Article
The Education Review Board: A Mechanism for Managing Potential Conflicts of Interest in Medical Education Jonathan F. Borus, MD, Erik K. Alexander, MD, Barbara E. Bierer, MD, F. Richard Bringhurst, MD, Christopher Clark, JD, Kaley E. Klanica, JD, MPH, Erin C. Stewart, and Lawrence S. Friedman, MD
Abstract Concerns about the influence of industry support on medical education, research, and patient care have increased in both medical and political circles. Some academic medical centers, questioning whether industry support of medical education could be appropriate and not a conflict of interest, banned such support. In 2009, a Partners HealthCare System commission concluded that interactions with industry remained important to Partners’ charitable academic mission and made recommendations to transparently manage such relationships. An Education Review Board (ERB) was created to oversee and manage all industry support of Partners educational activities.
B
y the late 2000s, long-simmering concerns about the influence of industry support on medical education, research, and patient care had become increasingly prominent in both medical and political circles. Several relationships between academic physicians and pharmaceutical and medical device companies that appeared to be inappropriate were highlighted in the press, and federal legislators launched investigations into potential conflicts of interest in such relationships.1–3 This heightened concern developed during a period of shrinking federal support for medical research and education from the National Institutes of Health and from the Centers for Medicare and Medicaid Services, which prompted some academic medical centers (AMCs) to look to industry to help Please see the end of this article for information about the authors. Correspondence should be addressed to Jonathan F. Borus, Brigham and Women’s Hospital, 75 Francis St., Boston, MA 02115; telephone: (617) 732-8140; e-mail: [email protected]. Acad Med. 2015;90:1611–1617. First published online June 16, 2015 doi: 10.1097/ACM.0000000000000788
Using a case review method, the ERB developed guidelines to implement the commission’s recommendations. A multi-funder rule was established that prohibits industry support from only one company for any Partners educational activity. Within that framework, the ERB established guidelines on industry support of educational conferences, clinical fellowships, and trainees’ expenses for attending external educational programs; gifts of textbooks and other educational materials; promotional opportunities associated with Partners educational activities; Partners educational activities under contract with an industry entity; and
industry-run programs using Partners resources.
fund their academic missions. Industry support has been closely scrutinized by professional organizations as well as by legislative bodies, and the Macy Foundation, Institute of Medicine, and Association of American Medical Colleges all have issued reports criticizing some of these relationships.4–6 They questioned the influence of industry on medical education, asking whether such support could be appropriate, not a conflict of interest, and transparent.4–6 AMCs were challenged to develop better methods to avoid both real and apparent conflicts of interest in their interactions with industry, and some (e.g., Stanford University School of Medicine, the University of Michigan Medical School) subsequently banned industry support of continuing medical education (CME) to avoid the appearance of undue industry influence on physician education.7 The “correct approach” to managing industry support of medical education remains a controversial issue.8
and Brigham and Women’s Hospital); several rehabilitation, psychiatric, and community hospitals; and a large number of affiliated primary care and subspecialty practitioners, established a Commission on Interactions with Industry to explore solutions to potential conflicts in the relationships between industry and Partners providers and trainees. In its 2009 report, the commission concluded that interactions with industry were important to Partners’ ability to carry out its charitable academic mission but must be transparent and managed to ensure that industry does not inappropriately influence patient care, research, or educational programs.9 It made specific recommendations for reporting, reviewing, and managing potential conflicts with industry, and established three new bodies to implement its recommendations: (1) an Office for Interactions with Industry (OII) that reports to the Partners general counsel and provides legal and administrative support relating to Partners interactions with industry; and two peer professional committees: (2) an Education Review Board (ERB) to oversee industry support of all Partners-sponsored educational activities and (3) a Committee on Conflicts
In 2007, Partners HealthCare System (Partners), the Boston-based health care system that includes two major AMCs (Massachusetts General Hospital
Academic Medicine, Vol. 90, No. 12 / December 2015
Although many changes have resulted from the implementation of the ERB guidelines, the number of industry grants for Partners educational activities has remained relatively stable, and funding for these activities declined only moderately during the first three full calendar years (2011–2013) of ERB oversight. The ERB continually educates both the Partners community and industry about the rationale for its guidelines and its openness to their refinement in response to changes in the external environment.
1611
Copyright © by the Association of American Medical Colleges. Unauthorized reproduction of this article is prohibited.
Article
of Interest to oversee research and other interactions between industry and Partners-affiliated individuals or groups, including those Partners faculty who speak at non-Partners educational activities.9 In this article, we focus on the ERB as a mechanism to address potential conflicts created by industry support of educational activities across the Partners system. Charge and Development of the ERB
Mission and goals of the ERB Analogous to an institutional review board whose mission is to ensure research integrity, the ERB was created to ensure the educational integrity of Partners industry-supported educational programs. The ERB was charged with reviewing, approving, and monitoring all industry-supported educational programs; conducting an additional review of presentations or programs deemed to be of particular concern because of faculty members’ connections to the program’s industry sponsors; reviewing the amount and source of industry funding for educational presentations and programs; and ensuring the adherence of such programs to accrediting body standards. The ERB also was charged with implementing the commission’s specific educational recommendations, foremost among which were that all industry-supported educational activities (presentations, conferences, training programs, etc.) have multiple funders and that all conferences, lectures, or other presentations meet the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support,10 whether or not the program is offered for CME credit. Working closely with OII, the ERB was tasked with developing guidelines and processes for implementing and monitoring compliance with the charge described above. As part of this charge, the ERB sets the requirements for soliciting and accepting industry funding, processing such gifts with administrative efficiency, and addressing any jurisdictional issues when applying accreditation standards. In addition, the ERB determines the appropriate level of content review for all Partners industry-supported educational activities and the guidelines for reviewing the financial relationships of individuals providing such content.
1612
The OII, in coordination with the ERB, was charged with collecting and reviewing all documentation required for the consideration and acceptance of such gifts; preparing issues for ERB consideration and action; negotiating contractual revisions when necessary to bring a proposed industry gift into compliance with ERB policies; communicating ERB actions and policies to relevant internal and external parties; reviewing the use of industry-provided funds as budgeted; and monitoring the return of excess funds when appropriate. The commission specifically granted the ERB authority to make exceptions and modify, when appropriate, its general recommendations. Structure of the ERB The ERB was established in September 2009; its co-chairs (JFB and LSF) were chosen for their seniority and professorial status, expertise in and commitment to education, and ability to withstand pressure if the ERB made unpopular decisions that required changes in relationships with, and potential support of, industry. The ERB’s 12 additional members were selected to represent Partners AMCs and community hospitals, multiple specialties both with and without significant histories of industry support of educational activities, and differing levels (undergraduate, graduate, CME) of medical education. In addition, two public members unaffiliated with Partners were appointed to provide community input. With voluntary co-chairs and members, new costs attributable to the ERB have been relatively modest (roughly $50,000 per year). These funds mainly provide those OII staff who have been redeployed from the Offices of the General Counsel or Development with additional support to assist the ERB. The ERB has met monthly since January 2010 to develop guidelines for system-wide implementation of the commission’s recommendations, to review and monitor individual educational programs seeking support from industry, and to use its experience with such “cases” to improve ways of avoiding both actual and perceived conflicts of interest. In the ERB’s early years, the co-chairs and OII staff interacted almost daily via e-mail and conference calls to review current cases,
develop recommendations for the ERB regarding specific cases, delineate broader policy implications stemming from such recommendations, and field questions from both industry and the Partners educational community. After the full ERB established the guidelines for industry support, the review of individual cases that meet these guidelines has been delegated to the OII staff in consultation with the co-chairs. Development of the ERB Guidelines for Industry Support
To develop the guidelines, the ERB first identified the areas in which Partners entities sought industry support for educational activities. The members of the ERB then discussed “case examples” of such industry support and worked to determine, when feasible, realistic guidelines that would allow such interactions to transparently continue without producing industry influence on the educational activities. From these discussions, OII staff and the ERB co-chairs drafted consensus guidelines and submitted them at subsequent ERB meetings for review, further modification, and eventual approval by the entire ERB. At the specific request of the commission, the ERB initially developed a “multifunder rule” (see List 1) that prohibits industry support from only one company for any Partners educational activity. The multi-funder rule includes the provision (“70–30 guideline”) that the maximum support a single industry funder can provide (set at 70%) be limited to ensure that one company’s gift does not dominate an educational program. The ERB defined a “Partners educational activity” as any educational presentation or training program for medical professionals sponsored by a Partners entity. In May 2010, the ERB agreed to consider requests for further review in exceptional cases and affirmed the policy that Partners educators were responsible for determining all educational program content without the influence of industry funders. Although Partners CME programs are governed by the multifunder rule, ensuring compliance with educational content and financial conflict policies remains the responsibility of the ACCME-accredited CME provider, and most of the ERB’s oversight activity has been focused on non-CME educational activities (e.g., fellowships, non-CME conferences).
Academic Medicine, Vol. 90, No. 12 / December 2015
Copyright © by the Association of American Medical Colleges. Unauthorized reproduction of this article is prohibited.
Article
List 1 Multi-funder Rule Established by the Education Review Board at Partners HealthCare System in 2010 to Manage Conflicts of Interest in Medical Education Multi-funder rule • The Education Review Board (ERB) may not approve industry support of any Partners educational activity (e.g., presentations, conferences, training programs) unless financial support for that specific activity comes from two or more companies. 70–30 guideline • An educational activity will be deemed to be in compliance with the multi-funder rule so long as no single industry entity contributes more than 70% of the total industry support for the program. • If an educational program receives industry support from more than one company, but one company is providing more than 70% of the total industry support, the arrangement is generally not allowed. Under special circumstances, it may be reviewed by the ERB. Approval of initial support • The ERB recognizes that often programs will receive support from one company (and wish to finalize such support) before receiving support from another company. If the support from the first company meets all applicable policies and ERB guidelines, it can be approved. However, to comply with the multi-funder rule, the support from the first company will be held in an administrative account (i.e., not cashed) until support from a second company is secured. In the meantime, all other paperwork/review for the support from the first company may be finalized. It is preferred that the documentation from the company providing the initial support contain a statement that the funds may be returned if a second supporter is not secured. In-kind gifts • In-kind gifts (e.g., equipment) need not comply with the multi-funder rule but still require review/approval of the ERB. An in-kind gift does not count as support from a second company to bring a program with only one source of industry cash support into compliance with the multi-funder rule. Nonprofit foundation support funded by industry • If, after investigation, the ERB determines that a foundation is sufficiently separate from its industry supporters, further support from that foundation will not need full ERB review for the next two years. Staff from the Office for Interactions with Industry will continue to track all support from such foundations and review the letters of agreement. º A foundation is deemed sufficiently independent if it is supported by multiple companies and decisions about the allocation of support for educational activities are made by independent expert practitioners rather than industry representatives. º Support from foundations that are sufficiently separate from industry will not be regarded as “industry” support for the purposes of complying with the multi-funder rule. As such, support from such a foundation does not count as a second source of industry funding, nor does it require a second funder, for the supported program to be in compliance with the multi-funder rule. • If the ERB determines that the foundation is not sufficiently separate from its industry supporters (e.g., has a single industry funder or educational support decisions are made by company representatives), all support from that foundation must be reviewed by the ERB. º A program receiving support from such a foundation must secure additional funding from another company or another industry-funded foundation to comply with the multi-funder rule.
Defining “industry support” was complex because industry-related funding for some Partners educational activities (e.g., fellowship stipends and trainee attendance at conferences) comes from nonprofit foundations directly affiliated with and/ or principally funded by drug or device companies. The ERB investigated each such foundation offering funding and considered it sufficiently independent (i.e., gifts would not be subject to the multifunder rule) if the foundation met certain
criteria. For example, if a foundation was funded by a single company or the decision to fund a particular educational activity was made by representatives of a supporting company, a grant from that foundation was considered to be industry support, and the Partners activity would need to meet the multi-funder rule. If, however, a foundation was funded by multiple companies and the decision to support a particular fellowship or conference was made by a selection committee composed of independent
Academic Medicine, Vol. 90, No. 12 / December 2015
expert practitioners, the foundation was considered “independent,” and its funding was not subject to the multi-funder rule. Determinations of the status of each foundation are reviewed biannually to ascertain whether the foundation’s structure had changed substantially during the previous two years. During the first four years, within this multifunder framework, the ERB developed guidelines in a number of areas, including industry support of educational conferences, clinical fellowships, and trainees’ expenses for attending external educational conferences and training programs; gifts of textbooks and other educational materials; promotional opportunities associated with Partners educational activities; Partners educational activities under contract with an industry entity; and industry-run educational programs using Partners resources. The ERB deliberated on the details of each of these guidelines to find the right balance between receptivity to funding from industry and the actuality, or appearance, of inappropriate industry influence on educational programs. The ERB was especially sensitive to the vulnerability of trainees to such influence. See Appendix 1 for a summary of these guidelines. Responses to the ERB Guidelines
The ERB guidelines generally have been well received internally and independently; Harvard Medical School (HMS), the academic affiliate of most Partners practitioners, as well as several non-Partners HMS-affiliated hospitals not subject to the ERB’s jurisdiction, adopted similar guidelines for educational programs in 2011. However, some in the Partners community who had grown accustomed to receiving ready support from industry for their educational programs have “pushed back” against the ERB policies. They have argued that “we’ve always done it this way”; “industry support is essential for our educational programs, which are among the best in the country, and the ERB guidelines make it more difficult to obtain that funding”; and “without such support we would not be able to fund trainees, which would decrease unique learning opportunities for young physicians (particularly subspecialty fellows) to receive cutting-edge training.”
1613
Copyright © by the Association of American Medical Colleges. Unauthorized reproduction of this article is prohibited.
Article
The ERB has been open both to refining its guidelines based on case experience or changes in the external environment and to making exceptions to guidelines based on extenuating circumstances. For example, in light of the 2013 Physician Payments Sunshine Act Final Rule,11 which requires the transparent reporting of industry payments to physicians and teaching hospitals, the ERB refined its guidelines to allow the disclosure of the names of the trainees in industry-supported fellowships because companies now are required to disclose such information publically. In addition, the ERB has permitted rare exceptions to the 70–30 guideline for extenuating circumstances (e.g., allowing a 75–25 breakdown of industry support of a scheduled activity that lost a funder at the last minute). Industry funders of Partners educational activities generally seem to have accepted the ERB guidelines. The multi-funder rule may discourage some companies that do not want to “share” support for an educational activity, but the ERB found that many companies now contribute to multifunded independent foundations rather than provide direct funding to AMCs, perhaps in part to meet multifunder requirements like that at Partners. Prior to the implementation of the Sunshine rule, companies had accepted the ERB’s decision to not provide feedback about the trainees whose fellowships the companies support, and independent foundations
1614
350
338
318
305
300
No. of grants
250 200
2011 2012
150
2013
100 50 0 Figure 1 Number of industry-supported grants to fund educational activities at Partners HealthCare System in the first three full calendar years (2011–2013) following implementation of the Education Review Board guidelines to manage conflicts of interest in medical education.
continue to not share any data about trainees with their industry funders. Before the inception of the ERB, comprehensive system-wide data on Partners educational activities, including the annual number of industry gifts and total amount of industry funding, were not collected, so the ERB and OII were tasked with systematically collecting such data for the first time. Many changes in industry funding at the national level occurred around the same time as the creation of the ERB. Reviewing the data for the first three full calendar years (2011–2013) of ERB activity, we were surprised to find—despite our increased oversight, declining sole-funded
industry support, and increasing external constraints on industry support—that the number of industry gifts for Partners educational programs remained relatively stable, while the total amount of industry funding declined approximately 22% (see Figures 1 and 2). In 2013, Partners received 303 grants for a total of approximately $5.5M, and only three grants (total $72,000) were declined because they did not meet the multifunder rule. The total amount of industry support of educational programs declined in 2012 but increased again in 2013. Our data differ from national data that suggest that the number of industry grants and amount of funding have declined substantially.12–14 We believe that
$8,000,000.00 $7,094,656.45 $7,000,000.00 $5,538,908.12
$6,000,000.00 $5,151,441.02 Total dollars
In addition, some have complained that the ERB’s policies are overly bureaucratic and likely to discourage industry sponsors from funding Partners educational programs when other AMCs have more permissive policies. In response to such criticism, the ERB has stressed its intention to not stifle industry support but instead maximize it with transparent practices to avoid both real and apparent conflicts of interest for Partners institutions and trainees. In addition, the ERB has invited some of its most vocal critics to discuss their concerns at ERB meetings and, in some cases, to join the ERB to help ensure that its policies do not discourage appropriate interactions with industry. Strong institutional support throughout the Partners system has been essential in reinforcing the ERB’s authority to make such decisions, and senior hospital leaders have referred critics back to the ERB to resolve issues.
$5,000,000.00 2011 $4,000,000.00 $3,000,000.00
2012 2013
$2,000,000.00 $1,000,000.00 $0.00 Figure 2 Amount of industry funding (in dollars) for educational activities at Partners HealthCare System in the first three full calendar years (2011–2013) following implementation of the Education Review Board guidelines to manage conflicts of interest in medical education.
Academic Medicine, Vol. 90, No. 12 / December 2015
Copyright © by the Association of American Medical Colleges. Unauthorized reproduction of this article is prohibited.
Article
the ERB’s clear guidelines, its engagement with Partners educators, and its openness to working with industry funders have contributed to the continuation of our fruitful academic–industry relationships. Outcomes of Implementing the ERB Guidelines
Short of banning such support, it is not possible to completely insulate educational activities from industry influence. However, we believe that the changes resulting from the implementation of the ERB guidelines have limited such influence substantially. Many of the pre-ERB industry-supported fellowships have continued, but they now have multiple funders, fellows’ participation in industry-run conferences is now limited, and fellows are aware when their program has industry support and are encouraged to notify the ERB and OII if they have concerns about a funder’s influence on their training. The multi-funder rule has stimulated more widespread requests for industry funding for both conferences and training programs, in some cases resulting in more rather than less total industry support of an educational activity. Presentations no longer are seen as the “Company X talk,” and fellows no longer are seen as the “Company Y fellow.” Textbooks may not be given directly to trainees or identified as coming from a particular company. All conferences, whether for CME credit or not, are held to the ACCME standards, and it is clearer to faculty that they, rather than the industry funders, are responsible for all presentation content. The ERB has defined who are considered faculty at such events, preventing “pseudofaculty” participants from having their expenses paid. Social events as part of industry-supported educational activities have been curbed, and such educational activities are now held in Partners hospitals or nearby hotels rather than more distant, resort-type venues. Educational activities’ budgets have been tightened and are more closely monitored so that only educational expenses are covered; any surplus revenues (resulting from the sum of clinical revenues, registration fees, and industry support) must be used for educational purposes. Lessons Learned
ERB members have learned many lessons from their experience to
date. First, the ERB should maintain the support of system and hospital administration as well as the educational community by having clear rationales for industry support guidelines. Second, it should “keep critics close,” listen carefully to their concerns, and seek their input into guideline development rather than shutting them out, while being clear that the ERB supports interactions with industry that are transparent and undertaken in a conflict-free manner. Third, ongoing modification of the guidelines is necessary as members learn from actual cases and as the external environment changes. Fourth, the ERB should continually educate the academic community and industry about the guidelines, their nonarbitrary rationales, and the ERB’s openness to appropriate change. Finally, the ERB should provide efficient ways for educators who seek industry support to have their requests facilitated, reviewed, and processed in a timely fashion. The ERB to date has helped the Partners community better understand areas of potential conflict when seeking industry support for educational activities, and it has developed guidelines to continue, when appropriate, such industry support in a nonconflicted manner. Going forward, the ERB plans to continue to review both cases presenting novel interactions with industry and changes in the external environment that require new or further refinement of the existing guidelines. Funding/Support: None reported. Other disclosures: None reported. Ethical approval: Reported as not applicable. J.F. Borus is Stanley Cobb Distinguished Professor, Department of Psychiatry, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts. E.K. Alexander is associate professor, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts. B.E. Bierer is professor, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts. F.R. Bringhurst is associate professor, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts. C. Clark is director, Office for Interactions with Industry, and senior counsel, Office of the General Counsel, Partners HealthCare, Boston, Massachusetts.
Academic Medicine, Vol. 90, No. 12 / December 2015
K.E. Klanica was manager, Office for Interactions with Industry, Partners HealthCare, Boston, Massachusetts, at the time this article was written. She is currently senior associate general counsel, Allina Health, Minneapolis, Minnesota. E.C. Stewart is senior project specialist, Office for Interactions with Industry, Partners HealthCare, Boston, Massachusetts. L.S. Friedman is Anton R. Fried Chair, Department of Medicine, Newton-Wellesley Hospital, Newton, Massachusetts, and professor of medicine, Harvard Medical School and Tufts University School of Medicine, Boston, Massachusetts.
References 1 U.S. Senate Committee on Finance. Committee Staff Report to the Chairman and Ranking Member: Use of Educational Grants by Pharmaceutical Manufacturers. Washington, DC: U.S. Government Printing Office. 2007. S. Prt 110-21. 2 Kaiser J. Ethics. Private money, public disclosure. Science. 2009;325:28–30. 3 Steenhuysen J. Doctors: Under the drug industry’s influence? Reuters. February 4, 2009. http://www.reuters.com/article/2009/02/04/ us-medical-ethics-idUSTRE5130ZZ20090204. Accessed April 21, 2015. 4 Hager M, Russell S, Fletcher SW, eds. Continuing Education in the Health Professions: Improving Healthcare Through Lifelong Learning. New York, NY: Josiah Macy, Jr. Foundation; 2008. 5 Association of American Medical Colleges. Industry Funding of Medical Education. Report of an AAMC Task Force. Washington, DC: Association of American Medical Colleges; 2008. 6 Lo B, Field MJ, eds; Committee on Conflict of Interest in Medical Research, Education, and Practice. Board on Health Sciences Policy. Institute of Medicine. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: National Academies Press; 2009. 7 Richter R. Stanford medical school severely restricts industry funding of continuing education for physicians [news release]. August 26, 2008. http://med.stanford.edu/ news/all-news/2008/08/stanford-medicalschool-severely-restricts-industry-fundingof-continuing-education-for-physicians. html. Accessed April 21, 2015. 8 Korn D, Carlat D. Conflicts of interest in medical education: Recommendations from the Pew task force on medical conflicts of interest. JAMA. 2013;310:2397–2398. 9 Partners HealthCare. Partners Commission on Interactions with Industry: Report. 2009. http://www.partners.org/documents/ CommissionReport_PartnersHealthCare2009. pdf. Accessed April 21, 2015. 10 Accreditation Council for Continuing Medical Education. Standards for commercial support: Standards to ensure independence in CME activities. http:// www.accme.org/requirements/accreditationrequirements-cme-providers/standards-forcommercial-support. Accessed April 21, 2015. 11 Transparency reports and reporting of physician ownership or investment interests. Final report. Center for Medicare and Medicaid Services. Department of
1615
Copyright © by the Association of American Medical Colleges. Unauthorized reproduction of this article is prohibited.
Article Health and Human Services. Fed Regist. 2013;78:9458–9528. 12 O’Reilly KB. As CME funding shifts from industry, others foot the bill. Am Med News. September 12, 2011. http:// www.amednews.com/article/20110912/
profession/309129948/2/. Accessed April 21, 2015. 13 Iskowitz M. Pharma slashed CME funding again last year: Report. Med Mark Media. July 25, 2012. http://www.mmm-online.com/ pharma-slashed-cme-funding-again-last-
year-report/article/251878/. Accessed April 21, 2015. 14 Steinman MA, Landefeld CS, Baron RB. Industry support of CME—are we at the tipping point? N Engl J Med. 2012;366:1069–1071.
Appendix 1 Summaries of Selected Education Review Board (ERB) Guidelines Established at Partners HealthCare System to Manage Conflicts of Interest in Medical Education Guidelines for Industry Support of Partners Educational Conferences All industry funds must be spent on expenses associated with the supported Partners educational program. It is permissible to use commercial support to pay for food and drinks at meal breaks that are held in the middle of, and are part of, a Partners educational activity, and all activities that include food or drinks must have an educational component. The meal/event may not compete with or take precedence over the educational activity, should be reasonable and appropriate for an academic program, and is for faculty and attendees only. The venue selected for the activity should be reasonable and appropriate for an academic program and should be located in or geographically close to the Partners hospital hosting the event. Speakers at industry-supported Partners educational programs may have their lodging, food, and ground transportation expenses paid at reasonable prevailing rates for the locale of the activity, and speakers’ honoraria should not exceed $2,500/day/speaker. Industry support cannot cover the expenses of spouses, industry attendees, or others who are not involved in the educational activity, social events, or any expenses of attendees who are not faculty of the program; gifts for participants are prohibited. Guidelines for Industry Support of Clinical Fellowships Clinical fellowships that receive industry support must submit a comprehensive budget for the entire program (i.e., all fellows) to the ERB for review, and the budget must include all revenue, including support from foundations and/or professional societies that are not affiliated with any industry entity. The ERB has created a list of standard fellowship expenses, including allowable limits on trainee and faculty compensation, supplies, license and other fees, trainee travel, and overhead expenses. All external support, including industry and foundation support, must be spent on the fellowship program’s expenses. If there are excess external funds remaining at the end of a fellowship program, it is the program’s and the department’s responsibility to return those funds. For fellowships that generate clinical revenue, as noted above, all external support must be spent on the fellowship program’s expenses. Clinical revenue may be attributed to any remaining expenses; however, if the clinical revenue generated from the clinical fellowship exceeds the remaining expenses (after taking all external funding into account), the excess clinical revenue will be placed in escrow to be spent in future years on the same fellowship program. The program director may seek an exception and request that the ERB approve use of the excess funds for another identified educational initiative within the department. Guidelines for Industry Support of Trainees’ Expenses While Attending Educational Conferences or Training Programs Industry support for trainees’ travel is usually acceptable in the following types of situations. Situation #1: A travel grant comes from a non-profit entity that received support from industry for trainees to travel to attend a course that is academic in nature (e.g., participants may receive Accreditation Council for Continuing Medical Education [ACCME] or comparable continuing medical education credit, or the program is put on by a professional society or academic institution with no industry influence on content); the nonprofit entity’s conference can be financially supported by industry, but industry can neither put on nor influence content of the conference. Situation #2: A travel grant comes directly from industry to the department to allow trainees to attend a course that is academic in nature (as above) with payments made to the department, not directly to the trainees. Situation #3: A travel grant comes directly from a device company to cover trainees’ travel and lodging expenses to attend a device training hosted by that company when it is obligated to cover such expenses pursuant to a purchase agreement between the Partners institution and the device company. The program director of the trainees’ program must affirm that the device training is an important part of the trainees’ learning experience, and any payment made by the company (including reimbursements) must be made to the department, not to the trainees. Situation #4: A travel grant comes directly from industry and goes into a multi-funder supported educational travel pool within the department, with payments made to the department, not an individual. Examples of industry support for travel that are prohibited include: • Industry provides funding directly to a trainee for any type of conference. • Industry provides funding to a department for a fellow to attend a training session put on by that industry entity for which only fellows are permitted to attend. • Industry offers to cover the travel and lodging expenses associated with a fellow’s attendance at a training session put on by that industry entity, but the industry entity is not obligated to cover such expenses pursuant to its purchase agreement with the hospital (or a bona fide amendment thereto).
(Appendix continues)
1616
Academic Medicine, Vol. 90, No. 12 / December 2015
Copyright © by the Association of American Medical Colleges. Unauthorized reproduction of this article is prohibited.
Article
Appendix 1 (Continued) Guidelines for Gifts of Textbooks or Other Educational Items to Support Educational Activities and Clinical Training Programs Partners’ policy prohibits the acceptance of gifts from vendors to the hospital for the personal use of staff members. However, industry support, whether in case or in-kind, is allowable to support a Partners educational program. The following guideline delineates when gifts of textbooks and other educational items, including but not limited to CD-ROMs, DVDs, and free subscriptions to journals, may and may not be permissible as a form of industry support for a Partners educational program (a residency or fellowship program), subject to ERB oversight. Companies cannot give textbooks and other educational items directly to trainees, and a single company may not give funds to a department to buy books for its trainees or its library. However, multiple companies can contribute funds or actual books to a department for its library. A single company may give a book to the department which the latter may choose to give to its trainees. Educational material must be academic in nature and selected by the program director, who must disclose who supplied the educational material. The educational materials must not have a name plate or any enduring acknowledgement of the company that provided the item. Guidelines for Promotional Opportunities Associated With Partners Educational Activities Promotional opportunities may be offered to companies at Partners educational activities only as long as they are separate from and do not interfere with the educational components of the activity (e.g., exhibit booths cannot be in the obligate path of the learning activity, and promotional advertisements should be separate from educational material in the program brochure). Participants should be able to attend a Partners educational activity without interacting with any advertisers or exhibitors if they so choose. In addition, consistent with ACCME requirements, exhibitors or advertisers at Partners educational activities may not receive advanced access to medical professional attendee registration lists unless the attendees, at the time of registration for the activity, specifically “opt-in” to be contacted. Exhibitors and advertisers also may not distribute any type of gift or trinket, hold a raffle, or provide any other enticement. There are additional requirements for promotional opportunities at Partners educational activities if the attendees are patients. Partners educational activities aimed at patients must post a disclaimer at the entrance to the exhibit hall that clearly indicates that the Partners hospital neither supports nor endorses the information or products advertised by the companies. The disclaimer should also include language that encourages patients to discuss any information that they learn while visiting the exhibit booths with their physician and/or other health care providers. Furthermore, companies are prohibited from distributing branded products and items, unbranded products (e.g., pens, notepads), candies, or other items that are not specifically designed for the disease state being discussed at the Partners educational activity for patients. Guidelines for Industry Programs Utilizing Partners Resources and Partners Educational Activities Under Contract With Industry An industry entity may seek to have a Partners hospital provide a training or educational program for its employees or other physicians with a specified focus or content. Generally these arrangements are made with only one company, and that company has an interest in making sure a particular topic is covered for its intended audience. In general, these educational programs are consistent with the charitable mission of Partners but do not comply with all Partners educational activity policies (e.g., multi-funder rule) so the ERB determined that these programs warrant different treatment. The ERB created two categories for programs initiated by an industry entity: “Industry Programs Utilizing Partners Resources” and “Partners Educational Activities Under Contract With Industry.” The major difference between the two categories is Partners’ involvement. For “Industry Programs Utilizing Partners Resources,” the program is viewed as an industry program, not as a Partners or joint program. The name and/or logo of the Partners hospital may not be used in any program materials other than to identify the location of the program and the speakers’ affiliations, if necessary. The industry entity organizes all aspects of the program, from inviting attendees to issuing certificates of attendance, except for putting together and presenting the content. All program expenses are covered by the industry entity. “Partners Educational Activities Under Contract With Industry” are usually advertised as a Partners or joint program between the Partners hospital and the industry entity. The Partners hospital may invite attendees and help advertise the program along with the industry entity. If the Partners hospital invites any attendees, it must contribute to the cost of the program. Because this program is a type of Partners educational activity, it must meet one of the following three criteria to be funded by a single industry entity: 1. The central component of the program requires collaboration with an academic medical center and is in an area in which Partners has particular expertise; 2. The central component of the program requires the use of a technology or an animal model that is not readily available outside of a Partners hospital; or 3. The training focuses on a disease state (i.e., not a company product) and is exclusively for company employees.
Academic Medicine, Vol. 90, No. 12 / December 2015
1617
Copyright © by the Association of American Medical Colleges. Unauthorized reproduction of this article is prohibited.
The Education Review Board: A Mechanism for Managing Potential Conflicts of Interest in Medical Education Jonathan F. Borus, MD, Erik K. Alexander, MD, Barbara E. Bierer, MD, F. Richard Bringhurst, MD, Christopher Clark, JD, Kaley E. Klanica, JD, MPH, Erin C. Stewart, and Lawrence S. Friedman, MD
Abstract Concerns about the influence of industry support on medical education, research, and patient care have increased in both medical and political circles. Some academic medical centers, questioning whether industry support of medical education could be appropriate and not a conflict of interest, banned such support. In 2009, a Partners HealthCare System commission concluded that interactions with industry remained important to Partners’ charitable academic mission and made recommendations to transparently manage such relationships. An Education Review Board (ERB) was created to oversee and manage all industry support of Partners educational activities.
B
y the late 2000s, long-simmering concerns about the influence of industry support on medical education, research, and patient care had become increasingly prominent in both medical and political circles. Several relationships between academic physicians and pharmaceutical and medical device companies that appeared to be inappropriate were highlighted in the press, and federal legislators launched investigations into potential conflicts of interest in such relationships.1–3 This heightened concern developed during a period of shrinking federal support for medical research and education from the National Institutes of Health and from the Centers for Medicare and Medicaid Services, which prompted some academic medical centers (AMCs) to look to industry to help Please see the end of this article for information about the authors. Correspondence should be addressed to Jonathan F. Borus, Brigham and Women’s Hospital, 75 Francis St., Boston, MA 02115; telephone: (617) 732-8140; e-mail: [email protected]. Acad Med. 2015;90:1611–1617. First published online June 16, 2015 doi: 10.1097/ACM.0000000000000788
Using a case review method, the ERB developed guidelines to implement the commission’s recommendations. A multi-funder rule was established that prohibits industry support from only one company for any Partners educational activity. Within that framework, the ERB established guidelines on industry support of educational conferences, clinical fellowships, and trainees’ expenses for attending external educational programs; gifts of textbooks and other educational materials; promotional opportunities associated with Partners educational activities; Partners educational activities under contract with an industry entity; and
industry-run programs using Partners resources.
fund their academic missions. Industry support has been closely scrutinized by professional organizations as well as by legislative bodies, and the Macy Foundation, Institute of Medicine, and Association of American Medical Colleges all have issued reports criticizing some of these relationships.4–6 They questioned the influence of industry on medical education, asking whether such support could be appropriate, not a conflict of interest, and transparent.4–6 AMCs were challenged to develop better methods to avoid both real and apparent conflicts of interest in their interactions with industry, and some (e.g., Stanford University School of Medicine, the University of Michigan Medical School) subsequently banned industry support of continuing medical education (CME) to avoid the appearance of undue industry influence on physician education.7 The “correct approach” to managing industry support of medical education remains a controversial issue.8
and Brigham and Women’s Hospital); several rehabilitation, psychiatric, and community hospitals; and a large number of affiliated primary care and subspecialty practitioners, established a Commission on Interactions with Industry to explore solutions to potential conflicts in the relationships between industry and Partners providers and trainees. In its 2009 report, the commission concluded that interactions with industry were important to Partners’ ability to carry out its charitable academic mission but must be transparent and managed to ensure that industry does not inappropriately influence patient care, research, or educational programs.9 It made specific recommendations for reporting, reviewing, and managing potential conflicts with industry, and established three new bodies to implement its recommendations: (1) an Office for Interactions with Industry (OII) that reports to the Partners general counsel and provides legal and administrative support relating to Partners interactions with industry; and two peer professional committees: (2) an Education Review Board (ERB) to oversee industry support of all Partners-sponsored educational activities and (3) a Committee on Conflicts
In 2007, Partners HealthCare System (Partners), the Boston-based health care system that includes two major AMCs (Massachusetts General Hospital
Academic Medicine, Vol. 90, No. 12 / December 2015
Although many changes have resulted from the implementation of the ERB guidelines, the number of industry grants for Partners educational activities has remained relatively stable, and funding for these activities declined only moderately during the first three full calendar years (2011–2013) of ERB oversight. The ERB continually educates both the Partners community and industry about the rationale for its guidelines and its openness to their refinement in response to changes in the external environment.
1611
Copyright © by the Association of American Medical Colleges. Unauthorized reproduction of this article is prohibited.
Article
of Interest to oversee research and other interactions between industry and Partners-affiliated individuals or groups, including those Partners faculty who speak at non-Partners educational activities.9 In this article, we focus on the ERB as a mechanism to address potential conflicts created by industry support of educational activities across the Partners system. Charge and Development of the ERB
Mission and goals of the ERB Analogous to an institutional review board whose mission is to ensure research integrity, the ERB was created to ensure the educational integrity of Partners industry-supported educational programs. The ERB was charged with reviewing, approving, and monitoring all industry-supported educational programs; conducting an additional review of presentations or programs deemed to be of particular concern because of faculty members’ connections to the program’s industry sponsors; reviewing the amount and source of industry funding for educational presentations and programs; and ensuring the adherence of such programs to accrediting body standards. The ERB also was charged with implementing the commission’s specific educational recommendations, foremost among which were that all industry-supported educational activities (presentations, conferences, training programs, etc.) have multiple funders and that all conferences, lectures, or other presentations meet the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support,10 whether or not the program is offered for CME credit. Working closely with OII, the ERB was tasked with developing guidelines and processes for implementing and monitoring compliance with the charge described above. As part of this charge, the ERB sets the requirements for soliciting and accepting industry funding, processing such gifts with administrative efficiency, and addressing any jurisdictional issues when applying accreditation standards. In addition, the ERB determines the appropriate level of content review for all Partners industry-supported educational activities and the guidelines for reviewing the financial relationships of individuals providing such content.
1612
The OII, in coordination with the ERB, was charged with collecting and reviewing all documentation required for the consideration and acceptance of such gifts; preparing issues for ERB consideration and action; negotiating contractual revisions when necessary to bring a proposed industry gift into compliance with ERB policies; communicating ERB actions and policies to relevant internal and external parties; reviewing the use of industry-provided funds as budgeted; and monitoring the return of excess funds when appropriate. The commission specifically granted the ERB authority to make exceptions and modify, when appropriate, its general recommendations. Structure of the ERB The ERB was established in September 2009; its co-chairs (JFB and LSF) were chosen for their seniority and professorial status, expertise in and commitment to education, and ability to withstand pressure if the ERB made unpopular decisions that required changes in relationships with, and potential support of, industry. The ERB’s 12 additional members were selected to represent Partners AMCs and community hospitals, multiple specialties both with and without significant histories of industry support of educational activities, and differing levels (undergraduate, graduate, CME) of medical education. In addition, two public members unaffiliated with Partners were appointed to provide community input. With voluntary co-chairs and members, new costs attributable to the ERB have been relatively modest (roughly $50,000 per year). These funds mainly provide those OII staff who have been redeployed from the Offices of the General Counsel or Development with additional support to assist the ERB. The ERB has met monthly since January 2010 to develop guidelines for system-wide implementation of the commission’s recommendations, to review and monitor individual educational programs seeking support from industry, and to use its experience with such “cases” to improve ways of avoiding both actual and perceived conflicts of interest. In the ERB’s early years, the co-chairs and OII staff interacted almost daily via e-mail and conference calls to review current cases,
develop recommendations for the ERB regarding specific cases, delineate broader policy implications stemming from such recommendations, and field questions from both industry and the Partners educational community. After the full ERB established the guidelines for industry support, the review of individual cases that meet these guidelines has been delegated to the OII staff in consultation with the co-chairs. Development of the ERB Guidelines for Industry Support
To develop the guidelines, the ERB first identified the areas in which Partners entities sought industry support for educational activities. The members of the ERB then discussed “case examples” of such industry support and worked to determine, when feasible, realistic guidelines that would allow such interactions to transparently continue without producing industry influence on the educational activities. From these discussions, OII staff and the ERB co-chairs drafted consensus guidelines and submitted them at subsequent ERB meetings for review, further modification, and eventual approval by the entire ERB. At the specific request of the commission, the ERB initially developed a “multifunder rule” (see List 1) that prohibits industry support from only one company for any Partners educational activity. The multi-funder rule includes the provision (“70–30 guideline”) that the maximum support a single industry funder can provide (set at 70%) be limited to ensure that one company’s gift does not dominate an educational program. The ERB defined a “Partners educational activity” as any educational presentation or training program for medical professionals sponsored by a Partners entity. In May 2010, the ERB agreed to consider requests for further review in exceptional cases and affirmed the policy that Partners educators were responsible for determining all educational program content without the influence of industry funders. Although Partners CME programs are governed by the multifunder rule, ensuring compliance with educational content and financial conflict policies remains the responsibility of the ACCME-accredited CME provider, and most of the ERB’s oversight activity has been focused on non-CME educational activities (e.g., fellowships, non-CME conferences).
Academic Medicine, Vol. 90, No. 12 / December 2015
Copyright © by the Association of American Medical Colleges. Unauthorized reproduction of this article is prohibited.
Article
List 1 Multi-funder Rule Established by the Education Review Board at Partners HealthCare System in 2010 to Manage Conflicts of Interest in Medical Education Multi-funder rule • The Education Review Board (ERB) may not approve industry support of any Partners educational activity (e.g., presentations, conferences, training programs) unless financial support for that specific activity comes from two or more companies. 70–30 guideline • An educational activity will be deemed to be in compliance with the multi-funder rule so long as no single industry entity contributes more than 70% of the total industry support for the program. • If an educational program receives industry support from more than one company, but one company is providing more than 70% of the total industry support, the arrangement is generally not allowed. Under special circumstances, it may be reviewed by the ERB. Approval of initial support • The ERB recognizes that often programs will receive support from one company (and wish to finalize such support) before receiving support from another company. If the support from the first company meets all applicable policies and ERB guidelines, it can be approved. However, to comply with the multi-funder rule, the support from the first company will be held in an administrative account (i.e., not cashed) until support from a second company is secured. In the meantime, all other paperwork/review for the support from the first company may be finalized. It is preferred that the documentation from the company providing the initial support contain a statement that the funds may be returned if a second supporter is not secured. In-kind gifts • In-kind gifts (e.g., equipment) need not comply with the multi-funder rule but still require review/approval of the ERB. An in-kind gift does not count as support from a second company to bring a program with only one source of industry cash support into compliance with the multi-funder rule. Nonprofit foundation support funded by industry • If, after investigation, the ERB determines that a foundation is sufficiently separate from its industry supporters, further support from that foundation will not need full ERB review for the next two years. Staff from the Office for Interactions with Industry will continue to track all support from such foundations and review the letters of agreement. º A foundation is deemed sufficiently independent if it is supported by multiple companies and decisions about the allocation of support for educational activities are made by independent expert practitioners rather than industry representatives. º Support from foundations that are sufficiently separate from industry will not be regarded as “industry” support for the purposes of complying with the multi-funder rule. As such, support from such a foundation does not count as a second source of industry funding, nor does it require a second funder, for the supported program to be in compliance with the multi-funder rule. • If the ERB determines that the foundation is not sufficiently separate from its industry supporters (e.g., has a single industry funder or educational support decisions are made by company representatives), all support from that foundation must be reviewed by the ERB. º A program receiving support from such a foundation must secure additional funding from another company or another industry-funded foundation to comply with the multi-funder rule.
Defining “industry support” was complex because industry-related funding for some Partners educational activities (e.g., fellowship stipends and trainee attendance at conferences) comes from nonprofit foundations directly affiliated with and/ or principally funded by drug or device companies. The ERB investigated each such foundation offering funding and considered it sufficiently independent (i.e., gifts would not be subject to the multifunder rule) if the foundation met certain
criteria. For example, if a foundation was funded by a single company or the decision to fund a particular educational activity was made by representatives of a supporting company, a grant from that foundation was considered to be industry support, and the Partners activity would need to meet the multi-funder rule. If, however, a foundation was funded by multiple companies and the decision to support a particular fellowship or conference was made by a selection committee composed of independent
Academic Medicine, Vol. 90, No. 12 / December 2015
expert practitioners, the foundation was considered “independent,” and its funding was not subject to the multi-funder rule. Determinations of the status of each foundation are reviewed biannually to ascertain whether the foundation’s structure had changed substantially during the previous two years. During the first four years, within this multifunder framework, the ERB developed guidelines in a number of areas, including industry support of educational conferences, clinical fellowships, and trainees’ expenses for attending external educational conferences and training programs; gifts of textbooks and other educational materials; promotional opportunities associated with Partners educational activities; Partners educational activities under contract with an industry entity; and industry-run educational programs using Partners resources. The ERB deliberated on the details of each of these guidelines to find the right balance between receptivity to funding from industry and the actuality, or appearance, of inappropriate industry influence on educational programs. The ERB was especially sensitive to the vulnerability of trainees to such influence. See Appendix 1 for a summary of these guidelines. Responses to the ERB Guidelines
The ERB guidelines generally have been well received internally and independently; Harvard Medical School (HMS), the academic affiliate of most Partners practitioners, as well as several non-Partners HMS-affiliated hospitals not subject to the ERB’s jurisdiction, adopted similar guidelines for educational programs in 2011. However, some in the Partners community who had grown accustomed to receiving ready support from industry for their educational programs have “pushed back” against the ERB policies. They have argued that “we’ve always done it this way”; “industry support is essential for our educational programs, which are among the best in the country, and the ERB guidelines make it more difficult to obtain that funding”; and “without such support we would not be able to fund trainees, which would decrease unique learning opportunities for young physicians (particularly subspecialty fellows) to receive cutting-edge training.”
1613
Copyright © by the Association of American Medical Colleges. Unauthorized reproduction of this article is prohibited.
Article
The ERB has been open both to refining its guidelines based on case experience or changes in the external environment and to making exceptions to guidelines based on extenuating circumstances. For example, in light of the 2013 Physician Payments Sunshine Act Final Rule,11 which requires the transparent reporting of industry payments to physicians and teaching hospitals, the ERB refined its guidelines to allow the disclosure of the names of the trainees in industry-supported fellowships because companies now are required to disclose such information publically. In addition, the ERB has permitted rare exceptions to the 70–30 guideline for extenuating circumstances (e.g., allowing a 75–25 breakdown of industry support of a scheduled activity that lost a funder at the last minute). Industry funders of Partners educational activities generally seem to have accepted the ERB guidelines. The multi-funder rule may discourage some companies that do not want to “share” support for an educational activity, but the ERB found that many companies now contribute to multifunded independent foundations rather than provide direct funding to AMCs, perhaps in part to meet multifunder requirements like that at Partners. Prior to the implementation of the Sunshine rule, companies had accepted the ERB’s decision to not provide feedback about the trainees whose fellowships the companies support, and independent foundations
1614
350
338
318
305
300
No. of grants
250 200
2011 2012
150
2013
100 50 0 Figure 1 Number of industry-supported grants to fund educational activities at Partners HealthCare System in the first three full calendar years (2011–2013) following implementation of the Education Review Board guidelines to manage conflicts of interest in medical education.
continue to not share any data about trainees with their industry funders. Before the inception of the ERB, comprehensive system-wide data on Partners educational activities, including the annual number of industry gifts and total amount of industry funding, were not collected, so the ERB and OII were tasked with systematically collecting such data for the first time. Many changes in industry funding at the national level occurred around the same time as the creation of the ERB. Reviewing the data for the first three full calendar years (2011–2013) of ERB activity, we were surprised to find—despite our increased oversight, declining sole-funded
industry support, and increasing external constraints on industry support—that the number of industry gifts for Partners educational programs remained relatively stable, while the total amount of industry funding declined approximately 22% (see Figures 1 and 2). In 2013, Partners received 303 grants for a total of approximately $5.5M, and only three grants (total $72,000) were declined because they did not meet the multifunder rule. The total amount of industry support of educational programs declined in 2012 but increased again in 2013. Our data differ from national data that suggest that the number of industry grants and amount of funding have declined substantially.12–14 We believe that
$8,000,000.00 $7,094,656.45 $7,000,000.00 $5,538,908.12
$6,000,000.00 $5,151,441.02 Total dollars
In addition, some have complained that the ERB’s policies are overly bureaucratic and likely to discourage industry sponsors from funding Partners educational programs when other AMCs have more permissive policies. In response to such criticism, the ERB has stressed its intention to not stifle industry support but instead maximize it with transparent practices to avoid both real and apparent conflicts of interest for Partners institutions and trainees. In addition, the ERB has invited some of its most vocal critics to discuss their concerns at ERB meetings and, in some cases, to join the ERB to help ensure that its policies do not discourage appropriate interactions with industry. Strong institutional support throughout the Partners system has been essential in reinforcing the ERB’s authority to make such decisions, and senior hospital leaders have referred critics back to the ERB to resolve issues.
$5,000,000.00 2011 $4,000,000.00 $3,000,000.00
2012 2013
$2,000,000.00 $1,000,000.00 $0.00 Figure 2 Amount of industry funding (in dollars) for educational activities at Partners HealthCare System in the first three full calendar years (2011–2013) following implementation of the Education Review Board guidelines to manage conflicts of interest in medical education.
Academic Medicine, Vol. 90, No. 12 / December 2015
Copyright © by the Association of American Medical Colleges. Unauthorized reproduction of this article is prohibited.
Article
the ERB’s clear guidelines, its engagement with Partners educators, and its openness to working with industry funders have contributed to the continuation of our fruitful academic–industry relationships. Outcomes of Implementing the ERB Guidelines
Short of banning such support, it is not possible to completely insulate educational activities from industry influence. However, we believe that the changes resulting from the implementation of the ERB guidelines have limited such influence substantially. Many of the pre-ERB industry-supported fellowships have continued, but they now have multiple funders, fellows’ participation in industry-run conferences is now limited, and fellows are aware when their program has industry support and are encouraged to notify the ERB and OII if they have concerns about a funder’s influence on their training. The multi-funder rule has stimulated more widespread requests for industry funding for both conferences and training programs, in some cases resulting in more rather than less total industry support of an educational activity. Presentations no longer are seen as the “Company X talk,” and fellows no longer are seen as the “Company Y fellow.” Textbooks may not be given directly to trainees or identified as coming from a particular company. All conferences, whether for CME credit or not, are held to the ACCME standards, and it is clearer to faculty that they, rather than the industry funders, are responsible for all presentation content. The ERB has defined who are considered faculty at such events, preventing “pseudofaculty” participants from having their expenses paid. Social events as part of industry-supported educational activities have been curbed, and such educational activities are now held in Partners hospitals or nearby hotels rather than more distant, resort-type venues. Educational activities’ budgets have been tightened and are more closely monitored so that only educational expenses are covered; any surplus revenues (resulting from the sum of clinical revenues, registration fees, and industry support) must be used for educational purposes. Lessons Learned
ERB members have learned many lessons from their experience to
date. First, the ERB should maintain the support of system and hospital administration as well as the educational community by having clear rationales for industry support guidelines. Second, it should “keep critics close,” listen carefully to their concerns, and seek their input into guideline development rather than shutting them out, while being clear that the ERB supports interactions with industry that are transparent and undertaken in a conflict-free manner. Third, ongoing modification of the guidelines is necessary as members learn from actual cases and as the external environment changes. Fourth, the ERB should continually educate the academic community and industry about the guidelines, their nonarbitrary rationales, and the ERB’s openness to appropriate change. Finally, the ERB should provide efficient ways for educators who seek industry support to have their requests facilitated, reviewed, and processed in a timely fashion. The ERB to date has helped the Partners community better understand areas of potential conflict when seeking industry support for educational activities, and it has developed guidelines to continue, when appropriate, such industry support in a nonconflicted manner. Going forward, the ERB plans to continue to review both cases presenting novel interactions with industry and changes in the external environment that require new or further refinement of the existing guidelines. Funding/Support: None reported. Other disclosures: None reported. Ethical approval: Reported as not applicable. J.F. Borus is Stanley Cobb Distinguished Professor, Department of Psychiatry, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts. E.K. Alexander is associate professor, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts. B.E. Bierer is professor, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts. F.R. Bringhurst is associate professor, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts. C. Clark is director, Office for Interactions with Industry, and senior counsel, Office of the General Counsel, Partners HealthCare, Boston, Massachusetts.
Academic Medicine, Vol. 90, No. 12 / December 2015
K.E. Klanica was manager, Office for Interactions with Industry, Partners HealthCare, Boston, Massachusetts, at the time this article was written. She is currently senior associate general counsel, Allina Health, Minneapolis, Minnesota. E.C. Stewart is senior project specialist, Office for Interactions with Industry, Partners HealthCare, Boston, Massachusetts. L.S. Friedman is Anton R. Fried Chair, Department of Medicine, Newton-Wellesley Hospital, Newton, Massachusetts, and professor of medicine, Harvard Medical School and Tufts University School of Medicine, Boston, Massachusetts.
References 1 U.S. Senate Committee on Finance. Committee Staff Report to the Chairman and Ranking Member: Use of Educational Grants by Pharmaceutical Manufacturers. Washington, DC: U.S. Government Printing Office. 2007. S. Prt 110-21. 2 Kaiser J. Ethics. Private money, public disclosure. Science. 2009;325:28–30. 3 Steenhuysen J. Doctors: Under the drug industry’s influence? Reuters. February 4, 2009. http://www.reuters.com/article/2009/02/04/ us-medical-ethics-idUSTRE5130ZZ20090204. Accessed April 21, 2015. 4 Hager M, Russell S, Fletcher SW, eds. Continuing Education in the Health Professions: Improving Healthcare Through Lifelong Learning. New York, NY: Josiah Macy, Jr. Foundation; 2008. 5 Association of American Medical Colleges. Industry Funding of Medical Education. Report of an AAMC Task Force. Washington, DC: Association of American Medical Colleges; 2008. 6 Lo B, Field MJ, eds; Committee on Conflict of Interest in Medical Research, Education, and Practice. Board on Health Sciences Policy. Institute of Medicine. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: National Academies Press; 2009. 7 Richter R. Stanford medical school severely restricts industry funding of continuing education for physicians [news release]. August 26, 2008. http://med.stanford.edu/ news/all-news/2008/08/stanford-medicalschool-severely-restricts-industry-fundingof-continuing-education-for-physicians. html. Accessed April 21, 2015. 8 Korn D, Carlat D. Conflicts of interest in medical education: Recommendations from the Pew task force on medical conflicts of interest. JAMA. 2013;310:2397–2398. 9 Partners HealthCare. Partners Commission on Interactions with Industry: Report. 2009. http://www.partners.org/documents/ CommissionReport_PartnersHealthCare2009. pdf. Accessed April 21, 2015. 10 Accreditation Council for Continuing Medical Education. Standards for commercial support: Standards to ensure independence in CME activities. http:// www.accme.org/requirements/accreditationrequirements-cme-providers/standards-forcommercial-support. Accessed April 21, 2015. 11 Transparency reports and reporting of physician ownership or investment interests. Final report. Center for Medicare and Medicaid Services. Department of
1615
Copyright © by the Association of American Medical Colleges. Unauthorized reproduction of this article is prohibited.
Article Health and Human Services. Fed Regist. 2013;78:9458–9528. 12 O’Reilly KB. As CME funding shifts from industry, others foot the bill. Am Med News. September 12, 2011. http:// www.amednews.com/article/20110912/
profession/309129948/2/. Accessed April 21, 2015. 13 Iskowitz M. Pharma slashed CME funding again last year: Report. Med Mark Media. July 25, 2012. http://www.mmm-online.com/ pharma-slashed-cme-funding-again-last-
year-report/article/251878/. Accessed April 21, 2015. 14 Steinman MA, Landefeld CS, Baron RB. Industry support of CME—are we at the tipping point? N Engl J Med. 2012;366:1069–1071.
Appendix 1 Summaries of Selected Education Review Board (ERB) Guidelines Established at Partners HealthCare System to Manage Conflicts of Interest in Medical Education Guidelines for Industry Support of Partners Educational Conferences All industry funds must be spent on expenses associated with the supported Partners educational program. It is permissible to use commercial support to pay for food and drinks at meal breaks that are held in the middle of, and are part of, a Partners educational activity, and all activities that include food or drinks must have an educational component. The meal/event may not compete with or take precedence over the educational activity, should be reasonable and appropriate for an academic program, and is for faculty and attendees only. The venue selected for the activity should be reasonable and appropriate for an academic program and should be located in or geographically close to the Partners hospital hosting the event. Speakers at industry-supported Partners educational programs may have their lodging, food, and ground transportation expenses paid at reasonable prevailing rates for the locale of the activity, and speakers’ honoraria should not exceed $2,500/day/speaker. Industry support cannot cover the expenses of spouses, industry attendees, or others who are not involved in the educational activity, social events, or any expenses of attendees who are not faculty of the program; gifts for participants are prohibited. Guidelines for Industry Support of Clinical Fellowships Clinical fellowships that receive industry support must submit a comprehensive budget for the entire program (i.e., all fellows) to the ERB for review, and the budget must include all revenue, including support from foundations and/or professional societies that are not affiliated with any industry entity. The ERB has created a list of standard fellowship expenses, including allowable limits on trainee and faculty compensation, supplies, license and other fees, trainee travel, and overhead expenses. All external support, including industry and foundation support, must be spent on the fellowship program’s expenses. If there are excess external funds remaining at the end of a fellowship program, it is the program’s and the department’s responsibility to return those funds. For fellowships that generate clinical revenue, as noted above, all external support must be spent on the fellowship program’s expenses. Clinical revenue may be attributed to any remaining expenses; however, if the clinical revenue generated from the clinical fellowship exceeds the remaining expenses (after taking all external funding into account), the excess clinical revenue will be placed in escrow to be spent in future years on the same fellowship program. The program director may seek an exception and request that the ERB approve use of the excess funds for another identified educational initiative within the department. Guidelines for Industry Support of Trainees’ Expenses While Attending Educational Conferences or Training Programs Industry support for trainees’ travel is usually acceptable in the following types of situations. Situation #1: A travel grant comes from a non-profit entity that received support from industry for trainees to travel to attend a course that is academic in nature (e.g., participants may receive Accreditation Council for Continuing Medical Education [ACCME] or comparable continuing medical education credit, or the program is put on by a professional society or academic institution with no industry influence on content); the nonprofit entity’s conference can be financially supported by industry, but industry can neither put on nor influence content of the conference. Situation #2: A travel grant comes directly from industry to the department to allow trainees to attend a course that is academic in nature (as above) with payments made to the department, not directly to the trainees. Situation #3: A travel grant comes directly from a device company to cover trainees’ travel and lodging expenses to attend a device training hosted by that company when it is obligated to cover such expenses pursuant to a purchase agreement between the Partners institution and the device company. The program director of the trainees’ program must affirm that the device training is an important part of the trainees’ learning experience, and any payment made by the company (including reimbursements) must be made to the department, not to the trainees. Situation #4: A travel grant comes directly from industry and goes into a multi-funder supported educational travel pool within the department, with payments made to the department, not an individual. Examples of industry support for travel that are prohibited include: • Industry provides funding directly to a trainee for any type of conference. • Industry provides funding to a department for a fellow to attend a training session put on by that industry entity for which only fellows are permitted to attend. • Industry offers to cover the travel and lodging expenses associated with a fellow’s attendance at a training session put on by that industry entity, but the industry entity is not obligated to cover such expenses pursuant to its purchase agreement with the hospital (or a bona fide amendment thereto).
(Appendix continues)
1616
Academic Medicine, Vol. 90, No. 12 / December 2015
Copyright © by the Association of American Medical Colleges. Unauthorized reproduction of this article is prohibited.
Article
Appendix 1 (Continued) Guidelines for Gifts of Textbooks or Other Educational Items to Support Educational Activities and Clinical Training Programs Partners’ policy prohibits the acceptance of gifts from vendors to the hospital for the personal use of staff members. However, industry support, whether in case or in-kind, is allowable to support a Partners educational program. The following guideline delineates when gifts of textbooks and other educational items, including but not limited to CD-ROMs, DVDs, and free subscriptions to journals, may and may not be permissible as a form of industry support for a Partners educational program (a residency or fellowship program), subject to ERB oversight. Companies cannot give textbooks and other educational items directly to trainees, and a single company may not give funds to a department to buy books for its trainees or its library. However, multiple companies can contribute funds or actual books to a department for its library. A single company may give a book to the department which the latter may choose to give to its trainees. Educational material must be academic in nature and selected by the program director, who must disclose who supplied the educational material. The educational materials must not have a name plate or any enduring acknowledgement of the company that provided the item. Guidelines for Promotional Opportunities Associated With Partners Educational Activities Promotional opportunities may be offered to companies at Partners educational activities only as long as they are separate from and do not interfere with the educational components of the activity (e.g., exhibit booths cannot be in the obligate path of the learning activity, and promotional advertisements should be separate from educational material in the program brochure). Participants should be able to attend a Partners educational activity without interacting with any advertisers or exhibitors if they so choose. In addition, consistent with ACCME requirements, exhibitors or advertisers at Partners educational activities may not receive advanced access to medical professional attendee registration lists unless the attendees, at the time of registration for the activity, specifically “opt-in” to be contacted. Exhibitors and advertisers also may not distribute any type of gift or trinket, hold a raffle, or provide any other enticement. There are additional requirements for promotional opportunities at Partners educational activities if the attendees are patients. Partners educational activities aimed at patients must post a disclaimer at the entrance to the exhibit hall that clearly indicates that the Partners hospital neither supports nor endorses the information or products advertised by the companies. The disclaimer should also include language that encourages patients to discuss any information that they learn while visiting the exhibit booths with their physician and/or other health care providers. Furthermore, companies are prohibited from distributing branded products and items, unbranded products (e.g., pens, notepads), candies, or other items that are not specifically designed for the disease state being discussed at the Partners educational activity for patients. Guidelines for Industry Programs Utilizing Partners Resources and Partners Educational Activities Under Contract With Industry An industry entity may seek to have a Partners hospital provide a training or educational program for its employees or other physicians with a specified focus or content. Generally these arrangements are made with only one company, and that company has an interest in making sure a particular topic is covered for its intended audience. In general, these educational programs are consistent with the charitable mission of Partners but do not comply with all Partners educational activity policies (e.g., multi-funder rule) so the ERB determined that these programs warrant different treatment. The ERB created two categories for programs initiated by an industry entity: “Industry Programs Utilizing Partners Resources” and “Partners Educational Activities Under Contract With Industry.” The major difference between the two categories is Partners’ involvement. For “Industry Programs Utilizing Partners Resources,” the program is viewed as an industry program, not as a Partners or joint program. The name and/or logo of the Partners hospital may not be used in any program materials other than to identify the location of the program and the speakers’ affiliations, if necessary. The industry entity organizes all aspects of the program, from inviting attendees to issuing certificates of attendance, except for putting together and presenting the content. All program expenses are covered by the industry entity. “Partners Educational Activities Under Contract With Industry” are usually advertised as a Partners or joint program between the Partners hospital and the industry entity. The Partners hospital may invite attendees and help advertise the program along with the industry entity. If the Partners hospital invites any attendees, it must contribute to the cost of the program. Because this program is a type of Partners educational activity, it must meet one of the following three criteria to be funded by a single industry entity: 1. The central component of the program requires collaboration with an academic medical center and is in an area in which Partners has particular expertise; 2. The central component of the program requires the use of a technology or an animal model that is not readily available outside of a Partners hospital; or 3. The training focuses on a disease state (i.e., not a company product) and is exclusively for company employees.
Academic Medicine, Vol. 90, No. 12 / December 2015
1617
Copyright © by the Association of American Medical Colleges. Unauthorized reproduction of this article is prohibited.
