The Education Review Board: 의학교육에서의 COI를 방지하는 메커니즘(Acad Med, 2015)

The Education Review Board: 의학교육에서의 COI를 방지하는 메커니즘(Acad Med, 2015)

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

NIH와 CMMS에서 의학 연구와 교육 지원이 줄어들면서 일부 AMC는 산업/기업으로 하여금 academic mission을 위한 지원을 찾고 있다. 산업/기업에서의 지원은 전문직 단체와 입법 기관으로부터 면밀한 감사를 받고 있으며, Macy Foundation, Institute of Medicine, and Association of American Medical Colleges 등이 이러한 관계에 대해서 비판하는 보고서를 발간한 바 있다.

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 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

2007년 Partners HealthCare System (이하 Partners)는 기업체와 Partners 제공자와 피훈련자의 잠재적 conflict에 대한 해결책을 찾기 위한 '산업/기업과의 관계에 대한 위원회'를 설립하였다. 2009년 보고서에서 위원회는 산업체와의 관계가 Partners가 academic mission을 수행하는데 중요하긴 하나, 반드시 투명해야 하고 산업체가 환자 진료, 연구, 교육프로그램에 부적절한 영향을 주지 않도록 유의해야 한다고 지적하였다. 기업체와의 잠재적 conflict에 대한 reporting, reviewing, and managing 을 위한 구체적 권고를 만들었으며, 이 권고를 도입할 세 개의 새로운 기구를 설립하였다.

In 2007, Partners HealthCare System (Partners), the Boston-based health care system that includes two major AMCs (Massachusetts General Hospital 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 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

ERB의 책임과 개발

Charge and Development of the ERB

ERB의 미션과 목표

Mission and goals of the ERB

연구의 integrity를 위한 IRB와 유사하게, ERB는 Partners의 기업체-지원 교육프로그램의 교육적 integrity를 확실히 하기 위하여 만들어졌다.

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.

ERB는 다음의 의무가 있다.

The ERB was charged with 

• 모든 기업체-지원 교육 프로그램의 검토/승인/감독 
  reviewing, approving, and monitoring all industry-supported educational programs; 
• 교수의 기업체 스폰서 관련성에 의해서 특수한 관심의 대상이 되는 발표나 프로그램에 대한 추가 검토 
  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; 
• 교육 관련 프리젠테이션과 프로그램에 대한 기업체 자금지원의 양과 출처 검토
  reviewing the amount and source of industry funding for educational presentations and programs; and 
• 인증기구 기준에 대한 적합성 확인 
  ensuring the adherence of such programs to accrediting body standards. 

또한 다음의 의무가 있다.

The ERB also was charged with 

• 위원회의 구체적 교욱 권고안을 도입하는 것
  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.

ERB의 구조

Structure of the ERB

2009년 설립. 공동위원장

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.

월간 정기 미팅

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.

기업체 지원에 대한 ERB 가이드라인 개발

Development of the ERB Guidelines for Industry Support

첫 4년간, multi-funder framework에 따라서 여러 영역에 대한 가이드라인 개발

During the first four years, within this multifunder framework, the ERB developed guidelines in a number of areas, including 

• 컨퍼런스/펠로우십/외부 교육 컨퍼런스/훈련 프로그램에 대한 기업체 지원 
  industry support of educational conferences, clinical fellowships, and trainees’ expenses for attending external educational conferences and training programs; 
• 교재 및 다른 교육 자료 선물
  gifts of textbooks and other educational materials; 
• Partners 교육 활동과 관련된 홍보 기회
  promotional opportunities associated with Partners educational activities;
  
• 기업체와 계약에 따른 Partners 교육활동 
  Partners educational activities under contract with an industry entity; and 
• Partners 자원을 활용하는 기업체-운영 교육 프로그램
  industry-run educational programs using Partners resources. 

위의 각 영역에 대한 가이드라인은 Appendix 1에 있음

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.

ERB 가이드라인에 대한 반응

Responses to the ERB Guidelines

일반적으로 내부적으로 잘 받아들여지고 있다. HMS 등에서 비슷한 가이드라인을 적용함.

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.

그러나 기업체 지원에 익술해진 채로 성장해온 일부 Partners 커뮤니티는 발발하고 있다. "늘 이렇게 해왔다"라고 말하며, "우리 교육 프로그램에 필수적이다", "피훈련자 지원이 불가능하다" 등의 불만을 말한다.

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.”

또한 일부는 ERB의 정책이 지나치게 행정중심적이며 기업체 스폰서를 discourage할 것을 우려한다.

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.

ERB는 가이드라인을 더 refine할 수 있다.

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.

기업체에서도 일반적으로 ERB 가이드라인을 받아들이고 있다.

Industry funders of Partners educational activities generally seem to have accepted the ERB guidelines.

ERB 이전에는 자료 수집이 없었으나, ERB와 OII는 그러한 자료를 최초로 수집하고자 한다. Partners 교육프로그램에 대한 기업체-Grants의 숫자는 거의 일정한 반면, 총 기업체 자금 지원은 22% 감소.

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).

ERB 도입의 성과

Outcomes of Implementing the ERB Guidelines

ERB 도입 이전의 기업체-지원 펠로우십은 지속되고 있으며, 지금은 다수의 자금제공처를 가지고 있다. 기업체-운영 컨퍼런스에 대한 펠로우들의 참가는 제한되며, 펠로우들은 이들 프로그램이 기업체 지원에 따라 이뤄질 때 그 사실을 알게 되며, ERB와 OII에 자금제공자의 영향력에 대한 우려를 알릴 수 있다.

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.

다수-자금제공자 규칙은 컨퍼런스와 훈련 프로그램 모두에서 기업체-자금지원을 더 당야하게 만들었으며, 일부 경우에는 교육활동에 대한 총 기업체-지원이 줄기보다는 늘어났다.

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.

프리젠테이션은 더 이상 "X기업체 발표" 자리가 아니며, 펠로우도 역시 "Y기업체 펠로우"로 인식되지 않는다. 교재는 직접 피훈련자에게 제공되지 않으며, 특정 기업에서 제공하는 것도 아니다.

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.

모든 컨퍼런스는 (CME credit이 있든 없든) ACCME 표준에 따라 열리며, 발표 내용에 대한 책임은 기업-자금제공자가 아니라 교수 자신에게 있다는 것이 명황해졌다.

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.

ERB는 그러한 컨퍼런스에서 '교수'로 간주되는 사람들을 정의했으며, "가짜-교수"참가자를 방지하였다. 

The ERB has defined who are considered faculty at such events, preventing “pseudo- faculty” participants from having their expenses paid.

기업체-제공 교육활동이 소셜 이벤트로 열리는 것이 규제되며, 그러한 교육활동은 Partners 병원이나 근처 호텔에서 열리며, 멀리 떨어진 리조트 타입의 장소에서 열리지 않는다.

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.

교육활동에 대한 예산은 교육 경비만 포함되도록 더 면밀히 감시받게 되며, 모든 추가적 수익은 교육 목적으로 사용되어야 한다.

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.

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Acad Med. 2015 Dec;90(12):1611-7. doi: 10.1097/ACM.0000000000000788.

The Education Review Board: A Mechanism for Managing Potential Conflicts of Interest in Medical Education.

Borus JF1, Alexander EK, Bierer BE, Bringhurst FR, Clark C, Klanica KE, Stewart EC, Friedman LS.

Author information

• 1J.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 MedicalSchool, 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 MedicalSchool, Boston, Massachusetts. C. Clark is director, Office for Interactions with Industry, and senior counsel, Office of the General Counsel, Partners HealthCare, Boston, Massachusetts. 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.

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 ofinterest, 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.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.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.

PMID:

 

26083402

 

[PubMed - in process]