FINANCIAL CONFLICT OF INTEREST POLICY

Transcription

1 FINANCIAL CONFLICT OF INTEREST POLICY Individuals who are appointed to serve on ABIM boards or committees are expected to have the American Board of Internal Medicine s (ABIM) mission as their primary interest when contributing to ABIM s work. A real or perceived conflict of interest may arise when, due to another interest that may compete with those of ABIM, an individual has the opportunity to influence ABIM work in ways that could lead to, or appear to lead to, personal or institutional gain, or advantage for another organization. This Conflict of Interest Policy is intended to provide guidelines for identifying and managing conflicts that arise from competing interests. It is intended to maintain the integrity of ABIM s decision-making processes and, thereby, maintain the confidence of the profession and the public in ABIM s standards and judgments. This policy applies to members of the Board of Directors, the ABIM Council, Specialty Boards, Exam Committees, Medical Knowledge Self-Assessment Product Committees, and any other standing and ad hoc committees or task forces of ABIM that develop ABIM policies or products. Those in service to ABIM on these or subsequently created entities are referred to collectively as members. The policy applies to public and interprofessional members as well as to physician members. Because the work of members in different groups varies considerably in focus, different types of management may be indicated for specific groups. Rationale The benefits of collaboration between physicians and healthcare-related industries (including but not limited to pharmaceutical companies, medical device makers, health information technology companies, health insurance companies and for-profit medical education companies, referred to collectively as industry ) are evident in the advances in therapies and technologies that have resulted from such relationships. ABIM recognizes that members who are well-suited to promote ABIM s mission through service on its boards and committees may have relationships with industry in a variety of ways, including funding of research, funding of educational activities, licensing of intellectual property and personal investments in healthcarerelated for-profit companies. In addition to the potential benefits to patients, these relationships may be valued by physicians for reasons distinct from financial compensation received, including interaction with colleagues, exposure to new ideas and the opportunity to share their own work. ABIM also recognizes that relationships with industry can introduce the risk of industry influence that may not be recognized by the individuals involved in the relationships, especially when the financial value of a relationship is high. Concern within the medical profession and the public about the influence of industry on many aspects of medicine has grown in recent decades; thus, ABIM further recognizes that the appearance of industry influence on its products and policies is a risk to ABIM, even if no actual influence on decision-making occurs. There are several tools available to help ABIM assure that competing interests do not affect decision-making by members on behalf of ABIM. These include detailed disclosure about the nature of the relationships (including products involved and members roles); open discussion among members of a group concerning those relationships and their possible impact on the work of the group; proactive management plans; and, in some cases, prohibition of certain types 1

2 of activities. In addition, the perspective of members who have no financial relationships with industry can help in assuring that decisions made on behalf of ABIM are free of industry influence; all boards and committees should therefore include members who have no financial relationships with industry, as described in Appendix A. Guidelines ABIM s financial conflict of interest policy outlines the areas in which industry frequently collaborates with physicians and other health care professionals, and defines activities that are allowed during board service and those that are prohibited. ABIM recognizes that exceptions may be appropriate in some circumstances. It is anticipated that this policy will evolve over time, as society, the profession and ABIM evolve. Appendix A describes the procedures that ABIM employs to administer this policy. These procedures are also expected to evolve over time as ABIM learns from the initial implementation of the policy what works and what could be improved. Although the policy applies to all members, management plans may differ for different groups. For example, if a member of an Exam Committee or Medical Knowledge Self-Assessment Product Committee acts as a consultant to industry concerning a particular drug or receives research funding for a clinical trial that includes that drug, questions written by the member that relate to this drug will be flagged so that the entire Committee can carefully consider whether or not there is any industry influence in the question. The work of the Specialty Boards, Council and Board of Directors is very different, but this policy applies to all members. A staff-level conflict of interest committee, working with the Chief Ethics Officer and overseen by the Conflict of Interest Subcommittee, will determine when additional management is necessary, and will provide management plans. Types of Activities and Compatibility with ABIM Service In determining which activities are to be allowed and which are to be prohibited during ABIM service, the potential value of different types of activities, principally to the public but also to the involved members, was considered, along with potential risk to ABIM. This risk includes not only the introduction of industry influence into decisions affecting ABIM s programs, policies and products, but also the risk of public perception of industry influence on its work. Activities that were judged as having high risk are judged to be incompatible with ABIM service. Research Activities Many members, both within and outside of academic settings, engage in research activities that are linked with industry. ABIM recognizes that such work may be of considerable benefit to society, and that it may also be vital to the careers of some researchers. The following activities are compatible with ABIM service, with detailed disclosure of the relationship: Funding for preclinical research. Funding for clinical trials, including salary support and other expenses. 2

3 Travel expenses associated with attending investigators meetings. Travel expenses and honoraria for service on data and safety monitory boards. The following activities are compatible with ABIM service, but may require management beyond disclosure, as described in Appendix A: Honoraria for attendance at investigators meetings. Travel expenses and honoraria for service on a research-related expert panel/advisory board. Consulting on design of new drugs or devices, clinical trials, the use of specific agents or other research-related activities. Post-marketing clinical research. In addition, because the likelihood of influence increases when the financial value of a relationship is high, members with above-salary income from consulting fees, honoraria or similar income above a specified level from any single company during a twelve-month period will be asked to provide additional information about their relationship with that company to determine if any additional management is needed. This level is specified in Appendix A and is expected to change over time. Educational Activities Many members are involved in educational activities, including basic science courses for medical students and others, clinical precepting of trainees in a variety of settings, and continuing medical education for practicing physicians. ABIM values the educational contributions of its members but recognizes that some types of activities may raise considerable public concern about industry influence in the profession. Standards of the Accreditation Council for Continuing Medical Education (ACCME) and of some individual institutions attempt to mitigate bias related to industry influence. The following activities are compatible with ABIM service, with detailed disclosure of the relationship: Work funded by educational grants, when grants are made to an institution or organization (rather than directly to the member). Continuing medical education funded by industry, when funding is provided to an institution or organization (rather than directly to the member). The following activities are compatible with ABIM service, but may require management beyond disclosure, as described in Appendix A: Work funded by educational grants, when grants are made to the member (rather than to an institution or organization). Continuing medical education funded by industry, when funding is provided to the member (rather than to an institution or organization) and the member controls all content of the educational activity. Teaching in industry-funded satellite symposia (e.g., sessions that are held in conjunction with specialty society meetings), provided that the member controls the content of his/her presentation. 3

4 Industry-funded training that is required by the FDA, in which the member as trainee receives no payment from industry and in which the member as trainer may receive from industry a reasonable fee or honorarium (e.g., FDA-required training on a new device). In addition, because the likelihood of influence increases when the financial value of a relationship is high, members with above-salary income from consulting fees, honoraria or similar income above a specified level from any single company during a twelve-month period will be asked to provide additional information about their relationship with that company to determine if any additional management is needed. This level is specified in Appendix A and is expected to change over time. The following activities are considered to be incompatible with ABIM service, because there is potential for strong industry influence in these activities, and because they are viewed as having less value to society and/or to the career of a member than other types of industryfunded educational activities: Any educational activity in which the speaker does not control the content (e.g., teaching using slides prepared by a pharmaceutical company). Industry-funded peer discussion groups (e.g., case discussion over dinner when industry provides an honorarium to the member to attend the dinner). Industry-funded, hands-on mentoring that is not required by the FDA (e.g., training other health care professionals in the use of a specific device, when the device maker provides an honorarium to the member for providing or receiving the training). Teaching or attending industry-sponsored events for trainees where industry controls the content. Intellectual Property Physicians and other health care professionals may work with industry in the development of intellectual property, including but not limited to therapeutic agents, diagnostic tests or approaches, information technology, and educational materials. ABIM recognizes the potential value of such work to the public and to the careers of its members. The following intellectual property relationships with industry are compatible with ABIM service, with detailed disclosure of the relationship: Royalties for print or electronic media. Compensation as an author or editor (as allowed within the limits of ABIM s Academic Conflict of Interest Policy). The following intellectual property relationships with industry are compatible with ABIM service, but may require management beyond disclosure, as described in Appendix A: Income from healthcare-related licensing fees. Income from healthcare-related patents. 4

5 Employment by or Service on Boards of Healthcare-related Companies An employment relationship can have considerable influence on the viewpoint of any individual. Therefore, employment by a healthcare-related company may, in some situations, be deemed incompatible with ABIM service. In other situations, employees of healthcare-related companies may bring valuable experience and perspective to ABIM, without unacceptably high risk of industry influence on ABIM decisions. Individuals employed by healthcare-related companies may be considered and selected for board service; management beyond disclosure for these individuals may be required (described in Appendix A). Service on the governing board of a for-profit or not-for-profit healthcare-related company brings with it fiduciary responsibility for the well-being of that company. ABIM recognizes that individuals invited to serve ABIM may also be asked to serve on the governing boards of healthcare-related companies. Such a role is compatible with ABIM service, but must be disclosed, and may require additional management, as described in Appendix A. Unrestricted Grants and Gifts to Individuals Most grant funding from industry, whether for research, education or another activity, clearly specifies the purpose of the funding and the expectations from the recipient of the grant. Unrestricted grants (a transfer of funds from industry to an individual to be used for purposes determined entirely by the individual) have become rare. Unrestricted grants are incompatible with ABIM service because of the risk that this type of grant can bring with it a strong influence from industry on the grant recipient. Gifts to an individual from industry carry a similar risk of strong industry influence and therefore, gifts of any size are incompatible with ABIM service. ABIM service may be permitted with management beyond disclosure (described in Appendix A) in the unusual circumstance when a gift is made to an individual for the development of a program that benefits patients directly. Investments Investments in pharmaceutical and other healthcare-related companies are common. While the chance that the actions of ABIM would have any influence on the stock price of a company is remote, members should make each other aware of investments in companies that make drugs, medical devices or health care technology, with the exception of mutual funds which may contain investments in the health care sector. Investments in companies unrelated to health care do not need to be disclosed. Investments in healthcare-related industry are compatible with ABIM service, but may require management beyond disclosure, as described in Appendix A: Owning stock in publicly held companies that make drugs, medical devices or health care technology (other than as part of a mutual fund). Holding stock options in companies that make drugs, devices or health care technology. Owning stock or equity in privately held companies that make drugs, devices or health care technology. 5

6 Promotional Speaking/Marketing Pharmaceutical companies, device makers and other healthcare-related companies make significant contributions to the health of the public, but they also have a responsibility to stockholders to provide a return on investments through the generation of profits. Because of ABIM s paramount need for independence and because the profession and the public must have no doubts about its independence ABIM members must not engage in activities that are viewed as primarily for the purpose of marketing. The following activities are incompatible with ABIM service, because their primary purpose is linked with the marketing of commercial products: Speaking on behalf of a pharmaceutical company, device maker or other healthcarerelated company, using slides provided by the company (e.g., speakers bureau service). Consulting on marketing plans (e.g., consulting on a post-development advertising campaign strategy). Compensation from a for-profit company for providing assistance to their marketing department and personnel. Not-for-Profit, Healthcare-related Organizations To assure a shared understanding of potential influence on members views, members must disclose grant funding, consulting fees, honoraria and other compensation received from not-for profit healthcare-related organizations, including medical societies and patient advocacy groups. Oversight and Administration If uncertain about these guidelines, individuals are urged to seek the advice of the ABIM Conflict of Interest staff, the Conflict of Interest Subcommittee or the Chair of the Board. Questions about activities not clearly covered by these guidelines will be taken to the Conflict of Interest Subcommittee Chair, who may choose to convene the full Conflict of Interest Subcommittee; members may also request a full Conflict of Interest Subcommittee review. Decisions of the Conflict of Interest Subcommittee concerning permitted and prohibited activities are to be considered final, and the Conflict of Interest Subcommittee may recommend to the Governance Committee sanctions for members found to be in violation of the Financial Conflict of Interest Policy or a decision of the Conflict of Interest Subcommittee, up to and including removal from board service or revocation of certification. Financial COI Policy revised by the Board of Directors on February 8,

7 APPENDIX A: PROCEDURES TO SUPPORT THE ADMINISTRATION OF ABIM CONFLICT OF INTEREST POLICIES The procedures described below are intended to support understanding of and adherence to ABIM's Conflict of Interest Policies, in order to assure the independence of ABIM programs, policies and products. As with the Conflict of Interest Policies, these procedures apply to physician, interprofessional and public members of the Board of Directors, the ABIM Council, the Specialty Boards, the Exam Committees, Medical Knowledge Self-Assessment Product Committees and other standing and ad hoc committees of ABIM that develop ABIM policies or products, referred to collectively as members. A staff conflict of interest committee, including but not limited to the Chief Ethics Officer, a staff physician and staff representing knowledge assessment and medical specialties departments, will support the procedures necessary to administer ABIM s Conflict of Interest Policies. Disclosure Individuals who are being considered for service must complete ABIM's disclosure forms. Their disclosures will be reviewed by ABIM conflict of interest staff, overseen by the Chief Ethics Officer, to assure that new members will be in compliance with ABIM Conflict of Interest Policies. Members will update their disclosures prior to each meeting, and any changes will be reviewed by staff. ABIM asks for detailed information concerning the relationships members have with healthcarerelated industry and organizations in order to judge whether any further management is indicated, and to enable informed and open conversations among boards and committees concerning these relationships. Disclosures will be shared among members who serve together. The disclosures of members of the Board of Directors and the Council are posted on ABIM's public website, and ABIM plans to post the disclosures of all ABIM boards and committees. When members earn more than $25,000 in above-salary income in consulting fees, honoraria or similar income from any single company that produces drugs, devices or health care technology, they will be contacted by a member of the staff conflict of interest committee to learn more about their relationship with the company, in order to determine if additional management beyond disclosure is required. Management Beyond Disclosure If ABIM conflict of interest staff identifies a situation where management beyond disclosure is required, this will be communicated to the member, to the chair of the board or committee on which the member serves, and to relevant staff (e.g., exam developers for Exam Committees and Medical Knowledge Self-Assessment Product Committees, sponsors of Specialty Boards). Because the work varies significantly among the Board of Directors, the Council, the Specialty Boards and the Exam Committees, and Medical Knowledge Self-Assessment Product Committees, different types of management may be indicated for specific groups. Exam Committees, Medical Knowledge Self-Assessment Product Committees and Other Product Development Groups The iterative nature of question development, exam blueprints and the reliance on medical evidence for all questions provides strong protection against bias. The steps described below 7

8 provide further assurance, especially to the public, that there is no industry influence in its products. 1. When members have relationships with industry that are described in the policy as potentially needing management beyond disclosure, any questions they write with content that relates to the area of the relationship will be flagged so that all members can review the questions for unintended bias. The member has an enhanced duty to report the evidence supporting correct answers. The chair will ask specifically if any members have concern about industry influence. 2. When multiple members of a committee have relationships with companies that make products relevant to questions, the committee will consider whether questions favor those products by flagging relevant questions for close review. 3. In some cases, based on recommendations from conflict of interest staff, question writing assignments may be adjusted to reduce risk of industry influence or the perception of industry influence. 4. All groups will have some members with no relationships, and these members can play an important role in adjudicating questions of industry influence. 5. Chairs will ask their committees if anyone has concerns about bias at the end of each day s work. Specialty Boards, Council and Board of Directors The work of the Specialty Boards, the ABIM Council and the Board of Directors may include determining whether or not a product developed by a specialty society or other organization receives credit in ABIM's programs. Therefore, members of these groups who hold leadership positions in societies or other organizations with products under such consideration will need to recuse themselves from voting on those products. For Specialty Boards, if a majority of members have links with a society or organization referral to the Council for a final decision is indicated. Members Free of Financial Relationships with Industry The presence of members free of financial relationships with industry (as defined below) on all boards and committees is important in assuring that the decisions made on behalf of ABIM are free of industry influence. Therefore, by January 1, 2016, Medical Knowledge Self-Assessment Product Committees shall have a minimum of one member free of financial relationships. By July of 2015, all other boards and committees shall have a minimum of two members free of financial relationships with industry. The Conflict of Interest Subcommittee shall review the composition of boards and committees at least annually to determine organizational goals for the minimum number of members free of financial relationships with industry. Definition: Free of Financial Relationships For purposes of establishing whether a member is free of financial relationships, a member whose only financial relationship(s) is one or more of the following may be considered free of financial relationships : Paid editorial work or compensation as an author (as described in the second paragraph of Intellectual Property section above). Service as a site investigator for an industry-funded clinical trial if the following criteria are met: 8

9 o Funding is for trial expenses and clinical research staff only, without salary support for the member. o Funding is provided directly to the institution or practice, not to the member. Financial relationships of his or her spouse/partner, pending review by the Conflict of Interest Subcommittee. Income from stock in publicly traded companies, if none of the product(s) of the company is relevant to the member's decision-making purview. The member's status as being free of financial relationships is a judgment of the Conflict of Interest Subcommittee. Role of the Governance Committee/Conflict of Interest Subcommittee In addition to developing policy that will be voted on by the Board of Directors, the Conflict of Interest Subcommittee provides oversight to staff through review of staff assessment of the Specialty Boards, Exam Committees and Medical Knowledge Self-Assessment Product Committees. The Conflict of Interest Subcommittee also answers questions about member activities that are not addressed in existing policy. Exceptions and Appeals ABIM recognizes that special situations not covered by this policy may occur. The Conflict of Interest Subcommittee will decide on members' requests for exceptions from the Conflict of Interest Policies, and it will decide on appeals from members concerning staff recommendations. The Conflict of Interest Subcommittee will also decide on extensions in situations where boards or committees may need additional time to come into compliance with this policy. The compliance decisions of the Conflict of Interest Subcommittee are the final decisions of the Board of Directors and of ABIM. 9 Appendix A revised by the Governance Committee on June 13, 2016