Official Sections CTRMS ISVCA IPITA IPTA ISODP IRTA IXA SPLIT TID

Conflict of Interest Policy

Purpose

This conflict of interest policy is to maintain the integrity of the International Pediatric Transplant Association (IPTA) and to protect IPTA’s interests when it is considering actions that might benefit the private interest of those in decision-making roles for IPTA.

Individuals who serve IPTA as volunteer leaders or speakers may have significant relationships with outside public and private entities that have an interest in healthcare-related entities. Significant financial or administrative relationships which might create a conflict of interest pertinent to the work being performed for IPTA must be fully disclosed.

Definitions

  • Disclosers
  • Council members, members of Committees, members developing practice guidelines, individuals involved in educational activities on behalf of IPTA and other individuals to whom the Council has delegated significant decision-making authority (e.g. contractors).

  • 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. This considers relationships to include financial relationships of immediate family members (Spouse or partner, children, parents, and siblings).

  • Administrative relationships
  • Those relationships in which an individual serves as an unpaid officer in a competitive or collaborating organization.

Processes and Procedures

Upon election or appointment to an IPTA position, and on an annual basis thereafter, individuals will be sent a disclosure request with a deadline for completion. Invited speakers or moderators for any IPTA-sponsored activity (including joint sessions with other organizations) will also be sent a disclosure request with a deadline for completion. Failure to complete a conflict of interest disclosure within the appointed time period will result in suspension from the committee/activity until or unless the disclosure is completed and reviewed.

Time Period : Occurring within the past 12 months, or are anticipated to occur within the next 12 months

All relationships or financial interests with healthcare-related entities must be disclosed (e.g. for- profit companies, professional societies, and government-sponsored activities).

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 IPTA and vice versa. 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. Relationship or collaboration with any institution or healthcare-related entities that does not endorse or does not adhere to the principles of the Declaration of Istanbul
  • 15. Other financial benefit
  • 16. 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 submitted to IPTA and reviewed at the subsequent Council meeting. Requests for any interim changes will be made verbally at the beginning of all conference calls and Council meetings.

Review of Disclosures

The IPTA Council or its delegate will review all disclosures. Any delegated reviews will be reported back to Council for approval. The IPTA Council 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 IPTA website. Only the member name, IPTA activity, entity, and relationship will be reported.

Management of Conflict of Interest

Disclosed administrative or financial interests or conflicts will be handled according to the conflict resolution procedures below. Circumstances will dictate whether the interested individual must be excluded from the relevant discussion or educational activity. Individuals may not vote on matters in which they are found to have a potential conflict of interest.

Industry and consultant participation in IPTA 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 IPTA Committees or be elected to the IPTA Council.

Conflict of Interest Resolution

The IPTA Council 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 IPTA Council may request additional information from disclosers for the purposes of clarification. In the event that the IPTA Council recommends that participation be altered, the member will be contacted.

For Committee or Council members, the determination may be that:

  • 1. Disclosure of Information is Sufficient
  • The disclosure itself, and awareness by the Council or committee leadership, is considered sufficient to correct for any bias it might entail. The Council or committee leadership will take the information into account as the discloser participates in decision-making.

  • 2. Recusal
  • In Council 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 leadership of the relevant 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 IPTA. In such an instance, the member must resign his/her leadership position within IPTA but may continue to participate as an IPTA member.

For Educational Activities, the determination may be 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.

All individuals involved in planning or participating in an IPTA educational activity must resolve all conflicts prior to the activity.

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:

  • 1. The name of the individual.
  • 2. The name of the entity.
  • 3. 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 Council 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 Council 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.

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