AACE Conflicts of Interests Policy

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

Accredited Continuing Education (CE) – onsists 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.accme.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.accme.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.

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.

RESTRICTIONS/REVIEW OF DISCLOSURES ON COI

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 (EC)	Disclosures are reviewed by the Professional Standards Committee and made public upon request. No DFR* with an Endocrine Ineligible Company. Employee, officer and/or board member of an Ineligible Company is not permitted. No service as a fiduciary, committee chair, or chair of major projects (e.g., guidelines) for Related Organizations. No participation, beyond that of an attendee, in promotional/ marketing events or Satellite CME Symposia at AACE or any Related Organization. No direct stock ownership by EC member, their spouse, domestic partner, or dependent children, in an amount greater than $50,000 of an Endocrine Ineligible Company. Stock ownership that exceeds $50,000 may be placed in a blind trust. Ownership of stock in a mutual, index, or similar fund, where the Volunteer does not have control of stock purchasing, is permissible. Scientific consultant/advisor to Related Organization or Ineligible Company, including development of educational presentations, and/or promotional educational activities, are not permissible. Data Safety Monitoring Board participation shall be disclosed. and subject to further review by PSC. Speaking or planning at a non-AACE Accredited Continuing Education shall be disclosed. Participation in Commercial Speakers’ Bureau are not permitted. Research grants are permissible and shall be disclosed. Funds must be paid to institution. Intellectual property rights (e.g., copyrights, trademarks, patents, royalties, licensing fees) are permissible and shall be disclosed and managed.
Board Member	Disclosures are reviewed by the Professional Standards Committee. Disclosures will be made public upon request. Any DFR* greater than $10,000 with an Endocrine Ineligible Company will be managed in a manner as described above. Employee, officer and/or board member of an Ineligible Company is not permitted. No service as a fiduciary for Related Organization. Participation as a committee chair, or chair of major projects (e.g., guidelines) for a Related Organization will be reviewed and may be disqualifying. No participation, beyond that of an attendee, in promotional/ marketing events or Satellite CME Symposia at AACE or any Related Organization. Direct stock ownership of an Endocrine Ineligible Company by the member, their spouse, domestic partner, or dependent children, in an amount greater than $50,000 will be treated as a COI and require management. Ownership of stock in a mutual, index, or similar fund, where the Volunteer does not have control of stock purchasing is permissible. Scientific consultant/advisor to Related Organization or Ineligible Company including development of educational presentations, and/or promotional educational activities shall be disclosed. These activities are permissible and will be managed if cumulative amount is greater than $10,000. Data Safety Monitoring Board participation shall be disclosed. and subject to further review by PSC. Speaking or planning at a non-AACE Accredited Continuing Education shall be disclosed. Participation in Commercial Speakers’ Bureau is permissible. However, these disclosures will be reviewed by Executive Committee and will receive heightened scrutiny and may be disqualifying. These disclosures will be managed if cumulative amount is greater than $10,000. Research grants are permissible and shall be disclosed. Funds must be paid to institution. Intellectual property rights (e.g., copyrights, trademarks, patents, royalties, licensing fees) are permissible and shall be disclosed and managed.
Committee Chair	Disclosures are reviewed by the Professional Standards Committee. Disclosures will be made public upon request. Any DFR* greater than $10,000 with an Endocrine Ineligible Company will be managed in a manner as described above. Employee, officer and/or board member of an Ineligible Company is not permitted. Participation with Related Organizations will be reviewed by PSC prior to appointment as chair and may be disqualifying. Leadership positions, i.e, board member, committee member, or participation in journal of Related Organizations are permissible but will be reviewed by PSC and may be disqualifying. Direct stock ownership of an Endocrine Ineligible Company in an amount greater than $50,000 will be treated as a COI and require management. Ownership of stock in a mutual, index, or similar fund, where the Volunteer does not have control of stock purchasing is permissible. Scientific consultant/advisor to Related Organization or Ineligible Company, including development of educational presentations, and/or promotional educational activities shall be disclosed. These activities are permissible and will be managed if cumulative amount is greater than $10,000. Data Safety Monitoring Board participation shall be disclosed and subject to further review by PSC. Speaking or planning at a non-AACE Accredited Continuing Education shall be disclosed. Participation in Commercial Speakers’ Bureau is permissible. However, these disclosures will be reviewed by Chair of PSC and will receive heightened scrutiny and may be disqualifying. These disclosures will be managed if amount is greater than $10,000. Research grants are permissible and shall be disclosed. Funds must be paid to institution. Intellectual property rights (e.g., copyrights, trademarks, patents, royalties, licensing fees) are permissible and shall be disclosed and managed.
Committee Member	Disclosures are reviewed by the respective Committee Chair and Professional Standards Committee. Disclosures will be made public upon request. DFR greater than $10,000 with an Endocrine Ineligible Company will require COI management. Employee, officer and/or board member of an Ineligible Company is permissible and shall be disclosed for review by Chair and PSC. These disclosures will receive heightened scrutiny and may be disqualifying. Leadership positions, i.e, board member, committee member, or participation in journal of Related Organizations are permissible and shall be disclosed and managed. Direct stock ownership of an Endocrine Ineligible Company in an amount greater than $50,000 will be treated as a COI and require management. Ownership of stock in a mutual, index, or similar fund, where the Volunteer does not have control of stock purchasing is permissible. Scientific consultant/advisor to Related Organization or Ineligible Company, including development of educational presentations, and/or promotional educational activities shall be disclosed. These activities are permissible and will be managed if cumulative amount is greater than $10,000. Data Safety Monitoring Board participation shall be disclosed and subject to further review by PSC. Speaking or planning at a non-AACE Accredited Continuing Education shall be disclosed. Participation in Commercial Speakers’ Bureau is permissible. However, these disclosures will be reviewed by PSC and will receive heightened scrutiny and may be disqualifying. These disclosures will be managed if amount is greater than $10,000. Research grants are permissible and shall be disclosed. Funds must be paid to institution. Intellectual property rights (e.g., copyrights, trademarks, patents, royalties, licensing fees) are permissible and shall be disclosed and managed. Disclose any other questionable relationship to be considered by committees or persons of jurisdiction.
Journal EIC/ Associate Editors	Disclosures are reviewed by the AACE Executive Committee and Professional Standards Committee. Disclosures will be made public upon request. No DFR* with an Endocrine Ineligible Company. Employee, officer and/or board member of an Ineligible Company is not permitted. No participation as EIC or Associate Editor in any competing journal. Leadership positions, i.e, board member, committee member, or participation in journal of Related Organizations are permissible but will receive a high level of scrutiny. Must disclose for review by EC and PSC prior to acceptance of position. No direct stock ownership by EIC or Associate Editor, their spouse, domestic partner, or dependent children, in an amount greater than $50,000 of an Endocrine Ineligible Company. Stock ownership that exceeds $50,000 may be placed in a blind trust. Ownership of stock in a mutual, index, or similar fund, where the Volunteer does not have control of stock purchasing, is permissible. Scientific consultant/advisor to Related Organization or Ineligible Company, including development of educational presentations, and/or promotional educational activities, are not permissible. Data Safety Monitoring Board participation shall be disclosed and subject to further review by PSC. Speaking or planning at a non-AACE Accredited Continuing Education shall be disclosed. Participation in Commercial Speakers’ Bureau are not permitted. Research grants are permissible and shall be disclosed. Funds must be paid to institution. Intellectual property rights (e.g., copyrights, trademarks, patents, royalties, licensing fees) are permissible and shall be disclosed and managed.
Task Force - Chairs of AACE Guidance Documents	No DFR* greater than $10,000 with an Endocrine Ineligible Company. In the event there are multiple chairs, a co-chair may, with special approval by CPG COI Subcommittee, have a DFR greater than $10,000 with an Ineligible Company. However, at least one chair MUST have no DFR greater than $10,000 with an Ineligible Company—see section 6 for more information. No participation, beyond that of an attendee, in promotional/ marketing events or Satellite CME Symposia at AACE or any Related Organization. No DFR with Ineligible Companies for at least 12 months after publication of AACE Guidance Document. May not be, or have been within the preceding 24 months, employed by any Ineligible Company. No direct stock ownership by the chair, their spouse, domestic partner, or dependent children, in an amount greater than $50,000 of an Endocrine Ineligible Company. Stock ownership that exceeds $50,000 may be placed in a blind trust. Ownership of stock in a mutual, index, or similar fund, where the Volunteer does not have control of stock purchasing is permissible. Other COI prohibitions as defined in section 6 below. No participation as chair of a related guidance document in the last 24 months.
Executive Staff (Members of Executive Leadership Team)	Disclosures are reviewed by the AACE CEO. Disclosures will be made public upon request. CEO will be reviewed by the AACE President and any questions will be reviewed by the PSC. No DFR* with an Endocrine Ineligible Company. No volunteer service for Related Organizations. No direct stock ownership by Executive Staff their spouse, domestic partner, or dependent children, in an amount greater than $50,000 of an Endocrine Ineligible Company. Stock ownership that exceeds $50,000 may be placed in a blind trust. Ownership of stock in a mutual, index, or similar fund, where the Executive Staff does not have control of stock purchasing, is permissible. The CEO may not have direct stock ownership in any Endocrine Ineligible Company that develops products related to endocrine disorders. All other Executive Staff are prohibited from holding a Significant Ownership Interest in an Endocrine Ineligible Company.

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.

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.

ADDENDUM

CONFLICTS OF INTEREST POLICY AND PROCEDURES FOR AACE CLINICAL GUIDANCE DOCUMENTS

DEFINITIONS Unless otherwise expressly defined below, the terms defined in the COI Policy shall have the same definition whenever used in this Addendum.

AACE Clinical 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 Clinical 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.

AACE Clinical Guidance Document Task Force (“Task Force") – a group of medical experts who apply or are nominated to develop an AACE Clinical 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.
Affected Company – any entity that sells, markets, or manufactures healthcare products with 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 Clinical Guidance Document.
Affected Organization – any entity that represents patients or healthcare professionals with a reasonable likelihood of any type of impact on the entity as a result of the development of an AACE Clinical Guidance Document.

INTRODUCTION

1.1 AACE Clinical 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 Clinical Guidance Documents, which are based on the best available evidence and knowledge and expertise of authors, are paramount. This confidence and trust in AACE Clinical 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. This addendum was developed using principles from Institute of Medicine (now National Academy of Medicine) standards for trustworthy clinical practice guidelines¹, the Council of Medical Specialty Societies Principles for the Development of Specialty Society Clinical Guidelines², and the Guidelines International Network: Principles for Disclosure of Interests and Management of Conflicts in Guidelines³.

1.2 The CPG COI Subcommittee and the CPG Oversight Committee as the parent Committee are responsible for applying this COI Policy to determine COI of individuals who serve on Task Forces that develop AACE Clinical Guidance Documents.

AFFECTED COMPANIES AND AFFECTED ORGANIZATIONS

2.1 Ineligible Companies and Related Organizations are umbrella terms that include any number of entities, including Affected Companies and Affected Organizations, as well as entities that may not be affected by an AACE Clinical Guidance Document (see “Definitions” for more information).

2.2 Affected Companies and Affected Organizations will be identified before development of any AACE Clinical Guidance Document and prior to selection of Task Force members by staff and/or Disease State Network member(s)who will not serve as a Task Force chair, author, or reviewer.

2.3 The lists of Affected Companies and Affected Organizations should remain current throughout empanelment and development of AACE Clinical Guidance Documents. The lists of entities affected by an AACE Clinical 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. If changes in the marketplace (e.g., FDA approval or withdrawal of a medication), at an Affected Organization (e.g. development of a relevant guidance document), or in the focus of an AACE Clinical Guidance Document occur, the relevant list of Affected Companies and/or Affected Organizations may be modified and reviewed by the CPG Oversight Committee.

DISCLOSURES

3.1 Disclosures Before Appointment

3.1.1 AACE requires all prospective Task Force members, as well as reviewers, advisors, and contractors to disclose all relationships/activities and associated details via the online Task Force disclosure form. The AACE Task Force disclosure form is specific and designed to identify financial and non-financial relationships with Ineligible Companies (including Affected Companies) and Related Organizations (including Affected Organizations).

3.1.2 If a prospective Task Force member (chair, author, reviewer, advisor, or contractor) does not have a current Task Force disclosure form on file with AACE, the prospective Task Force member will be required to complete the disclosure form as part of the application process.

3.1.3 Invited Task Force members will be required to update the disclosure form prior to participating in any aspect of development of an AACE Clinical Guidance Document.

3.2 Disclosures During Document Development

3.2.1 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 disclosure form. If this relationship was not disclosed initially in the AACE disclosure form, all prospective Task Force members should inform appropriate staff of the relationship and update disclosures as necessary to maintain accuracy.

3.2.2 Before engaging in any new relationship/activity during document development, Task Force members should provide information about the relationship/activity to staff for review of the COI Subcommittee.

3.2.3 For all Task Force members, any new relationship/activity that is determined to be a conflict should be avoided during document development and for 12 months after final publication.

3.2.4Task Force members must update the disclosure form whenever they engage in a new relationship/activity or have an update to previously disclosed information, during document development and for 12 months after final publication.

3.2.5 If Task Force members have no new disclosures, they must confirm disclosures annually from the date of the initial disclosure and for 12 months after final publication.

3.3 CPG COI Subcommittee Review of Disclosures

3.3.1 The CPG COI Subcommittee reviews disclosures of prospective/appointed Task Force members against relevant lists of Affected Companies and Affected Organizations and may request more detailed information from an individual about the nature, value, or extent of their disclosed relationship in order to apply this COI Policy.

3.3.2 The CPG COI Subcommittee determines whether any interests of prospective/appointed Task Force members constitute a COI and provides a report on disclosures that are determined to be COIs to the CPG Oversight Committee.

3.4 Accessibility and Transparency of Disclosures

3.4.1 Staff create a summary of disclosures that identifies and specifies Task Force members’ relationships with Affected Companies and Affected Organizations, and shares with Task Force throughout the development of every AACE Clinical Guidance Document.

3.4.2 Staff provide Task Force disclosures and COI to the CPG Oversight Committee during review of an AACE Clinical Guidance Document for approval.

3.4.3 AACE publishes a summary of the AACE COI Policy, disclosures of Task Force members, and any management of COI in each AACE Clinical Guidance Document.
CHAIRS: ELIGIBILITY OF PARTICIPATION IN DEVELOPMENT OF AACE CLINICAL GUIDANCE DOCUMENTS

4.1 Generally, individuals who have disclosed financial interests in or relationships with Affected Companies will not be appointed as chairs/vice chairs of AACE Clinical Guidance Documents. A Task Force chair/vice chair must have been free of all conflict of interests for 24 months prior to appointment and remain free of these conflicts during development of the assigned AACE Clinical Guidance Document and for 12 months after the final version of the AACE Clinical Guidance Document is published.

4.2 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 provide the necessary expertise otherwise unavailable to develop the AACE Clinical Guidance Document. In this case, the Committee must appoint a -vice chair who has no COI with Affected Companies and Affected Organizations, including research funding or relationships with Related Organizations.

4.3 If a Task Force chair wants to continue to serve as chair for future updates of an AACE Clinical 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.

AUTHORS: ELIGIBILITY OF PARTICIPATION IN DEVELOPMENT OF AACE CLINICAL GUIDANCE DOCUMENTS

Having a relationship with an entity does not necessarily mean an individual is biased or has a COI. However, certain 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 Clinical Guidance Documents. AACE sets limits on the financial and non-financial relationships that chairs, authors, and reviewers can have with Ineligible Companies and Related Organizations (see Section 2.1 for additional information).

5.1 An individual is not eligible to serve on a Task Force if they:

5.1.1 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. Relevance to the topic of the AACE Clinical Guidance Document does not matter.

5.1.2 hold a significant ownership interest and/or greater than $25,000 in stocks in an Affected Company.

5.1.3 have a DFR, including speaker, consultant, or other compensation, greater than $10,000 with an Affected Company that, in CPG COI Subcommittee’s discretion, cannot be effectively managed.

5.1.4 have been appointed within the last 24 months to a Speakers’ Bureau with an Affected Company.

5.1.5 receive research funding from an Affected Company if research payments are made directly from the Affected Company to the individual or the individual’s company (company owned in part or whole by the individual).

5.1.7 serve as an author of an Affected Organization’s related or overlapping guidance document currently or of a document that was published in the 24 months prior to disclosure, if previously approved by the AACE Executive Committee or AACE Board to do so.

5.2 An individual may not be eligible to serve but could be considered to serve in the conflicted minority on a Task Force if they:

5.2.1 hold less than $25,000 in stocks in an Affected Company. If an individual, spouse, domestic partner, or dependent children own more than $25,000 in stock, it may be placed in a blind trust or divested to meet this requirement.

IS NOT

5.2.3 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 Affected Company.

5.2.4 have a DFR, including speaker, consultant, or other compensation, greater than $10,000 with an Affected Company that, in AACE’s discretion, can be effectively managed.

5.2.5 are responsible or have been responsible within the last 24 months for designing a study protocol funded by an Affected Company that is related to the topic of the AACE Clinical Guidance Document.

5.2.6 received royalties from an agreement, product, or patent with an Affected Company within the past 24 months.

5.2.7 participate or have participated within the last 24 months on an advisory board or as a consultant with an Affected Company.

5.2.8 serve in a leadership position at AACE or an Affected Organization (e.g., AACE Board, Executive Committee, or equivalent at another organization), depending on the organization and role of the individual.
COMPOSITION OF TASK FORCES RELATIVE TO MANAGEABLE COI

6.1 In accordance with the Council of Medical Specialty Societies Code, at least 60% of Task Force members must be free of COI relevant to the subject matter of an AACE Clinical Guidance Document. The remaining 40% of Task Force members who develop AACE Clinical Guidance Documents may be appointed if they hold some relationships with Affected Companies and Affected Organizations if the COI Subcommittee determines those disclosed relationships to be manageable conflicts; however, the CPG Oversight Committee is encouraged to form Task Forces with minimal or no COI.

6.2. If an individual’s relationship changes such that they are no longer eligible to serve in the majority of the Task Force, the Task Force member will participate as part of the Task Force minority. If participating in the minority is not feasible given the composition of the Task Force, the individual will be dismissed from the Task Force (see Section 7.4 for more information on dismissal).

CONFLICT MANAGEMENT

7.1 Role of Chairs in Management

7.1.1 Task Force chairs must adhere to and implement this COI policy throughout development.

7.1.2 Task Force chairs should review and become familiar with Task Force members’ disclosures prior to development and manage COI relevant to the AACE Clinical Guidance Document throughout development during discussions and voting, and for assignments.

7.1.3 Processes for conflict management include written and verbal disclosure, recusal from discussions or voting on specific recommendations directly related to a COI, recusal from authorship of sections of the AACE Clinical Guidance Document relevant to a COI, and dismissal.

7.1.4 Task Force chairs should present to the Task Force a predetermined strategy for management of any COI that could be related to discussion, assignment, or voting before they begin, and document management of COI after each meeting of the task force.

7.1.5 Task Force chairs should ensure that Task Force members disclose and recuse in accordance with Sections 7.2 and 7.3. If a Task Force member fails to verbally disclose a COI or to recuse themselves, the Task Force chair should request the appropriate action.

7.2 Written and Verbal Disclosure

7.2.1 Written disclosure in the online AACE Task Force disclosure form (web link) is required for Task Force members of AACE Clinical Guidance Documents and provides the foundation for determination and management of COI. Task Force members must complete the disclosure form in accordance with Section 3.6 (Disclosures during development).

7.2.2 Staff share a table of disclosures and COI of all Task Force members as the first agenda item at every in-person or virtual meeting throughout development for transparency and review.

7.2.3 Task Force chairs request disclosure of any new or updates to relationships/activities from Task Force members at the beginning of every in-person or virtual meeting for continual management of COI.

7.2.4 Some conflicts require verbal disclosure. If a Task Force member has a COI with an Affected Company, but discussion is broad enough that it does not implicate a specific product marketed by that company, the member should announce their conflict before commenting on the issue.

7.3 Recusal

7.3.1 All COI due to relationships with Affected Companies will be managed through recusal. Other COI may be managed through recusal, depending on the circumstances which will be determined by the Task Force chair. Recusals will be implemented on a recommendation-by-recommendation basis as follows:

7.3.2 Task Force members should recuse themselves from discussing or voting on recommendations or authoring sections of an AACE Clinical Guidance document that address any devices or class of drug manufactured or marketed by any Affected Company with which they have disclosed a COI. If a Task Force member fails to recuse themselves, the Task Force chair will request recusal.

7.3.3 Task Force members may discuss but not vote on topics indirectly related to any devices or class of drug manufactured or marketed by any Affected Company with which they have disclosed a COI.

7.3.4 Task Force chairs should not make writing assignments for development of an AACE Clinical Guidance Document to Task Force members who have disclosed a COI relevant to the section needing assignment.

7.4 Dismissal

7.4.1 If after appointment to the Task Force, an individual engages in a relationship/activity that is determined to be a COI, they may be dismissed from the panel:

7.4.2 If a Task Force member engages in a relationship or an activity that would deem them ineligible to participate in development of an AACE Clinical Guidance Document, the 17 individual will be dismissed from the Task Force (See Sections 5 and 6 for additional information on eligibility).

7.4.3. If a Task Force member’s relationships/activities change such that they are no longer eligible to serve in the majority of the Task Force, and participating in the minority of the Task Force is not feasible (due to Task Force composition or other potential concerns), the individual will be dismissed.

7.4.4 If a Task Force member engages in a relationship/activity that is determined to be a COI and not manageable by AACE, the individual will be dismissed.

7.4.5 Any questions regarding deviations from COI management policies should be referred to the Professional Standards Committee or CPG Oversight Committee/CPG COI Subcommittee. See additional information about management of conflicts in section 4 (Management of Conflicts) of the AACE COI Policy.
CO-WRITTEN CLINICAL GUIDANCE DOCUMENTS

8.1 Any representative of an organization that is invited to co-sponsor an AACE Clinical Guidance Document must adhere to AACE COI Policy.

8.2 If AACE co-sponsors a guidance document led by another organization, selection of the AACE representative must comply with the AACE COI and DEI policies.

Sources

1 Institute of Medicine (US) Committee on Standards for Developing Trustworthy Clinical Practice Guidelines. Clinical practice guidelines we can trust. National Academies Press, 2011.
2 Council of Medical Specialty Societies. CMSS principles for the development of specialty society clinical guidelines. https://cmss.org/wp-content/uploads/2017/11/Revised-CMSS-Principles-for-Clinical-Practice-Guideline-Development.pdf
3 Schünemann HJ, Al-Ansary LA, Forland F, Kersten S, Komulainen J, Kopp IB, Macbeth F, Phillips SM, Robbins C, van derWees P, Qaseem A; Board of Trustees of the Guidelines International Network. Guidelines International Network:Principles for Disclosure of Interests and Management of Conflicts in Guidelines. Ann Intern Med. 2015 Oct 6;163(7):548-53. doi: 10.7326/M14-1885. PMID: 26436619.

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