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Institutional Oversight of Faculty-Industry Consulting Relationships in U.S. Medical Schools: A Delphi Study
Published online by Cambridge University Press: 01 January 2021
Extract
Consulting relationships between medical school faculty and the biopharmaceutical and medical device industries offer the potential to advance research and promote the translation of academic discoveries into technologies that can benefit the health of individuals and populations. Such relationships are common, and studies suggest that faculty with industry relationships are more productive than their peers without such relationships. These benefits notwithstanding, numerous academic studies, government hearings, and litigation have called attention to the potential risks associated with these relationships.
Consulting includes a broad range of activities in which a faculty member provides advice or services to a company related to his/her area of professional expertise, typically in exchange for payment. Many universities permit faculty members to devote a portion of their faculty time to consulting (e.g., one business day per week), and faculty members are typically paid directly by the company, rather than through the university.
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- Copyright © American Society of Law, Medicine and Ethics 2015
References
Zinner, D. E. Bolcic-Jankovic, D. Clarridge, B. Blumenthal, D. Campbell, E. G., “Participation of Academic Scientists in Relationships with Industry,” Health Affairs 28, no. 6 (2009): 1814–1825; Menachemi, N. Morrisey, M. A. Ginter, P. M., “Outside Consulting Income by University Faculty in Health Administration,” Journal of Health Administration Education 27, no. 4 (2010): 297–310.CrossRefGoogle Scholar
Mowatt, G. L. Shirran, J. M. Grimshaw, D. Rennie, A. Flanagin, V. Yank, G. MacLennan, P. C. Gotzsche, P. C. Bero, L. A., “Prevalence of Honorary and Ghost Authorship in Cochrane Reviews,” JAMA 287, no. 21 (2002): 2769–2771; Psaty, B. M. Rennie, D., “Clinical Trial Investigators and Their Prescribing Patterns: Another Dimension to the Relationship between Physician Investigators and the Pharmaceutical Industry,” JAMA 299, no. 23 (2006): 1813–1817.Google Scholar
United States Senate Committee on Finance, Use of Educational Grants by Pharmaceutical Manufacturers (Washington, D.C.: U.S. Government Printing Office, April 2007); United States Senate Committee on Finance Minority Staff Report, Ghostwriting in Medical Literature (U.S. Washington, D.C.: Senate Committee on Finance, June 2010); United States General Accounting Office (now the U.S. Government Accountability Office), HHS Direction Needed to Address Financial Conflicts of Interest, Report to the Ranking Minority Member, Subcommittee on Public Health, Committee on Health, Education, Labor, and Pensions, U.S. Senate (Washington, D.C.: Government Accountability Office, 2001); Medicare Payment Advisory Committee (MedPAC), Public Reporting of Physicians’ Financial Relationships with Drug and Device Manufacturers, Hospitals, and ASCs, MedPAC public meeting, March 5, 2008 (Washington, D.C.: MedPAC, 2008).Google Scholar
Ross, J. S. Hill, K. P. Egilman, D. S. Krumholz, H. M., “Guest Authorship and Ghost-Writing in Publications Related to Rofecoxib: A Case Study of Industry Documents from Rofexocib Litigation,” JAMA 299, no. 15 (2008): 1800–1812; Hill, K. P. Ross, J. S. Egilman, D. S. Krumholz, H. M., “The ADVANTAGE Seeding Trial: A Review of Internal Documents,” Annals of Internal Medicine 149, no. 4 (2008): 251–258.CrossRefGoogle Scholar
Institute of Medicine, Committee on Conflict of Interest in Medical Research, Education, and Practice, Conflict of Interest in Medical Research, Education, and Practice (Washington, D.C.: National Academies Press, 2009): At 6.Google Scholar
Liang, B. A. Mackey, T., “Confronting Conflict: Addressing Institutional Conflicts of Interest in Academic Medical Centers,” American Journal of Law & Medicine 36, no. 1 (2010): 136–187; Shim, D. S. Spence, R. G., “Industry Reimbursement for Entering Patients into Clinical Trials: Legal and Ethical Issues,” Annals of Internal Medicine 115, no.2 (1991): 148–151.CrossRefGoogle Scholar
Dickersin, K., “The Existence of Publication Bias and Risk Factors for Its Occurrence,” JAMA 263, no. 10 (1990): 1385–1389.CrossRefGoogle Scholar
Schulman, K. A. Rubenstein, L. E. Glick, H. A. Eisenberg, J. M., “Relationships between Sponsors and Investigators in Pharmacoeconomic and Clinical Research,” Pharmacoeconomics 7, no. 3 (1995): 206–220; 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,” JAMA 277, no. 15 (1997): 1224–1228; Wise, J., “Research Suppressed for Seven Years by Drug Company,” BMJ 314, no. 7088 (1997): 1145.Google Scholar
Weatherall, D., “Problems for Biomedical Research at the Academia-Industrial Interface,” Science and Engineering Ethics 9, no. 1 (2003): 43–48.CrossRefGoogle Scholar
Blumenthal, D., “Doctors and Drug Companies,” New England Journal of Medicine 351, no. 18 (2004): 1885–1890; Angell, M., “Is Academic Medicine for Sale?” New England Journal of Medicine 342, no. 20 (2000): 1516–1518; Bodenheimer, T., “Uneasy Alliance: Clinical Investigators and the Pharmaceutical Industry,” New England Journal of Medicine 342, no. 20 (2000): 1539–1544.CrossRefGoogle Scholar
See Schulman, et al., supra note 9; Mello, M. M. Clarridge, B. R. Studdert, D. M., “Academic Medical Centers’ Standards for Clinical-Trial Agreements with Industry,” New England Journal of Medicine 352, no. 21 (2005): 2202–2210.Google Scholar
Lipsitch, M., “The Hidden Risk to Academic Freedom in Corporate Consulting Contracts,” Chronicle of Higher Education, June 27, 2010 [cited August 22, 2014], available at <http://chronicle.com/article/The-Hidden-Risk-to-Academic/66050/> (last visited April 29, 2015).+(last+visited+April+29,+2015).>Google Scholar
Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc., 563 U.S. No. 09–1159.Google Scholar
See Lipsitch, , supra note 13.Google Scholar
Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought. 42 C.F.R. Part 50, Subpart F (2011) [cited August 22, 2014].Google Scholar
Association of American Medical Colleges, Task Force on Financial Conflicts of Interest in Clinical Research, Protecting Subjects, Preserving Trust, Promoting Progress – Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research, Washington, D.C., December 2001, available at <https://www.aamc.org/download/75302/data> (last visited April 29, 2015).+(last+visited+April+29,+2015).>Google Scholar
See Institute of Medicine, supra note 6.Google Scholar
International Committee of Medical Journal Editors, “Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Updated 2010 [cited August 22, 2014],” available at <http://www.icmje.org/> (last visited April 29, 2015).+(last+visited+April+29,+2015).>Google Scholar
Centers for Medicare and Medicaid Services, Medicare, Medicaid, Children's Health Insurance Programs, Transparency Reports and Reporting of Physician Ownership or Investment Interests, 42 CFR 402, 42CFR 403 CMS-2011-0191, Washington, D.C., 2013 [cited August 22, 2014], available at <https://federalregister.gov/a/2013–02572> (last visited April 29, 2015).+(last+visited+April+29,+2015).>Google Scholar
The Business–Higher Education Forum, Working Together, Creating Knowledge: University-iIndustry Research Collaboration Initiative, Washington, D.C., American Council on Education, 2001, available at <http://www.eric.ed.gov/ERICWebPortal/search/detailmini.jsp?_nfpb=true&_&ERICExtSearch_SearchValue_0=ED457765&ERICExtSearch_SearchType_0=no&accno=ED457765> (last visited April 29, 2015).+(last+visited+April+29,+2015).>Google Scholar
See Association of American Medical Colleges, supra note 17.Google Scholar
American Association of University Professors, Recommended Principles to Guide Academic-Industry Relations (Urbana, IL: University of Illinois Press, 2014).Google Scholar
Institute on Medicine as a Profession, Consulting and Honoraria: Best Practices for Academic Medical Centers, October 10, 2013, available at <http://imapny.org/wp-content/themes/imapny/File%20Library/Best%20Practice%20toolkits/Best-Practices_Consulting-and-Honoraria.pdf> (last visited April 29, 2015).+(last+visited+April+29,+2015).>Google Scholar
Lindstone, H. Turloff, M., The Delphi Method: Techniques and Applications (London: Addison Wesley, 1975); Adler, M. Ziglio, E., Gazing into the oracle: The Delphi Method and Its Application to Social Policy and Public Health (London: Jessica Kingsley Publishers, 1996).Google Scholar
Minter, R. M. Angelos, P. Coimbra, R. Dale, P. de Vera, M. E. Hardacre, J. et al., “Ethical Management of Conflict of Interest: Proposed Standards for Academic Surgical Societies,” Journal of the American College of Surgeons 213, no. 5 (2011): 677–682.CrossRefGoogle Scholar
Smith, D., “Establishing National Priorities for Australian Occupational Health and Safety Research,” Journal of Occupational Health 52, no. 4 (2010): 241–248; Moscovice, I. Armstrong, P. Shortell, S. Bennett, R., “Health Services Research for Decision-Makers: The Use of the Delphi Technique to Determine Health Priorities,” Journal of Health Politics Policy & Law 2, no. 3 (1977): 388–310.Google Scholar
Pincus, T. Miles, C. Froud, R. Underwood, M. Carnes, D. Taylor, S. J. C., “Methodological Criteria for the Assessment of Moderators in Systematic Reviews of Randomised Controlled Trials: A Consensus Study,” BMC Medical Research Methodology 11, no. 14 (2011), available at <http://www.biomedcentral.com/1471–2288/11/14> (last visited May 8, 2015).Google Scholar
Banks, D. E. Shi, R. McLarty, J. Cowl, C. T. Smith, D. Tarlo, S. M., “American College of Chest Physicians Consensus Statement on the Respiratory Health Effects of Asbestos,” Chest 135, no. 6 (2009): 169–127; De Vos, E. Spivak, H. Hatmaker-Flanigan, E. Sege, R. D., “A Delphi Approach to Reach Consensus on Primary Care Guidelines Regarding Youth Violence Prevention,” Pediatrics 118, no. 4 (2006): e1109–e1115; Akins, R. B., “A Process-Centered Tool for Evaluating Patient Safety Performance and Guiding Strategic Improvement,” in Henriksen, K. Battles, J. B. Marks, E. S. Lewin, D. I., eds., Advances in Patient Safety: From Research to Implementation Volume 4: Programs, Tools, and Products (Rockville: Agency for Healthcare Research and Quality, 2005); Hawryluck, L. A. Harvey, W. R. Lemieux-Charles, L. Singer, P. A., “Consensus Guidelines on Analgesia and Sedation in Dying Intensive Care Patients,” BMC Medical Ethics 3, no. 3 (2002): E3.CrossRefGoogle Scholar
Fitch, K. Bernstein, S. J. Aguilar, M. S. Burnand, B. LaCalle, J. R. Lazaro, P., The RAND/UCLA Appropriateness Method User's Manual (Santa Monica: RAND, 2001).Google Scholar
United Nations International Development Organization, Kerstin Cuhls, Fraunhofer Institute for Systems and Innovation Research (DE), The Delphi Method, citing Wechsler, W., Delphi-Methode, Gestaltung und Potential für betriebliche Prognoseprozesse, Schriftenreihe Wirtschaftswissenschaftliche Forschung und Entwicklung, München (1978) [cited August 22, 2014], available at <http://www.unido.org/fileadmin/import/16959_DelphiMethod.pdf> (last visited April 29, 2015).+(last+visited+April+29,+2015).>Google Scholar
Brown, B. B., Delphi Process: A Methodology Used for the Elicitation of Opinion of Experts (Santa Monica: RAND Corporation, 1968).Google Scholar
Mello, M. M. Murtagh, L. Joffe, S. Taylor, P. L. Greenberg, Y. Campbell, E. G., “Beyond Financial Conflicts of Interest: Institutional Oversight of Faculty Consulting Agreements at Schools of Medicine and Public Health,” Working Paper, September 18, 2014.Google Scholar
Chimonas, S. Evarts, S. D. Littlehale, S. K. Rothman, D. J., “Managing Conflicts of Interest in Clinical Care: The ‘Race to the Middle’ at U.S. Medical Schools,” Academic Medicine 88, no. 10 (2013): 1464–1470.Google Scholar
Rothman, D. J. Chimonas, S., “New Developments in Managing Physician-Industry Relationships,” JAMA 300, no. 9 (2008): 1067–1069.Google Scholar
American Bar Association, Center for Professional Responsibility, Model Rules of Professional Conduct, Rule 1.7, Conflict of Interest: Current Clients [cited February 25, 2014], available at <http://www.americanbar.org/groups/professional_responsibility/publications/model_rules_of_professional_conduct/model_rules_of_professional_conduct_table_of_contents.html> (last visited April 29, 2015).+(last+visited+April+29,+2015).>Google Scholar