The goal of the American Society of Transplantation (“AST”) is to support clinical care, scientific research and professional and public education related to organ transplantation. Many who participate in the activities of AST have significant financial relationships with outside public and private entities that have an interest in transplantation issues. These relationships may be direct, through immediate family members, or via institutional contracts. It is essential that every effort be made to ensure that all participants in the activities of AST are governed exclusively by the best interests of AST. Significant financial relationships which might create a conflict of interest must be fully disclosed and mechanisms established to deal with such conflicts.
A. Who is covered by the Policy? Board members, members of committees and advisory councils, community of practice executive committee members, members developing practice guidelines, members involved in educational activities and other individuals to whom the Board has delegated significant decision-making authority (e.g. Senior Employees, Senior-level contract staff, Program Chairs and the Editors, Associate Editors and Editorial Boards for Society publications).
B. What is to be disclosed? All relationships occurring within the past 12 months in which a covered individual or immediate family member may have a material interest, including but not limited to grants or other funding from another entity; participation in a speakers’ bureau sponsored by another entity; or financial interest in another entity where such investments of the reporting individual or his or her immediate family must be disclosed. Disclosable conflicts may arise from administrative roles in other organizations whose activities may be affected by activities of AST. Current AST Board members and members submitting a nomination for service on the AST Board of Directors must report administrative positions regardless of whether the covered individual has a financial interest in the outside entity. With the exception of the aforementioned individuals, it is not mandatory for AST members to report administrative relationships.
C. When is disclosure to be made? Each covered individual shall file with the AST national office at the beginning of the Board/committee term (or where the individual assumes a position during the year requiring reporting, upon assuming such position) a completed disclosure form. Failure to complete a conflict of interest disclosure will result in suspension from the committee/activity.
If at any time there is a change in circumstances for a reporting individual that materially affects the disclosure form filed for a period, an additional disclosure form containing updated information shall be filed with the administrative office of the AST. Board and committee members shall 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. All other persons subject to the Conflict Policy (including Board/committee members who were not present at the most recent Board/committee meeting) must provide an annual certification verifying that no changes need be made to the material previously disclosed or, if applicable, disclosing such matters required to render the total disclosure accurate.
D. Who shall have access to the disclosure forms filed? Copies of the disclosure forms filed by Board and committee members shall be circulated to the Board/committee at each meeting. Financial information in the committee disclosure forms may be disclosed only upon approval by the Board or Executive Committee of the AST.
The Conflict of Interest Committee will review all board nominee disclosures. Disclosures completed by non-Board members will be provided to the Conflict of Interest Committee for review if financial relationships greater than $5000 are reported with outside entities. The Conflict of Interest Committee will resolve conflicts according to the approved conflict resolution procedures.
All relationships will be reported on the AST website. Only the member name, AST activity, entity and relationship will be reported.
E. What rules govern the activities of individuals on behalf of AST with declared or perceived conflicts of interest? Covered individuals should be sensitive to interests they may have in decisions to be made on behalf of AST or by the AST Board or decision-making panel 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 conflicts will be handled by the Conflict of Interest Committee according to the approved conflict resolution procedures. Circumstances will dictate whether the interested individual should be excluded from the relevant discussion or educational activity.
Covered individuals may not vote on matters in which they have a potential conflict of interest.
F. Industry participation in AST activities. Individuals who are employees of pharmaceutical industry companies may not be involved in the development of educational activities or clinical guidelines and cannot participate on AST committees or be elected to the Board of Directors. However, this should not affect their participation in communities of
practice or advisory councils.
Board and Committee Member Resolution Procedures: The 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 Conflict of Interest Committee may request additional information from disclosees for the purposes of clarification.
On an annual basis, a list of the reported potential conflicts of interest will be submitted to the national office. Financial relationships greater than $5,000 with outside entities will be reviewed by the Conflict of Interest Committee. This committee has the authority and responsibility to decide the appropriate action to any disclosure in question. This may be:
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. Although the disclosee clearly has some other interest, the committee leadership or Board will simply take the information into account as the disclosee participates in decision-making.
2. Recusal. In board or committee discussions, a disclosee 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 disclosee is required to recuse her/himself 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. In rare instances, a disclosee may have an affiliation with another entity of such a magnitude that it could potentially compromise the ability of the disclosee to act in the best interest of AST. In such an instance or if there is an egregious breach of policy, the member should 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 President.
Resolution for Speakers Involved in AST activities: All individuals involved in planning or participating in an AST educational activity must disclose potential conflicts of interest and resolve all conflicts prior to the activity. Mechanisms for resolution include the following:
After a conflict of interest has been identified and resolved, it must be made known to the leaders in advance of the educational activity. This must be done through a verbal disclosure at the beginning of the presentation and acknowledgement via the first presentation slide. For an individual with no relevant financial relationship(s) the learners must be informed that no relevant financial relationship(s) exist.
An individual must disclose to learners any relevant financial relationship(s), to include the following information:
Additionally, all educational activities should 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. Moderators will also be asked to provide feedback from their sessions.
Definitions: A commercial interest is an entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.
Financial Relationships: Financial relationships are those relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit. Financial benefits are usually associated with roles such as employment, management position, 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.
View disclosed relationships from participants in AST activities:
The American Society of Transplantation is an international organization of professionals dedicated to advancing the field of transplantation and improving patient care by promoting research, education, advocacy, and organ donation.