Conflict of Interest Policy
I. PURPOSE
The purpose of this policy is to establish a framework for identifying and managing conflicts of interest that may impact actions, decisions, and transactions of the American Society of Transplantation (AST).
II. POLICY STATEMENT
In pursuit of its mission to advance the field of transplantation and enhance patient care, the AST engages in thoughtful, strategic, and complex partnerships with professional and patient organizations, academia, government agencies, companies1, and others. It is essential that these collaborative relationships do not create conflicts of interest that might compromise the integrity or credibility of the AST or its mission.
Individuals who serve the AST in a leadership role may, from time to time, have financial, fiduciary, or other relationships with entities that have financial or strategic interests in actions or transactions undertaken by the AST. Since the AST pursues broad advocacy, educational, clinical care, scientific, and policy initiatives that may in principle overlap with these entities with similar general objectives, it is essential that all individuals acting on behalf of the AST through these initiatives are governed exclusively by the best interests of the AST. A conflict of interest emerges when a set of circumstances creates a risk that an individual’s professional judgment or actions regarding the AST may be unduly influenced by their secondary financial, fiduciary, or other interest.2
Therefore, this Conflict of Interest Policy (“COI Policy”) is designed to foster Member and public confidence in the integrity and credibility of the AST and to protect AST interests when it is contemplating actions or transactions that might benefit the personal interests of those in decision-making roles for AST. The COI Policy outlines practices, guidelines, and requirements for disclosing and managing potential conflicts of interest so that collaborations that are important to the mission of the AST can be pursued without compromising integrity and credibility.
All individuals acting in, or selected to act in, a leadership role within the AST (“Covered Individuals”) are required to comply with this COI Policy. Financial, fiduciary, or other relationships that might create a conflict of interest pertinent to the work being performed for the AST must be fully disclosed, reviewed, and managed, as required in the COI Policy.
The COI Policy shall be subject to appropriate modifications, from time to time, to conform to emerging organizational standards and to remedy unintended omissions or consequences.
AST Organization policies include those policies which govern the AST’s operational needs. They include the bylaws defining how AST is organized; documents defining its mission, vision, and strategic plan; and documents defining standards and requirements for those who act on behalf of the AST in order to protect its integrity and credibility.3
III. CORE UNDERLYING PRINCIPLES
a. Integrity and credibility: Preserving the integrity and credibility of the AST is of utmost importance in fulfilling its mission to promote research, education, advocacy, organ donation, and service to the community that advances the field of transplantation and enhances patient care.
b. Respect: The AST respects the autonomy of its Members to pursue and hold diverse relationships with professional and patient organizations, academia, government agencies, companies, and others. The AST respects the privacy of personal information of its Members, including the monetary value of relevant disclosures required by the COI Policy.
c. Transparency: The AST believes that COI disclosures, as defined herein, by Covered Individuals should be accessible to all Members. Additionally, COI disclosures of all organizers, speakers, moderators, and discussants in AST educational events shall be accessible to all participants.
d. Consistency: The AST believes that the COI Policy should be implemented fairly, impartially, and consistently across all Covered Individuals.
IV. COVERED INDIVIDUALS
All individuals providing service to the AST in an official capacity are required to comply with the COI Policy, including but not limited to:
a. executive-level staff;
b. members of the Board of Directors;
c. members of standing and ad hoc committees and task forces;
d. members of Community of Practice executive committees;
e. members of organizing or program planning committees for AST educational events and conferences;
f. authors of manuscripts, white papers, and guidelines for submission to a peer reviewed journal, and educational materials produced on behalf of the AST, or to be disseminated by the AST as a product of an AST-sponsored activity;
g. all speakers and moderators at official AST conferences and workshops and discussants as appropriate (e.g. controversies conferences); and
h. nominees for leadership positions within the AST.
V. DISCLOSURES
All relevant financial, fiduciary, or other relationships with professional and patient organizations, academia, government agencies, companies, and other entities with financial or strategic interests in organ transplantation or donation must be disclosed for the Covered Individual and their spouse/domestic partner.
a. Relevant disclosures: Relevant disclosures include those financial, fiduciary, and other relationships that are:
i. active, current, or ongoing;
ii. inactive, or terminated, but which existed in the 12 months prior to the disclosure requirement; and
iii. under negotiation, and contractual terms can reasonably be expected to be executed within 3 months following the disclosure requirement.
b. Financial relationships: Financial relationships are those relationships in which the Covered Individual receives:
i. salary
ii. royalty
iii. intellectual property rights
iv. consulting fees
v. independent contractor fees
vi. stipends or honoraria, including travel to non-academic institutions
vii. stocks, stock options or other ownership interest, excluding diversified mutual funds
viii. research, training, or unrestricted educational or philanthropic funds
ix. other personal financial benefit
Typically, these financial benefits accrue in roles including, but not limited to, employment, management positions, independent contractor (including contracted research), consulting, speaking and teaching, membership on advisory committees or review panels, board membership, and other activities from which remuneration is received or expected.
c. Fiduciary relationships: Fiduciary relationships are those relationships in which the Covered Individual plays a major leadership role in the strategic direction and/or financial oversight of a non-profit organization, company, or healthcare entity, even when such a role occurs in a volunteer capacity. Typically, these roles include, but are not limited to, director, council member, officer, and trustee.
d. Other relationships: Other relationships are those relationships in which the Covered Individual has a leadership role in an entity that may compete with the AST, either financially or in mission. Typically, these roles include, but are not limited to, editor of a non-AST journal, and chair of a committee or task force in another patient or professional organization whose mission includes organ transplantation or donation.
Primary employment at an academic institution, non-profit medical center, independent clinical practice, or organ procurement organization does not require disclosure.
VI. DISCLOSURE PERIOD AND PROCEDURES
a. Prior to engaging in an official capacity with the AST, and at least once a year thereafter, Covered Individuals will be sent an electronic disclosure form with a deadline for completion.
b. All relevant disclosures must be made by the deadline, prior to engaging in an official capacity with the AST as a Covered Individual.
c. While still engaged as a Covered Individual with the AST, new relationships that emerge after the initial disclosure requirement, and modifications to previously disclosed relationships, must be disclosed via the electronic disclosure form within 30 days of the effective date or modification of the relationship
d. Disclosure information for each relationship must include, at a minimum:
i. the name of the Covered Individual
ii. the name of the entity with which the Covered Individual (or spouse/partner) has a financial, fiduciary, or other relationship
iii. the type of relationship
iv. a description of the Covered Individual’s (or spouse/partner) role with the entity
v. the inclusive dates of the relationship (or, in the case of an ongoing or anticipated new relationship, an estimated future date of termination)
vi. compensation received from the entity within the past 12 months or, in the case of an anticipated new relationship, an estimate of the total compensation expected in the next 12 months
e. Each AST meeting in which Covered Individuals are participants must have COI Disclosures as the first agenda item. A list of all relevant disclosures must be presented and reviewed. Relevant disclosures from the list that may be pertinent to one or more agenda items must be identified to determine whether any conflict management actions of participating Covered Individual(s) must be taken. By vote of the meeting members, the Covered Individual(s) may be recused from discussion, voting, or both pertinent to that agenda item.
f. Covered Individuals must disclose verbally, prior to the business of the meeting, if their list of relevant disclosures is inaccurate or incomplete and make a verbal report of required modifications or new disclosures at that time. Such modifications should be captured in the meeting minutes. The Covered Individual with modified disclosures should submit an updated electronic disclosure form, per VI.(c) above.
g. Covered Individuals must disclose verbally, prior to the business of the meeting, if they have any actual, potential or perceived conflicts (i.e., other than relevant disclosures required by the COI Policy) with an agenda item to be discussed during the meeting. By vote of the meeting members, the Covered Individual(s) may be recused from discussion, voting, or both pertinent to that agenda item.
VII. CONFLICT OF INTEREST (COI) COMMITTEE
a. Purpose: The COI Committee is charged by the AST Board of Directors to:
i. apply the COI Policy
ii. review all relevant disclosures of Covered Individuals
iii. consider whether conflicts exist per COI Policy
iv. recommend whether conflicts are disqualifying or can be managed for final Board consideration and approval
v. recommend modifications in the COI Policy for the Board’s consideration and approval
b. Members: The COI Committee shall be comprised of representatives from the AST membership and include 9 voting members, selected by the Executive Committee and approved by the Board of Directors, and 2 non-voting members, as follows:
i. Voting Members (9): Chair; Co-Chair; 7 Members-at-Large
ii. Non-Voting Members (2): Past Chair of Education Committee; Board Liaison appointed by the President
Whenever possible, the Executive Committee should select a COI Committee Chair and Co-Chair with relevant prior or current experience on COI committees in their primary institutions, the AST, or another organization. Additionally, similar COI committee experience should be an important consideration in the selection of Members-at-Large for the AST COI Committee.
COI Committee members shall not have any disqualifying conflicts nor any financial, fiduciary, or other relationships that cannot reasonably be managed within the framework of the COI Policy.
c. COI Review: The President shall appoint no less than two Board members to review all relevant disclosures of COI Committee members. These appointed Board members will consider whether conflicts exist per COI Policy, recommend whether conflicts are disqualifying or can be managed, and share these recommendations regarding Committee membership to the Board for final consideration and approval.
d. Term: The Chair and Co-Chair shall each serve a term of 3 years. Members-at-Large shall serve 2 years, staggered so that no more than half rotate off the Committee each year to provide continuity and historical reference from year to year. Reappointment of the Chair, Co-Chair, and/or Members-at-Large is at the discretion of the Executive Committee and requires approval by the Board of Directors.
VIII. DISCLOSURE ASSESSMENT
Except as noted in VII(c) above, the COI Committee shall be responsible for reviewing all disclosures and, first, determining whether a disclosure is relevant. For relevant disclosures, the COI Committee shall then recommend whether the conflict is disqualifying or can reasonably be managed to reduce bias and preserve AST integrity and credibility.
The COI Committee may request additional information from the Covered Individual for purposes of its review and recommendation, and the Covered Individual shall provide requested information. If the Covered Individual does not provide the additional information requested by the COI Committee for this purpose, then the Covered Individual may no longer be considered for the role in question.
A Covered Individual in an AST leadership position must be free of all such prohibited relationships during their term of service.
a. Disqualifying conflict: Certain income interests and other relationships are disqualifying, or prohibited, for some Covered Individuals in AST leadership positions to protect against the introduction of bias, conflict of mission, or unnecessary risk to the integrity and credibility of the organization. A disqualifying conflict exists when a relevant disclosure includes:
i. employment income or salary from a company with financial interests in organ transplantation or donation.
ii. paid or unpaid fiduciary relationship (i.e., Board of Directors member or its equivalent) with a patient or professional organization whose mission includes organ transplantation or donation that creates a conflict of commitment or conflict of interest.
1. Individuals with such fiduciary relationships that are interested in pursuing service on the AST Board of Directors must consult with the Executive Director before applying. Any potential conflicts will be discussed with the Governance Committee, and the Governance Committee’s recommendation will be presented for the Board of Directors’ consideration. The Executive Director will then inform the individual of the Board’s final decision regarding whether the fiduciary relationship in question is a disqualifying conflict.
iii. Ownership, partnership, or principal (e.g., CEO, chair of the Board) in a company with financial interests in organ transplantation or donation.
iv. Simultaneous service as a member of the AST Board of Directors and as Editor-in-Chief of a journal in the field of organ donation and transplantation.
b. Manageable conflict: A manageable conflict is a conflict for which disclosure alone is insufficient and elimination of the conflict, or disqualification, is too extreme. Manageable conflicts include:
i. leadership position (e.g., Committee Chair or Chair-Elect/Vice Chair) within a patient or professional organization whose mission includes organ transplantation or donation.
ii. receiving $25,000 or more in the past 12 months from a company with financial interests in organ transplantation or donation in (a) non-salary compensation (e.g., consulting fees, independent contractor fees, etc.) and/or (b) equity interest.
iii. Intellectual Property Rights (patents, royalties, licensing fees) related to organ transplantation or donation with income in the past 12 months of $25,000 or more
iv. Stock or stock options in a company with financial interests in organ transplantation or donation with a value of $25,000 or more (not part of a diversified fund)
v. Editor-in Chief of a non-AST journal in the field of organ donation and transplantation
If the Covered Individual has a manageable conflict, the conflict will be managed as follows:
i. Removal from the room during discussion and voting on matters pertinent to the relevant relationship is required if the Covered Individual received $25,000 or more in the past 12 months from a company with financial interests in organ transplantation or donation in (a) non-salary compensation (e.g., consulting fees, independent contractor fees, etc.) and/or (b) equity interest.
ii. Recusal from discussion, voting, or both on matters pertinent to all other relevant relationships, as determined by vote of meeting attendees.
These presumptively prohibited relationships may also extend to the spouse/partner if such relationships would otherwise be prohibited for the Covered Individual. The spouse/partner presumption may be overcome when, as reviewed by the COI Committee and approved by the Board, the Covered Individual has presented demonstrable, compelling justification for being permitted to simultaneously hold an AST leadership position while the spouse/partner has a substantial conflict.
IX. EDUCATIONAL EVENTS OR ACTIVITIES
Speakers and moderators selected to participate in AST educational events or activities must disclose financial, fiduciary, or other relationships relevant to content of the presentation and/or program session.
When the AST contracts with a CME vendor, the vendor will review electronic disclosures and presentation slides for bias in advance of the educational event. The vendor will report any concerns about bias to the COI Committee for further assessment of any potential bias. The COI Committee may request additional information from the speaker and moderator to facilitate their review, including the slides of planned presentations. The COI Committee will communicate any required modifications in the presentation slides or content to the speaker and moderator for the session. If the potential bias is severe, cannot reasonably be mitigated by simple disclosure, and compromises the integrity of the activity or the AST, the COI Committee may determine that voluntary termination of the relationship with the entity, withdrawal from the program, or requiring that a co-author with no conflict of interest present is necessary.
To ensure transparency and full disclosure to participants, each AST educational event or activity shall include a written statement informing participants and attendees of their shared obligation to report to the COI Committee any concerns about undisclosed potential conflicts of interest and/or bias due to conflicts of interest.
X. CONFLICT OF INTEREST (COI) MANAGEMENT
For all AST meetings in which a Covered Individual has a relevant disclosure that is pertinent to one or more agenda items and that does not require removal from the room per VIII above, meeting members must vote to determine whether the Covered Individual must be:
a. recused from discussion, vote, or both on matters directly related to the Covered Individual’s financial, fiduciary, or other relationship interests; and/or;
b. removed from the room to eliminate the risk that information being shared during the discussion may benefit the Covered Individual or a relationship entity
For manuscripts, white papers, guidelines, and educational materials produced on behalf of the AST in which a Covered Individual has a relevant disclosure that is pertinent to the product being disseminated, the COI Committee will determine whether the Covered Individual must:
a. publicly disclose the relevant relationship in the document or product; and/or
b. revise the educational product to mitigate potential bias
For AST educational events or activities, all speakers and moderators must verbally disclose at the beginning of the session (moderator) or talk (presenter) all financial, fiduciary, and other relationships, or lack thereof, that are relevant to the presentation or program session topic. Such verbal disclosure must include a slide that includes the Covered Individual’s name, the name of the entity with whom the Covered Individual has a relationship, and the type of relationship (e.g., paid employee, consultant, equity interest, fiduciary role, etc.). Any slide that includes disclosures must be visible to attendees.
Discussants should share their name, institution, and financial, fiduciary, and other relationships, or lack thereof, that are relevant to the presentation or program session topic.
The COI Committee may recommend additional requirements to the Board any relevant disclosure.
XI. COI POLICY VIOLATIONS
A Covered Individual must adhere to all aspects of the COI Policy. If the Board has reasonable cause to believe that a Covered Individual failed to disclose actual or possible conflicts of interest, failed to make disclosures within the time specified by policy, or failed to adhere to conflict management strategies, it must inform the Covered Individual of the basis for such belief and afford them an opportunity to explain the alleged failure to disclose, untimely disclosure, or management plan nonadherence.
If, after hearing the Covered Individual’s response and further investigation, as may be warranted, the Board determines that the Covered Individual is in violation of the COI Policy, it will take appropriate corrective action. Such corrective action may include delay in assuming official capacity with the AST, suspension of official capacity with the AST, disqualification from serving in an official capacity with the AST, suspension from participating as a speaker at future AST education events, and revocation of membership in the organization.
XII. DISPUTE RESOLUTION
Covered Individuals are strongly advised to seek consultation with AST staff and/or the COI Committee for guidance or clarification regarding the COI Policy.
If a dispute arises between a Covered Individual and the AST on matters related to COI determination or management, the President will appoint an Ad Hoc Adjudication Committee. This ad hoc committee should comprise no more than three Members, which may include a Past-President, a Past-Chair or former member of the COI Committee, and/or a former Board member. The ad hoc committee will review and assess the matter for purposes of advising the Executive Committee, which will determine the final resolution or disposition.
XIII. MODIFICATION OF POLICY ENFORCEMENT
Implementation and enforcement of the COI Policy may be modified by the Board when engaging in joint activities involving one or more other organizations with different COI policies.
XIV. PERIODIC REVIEW OF POLICY
This COI Policy will be reviewed by the Board no less frequently than every three years.
XV. PUBLIC DISCLOSURE
The AST will make available to Members and to the public via its website this COI Policy and make available, upon request, all relevant disclosures, or lack thereof, of all executive-level staff, members of the Board of Directors, COI Committee members, Community of Practice Chairs and Co-Chairs, and Program Planning Committee members.
XVI. CODE FOR INTERACTIONS WITH COMPANIES
The AST endorses the Council of Medical Specialty Societies’ Code for Interactions with Companies (www.cmss.org), which describes guidelines to minimize conflicts of interest and achieving the highest ethical standards in interactions with commercial entities. The AST Board considers the Code a procedural appendix to the COI Policy.
Dates
Adopted First – February 15, 2001
Revised – July 19, 2008
Revised – March 10, 2010
Revised – July 23, 2010
Revised – December 1, 2011
Revised – January 15, 2013
Revised – July 26, 2013
Revised – August 19, 2014
Revised – November 18, 2014
Revised – September 23, 2019
Revised – April 21, 2021
Revised – June 2, 2022
Revised – September 7, 2023
1 The AST defines “company” as a for-profit entity that develops, produces, markets, or distributes drugs, devices, services or therapies used to diagnose, treat, monitor, manage, and alleviate health conditions, or a for-profit entity that provides fee-based consultation services to healthcare entities that deliver transplantation clinical services to patients. See Accreditation Council for Continuing Medical Education (ACCME; Standards for Integrity and Independence in Accredited Continuing Education) and Council of Medical Specialty Societies (CMSS; Code for Interactions with Companies).↩
2 Institute of Medicine. 2009. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: The National Academies Press.↩
3 Other related policies: GOV-210: Service on the AST Board and Committees; GOV-200: Governance Committee Policy and Procedures.↩