Conflict of Interest Statement
Medical Specialty Societies are required to balance sometimes competing interests. By virtue of expertise, our members are called upon to guide biomedical research, discover new therapies, and engage in high quality medical practice. Simultaneously, professional interactions serve to influence actions of health professionals, patients, and other groups through education, skills training, health care policy, socioeconomics, and advancement of the standard of care.
For-profit entities that develop, produce, or market drugs, devices, services or therapies used to diagnose, treat, monitor, manage, and alleviate health conditions, referred to in this Code as “Companies,” also strive to help patients live longer and healthier lives. Companies invest resources to bring new drugs, devices and therapies out of the laboratory and to the patient while maximizing value for shareholders. Members and patients count on Societies to be authoritative, independent voices in the world of science and medicine. Public confidence in our objectivity is critical to carrying out the mission of the ARS. We know the public relies on us to minimize actual and perceived conflicts of interest.
ARS interactions with Companies may include receiving charitable donations, applying for grants in support of programmatic activities, and conducting a range of business transactions. In all of these interactions, the ARS is committed to acting with integrity. The ARS adopts this Code to reinforce the core principles that help us maintain actual and perceived independence. Adopting this Code means the ARS interactions with Companies will be for the benefit of patients and members and for the improvement of care in our respective specialty fields.
The following terms are defined for purposes of this Code. They are defined here in terms of for-profit Companies in order to create a common vocabulary for the principles under the Code.
Advertising: Advertising is a Business Transaction in which a Company pays a fee to a Society in exchange for the Society’s publication of a promotional announcement that highlights the Company or the Company’s products or services. Unlike Sponsorship, Advertising does not expressly support the cost of a particular Society product, service, or event.
Business Transaction: A Business Transaction is an interaction between a Society and a Company in which a Company pays a fee to the Society in exchange for the Society’s item, service, or product. Examples of Business Transactions include Company payment of fees associated with subscriptions to Society publications, Advertising in Society publications, registrations for Society meetings, and exhibit space rental.
Charitable Donation: A Charitable Donation is a gift given by a Company to a qualified tax-exempt organization (e.g., a Society or its affiliated foundation) for use in furthering its charitable purposes.
Clinical Practice Guideline: A Clinical Practice Guideline (or Guideline) is a systematically developed statement to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances. As used in this Code, the term Clinical Practice Guideline also refers to medical technology assessments, clinical opinions, and other evidence-based clinical practice tools, as well as updates to existing Clinical Practice Guidelines.
Company: A Company is a for-profit entity that develops, produces, or markets drugs, devices, services or therapies used to diagnose, treat, monitor, manage, and alleviate health conditions. This does not include non-profit entities or entities outside of the healthcare sector.
Conflict of Interest: A condition which occurs when an individual or organization has an interest that might compromise their actions. The presence of a conflict of interest is independent from the execution of impropriety.
Continuing Medical Education (CME): According to the Accreditation Council for Continuing Medical Education (ACCME), “[c]ontinuing medical education consists of educational activities which serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession.”
Educational Grant: An Educational Grant is a sum awarded by a Company, typically through its grants office, for the specific purpose of supporting an educational activity offered by the Society (or sometimes a scientific activity). Such Educational Grants are referred to in ACCME Standards as “commercial support” of CME.
Key Society Leaders: Key Society Leaders are the governing officers (e.g. Committee Chairs, Board of Directors, Executive Committee, etc.) and chief executive officer of the Society and the Editor(s)-in-Chief of Society Journal(s).
Satellite Symposia: Satellite Symposia are Company-supported CME programs held adjunct to Society meetings where CME credit is provided by a third party CME provider. Societies do not plan or control Satellite Symposia, but may review proposals for symposia topics and typically receive a fee.
Society CME: Society CME refers to CME programs that are planned by a Society and for which the Society provides CME credit.
Society Journal: A Society Journal is a peer-reviewed scientific journal published by a Society or by a publisher on a Society’s behalf.
Sponsorship: Sponsorship is an arrangement in which a Company, typically through its marketing department, underwrites a particular Society product, service, or event in order to have the Company’s name associated with the product, service or event. This definition differs from ACCME Standards, which use the term “sponsor” to refer to the provider of CME credit for an educational program.
Principles for Interaction
- The American Rhinologic Society (ARS) will develop all programs, products, services and advocacy positions independent of company influence.
- The ARS will separate fundraising efforts and Business Transactions from programmatic decisions.
- The ARS will establish and maintain high-level groups (e.g. Board of Directors, a subcommittee of the Board, Ethics Committee, or Conflict of Interest Committee, or a new group created for this purpose) responsible for guiding Society interactions with Companies.
- Direct financial relationships (i.e. Exchange of goods, services, or monies in excess of $500 between Companies and Key Society Leaders during their terms of service are to be highly scrutinized and may be addressed in the following ways:
- Dissolution of any direct financial relationship with Companies during the Key Society Leaders’ term of service, or
- Disclosure of all financial relationships with Companies during the Key Society Leaders’ term of service to include total value of compensation received exceeding ($500 or $1000), and recusal from voting on issues related to such conflicts
- Disclosure will include the following information:
- Total compensation received to include remuneration, goods and services valued at greater than ($500 or $1000
- Description of services provided by the individual (i.e. speakers bureau, consultant services, research support, advisory board, etc.)
- Key Society Leaders may provide uncompensated service to Companies and accept reasonable travel reimbursement in connection with those services.
- Key Society Leaders may accept research support as long as grant money is paid to the institution where the research is conducted
(e.g., academic medical center), not to the individual.
- Research support, uncompensated services, and other permitted relationships should nevertheless be disclosed to the Society and to the public in accordance with Principles 2.3 and 2.4.
- The ARS will use written agreements with Companies for grants, Sponsorships, Charitable Donations and Business Transactions.
- Written agreements will specify the following:
- Specific intended use of funds,
- Amount of funds, goods, and/or services provided,
- Specific separate roles of the Company and the Society.
- Such agreements show that a transaction is “arms length,” establish clear parameters for the use of funds, and affirm the independence of the Society.
- Resolution of Conflict of Interest involving organizational committees, task forces, and panels. The ARS will minimize the risk of actual and perceived bias if some panel members do have conflicts of interest by way of the following process:
- Disclosure - Panel members will disclose pertinent actual and perceived conflicts of interest prior to all panel meetings
- Panel members with pertinent actual and perceived COI may participate in panel discussion.
- Panel members with pertinent actual and perceived COI may not participate in the drafting of policy (e.g. Panel members with pertinent actual or perceived COI related to policy development may serve in the role of “content
- In the event that an individual panel member’s level of pertinent actual or perceived COI raises concern within the panel, the panel may hold a vote to determine the level of involvement of the member in question.
- Recusal – Panel members with pertinent actual or
perceived COI will recuse themselves from voting
- Resolution –When questions regarding significance of COI arise, such issues will be resolved by majority vote of eligible panel members.
- Records – Panel members participation in the process of panel proceedings will be recorded within the minutes of the meeting and will include:
- Panel members’ pertinent actual and perceived COI
- Panel members’ actions (i.e. recusal vs participation) at the time of voting.
- Actions of the committee or panel (e.g. vote, arbitration, discussion, etc.) addressing pertinent actual or perceived COI of panel members.
- The ARS will make their conflict of interest policies and forms available to their members and the public.
- Conflict of interest is defined as receipt of remuneration, goods, or services in excess of $500.
- The ARS will publicly disclose Company support (at a minimum Educational Grants, Sponsorships, and Charitable
Donations) exceeding $1000.
- The ARS will disclose relationships that Society Officers and members of the Board of Directors have with Companies exceeding $500.
- The ARS will use disclosed information to manage conflicts of interest in decision-making) for Key Society Leaders, committee members and others who serve on behalf of the Society in accordance with Principles 1.iv, 2.i, and 1.vi.
- Accepting Charitable Donations
- The ARS will control the use of Charitable Donations (directly or through an affiliated foundation ), consistent with the ARS strategic plan and mission.
- The ARS will decline Charitable Donations where the donor expects to influence Society programs or advocacy positions, or where donor restrictions would influence Society programs or advocacy positions in a manner that is inconsistent with the Society’s mission.
- The ARS will adhere to applicable tax rules and legal standards for acceptance of Charitable Donations and management of institutional funds.
- Reasonable restrictions on the purposes for which Charitable Donations will be used are acceptable, as are reasonable requirements for reporting on the uses of the donated funds. It is reasonable for the use of Charitable Donations to be restricted to broad categories that are consistent with the Society’s mission, such as research, international programs or patient information.
- The ARS will have policies for consistent and appropriate recognition of donors.
- Accepting Sponsorships from Companies
- The ARS will only accept Sponsorship of an item or program if the item or program is consistent with the ARS strategic plan and mission.
- The ARS will make efforts to seek multiple sources of outside funding for sponsored items or programs, including sources outside the for-profit healthcare sector. Recognizing that there are times when sole Sponsorship can occur, all reasonable efforts to have items and programs underwritten by multiple sponsors will be made.
- The ARS will not place the names or logos of Companies or products on non-educational “reminder” items (e.g., tote bags, lanyards, highlighters, notebooks, and luggage tags) that Companies are not permitted to give directly to healthcare professionals under generally accepted standards for ethical interactions (i.e., PhRMA Code, AdvaMed Code).
- If accepting Sponsorship of data registries, the ARS will prohibit sponsors from influencing management of the registry.
- Society Meetings
- Educational Grants and Society CME
- The ARS will comply with ACCME Standards for Commercial Support.
- The ARS will retain control over the use of Educational Grants, and implement safeguards designed to ensure that educational programs are non-promotional and free from commercial influence and bias.
- The ARS will limit support opportunities to general topics (i.e., not product-specific).
- The ARS will make efforts to achieve a balanced portfolio of support for each CME program.
- Satellite Symposia
- The ARS will require Satellite Symposia to undergo a rigorous application and approval process.
- The ARS will require Satellite Symposia to comply with ACCME Standards.
- The ARS will not permit Key Society Leaders to participate in Satellite Symposia.
- The ARS will have written policies governing the nature of exhibits and the conduct of exhibitors. Such policies will require exhibitors to comply with applicable laws, regulations, and guidance. The tone of the exhibit hall will be professional in nature. Policies will be provided to exhibitors and made available to others upon request.
- The ARS will only permit exhibitor giveaways that are educational and modest in value.
- The ARS will ensure that educational sessions and poster sessions for which CME credits are granted are physically separated from Company exhibits, and can be accessed independently.
- Key Society Leaders may not participate as leaders or presenters in Company promotional/marketing events held in exhibit space.
- Awarding of Company-Supported Research Grants
- The ARS will not permit Companies to select (or influence the selection of) recipients of Society-awarded research grants and awards.
- The ARS will not name research grants for Company supporters.
- The ARS will not require grant recipients to meet with Companies that supported the Society-awarded grants.
- The ARS will not permit Companies who support Society-awarded research grants to receive intellectual property rights or royalties arising out of the grant-funded research.
- The ARS will not permit Companies who support Society-awarded research grants to control or influence manuscripts that arise from the grantfunded research.
- If the ARS receives Company societal support for its own research, that support will be disclosed. The ARS will act independently in the selection of research topics and the conduct of the research itself.
- Clinical Practice Guidelines and Societal Position Statements
- The ARS will base Clinical Practice Guidelines and Societal Position Statements on scientific evidence.
- Recognizing that healthcare providers, payors, and patients regard Professional Society Clinical Practice Guidelines and Societal Position Statements as an important source of information from experts in the field, the ARS must assure that Guidelines and Position Statements are independent from commercial bias and Company influence. The ARS will therefore follow a transparent Guideline and Societal Position Statement development process that is not subject to Company influence.
- The ARS will not permit Company support of the development of Clinical Practice Guidelines and Societal Position Statements.
- The ARS will not permit direct Company support for the original printing, publication, and distribution of Clinical Practice Guidelines or Societal Position Statements.
- The ARS will require that Guideline recommendations be subject to multiple levels of review, including rigorous peer-review by a range of experts.
- The ARS will require a majority of panel members to be free of conflicts of interest relevant to the subject matter of the Guideline.
- The ARS will develop processes (See 2.1.1,and 1.6) for determining whether financial or other relationships between panel members and Companies constitute conflicts of interest relevant to the subject matter of the Guideline/Societal Position Statements, and for managing conflicts that are identified.
- The ARS will require all panel members to disclose relevant relationships prior to panel deliberations, and to update their disclosure throughout the guideline development process. At least 51% of panel members will be free of relevant conflicts of interest as determined by the ARS.
- The ARS will require the panel chair (or at least one chair if there are co-chairs) to be free of conflicts of interest, and to remain free of conflicts of interest for a reasonable period after Guideline publication.
- The ARS will minimize the risk of actual and perceived bias if some panel members do have conflicts of interest in accordance with Principle 1.vi.
- The ARS will publish panel members’ disclosure information adjacent to each Guideline and will identify abstentions and recusals from voting.
- The ARS will require all Guideline/Position Statement contributors, including expert advisors or reviewers who are not officially part of a Guideline panel, to disclose financial or other substantive relationships that may constitute conflicts of interest.
- The ARS will recommend that panel members decline offers from affected Companies to speak about the Guideline or serve as an expert witness about the Guideline for a reasonable period (e.g. one year) after publication.
- The ARS will not permit panel members or staff to discuss a Guideline’s development with Company employees or representatives, will not accept unpublished data from Companies, and will not permit Companies to review Guidelines in draft form.
- Society Journals
- ARS Journals will have editorial independence from the Society and its advertisers.
- ARS Journals will require all authors to disclose financial and other relationships with Companies exceeding ($500 or $1000).
- ARS Journals will require editors and reviewers to disclose financial and other relationships with Companies.
- ARS Journals will require editors and reviewers to decline to review manuscripts when conflicts arise. The editor will have the ultimate responsibility for determining when a conflict of interest should disqualify an editor or reviewer.
- ARS Journals will adopt policies prohibiting the submission of “ghostwritten” manuscripts prepared by or on behalf of Companies.
- The ARS will adopt written policies that set standards for advertisements. Such advertisements are required to be easily distinguishable from editorial content.
- The ARS will adopt written policies that set standards for licensing intended to prevent misuse, unintended use, and modification of licensed materials.
- Reference Materials: This Code was based primarily upon the “Medical Specialty Society Code for Interactions with Companies” provided as guidance by the Council for Medical Specialty Societies (CMS). It was modified as necessary to accommodate the American Rhinologic Society.
- Adapted from Advanced Medical Technology Association. Code of ethics on interactions with health care professionals.
http://www.advamed.org/MemberPortal/About/code/. Accessed May 4, 2009.
- Lo B. Field MJ (eds): Conflict of Interest in Medical Research, Education and Practice. Washington, DC, National Academies Press, 2009.
- This Code does not address a Society’s interactions with non-profit entities or entities outside of the healthcare sector.
- National Guideline Clearinghouse. Definition of Clinical Practice Guideline. http://www.guidelines.gov/about/inclusion.aspx. Accessed October 25, 2009.
- Advanced Medical Technology Association. Code of ethics on interactions with health care professionals. http://www.advamed.org/MemberPortal/About/code/. Accessed May 4, 2009.
- Accreditation Council for Continuing Medical Education. CME Content. http://www.accme.org/index.cfm/fa/Policy.policy/Policy_id/16f1c694-d03b-4241-bd1a-44b2d072dc5e.cfm. Accessed October 25, 2009.
- International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Ethical Considerations in the Conduct and Reporting of Research: Editorship. http://www.icmje.org/ethical_2editor.html. Accessed October 20, 2009; World Association of Medical Editors. The Responsiblities of Medical Editors. http://www.wame.org/resources/policies#responsibilities. Accessed October 20, 2009.
©American Rhinologic Society