the Conduct and Reporting of Research: Conflicts of Interest, available at <http://www.icmje.org/ethical_4conflicts.html>(last visited July 24, 2012).(last+visited+July+24,+2012).>Google Scholar
See Sollitto, supra note 10.Google Scholar
Wolf, L. E. et al. , “Ethical Issues in Clinical Research: An Issue for All Internists,” American Journal of Medicine 109, no. 1 (2000): 8285. Cope, M. B. et al. , “White Hat Bias: A Threat To The Integrity of Scientific Reporting,” Acta Paediatrica 99, no. 11 (2010): 1615–1617.CrossRefGoogle Scholar
Korn, D., “Conflicts of interest in Biomedical Research,” JAMA 284, no. 17 (2000): 22342237.CrossRefGoogle Scholar
See Kuszler, P. C., “Curing Conflicts of Interest in Clinical Research: Impossible Dreams and Harsh Realities,” Widener Law Symposium Journal 8 (2001): 115152; Institute of Medicine, Responsible Research: A Systems Approach to Protecting Research Participants Washington, D.C.: The National Academies Press, 2002) (hereinafter cited as IOM, Responsible Research): At 187.Google Scholar
See Levinsky, supra note 13, at 760.Google Scholar
In the federally sponsored Tuskegee Syphilis Study, poor African-American men suffering from syphilis were deliberately left untreated as part of an investigation of the natural history of the disease. The subjects were not aware that they were in the study and several were not even told that they had syphilis. See generally Jones, J., Bad Blood: The Tuskegee Syphilis Experiment – A Tragedy of Race and Medicine (New York: The Free Press, 1981).Google Scholar
Live cancer cells were injected into elderly patients at the Jewish Chronic Disease Hospital in Brooklyn without the patients' knowledge or consent. The study, funded in part by the United States Public Health Service and American Cancer Society, investigated how a weakened immune system influenced the spread of cancer. See Hyman v. Jewish Chronic Disease Hospital, 251 N.Y.S.2d 818 (N.Y. App. Div. 1964); Rice, T. W., “The Historical, Ethical, and Legal Background of Human Subjects Research,” Respiratory Care 53, no. 10 (2008): 13251329.Google Scholar
National Research Act of 1974, Pub. L. No. 93–348 (1974), 88 Stat. 342. The Act required that institutions receiving Department of Health, Education, and Welfare funding for research studies establish institutional review boards in order to protect subjects. It also authorized creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Id.Google Scholar
In 1981, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) substantially revised their regulations, implementing various provisions of the National Research Act of 1974, see id., and recommendations of the Belmont Report issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. See 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 Research (1978). The 1981 research rules have remained largely unchanged to present day, although HHS and FDA are considering more comprehensive changes to the regulations. See Department of Health and Human Services and the Food and Drug Administration, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” 76 Federal Register 44512 (July 26, 2011) (Advanced notice of proposed rulemaking).Google Scholar
See IOM, Responsible Research, supra note 18, at 117. See also Ossorio, P. N., “Pills, Bills, and Shills: Physician-Researcher's Conflicts of Interest,” Widener Law Symposium Journal 8, no.1 (2001): 75103.Google Scholar
See Landon, M. B. et al. , “A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes,” New England Journal of Medicine. 361, no. 14 (2009): 13391348.CrossRefGoogle Scholar
Stell, L. K., “Conflict of Interest in Diabetes Research,” Journal of Diabetes 2, no. 1 (2010): 56, at 5 (“imagine the outcry were similar excess harm to an at-risk population of pregnant women and infants allowed to accumulate in an industry-sponsored trial where its physician-investigators held equity interests in the outcome.”).CrossRefGoogle Scholar
See Werth, B., “The Drug That Works in Pittsburgh,” New York Times, September 30, 1990.Google Scholar
See generally World Health Organization, Evidence on The Long-Term Effects of Breastfeeding: Systematic Reviews and Meta-Analyses (WHO Press, Geneva: 2007); Atkinson, R. L. et al. , “White Hat Bias: The Need for Authors to Have the Spin Stop with Them,” International Journal of Obesity 34, no. 1 (2010): 83.CrossRefGoogle Scholar
See Cope, supra note 16, at 1616.Google Scholar
See Kjaergard, L. L. et al. , “Association Between Competing Interests and Authors' Conclusions: Epidemiological Study of Randomised Clinical Trials Published in the BMJ,” British Medical Journal 325, no. 7358 (2002): 14.CrossRefGoogle Scholar
See Luborsky, L. et al. , “The Researcher's Own Therapy Allegiances: A ‘Wild Card’ In Comparisons of Treatment Efficacy,” Clinical Psychology: Science and Practice 6, no. 1 (1999): 95106. Maj, M., “Non-Financial Conflicts of Interest in Psychiatric Research and Practice,” The British Journal of Psychiatry 193, no. 2(2008): 91–92; The PLoS Medicine Editors, supra note 14.Google Scholar
See infra notes 44 to 47 and accompanying text.Google Scholar
Menikoff, J. Richards, E., What the Doctor Didn't Say: The Hidden Truth about Medical Research (New York: Oxford University Press, 2006): At 226.
The PLoS Medicine Editors, supra note 14, at 1299.Google Scholar
See Korn, supra note 17, at 2234.Google Scholar
Sharmon Sollitto and colleagues assert that “intrinsic Conflicts of interest pose as grave a problem as overt personal financial conflicts.” Sollitto, , supra note 10, at 85 (2003). See also Horrobin, D.F., “Non-Financial Conflicts Are More Serious Than Financial Conflicts,” British Medical Journal 318, no.7181 (1999): 466 (“non-financial Conflicts are much more serious barriers to the fair conduct, reporting, and criticism of research studies.”).Google Scholar
See IOM, Conflict of Interest Report, supra note 3, at 47.Google Scholar
See Guyatt, G. et al. , “The Vexing Problem of Guidelines and Conflict of Interest: A Potential Solution,” Annals Internal Medicine 152, no. 11 (2010): 738741.CrossRefGoogle Scholar
Tsai, A. C., “Managing Nonfinancial Conflicts of Interest: How the New McCarthyism Could Work,” American Journal of Bioethics 11, no. 1 (2011): 4244, at 42–43.CrossRefGoogle Scholar
Boyd, E. A., “Defining Financial Conflicts and Managing Research Relationships: An Analysis of University Conflict of Interest Committee Decisions,” Science and Engineering Ethics 13, no. 4 (2007): 415435.CrossRefGoogle Scholar
Huddle, T. S., “Clarifying the Dispute over Academic-Industry Relationships,” American Journal of Bioethics 11, no. 1 (2011): 4749.CrossRefGoogle Scholar
Horton, R., “Conflicts of Interest in Clinical Research: Opprobrium or Obsession?” The Lancet 349, no. 9059 (1997): 11121113.CrossRefGoogle Scholar
See notes 30 to 32 supra and accompanying text.Google Scholar
See Robertson, C., “Effect of Financial Relationships on the Behaviors of Health Care Professionals: A Review of the Evidence,” Journal of Law, Medicine & Ethics 40, no. 3 (2012): 502516. Warner, T. D. et al. , “What Do We Really Know about Conflicts of Interest in Biomedical Research?” Psychopharmacology 171, no. 1 (2003): 36–46. Bailey, R., Scrutinzing Industry-Funded Science: The Crusade against Conflicts of Interest (New York: American Council on Science and Health, 2008), available at <http://fbae.org/2009/FBAE/website/images/PDF%20files/ACSH-Scrutinizing%20Industry%20Science.pdf>(last visited August 19, 2012).CrossRefGoogle Scholar
Stossel, T. P., “Regulating Academic-Industrial Research Relationships – Solving Problems or Stifling Progress?” New England Journal of Medicine 353, no. 10 (2005): 10601065.CrossRefGoogle Scholar
See Johnston, J., “Financial Conflicts of Interest in Biomedical Research,” in Trust and Integrity in Biomedical Research (The Johns Hopkins University Press, Baltimore: 2010): At 16. As even the IOM 2009 Conflict of Interest Report concedes, “on many topics related to Conflicts of interest, no systematic studies are available… [while] for other topics, data are suggestive rather than definitive.” IOM, Conflict of Interest Report, supra note 3, at 4.Google Scholar
See IOM Conflict of Interest Report, supra note 3, at 25.Google Scholar
Remarks of Marcia Angell, HHS Conference on Financial Conflicts of Interest, August 16, 2000, available at <http://www.hhs.gov/ohrp/archive/coi/angell.htm>(last visitedJuly 24, 2012).(last+visitedJuly+24,+2012).>Google Scholar
See Sollitto, , supra note 10, at 85.Google Scholar
Kachuck, N. J., “Managing Conflicts of Interest and Commitment: Academic Medicine and the Physician's Progress,” Journal of Medical Ethics 37, no. 1 (2011): 25, at 4.Google Scholar
See Ossorio, supra note 24, at 99.Google Scholar
See Menikoff, supra note 33, at 226.Google Scholar
Nelson, D. K., “Conflict of Interest: Researchers,” in Amdur, R. Bankert, E., Institutional Review Board: Management and Function (Sudbury, MA: Jones and Bartlett Publishers, 2002): 197203, at 198.Google Scholar
See Stossel, supra note 46.Google Scholar
See IOM Conflict of Interest Report, supra note 3, at 47.Google Scholar
See Part IV infra.Google Scholar
See supra notes 24 to 33 and accompanying text.Google Scholar
See Nelson, supra note 55, at 198.Google Scholar
See Korn, supra note 17, at 2234.Google Scholar
See supra notes 24 to 33 and accompanying text.Google Scholar
See The Center for Health and Pharmaceutical Law and Policy, Seton Hall University School of Law, The Limits of Disclosure as a Response to Financial Conflicts of Interest in Clinical Research (2010), available at <http://law/shu.edu/Programs-Centers/HealthTechIP/HealthCenter/upload/health-center-whitepaper-dec2010.pdf>..>Google Scholar
Department of Health and Human Services, Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors, 76 Federal Register 53256, 53258 (August 25, 2011) (implementing final rule). HHS also justified the exclusive focus on financial ties because the authorizing legislation for the regulations expressly references financial conflicts. Id. See also 42 U.S.C. § 289b-1.Google Scholar
See, e.g., Brennan, T. A. et al. , “Health Industry Practices That Create Conflicts of Interest,” JAMA 295, no. 4 (2006): 429433. Dana, J., “How Psychological Research Can Inform Policies for Dealing with Conflicts of Interest in Medicine,” in IOM Conflict of Interest Report, Appendix D, supra note 3, at 370.CrossRefGoogle Scholar
See, e.g., Katz, D. et al. , “All Gifts Large and Small: Toward an Understanding of the Ethics of Pharmaceutical Industry Gift-Giving,” American Journal of Bioethics 3, no. 3 (2003): 3946; Association of American Medical Colleges et al., The Scientific Basis of Influence and Reciprocity: A Symposium (Washington, D.C.: 2007), available at <https://www.aamc.org/download/157014/data/new_document.pdf>(last visited August 10, 2012). Dana, J. et al. , “A Social Science Perspective on Gifts to Physicians From Industry,” JAMA 290, no. 2 (2003): 252–255.CrossRefGoogle Scholar
Magnus, S. A., “Physicians' Financial Incentives in Five Dimensions: A Conceptual Framework for HMO Managers,” Health Care Management Review 24, no. 1 (1999): 5772. Saver, R. S., “Squandering the Gain; Gainsharing and the Continuing Dilemma of Physician Financial Incentives,” Northwestern University Law Review 98, no. 1 (2003): 145–238.Google Scholar
See Magnus, supra note 67. Saver, supra note 67, at 191–194.Google Scholar
See Magnus, supra note 67, at 67.Google Scholar
Fry-Revere, S. et al. , “More Regulation of Industry Supported Biomedical Research: Are We Asking the Right Questions?” Journal of Law, Medicine & Ethics 37, no. 3 (2009): 420430.CrossRefGoogle Scholar
See, e.g., Bailey, R., “Ties that Bind: The Canonical Conflict of Interest Cases,” Reason, October 2007, available at <http://reason.com/archives/2007/10/01/ties-that-bind>(last visited July 24, 2012) (“One of the often-expressed concerns about Conflicts of interest is that greedy researchers will harm subjects and patients as they rush treatments to market. [The Gelsinger] case stands out in this respect.”).(last+visited+July+24,+2012)+(“One+of+the+often-expressed+concerns+about+Conflicts+of+interest+is+that+greedy+researchers+will+harm+subjects+and+patients+as+they+rush+treatments+to+market.+[The+Gelsinger]+case+stands+out+in+this+respect.”).>Google Scholar
See Stolberg, S. G., “The Biotech Death of Jesse Gelsinger,” New York Times Magazine, November 28, 1999, at 136. Goldner, J. A., “Dealing with Conflicts of Interest in Biomedical Research: IRB Oversight as the Next Best Solution to the Abolitionist Approach,” Journal of Law, Medicine & Ethics 28, no. 4 (2000): 379404.Google Scholar
See Menikoff, , supra note 33, at 224. Wilson, R. F., “Estate of Gelsinger v. Trustees of University of Pennsylvania: Money, Prestige, and Conflicts of Interest in Human Subjects Research,” in Johnson, S. et al. , eds., Health Law and Bioethics: Cases in Context (New York: Aspen Publishers, 2009): At 229231.Google Scholar
See Alvino, L. A., “Who's Watching the Watchdogs? Responding to the Erosion of Research Ethics by Enforcing Promises,” Columbia Law Review 103 (2003): 893923, at 902 note 67 (“Although the news stories written immediately after Jesse Gelsinger's death portrayed the experiment as a noble endeavor with a tragic outcome, that tone was soon replaced with one of anger and general distrust of the medical research community, as evidence of apparent financial conflicts of interest and breaches of protocol eventually emerged.”).CrossRefGoogle Scholar
Nelson, D. Weiss, R., “Hasty Decision in the Race to a Cure? Gene Therapy Study Proceeded Despite Safety, Ethics Concerns,” Washington Post, November 21, 1999.Google Scholar
Wilson, J. M., “Lessons Learned From the Gene Therapy Trial For Ornithine Transcarbamylase Deficiency,” Molecular Genetics and Metabolism 96, no. 4 (2009): 151157.CrossRefGoogle Scholar
Id., at 155.Google Scholar
See Menikoff, , supra note 33, at 226; Wolf, supra note 16, at 84.Google Scholar
Wilson, , supra note 73, at 251.Google Scholar
See Menikoff, , supra note 33, at 227 (“[I]t seems unlikely that administrators at one of the nation's most prestigious institutions, who regularly deal with amounts in the many millions of dollars, would have been pressuring researchers to cut corners because of the possibility that Penn's rather modest share of the company ($1.4 million) would then be worth more.”).Google Scholar
Steinbrook, R., “The Gelsinger Case,” in the Oxford Textbook of Clinical Research Ethics (Oxford: New York, 2008): 110120, at 118. See also Menikoff, , supra note 33, at 226 (“There is little reason to think that financial interests had anything to do with the specific ‘wrong things’ that were considered to have taken place in the study.”).Google Scholar
See Steinbrook, supra note 81, at 116.Google Scholar
Department of Health and Human Services, Financial Relationships and Interests in Research involving Human Subjects: Guidance for Human Subject Protection, 69 Federal Register 26393 (2004).Google Scholar
See Steinbrook, supra note 81, at 118.Google Scholar
See supra notes 65 to 66 and accompanying text.Google Scholar
See, e.g., Cialdini, R. B., Influence: The Psychology of Persuasion, 2nd ed. (New York: Quill, 1993): At 18.Google Scholar
See, e.g., Katz, , supra note 66. Blumenthal, D., “Doctors and Drug Companies,” New England Journal of Medicine 351, no. 18 (2004): 18851890.Google Scholar
See The PLoS Medicine Editors, supra note 14, at 1299.Google Scholar
See IOM Conflict of Interest Report, supra note 3, at 47.Google Scholar
See id., at 52–56.Google Scholar
See Sage, supra note 12, at 1427.Google Scholar
See IOM Conflict of Interest Report, supra note 3, at 5.Google Scholar
Gray, S. et al. , “Attitudes Toward Research Participation and Investigator Conflicts of Interest Among Advanced Cancer Patients Participating in Early Phase Clinical Trials,” Journal of Clinical Oncology 25, no. 23 (2007): 34883494.CrossRefGoogle Scholar
See Hampson, L. et al. , “Patients' Views on Financial Conflicts of Interest in Cancer Research Trials,” New England Journal of Medicine 355, no. 22 (2006): 23302337.CrossRefGoogle Scholar
Grady, C. et al. , “The Limits of Disclosure: What Research Subjects Want to Know About Investigator Financial Interests,” Journal Law, Medicine & Ethics 34, no. 23 (2006): 592599. Weinfurt, K. et al. , “Effects of Disclosing Financial Interests on Attitudes toward Clinical Research,” Journal of General Internal Medicine 23, no. 6 (2008): 860–866.CrossRefGoogle Scholar
See Gray, supra note 94.Google Scholar
See Grady, supra note 97, at 594.Google Scholar
See Hampson, supra note 96, at 2334.Google Scholar
See supra note 64 and accompanying text.Google Scholar
See, e.g., Stossel, supra note 46.Google Scholar
Williams-Jones, B., “Beyond a Pejorative Understanding of Conflict of Interest,” American Journal of Bioethics 11, no. 1 (2011): 12.CrossRefGoogle Scholar
See IOM Conflict of Interest Report, supra note 3.Google Scholar
Id., at 5256.Google Scholar
See supra notes 67 to 70 and accompanying text.Google Scholar
See Guzzo, R. A. Katzell, R. A., “Effects of Economic Incentives on Productivity,” in Incentives, Cooperation, and Risk Sharing (Totowa, New Jersey: Rowman and Littlefield: 1987): 107119, at 109.Google Scholar
See IOM Conflict of Interest Report, supra note 3, at 223226.Google Scholar
See, e.g., National Bioethics Advisory Commission, Ethical and Policy Issues In Research Involving Human Participants, Bethesda, MD, 2001, at 64. see IOM, Responsible Research, supra note 18, at 96.Google Scholar
See Saver, R. S., “Medical Research Oversight from the Corporate Governance Perspective: Comparing Institutional Review Boards and Corporate Boards,” William and Mary Law Review 46, no. 2 (2004): 619730, at 699–705.Google Scholar
See id., at 699–705, 713–719.Google Scholar
See Levinsky, , supra note 13, at 760.Google Scholar
See id.; Jackson, C. I. et al. , “Honor in Science,” American Scientist 71, no. 5 (1983): 462464. Along these lines, recent changes to the standard NIH grant application, made as part of the agency's enhancing peer review process, limit the applicant to listing 15 previously published studies, in an effort to reward for quality over quantity. See generally National Institutes of Health, Details of Application Changes for Research Grants and Cooperative Agreements available at <http://enhancing-peer-review.nih.gov/docs/application_changes.pdf>(last visited July 24, 2012).Google Scholar
See supra note 24 and accompanying text.Google Scholar
See Cope, supra note 16, at 1616.Google Scholar
See Shepherd, , supra note 8; Kesselheim, A. S. et al. , “Managing Financial and Nonfinancial Conflicts of Interest in Healthcare Delivery,” American Journal of Therapeutics 17, no. 4 (2010): 440443. Ulrich, C. M. et al. , “Respondent Burden in Clinical Research: When Are We Asking Too Much of Subjects?” IRB: Ethics and Human Research 27, no. 4 (2005): 1720, at 19.Google Scholar
See IOM, Responsible Research, supra note 18, at 104105.Google Scholar
See Sollitto, , supra note 10, at 87.Google Scholar
See Kesselheim, , supra note 116, at 442. see The Center for Health and Pharmaceutical Law and Policy, supra note 63.Google Scholar
See International Committee of Medical Journal Editors, Form For Disclosure Of Potential Conflicts of Interest, Part 4, available at <http://www.icmje.org/coi_disclosure.pdf>(last visited July 24, 2012).(last+visited+July+24,+2012).>Google Scholar
See IOM Conflict of Interest Report, supra note 3, at xii.Google Scholar
See, e.g., Sunstein, C., “On the Expressive Function of Law,” University of Pennsylvania Law Review 144 (1996): 20212053. Hall, M., “Law, Medicine, and Trust,” Stanford Law Review 55, no. 2 (2002): 463–526.CrossRefGoogle Scholar