Conflict of Interest Policy
Purpose and Scope
This conflict of interest policy is designed to foster member and public confidence in the integrity of the American Society of Transplantation (AST) and to protect AST’s interests when it is contemplating actions or transactions that might benefit the private interest of those in decision-making roles for AST. The Society encourages member engagement and enrichment in activities outside of their work responsibilities. Many individuals who serve AST as volunteer leaders or speakers have significant relationships with outside public and private entities that have an interest in healthcare-related entities. It is essential that all participants in the activities of AST are governed exclusively by the best interests of AST. Significant financial or administrative relationships which might create a conflict of interest pertinent to the work being performed for the AST must be fully disclosed.
AST Organization policies include those policies which govern AST’s operational needs. They include the bylaws which define how AST is organized; documents which define its mission, vision, and strategic plan; and guidelines which define standards for those who act on behalf of AST in order to protect its integrity.
Board members, members of Committees, advisory councils and task forces, Community of Practice Executive Committee members, members developing practice guidelines, individuals involved in educational activities on behalf of the AST and other individuals to whom the board has delegated significant decision-making authority (e.g. Senior Employees, Senior-level contract staff, Program Chairs). Disclosures for volunteers or employees of contracted partners, such as Society journals and meeting managers, are handled by the partner.
- Conflict of Interest Committee:
This Committee is composed of members appointed by the AST President and is responsible for reviewing all disclosures and managing the conflict resolution process.
- Commercial interest:
Any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.
- Financial relationships:
Those relationships in which the individual benefits through employment by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria (other than from invited academic lectures at professional society conferences or other medical institutions), ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit. AST considers relationships to include financial relationships of a spouse or partner.
- Administrative relationships:
Those relationships in which an individual serves as an unpaid officer in a competitive or collaborating organization.
- Disclosure request period:
Upon election or appointment to an AST position, and on an annual basis thereafter, individuals will be sent a disclosure request with a deadline for completion. Invited speakers or moderators will also be sent a disclosure request with a deadline for completion. This time period is the disclosure request period. Failure to complete a conflict of interest disclosure within the disclosure request period will result in suspension from the committee/activity until or unless the disclosure is completed and reviewed.
Immediate family members:
Spouse or partner, children, parents, and siblings.
All relationships or financial interests with healthcare-related entities must be disclosed (e.g. for-profit companies, professional societies, and government-sponsored activities). These relationships or financial interests must be disclosed if occurring within the past 12 months, or are anticipated to occur within the next 12 months, and they are relevant to the individual AST member and/or their immediate family members. Immediate family members are only required to disclose the relationships and not the details of the financial interests.
In addition to financial relationships or interests, disclosable conflicts may arise from administrative roles in other organizations whose activities may be affected by activities of AST. All disclosers must report administrative positions outside of their current institution in healthcare-related entities regardless of whether the individual has a financial interest in the outside entity.
Examples of relationships or financial interests in healthcare-related entities include:
1. Consulting fees / honoraria (or in-kind gift or travel not to an academic institution)
2. Participation in a speaker’s bureau
3. Participation in a CME program sponsored by a company that may impact or be impacted by organ donation and transplantation
4. Equity interests / stock options including a non-publicly traded company
5. Equity interests / in a publicly traded and financially related company
6. Royalty income
7. Non-royalty payments
8. Officer, trustee, director, or any other at-large leadership role, whether or not remuneration is received for service
9. Ownership / partnership / principal
10. Research grants from a financially interested company
11. Industry supported fellowship support
12. Salary or position funding (partial or full) or “in-kind” support of program
13. Intellectual property rights including patent or other intellectual property in a for-profit corporation
14. Other financial benefit
15. Other relationship
If at any time there is a change in circumstances for a reporting individual that materially affects the disclosure form filed for the current period, an additional disclosure form containing updated information must be filed with the AST National Office. Board and committee members must additionally disclose any new or additional information regarding their previous financial disclosures during board and committee meetings and such changes, if any, will be recorded in the meeting minutes.
A summary of disclosures for each member of the Board or Committee must be circulated at the beginning of each meeting. In addition, annual disclosures must be summarized and shared with AST membership. Financial information in the committee disclosure forms may be disclosed only upon approval by the Board or Executive Committee of the AST.
Review of Disclosures
The AST Conflict of Interest Committee will review all disclosures. The Conflict of Interest Committee will take appropriate actions to resolve or avoid conflicts according to the conflict resolution procedures outlined below. '
All disclosed relationships will be reported on the AST website. Only the member name, AST activity, entity, and relationship will be reported.
Management of Conflict of Interest
What rules govern the activities of individuals on behalf of AST with declared or perceived conflicts of interest? Disclosers must be sensitive to interests they may have in decisions to be made on behalf of AST and have an obligation to disclose such interests prior to the discussion or presentation of such matter before the board or decision-making panel.
Disclosed administrative or financial interests or conflicts will be handled by the Conflict of Interest Committee according to the conflict resolution procedures. Circumstances will dictate whether the interested individual must be excluded from the relevant discussion or educational activity. Covered individuals may not vote on matters in which they are found to have a potential conflict of interest.
Industry and consultant participation in AST activities
Individuals who are employees of pharmaceutical or biotech companies or other companies that are in the business of transplantation or those that serve as full-time “for-profit” consultants may not be involved in the development of content for educational activities or clinical guidelines. They must not participate on AST Committees, COP Executive Committees, or be elected to the AST Board of Directors. However, this will not affect their participation in Communities of Practice or advisory councils. Conflict of Interest Resolution The AST Conflict of Interest (COI) Committee will determine whether each issue raised on a disclosure form or on an ad hoc basis requires that the member’s participation be altered. In the process of reviewing disclosures, the COI Committee may request additional information from disclosers for the purposes of clarification. In the event that the COI Committee recommends that participation be altered, the Board Executive Committee will be informed and then the member will be contacted.
For Committee or Board members, the COI Committee may determine that:
1. Disclosure of Information is Sufficient: Conflicts relevant to AST activities will be forwarded to the AST President or appropriate committee chair/co-chair after review by the COI Committee. The disclosure itself, and awareness by the board or committee leadership, is considered sufficient to correct for any bias it might entail. The board or committee leadership will take the information into account as the discloser participates in decision-making.
2. Recusal: In board or committee discussions, a discloser may directly and openly represent the interests of another entity where a potential conflict of interest exists. However, to assure decision-making is without bias, verbal disclosure is required at that time. In addition, the discloser is required to recuse themselves during final discussion and voting, depending on the circumstances. Recusal in such instances can either be voluntary or at the discretion of the President or leadership of the relevant AST committee.
3. Resignation: A discloser may have an affiliation with another entity of such a magnitude that it could potentially compromise the ability of the discloser to act in the best interest of AST. In such an instance or if there is an egregious breach of policy, the member must resign his/her leadership position within AST but may continue to participate as an AST member. Resignation due to a widely pervasive conflict is at the discretion of the Executive Committee.
All individuals involved in planning or participating in an AST educational activity must resolve all conflicts prior to the activity.
For Speakers involved in AST educational activities, the COI Committee may determine that:
- The relationship with the commercial entity must be altered, thereby eliminating the COI.
- The presentation must be submitted for peer review. If necessary, the content of the presentation must be altered in a balanced way so that it does not relate solely to the products or services of the commercial entity in question.
- The speaker must withdraw, and an alternative be found.
After a conflict of interest has been identified and resolved, it must be made known to the learners in advance of the educational activity. This must be done through a verbal disclosure at the beginning of the presentation and acknowledgment via the first presentation slide. For an individual with no relevant financial relationships the learners must be informed that no relevant financial relationships exist.
When a presenter discloses their relevant relationships to learners, the presenter must include the following information:
- The name of the individual;
- The name of the entity;
The nature of the relationship the person has with each entity
Additionally, all educational activities will be systematically surveyed for audience perception of bias as part of the post activity evaluation. Moderators will also be asked to provide feedback from their sessions.
Violations of the Conflict of Interest Policy
If the Board has reasonable cause to believe that a discloser has failed to disclose actual or possible conflicts of interest, it must inform the member of the basis for such belief and afford him or her an opportunity to explain the alleged failure to disclose.
If, after hearing the discloser’s response and further investigation as may be warranted by the situation, the Board determines that the discloser has failed to disclose a possible conflict of interest, it will take appropriate corrective action, up to and including revocation of membership.