Conflict of Interest Policy Statement
Conflict of Interest Policy Statement
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 solid organ transplantation. 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 pertinent to the work being performed for the AST must be fully disclosed and mechanisms established to deal with such conflicts.
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).
What is to be disclosed? All relationships or financial interests with companies and/or professional societies that provide services for transplantation research or the care of transplant patients must be disclosed. The conflict of interest committee will review these disclosures on an annual basis. These relationships or financial interests must be revealed if occurring within the past 12 months, or are anticipated to incur 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. The disclosures include any financial interests, including grants from pharmaceutical companies to an institution for individuals who are primary or co-investigators, participation in a speakers’ bureau sponsored by another entity, or financial interest in any other entity that is involved in solid organ transplantation, inclusive of individually held stocks. 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 outside of their current institution in transplant-related entities 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 which are not financial interests.
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 of Interest 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.
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 the beginning of 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 AST 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 interests greater than $5000 are reported with outside entities. The conflict of interest committee will take appropriate actions to resolve or avoid conflicts according to the conflict resolution procedures outlined in the subsequent document.
All relationships will be reported on the AST website. Only the member name, AST activity, entity and relationship will be reported.
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 financial interests or 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 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 educational activities or clinical guidelines and cannot participate on AST committees, COP executive committees, or be elected to the AST Board of Directors. However, this should not affect their participation in communities of practice or advisory councils.
Prohibition on Use of AST Association for Advertising. An association with the AST cannot be used as advertising validation or promotion of non-AST activities. If it is discovered that there are violations to this policy, they will be reviewed by the Conflict of Interest committee with a recommendation to the AST Board of Directors for appropriate action.
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 COI 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 COI 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:
- Alter the relationship with the commercial entity, thereby eliminating the COI
- Submit presentation for peer review and revise content as needed based on feedback
- Alter the content of the presentation in a balanced way so that it does not relate solely to the products or services of the commercial entity in question
- Withdraw as a speaker and suggest alternative replacement
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:
- The name of the individual;
- The name of the commercial interest(s);
- The nature of the relationship the person has with each commercial interest.
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.
Conflict of Interest Policy Statement approved by the AST Board of Directors: 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