The American Association of Clinical Endocrinologists, Inc. and the American College of Endocrinology, Inc. d/b/a American Association of Clinical Endocrinology (collectively “AACE”) is dedicated to elevating the practice of clinical endocrinology to improve global health. AACE is a recognized leader in the delivery of education, clinical practice guidelines, and other resources worldwide. Confidence and trust in the integrity of AACE’s resources are enhanced by maintaining independence and transparency in all relationships with related organizations and other entities. That integrity may be questioned if AACE does not demonstrate a commitment to these values via a robust conflict of interest policy (“COI Policy”) including disclosures, management, and restriction of any relationships that could be perceived to compromise AACE’s objective voice.
- APPLICABILITY
The COI Policy applies to any and all individuals involved with AACE, including but not limited to all persons who participate on AACE’s boards, leadership, committees, task forces, and staff, or in any volunteer activity, whether or not the activity includes a stipend, in an official capacity for AACE (collectively “Volunteers”). The COI Policy is intended to be adapted for implementation in connection with particular roles and/or activities.
This COI Policy interprets and implements AACE’s COI principles as they relate to any individual within and for AACE. Specific decisions made in accordance with this COI Policy are included in this document. Any issue not specifically addressed herein will be managed on a case-by-case basis consistent with AACE policies and procedures.
- DEFINITIONS
- AACE Guidance Documents – clinical practice guidelines and consensus statements (including algorithms), which represent the mission and position of AACE on specific topics in clinical endocrinology. AACE Guidance Documents require review and approval by the CPG Oversight Committee and final approval by the AACE Board and must be submitted to Endocrine Practice and undergo the journal’s peer review process.
- Clinical Practice Guidelines (“CPG” or “Guideline”) – provide evidence-based recommendations to improve patient care related to specific clinical endocrinology topics. Recommendations are informed by unbiased assessment of evidence and developed according to a systematic process based on National Academy of Medicine (formerly Institute of Medicine) standards.
- Consensus Statements – reflect the mission and opinion of AACE and provide expert guidance on specific and timely clinical endocrinology topics. While referenced and scholarly, consensus statements do not require systematic appraisal of evidence and follow a consistent yet less rigorous and formal development process than AACE Clinical Practice Guidelines. Clinical algorithms are a type of consensus statement that provide a graphic representation of information presented in a clinical practice guideline to assist with clinical decision-making.
- Accredited Continuing Education (CE) – consists of educational activities for which the learner may receive continuing medical education (CME)/CE credits based on accreditation awarded to the CE provider by a recognized accrediting body (e.g., Accreditation Council for Continuing Medical Education (ACCME; www.aacme.org) or similar accrediting body). Accredited CE activities “serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician, care team member, or other professional healthcare provider uses to provide services for patients, the public, or the profession.” Please see the Accredited Continuing Education Policies for further information on COI for accredited activities.
- Blind Trust – a trust instrument in which the trustee has full discretion over the assets, and the trust beneficiaries have no knowledge of the holdings of the trust. The trustor initiates the trust and maintains the ability to terminate the trust, but otherwise exercises no control over the actions taken within the trust and receives no reports from the trustee while the blind trust is in force.
- Conflict of Interest (COI) – a situation when professional judgment concerning some primary interest or responsibility is affected by a secondary interest or responsibility. This may occur whenever the interests of a Volunteer may be seen as competing with the interests of AACE. A monetary payment or in-kind value given to an individual by a third party in association with giving a CME presentation does not create a presumption of a COI.
- Council of Medical Specialty Societies (“CMSS”) Code for Interactions with Companies (“CMSS Code” or “Code”) – a voluntary “code of conduct” for medical specialty societies developed by CMSS to enhance professionalism and to disclose, manage, and resolve relationships with industry. AACE follows the CMSS Code for Interactions with Companies: http://cmss.org/wp-content/uploads/2016/02/CMSS-Code-for-Interactions-with-Companies-Approved-Revised-Version-4.13.15-with-Annotations.pdf.
- Covered Transactions – any Direct Financial Relationship in which there may be an actual or perceived conflict of interest.
- Direct Financial Relationship (DFR) – a relationship held with any Endocrine Ineligible Company and/or Ineligible Company by an individual that results in wages, consulting fees, honoraria, or other compensation (in cash, in stock or stock options, or in kind), whether paid to the individual or to another entity at the direction of the individual, for the individual’s services or expertise. This definition does not include intellectual property licensing arrangements or payments in connection with giving an Accredited Continuing Education presentation.
- Endocrine Ineligible Company – any entity whose primary business is producing, marketing, selling, re-selling, or distributing endocrine products used by or on patients.
- Ineligible Company – any entity whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. For specific examples of ineligible companies visit www.aacme.org/standards.
- Journal – “journal of a Related Organization” is a peer-reviewed scientific journal published by a Related Organization or by a publisher on a Related Organization’s behalf.
- Related Organization – any professional, scientific, education, research, or advocacy organization whose primary mission includes the prevention, diagnosis, or treatment of any endocrine disease, except for certifying bodies and graduate and undergraduate medical education organizations.
- Satellite CME Symposium – a Company-supported CME program held as an adjunct to a Related Organization’s meeting where CME credit for the symposium is provided by a third-party CME provider, and for which the Related Organization receives a fee.
- Significant Ownership Interest – possession of shares of a publicly traded Endocrine Ineligible Company, greater than $50,000 in value or an equity interest in a privately held Endocrine Ineligible Company greater than 5% at the time of disclosure. This does not include interests invested in diversified funds whose holdings cannot be controlled by the disclosing individual.
- Speakers’ Bureau – a compensated role as a presenter for which any of the following criteria are met: (a) an entity has a contractual right to dictate or control the content of the presentation or talk; (b) an entity creates the slides or presentation material and has final approval of the content and edits; or (c) the presenter is expected to act as an entity’s agent or spokesperson for the primary purpose of disseminating company or product information. Some activities called “speakers’ bureaus” may not meet these criteria and, conversely, activities may meet these criteria and not be termed “speakers’ bureaus.” AACE will rely on the judgment and integrity of disclosing individuals to determine whether an activity constitutes a Speakers’ Bureau.
- Task Force – a group of medical experts who apply or are nominated to develop an AACE Guidance Document on a specific topic. Task Force members must meet required author qualifications for consideration and be approved first by the COI Subcommittee, then the CPG Oversight Committee, receive final approval of the AACE President, and comply with AACE COI Policy throughout development. Task Forces also include a methodology fellow and staff methodologist.
- COI DISCLOSURES
At the beginning of each association year, and on an as-needed basis throughout the year, Volunteers must provide a disclosure of all DFR with any entity and include other relationships that may give rise to COI, including non-financial relationships, such as certain volunteer positions with Related Organizations. Specific disclosure requirements will be included in COI disclosure forms provided to Volunteers. The COI disclosure forms will assist AACE in managing COI.
Disclosures should be made at the beginning of service, then annually, and include any disclosable exchange that occurred over the previous 24 months, as indicated on the disclosure form. Disclosures should be updated when there are material changes in the information disclosed. Disclosures must be made whether or not compensation is paid directly to the individual Volunteer or to the Volunteer’s institution or to another entity. Disclosures should include financial interests and relationships held by the individual’s spouse, domestic partner, or dependent child. These disclosures will remain under consideration for COI purposes until the start of the next association year when the Volunteer updates or completes a new disclosure form.
Staff will compare COI disclosure forms to publicly available sources of information (e.g., the Open Payments database) of a Volunteer’s DFR. This will be done to ensure that publicly available data matches the information provided to AACE. Volunteers may be asked to provide an explanation for any discrepancies, so that AACE is prepared to respond to any questions regarding AACE management of Volunteer COI. Please see the Accredited Continuing Education Policies for further information on COI for accredited activities.
- MANAGEMENT OF CONFLICTS
The management of actual or potential COI will depend on particular circumstances, including, but not limited to, the nature and extent of the financial interest or relationship. Volunteers should recuse themselves from decisions in situations where they have a COI or a potential conflict. Participation in discussions and deliberations, and speaking publicly on behalf of AACE, may be permissible as long as the financial interest or relationship is disclosed.
Any COI management procedures, including announcing a conflict; dismissals from discussion virtually, in person, or via email; and recusals from voting, will be documented in meeting minutes.
The Professional Standards Committee (PSC) will work with staff to ensure that conflicts are managed appropriately. Prior to any deliberative session, staff will work with appropriate chairs to identify potential COI and determine the appropriate strategy to manage the COI. Any questions regarding COI management should be addressed to the PSC.
Conflict management procedures are as follows:
- If the Volunteer has a conflict with an entity who is specifically implicated by a policy, the member will not vote on that specific issue, and the President or chair may ask the member to exit the room, or not otherwise participate, during discussion.
- If the Volunteer has a conflict with an entity that is generally, but not specifically, implicated by a policy, the member may discuss the policy but not vote. This will be the level of scrutiny applied to votes approving guidelines or other papers or positions regarding clinical guidance.
- If the Volunteer has a conflict with an entity who makes a product for a disease state, but the discussion is broad enough that it does not implicate the product generally, the member should announce their conflict before commenting on the issue, but the member may vote.
- When the President or chairs consider conflict management issues prior to meetings, they will also consider the dollar values at issue and any other variables that are relevant to a perceived conflict. If the President or chair believes that the conflict is so great as to require higher scrutiny than what is otherwise prescribed, they may exercise their discretion and require heightened management. Please see the Accredited Continuing Education Policies for further information on COI for accredited activities.
- RESTRICTION ON FINANCIAL RELATIONSHIPS
Certain Volunteer positions, because of their public visibility, or necessity for the perception of unbiased work product, require a more stringent approach to COI. The following table includes COI rules for each Volunteer position:
Volunteer Position |
COI Restrictions |
Executive Committee |
|
Board Member |
|
Committee Chair |
|
Committee Member |
|
Journal EIC/ Associate Editors |
|
Task Force - Chairs of AACE Guidance Documents |
|
Task Force - Authors of AACE Guidance Documents |
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Executive Staff |
|
- Where there is a prohibition on DFR, or a DFR triggers a COI relationship at a specific dollar value, where asterisked, the Volunteer: may provide uncompensated service to entities and accept reasonable travel reimbursement in connection with those services; may accept research funding as long as grant money is paid to the institution (e.g., academic medical center) or practice where the research is conducted, not to the individual; may receive wages or other compensation from an entity in exchange for providing or overseeing the provision of health services to the entity’s personnel; and may accept reasonable compensation for serving on an independent data safety monitoring board in an entity study.
Any requests for deviations from the restrictions listed above will be evaluated by the PSC and require approval from the Executive Committee. Please see the Accredited Continuing Education Policies for further information on COI for accredited activities.
- CONFLICTS OF INTEREST PROCEDURES FOR TASK FORCE, AACE GUIDANCE DOCUMENTS INCLUDING CLINICAL PRACTICE GUIDELINES AND CONSENSUS STATEMENTS
AACE Guidance Documents including Clinical Practice Guidelines (CPG) and Consensus Statements are a critical tool for care and treatment of endocrine disorders worldwide. Confidence and trust of health care professionals and the public in AACE Guidance Documents, which are based on the best available evidence and knowledge and expertise of authors, are paramount. This confidence and trust in AACE Guidance Documents depend on their development in a manner designed to minimize actual and perceived conflicts of interest (COI) with transparency of disclosures provided by all who participate. The CPG COI Subcommittee, with the CPG Oversight Committee as the parent Committee, is responsible for applying this COI Policy to determine and recommend strategies to manage COI of individuals who serve on Task Forces that develop AACE Guidance Documents.
AACE requires disclosures by individuals involved in development of all AACE Guidance Documents, including but not limited to, selecting, assessing, and grading evidence that supports CPG recommendations, drafting, reviewing, and approving guideline recommendations and consensus statements. AACE sets limits on the financial relationships that chairs, authors, and reviewers can have with entities that could reasonably be affected by care delivered in accordance with AACE Guidance Documents. AACE requires the majority of Task Force members (60%), including the chairs/co-chairs/vice chairs, to be free of certain relationships with Ineligible Companies. The remaining 40% of Task Force members who develop AACE Guidance Documents may be appointed if they hold some relationships with Ineligible Companies and competing organizations if the COI Subcommittee determines those disclosed relationships to be manageable conflicts; however, the CPG Oversight Committee is encouraged to form Task Forces/workgroups with minimal COI.
- Identifying Ineligible Companies
Entities with products affected by AACE Guidance Documents are considered “Ineligible Companies” for purposes of determining whether COI exist for chairs and authors selected to develop AACE Guidance Documents. An entity is an “Ineligible Company” if there is a reasonable likelihood of direct regulatory or commercial impact (positive or negative) on the entity as a result of care delivered in accordance with an AACE Guidance Documents.
Ineligible Companies will be identified before development of any guidance document and prior to selection of Task Force members. Ineligible Companies will be identified by the CPG Oversight Committee who will not serve as a Task Force chair, author, or reviewer. The list of Ineligible Companies should remain consistent throughout development and adoption of AACE Guidance Documents. If changes in the marketplace (e.g., FDA approval or withdrawal of a medication) or in the focus of the AACE Guidance Document make revisions necessary, a modified list may be developed or reviewed by the CPG Oversight Committee The list of entities affected by AACE Guidance Document will be made available to the CPG Oversight Committee and the CPG COI Subcommittee for consideration during selection of prospective Task Force chairs and authors.
- Disclosures
All prospective Task Force members will disclose financial interests and other relationships with entities in accordance with AACE COI Policy. The AACE disclosure forms are specific and designed to identify relationships with Ineligible Companies and Related Organizations. If a potential Task Force chair/author is not currently serving on an AACE committee and, therefore, does not have a current COI form on file with AACE, the prospective Task Force chair/author will be required to complete the COI disclosure form prior to participating in any aspect of development of AACE Guidance Document.
After reviewing disclosures of prospective Task Force chairs/authors and a relevant list of Ineligible Companies, the CPG COI Subcommittee or staff may request more detailed information from an individual about the nature, value, or extent of their disclosed relationship with an Ineligible Company in order to apply this COI Policy.
If an individual has a relevant indirect or non-financial interest or relationship, such as an intellectual property interest from which no royalties or other payments have yet been received; a strong professional or research opinion; or an outside affiliation, the interest should be disclosed in the AACE COI disclosure form. If this relationship was not disclosed in the AACE COI disclosure form, all prospective Task Force members should inform appropriate staff of the relationship and update disclosures as necessary to maintain accuracy.
Reports of disclosures that identify and specify Task Force members’ relationships with Ineligible Companies will be available to Task Forces throughout the development process. The CPG Oversight Committee will have this information available when reviewing an AACE Guidance Document for approval. A summary of the AACE COI Policy and disclosures of the Task Force members will be published in each AACE Guidance Document.
- Authors: Eligibility of Participation in Development of AACE Guidance Documents
Having a relationship with an entity does not necessarily mean an individual is biased or has a COI. However, certain financial relationships give rise to COI that are not capable of being effectively managed and are, in fact, inconsistent with actual and perceived independence of the development process for AACE Guidance Documents. See below for additional information related to eligibility of chairs of AACE Guidance Documents.
An individual is not eligible to serve on a Task Force if they:
- own or are employed by an Ineligible Company or have been employed by an Ineligible Company at any time during the past 24 months prior to application to serve on a Task Force
- hold a significant ownership interest and/or greater than $50,000 in stocks in an Ineligible Company
- have a DFR, including speaker, consultant, or other compensation, greater than $10,000 with an Ineligible Company that, in AACE’s discretion, cannot be effectively managed
- receive research funding from an Ineligible Company if research payments are made directly from the Ineligible Company to the individual or the individual’s company (company owned in part or whole by the individual)
An individual may not be eligible to serve but could be considered to serve in the conflicted minority on a Task Force if they:
- serve as a principal investigator (PI) or on a steering committee for a study funded by an Endocrine Ineligible Company.
- currently or have in the past 24 months received research funding from an Endocrine Ineligible Company
- receive research funding directly to the practice or institution and the individual’s salary is directly supported (in whole or in part) through a research grant from an Ineligible Company
- receive salary support directly to individual or individual’s company in part or in whole through a research grant from an Ineligible Company /li>
- have a DFR, including speaker, consultant, or other compensation, greater than $10,000 - with an Ineligible Company that, in AACE’s discretion, can be effectively managed
- are responsible or have been responsible within the last 24 months for designing the study protocol funded by an Endocrine Ineligible Company
- received royalties from an agreement, product, or patent with an Ineligible Company within the past 24 months
- have been invited or appointed within the last 24 months to a Speakers’ Bureau with an Ineligible Company
- participate or have participated within the last 24 months on an advisory board or as a consultant with an Ineligible Company
- serve as a current author of another organization’s related or overlapping guidance document, depending on the topic and role of the individual
- currently serve on the board for ABIM/ABOM or as an author of a non-AACE board review product/item serve as chair of a similar guidance document in the last 24 months
- serve on a leadership committee at AACE or another organization (e.g., AACE Board, Executive Committee, or equivalent at another organization)
- Chairs: Eligibility of Participation in Development of AACE Guidance Documents
Generally, individuals who have disclosed financial interests in or relationships with Ineligible Companies will not be appointed as chairs/co-chairs/vice chairs of AACE Guidance Documents. A Task Force chair/co-chair/vice chair must have been free of all interests and relationships for 24 months prior to appointment and remain free of these interests and relationships during development of assigned AACE Guidance Document and for 12 months after the AACE Guidance Document is published.
Although the CPG Oversight Committee should strive to nominate Task Force chairs who are free of conflicts, the CPG Oversight Committee may on a case-by-case basis nominate a Task Force chair who has a COI relationship that is permissible for service in the conflicted minority of the Task Force, if doing so would ultimately provide the necessary expertise otherwise unavailable to develop the AACE Guidance Document. In this case, the Committee must appoint a co-chair who has no COI with Ineligible Companies, including research funding, or relationships with Related Organizations.
If a Task Force chair or co-chair wants to continue to serve as chair for future updates of an AACE Guidance Document, they must remain eligible as described above. If, at the time of update, an individual is no longer eligible to serve as a Task Force chair, they will be eligible to serve as a Task Force author at the discretion of the CPG COI Subcommittee and the CPG Oversight Committee and in accordance with this COI Policy.
- Activities related to Guidelines and Consensus Statements
In accordance with the CMSS Code, the majority of Task Force members must be free of COI relevant to the subject matter of an Guidance Document. All relationships with entities must be disclosed as described above. The CPG COI Subcommittee, the CPG Oversight Committee chair(s), or staff may ask for additional information about a relationship with an Ineligible Company to apply this COI Policy consistently. The CPG COI Subcommittee will determine whether any interests of nominated Task Force members constitute a conflict and will provide a report on disclosures of COI that are determined to be conflicts to the CPG Oversight Committee.
For the purpose of appointing at least 60% of Task Force members who are free of COI, AACE defines the following relationships as COI:
- Research funding from an Ineligible Company if: (a) research payments are made directly from the Ineligible Company to the individual or the individual’s company (company owned in part or whole by the individual); (b) research payments are made to the practice or institution and the individual’s salary is directly supported (in whole or in part) through a research grant from an Ineligible Company; (c) the individual is a principal investigator for a study funded by an Ineligible Company, only if the product in the study is not for a class of drug, medical device, or medical product indicated for use by the proposed AACE Guidance Document; (d) the individual is a member of a steering committee of such a study; or (e) the individual designed a study protocol on the AACE Guidance Document topic.
- Compensation (including honoraria) from any one Ineligible Company or other organization that equals, in aggregate, $10,000 or more in a calendar year, including fees and honoraria for Volunteer positions, consulting activities, speaking engagements, expert testimony, and patent or other licensing fees. This definition does not include disqualifying payments, as defined above.
- Involvement in development of another organization’s guidance document on a similar/overlapping topic, depending on the subject matter and role of the individual.
Individuals with any of these relationships are not eligible to serve in the majority but may be eligible to serve in the minority of a Task Force. A member of the majority must remain free of these COI from the time of their appointment to the Task Force through 12 months after publication. If an individual’s relationship changes during that period such that they are no longer eligible to serve in the majority, the Task Force member will count as part of the Task Force minority. If that is not feasible given the composition of the Task Force, the individual must resign from the Task Force.
- Conflict Management
Processes for conflict management will include rules for recusal from discussion, voting on specific recommendations, and authorship. Task Force chairs will adhere to this COI policy for conflict management and will request conflict of interest from Task Force members before every meeting for continual management of COI. Any questions regarding deviations from COI management policies should be referred to the PSC or CPG Oversight Committee.
- Co-written Guidelines
In the event that another organization is the lead or co-lead sponsor of a guidance document and AACE is listed as a co-author, co-sponsor, endorser, or some indication is given that AACE approves of the content of the document, the Task Force must comply with COI policies at least as rigorous as the AACE COI Policy.
Any organization that is invited to co-author, cosponsor, endorse, or otherwise provide input and approval of an AACE-sponsored guidance document must adhere to AACE COI Policy
- QUESTIONS
Questions about this COI Policy should be directed first to PSC staff. Any question that cannot be resolved by the PSC staff, or any request for an exception to this COI Policy will be referred to the PSC, and if needed, will be escalated to the Executive Committee or Board. Exceptions will be granted only in rare circumstances.
- VIOLATION OF COI POLICY
This COI Policy has been created to ensure that the public is certain of AACE’s ability to enact business in a fair and objective manner. Correct and consistent application and communication of this COI Policy serves as a guarantee to the public and as an important risk management tool for AACE. Any Volunteer found to be in violation of this COI Policy may face punitive action from AACE, up to and including revocation of their Volunteer position and potential expulsion as a member of AACE.
Any violation of this COI Policy will be reviewed by the PSC. Recommendations regarding punitive actions will be referred to the Executive Committee or Board, consistent with AACE Bylaws and COI Policy.