Opinion
VIEWPOINT
Etta D. Pisano, MD College of Medicine, Medical University of South Carolina, Charleston. Robert N. Golden, MD School of Medicine and Public Health, University of Wisconsin-Madison. Laura Schweitzer, PhD Union Graduate College, Schenectady, New York.
Corresponding Author: Etta D. Pisano, MD, College of Medicine, Medical University of South Carolina, 96 Jonathan Lucas St, MSC617, Charleston, SC 29425 ([email protected]).
Conflict of Interest Policies for Academic Health System Leaders Who Work With Outside Corporations direct business inappropriately to the outside company on whose board he or she sits? Will the leader inappropriately use information about the institution he or she leads to influence decisions by the outside corporation? It is difficult to separate these types of activities and decisions. In addition, there are administrative costs associated with the management of this level of conflict, and such relationships might have a “chilling effect” on other companies that could do business with the academic health system. Beyond service on fiduciary boards, undertaking any paid role (consulting, participation on advisory boards, etc) with an outside entity with interests that overlap those of the leader’s institution raises the same issues. For these reasons, the fiduciary responsibilities of presidents, provosts, vice presidents, deans, chief executive officers, and those who report to them should preclude a paid relationship with an outside entity in related and relevant areas, unless a case can be made that there is a compelling institutional interest in the leader’s service in such a role, or if the role with the outside organization is outside the scope of the leader’s role at the acaLeaders have a responsibility to set an demic health system. An example of a compelling instituexample for others in their institution, tional interest might be an equity partespecially for those training to be health nership between the academic health system and the outside corporate encare professionals. tity that ties the financial success of the 2 entities, eg, in managing outpatient surers in their institution, especially for those training to be gery centers. Another example might be the leader’s role health care professionals.3,4 Independence and integrity as a founder of an academic health system start-up comof judgment are core precepts of professionalism.5 Ev- pany based on his or her intellectual property. The value ery employee, faculty member, and student in an aca- to the academic health system of potential information demic health system should feel confident that their lead- and insights gained by the leader through other types ers are making decisions based on the best interests of the of compensated roles might also constitute a compelinstitution and not driven by biases secondary to finan- ling institutional interest. Compensated roles that are cial connections to outside corporate entities. outside the scope of the leader’s role at the system might Simultaneous service as an academic health sys- include service on a National Institutes of Health study tem senior leader and as a board member for another section or as the editor of a specialty journal. organization with interests that overlap those of the To support these proposed policies, academic academic health system creates a clear COI. In a survey health systems should create COI committees that preconducted in 2006, 459 of 688 responding depart- approve and manage the activities, a mechanism simimental chairs acknowledged “some form of personal lar to the one proposed in the Association of American relationship with industry.…”6 What steps can assure Medical Colleges Task Force recommendations for students, faculty, staff, and the public that the aca- oversight of COIs for senior leaders regarding clinical demic health system leader is keeping institutional research.3,4 Some institutions have adopted this recinterests paramount in fiscal decision making that may ommendation, but adoption is likely not universal. benefit the outside entity? These COI committees should consist of at least 2 indiHaving a fiduciary responsibility to 2 separate en- viduals who are either higher in the organizational hiertities is at best a very difficult situation. Will the leader archy or who do not report to the leader. Instances in New “Sunshine Act” requirements for disclosure by pharmaceutical and medical device companies of payments to faculty have led to increased conversation about conflict of interest (COI).1 Conflict of interest is defined as “circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest.”2 Conflict of interest is particularly relevant for those in the upper echelons of academic health system leadership— presidents, vice presidents, provosts, deans, chief executive officers, and the senior administrators who report to them. Unlike most faculty and staff, senior institutional officials are involved in financial and business decisions, including purchasing, resource allocation, and development of corporate partnerships, and have fiduciary responsibility to the entire institution. In addition, it is critical that the public, students, employees, and faculty maintain confidence in the integrity of institutional leaders. Leaders have a responsibility to set an example for oth-
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JAMA March 19, 2014 Volume 311, Number 11
Copyright 2014 American Medical Association. All rights reserved.
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Opinion Viewpoint
which the leader is the most senior person in an academic health system might require that COI committee members be appointed from outside the organization. When there is a change in the relationship of the 2 entities, the committee should be consulted to ensure that the interests of the academic health system are best served. In addition, the system should have explicit rules regarding the use of specific institutional resources by the senior leader in his or her outside activities.7 There may be cases in which academic health system leaders also participate in uncompensated roles for outside entities that might create a COI. For example, a voluntary role within the American Cancer Society may involve decision making about policy statements that could affect the leader’s organization. Such potential conflicts should also be managed by an academic health system COI committee. Service on boards of organizations outside the scope of the missions of the academic health system, ie, for local charities, creates no COI and should not require oversight by an institutional committee, unless the amount of time involved could represent a conflict of commitment. Because outside roles should serve a compelling institutional interest, the best way to compensate individuals is through a contract for the leader’s service with the institution that delineates the responsibilities and compensation for time spent, either as a perARTICLE INFORMATION Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Pisano reported that she is cofounder and uncompensated board member for NextRay Inc; has received grants from a number of entities, and has contracts to her university from Sectra, VuComp, Konica-Minolta, Koning, and Zumatek. Dr Golden reported receiving honoraria from the American Board of Psychiatry and Neurology, the American Psychosomatic Society, APA Press, and the Shapiro Foundation. Dr Schweitzer reported serving as an uncompensated board member for the Washington University Undergraduate Board, the YWCA, and Ellis Hospital. Additional Contributions: The topic of this article was conceived through conversations over many years with Bernard M. Gert, PhD, of Dartmouth College. Unfortunately, Professor Gert died in 2011 just as the first draft of the article was being
1112
cent effort or in hours. Ideally, funding from the outside entity would pay some of the leader’s institutional salary and not increase his or her compensation. Since presumably all of the leader's work time is committed to the academic health system, the leader’s institutional compensation sets a fair market value for the time he or she spends on all work-related activities. Payment with stock or stock options would only be permissible if approved by the COI committee. This clearly indicates to all academic health system constituencies that the time spent on the outside activity is intended to bring value to the system. In summary, fiduciary board memberships and compensated roles for academic health system senior leaders with outside entities that have overlapping interests with the system missions should not be permitted, except when there is a clear and compelling institutional interest for the system or when the external role falls outside the scope of the leadership position. All such roles should fall under the purview of a committee consisting of at least superiors, individuals who do not report to the leader, or individuals appointed from outside the organization; this committee should preapprove and manage potential conflicts. In addition, additional compensation for such roles should be provided through a contract with the entity, with payment to the academic health system for the leader’s time and effort.
prepared. He would have been a contributor to this article had he lived. Instead, we dedicate this article to his memory. Robert N. Sade, MD, Eric T. Juengst, PhD, Jennifer Nall, and Elodia Cole also contributed to the ideas in this article. REFERENCES 1. Chimonas S, Patterson L, Raveis VH, Rothman DJ. Managing conflicts of interest in clinical care: a national survey of policies at U.S. medical schools. Acad Med. 2011;86(3):293-299. 2. Institute of Medicine (IOM). Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: National Academies Press; 2009. 3. Task Force on Financial Conflicts of Interest in Clinical Research. Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution’s Financial Interests in Human Subjects Research. Association of American Medical Colleges
website. https://members.aamc.org/eweb/upload /Protecting Subjects, Preserving Trust, Promoting Progress II.pdf. October 2002. Accessed January 27, 2014. 4. Campbell EG, Weissman JS, Ehringhaus S, et al. Institutional academic industry relationships. JAMA. 2007;298(15):1779-1786. 5. Swick HM. Toward a normative definition of medical professionalism. Acad Med. 2000;75(6):612-616. 6. Campbell EG, Weissman JS, Ehringhaus S, et al. Institutional academic-industry relationships. JAMA. 2007;298(15):1779-1786. 7. University of North Carolina at Chapel Hill. Guidelines on Policy for Use of University Resources in Support of Entrepreneurial Activities. University of North Carolina at Chapel Hill website. http://research.unc.edu/files/2013/03/CCM1 _030168.pdf. Accessed January 6, 2014.
JAMA March 19, 2014 Volume 311, Number 11
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Otterbein University User on 06/01/2015
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VIEWPOINT
Etta D. Pisano, MD College of Medicine, Medical University of South Carolina, Charleston. Robert N. Golden, MD School of Medicine and Public Health, University of Wisconsin-Madison. Laura Schweitzer, PhD Union Graduate College, Schenectady, New York.
Corresponding Author: Etta D. Pisano, MD, College of Medicine, Medical University of South Carolina, 96 Jonathan Lucas St, MSC617, Charleston, SC 29425 ([email protected]).
Conflict of Interest Policies for Academic Health System Leaders Who Work With Outside Corporations direct business inappropriately to the outside company on whose board he or she sits? Will the leader inappropriately use information about the institution he or she leads to influence decisions by the outside corporation? It is difficult to separate these types of activities and decisions. In addition, there are administrative costs associated with the management of this level of conflict, and such relationships might have a “chilling effect” on other companies that could do business with the academic health system. Beyond service on fiduciary boards, undertaking any paid role (consulting, participation on advisory boards, etc) with an outside entity with interests that overlap those of the leader’s institution raises the same issues. For these reasons, the fiduciary responsibilities of presidents, provosts, vice presidents, deans, chief executive officers, and those who report to them should preclude a paid relationship with an outside entity in related and relevant areas, unless a case can be made that there is a compelling institutional interest in the leader’s service in such a role, or if the role with the outside organization is outside the scope of the leader’s role at the acaLeaders have a responsibility to set an demic health system. An example of a compelling instituexample for others in their institution, tional interest might be an equity partespecially for those training to be health nership between the academic health system and the outside corporate encare professionals. tity that ties the financial success of the 2 entities, eg, in managing outpatient surers in their institution, especially for those training to be gery centers. Another example might be the leader’s role health care professionals.3,4 Independence and integrity as a founder of an academic health system start-up comof judgment are core precepts of professionalism.5 Ev- pany based on his or her intellectual property. The value ery employee, faculty member, and student in an aca- to the academic health system of potential information demic health system should feel confident that their lead- and insights gained by the leader through other types ers are making decisions based on the best interests of the of compensated roles might also constitute a compelinstitution and not driven by biases secondary to finan- ling institutional interest. Compensated roles that are cial connections to outside corporate entities. outside the scope of the leader’s role at the system might Simultaneous service as an academic health sys- include service on a National Institutes of Health study tem senior leader and as a board member for another section or as the editor of a specialty journal. organization with interests that overlap those of the To support these proposed policies, academic academic health system creates a clear COI. In a survey health systems should create COI committees that preconducted in 2006, 459 of 688 responding depart- approve and manage the activities, a mechanism simimental chairs acknowledged “some form of personal lar to the one proposed in the Association of American relationship with industry.…”6 What steps can assure Medical Colleges Task Force recommendations for students, faculty, staff, and the public that the aca- oversight of COIs for senior leaders regarding clinical demic health system leader is keeping institutional research.3,4 Some institutions have adopted this recinterests paramount in fiscal decision making that may ommendation, but adoption is likely not universal. benefit the outside entity? These COI committees should consist of at least 2 indiHaving a fiduciary responsibility to 2 separate en- viduals who are either higher in the organizational hiertities is at best a very difficult situation. Will the leader archy or who do not report to the leader. Instances in New “Sunshine Act” requirements for disclosure by pharmaceutical and medical device companies of payments to faculty have led to increased conversation about conflict of interest (COI).1 Conflict of interest is defined as “circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest.”2 Conflict of interest is particularly relevant for those in the upper echelons of academic health system leadership— presidents, vice presidents, provosts, deans, chief executive officers, and the senior administrators who report to them. Unlike most faculty and staff, senior institutional officials are involved in financial and business decisions, including purchasing, resource allocation, and development of corporate partnerships, and have fiduciary responsibility to the entire institution. In addition, it is critical that the public, students, employees, and faculty maintain confidence in the integrity of institutional leaders. Leaders have a responsibility to set an example for oth-
jama.com
JAMA March 19, 2014 Volume 311, Number 11
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Otterbein University User on 06/01/2015
1111
Opinion Viewpoint
which the leader is the most senior person in an academic health system might require that COI committee members be appointed from outside the organization. When there is a change in the relationship of the 2 entities, the committee should be consulted to ensure that the interests of the academic health system are best served. In addition, the system should have explicit rules regarding the use of specific institutional resources by the senior leader in his or her outside activities.7 There may be cases in which academic health system leaders also participate in uncompensated roles for outside entities that might create a COI. For example, a voluntary role within the American Cancer Society may involve decision making about policy statements that could affect the leader’s organization. Such potential conflicts should also be managed by an academic health system COI committee. Service on boards of organizations outside the scope of the missions of the academic health system, ie, for local charities, creates no COI and should not require oversight by an institutional committee, unless the amount of time involved could represent a conflict of commitment. Because outside roles should serve a compelling institutional interest, the best way to compensate individuals is through a contract for the leader’s service with the institution that delineates the responsibilities and compensation for time spent, either as a perARTICLE INFORMATION Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Pisano reported that she is cofounder and uncompensated board member for NextRay Inc; has received grants from a number of entities, and has contracts to her university from Sectra, VuComp, Konica-Minolta, Koning, and Zumatek. Dr Golden reported receiving honoraria from the American Board of Psychiatry and Neurology, the American Psychosomatic Society, APA Press, and the Shapiro Foundation. Dr Schweitzer reported serving as an uncompensated board member for the Washington University Undergraduate Board, the YWCA, and Ellis Hospital. Additional Contributions: The topic of this article was conceived through conversations over many years with Bernard M. Gert, PhD, of Dartmouth College. Unfortunately, Professor Gert died in 2011 just as the first draft of the article was being
1112
cent effort or in hours. Ideally, funding from the outside entity would pay some of the leader’s institutional salary and not increase his or her compensation. Since presumably all of the leader's work time is committed to the academic health system, the leader’s institutional compensation sets a fair market value for the time he or she spends on all work-related activities. Payment with stock or stock options would only be permissible if approved by the COI committee. This clearly indicates to all academic health system constituencies that the time spent on the outside activity is intended to bring value to the system. In summary, fiduciary board memberships and compensated roles for academic health system senior leaders with outside entities that have overlapping interests with the system missions should not be permitted, except when there is a clear and compelling institutional interest for the system or when the external role falls outside the scope of the leadership position. All such roles should fall under the purview of a committee consisting of at least superiors, individuals who do not report to the leader, or individuals appointed from outside the organization; this committee should preapprove and manage potential conflicts. In addition, additional compensation for such roles should be provided through a contract with the entity, with payment to the academic health system for the leader’s time and effort.
prepared. He would have been a contributor to this article had he lived. Instead, we dedicate this article to his memory. Robert N. Sade, MD, Eric T. Juengst, PhD, Jennifer Nall, and Elodia Cole also contributed to the ideas in this article. REFERENCES 1. Chimonas S, Patterson L, Raveis VH, Rothman DJ. Managing conflicts of interest in clinical care: a national survey of policies at U.S. medical schools. Acad Med. 2011;86(3):293-299. 2. Institute of Medicine (IOM). Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: National Academies Press; 2009. 3. Task Force on Financial Conflicts of Interest in Clinical Research. Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution’s Financial Interests in Human Subjects Research. Association of American Medical Colleges
website. https://members.aamc.org/eweb/upload /Protecting Subjects, Preserving Trust, Promoting Progress II.pdf. October 2002. Accessed January 27, 2014. 4. Campbell EG, Weissman JS, Ehringhaus S, et al. Institutional academic industry relationships. JAMA. 2007;298(15):1779-1786. 5. Swick HM. Toward a normative definition of medical professionalism. Acad Med. 2000;75(6):612-616. 6. Campbell EG, Weissman JS, Ehringhaus S, et al. Institutional academic-industry relationships. JAMA. 2007;298(15):1779-1786. 7. University of North Carolina at Chapel Hill. Guidelines on Policy for Use of University Resources in Support of Entrepreneurial Activities. University of North Carolina at Chapel Hill website. http://research.unc.edu/files/2013/03/CCM1 _030168.pdf. Accessed January 6, 2014.
JAMA March 19, 2014 Volume 311, Number 11
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ by a Otterbein University User on 06/01/2015
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