Conflict of Interest Policy
Article I Purpose
The purpose of the present conflict of interest policy is to protect the integrity and reputation of the International Society for CNS Clinical Trials and Methodology, Inc. (hereafter “the Organization”) and prevent the occurrence of any action taken which may result in or create the appearance of:
- Giving preferential treatment to a person or an organization.
- Using an office in the ISCTM for personal gain.
- Acting with less than complete impartiality or independence.
- Adversely affecting the confidence of the membership, regulatory agencies, patients, patient advocacy organizations, or the general public in the Organization.
When the Organization is contemplating entering a transaction, an arrangement, a presentation, or a poster presentation that might benefit the private interest of an officer or committee member of the Organization, there is potential for conflict of interest. Conflict of interest might also result in a possible excess benefit transaction.
This policy is intended to supplement but not replace any applicable law or regulation governing conflict of interests relevant to nonprofit and charitable organizations.
Article II Definitions
- Interested Person: Any director, principal officer, committee member, or working group chair with governing board delegated powers, who has a direct or indirect financial interest, as defined below, is an interested person. Any member at large of the Organization or a non-member expert when engaged in ISCTM-specific events, projects, or programs is an interested person.
- Financial Interest: A person has a financial interest if the person has directly or indirectly, through business, investment, or family:
- An ownership or investment interest in any entity with which the Organization has a transaction or arrangement,
- A compensation arrangement with the Organization or with any entity or individual with which the Organization has a transaction or arrangement, or
- A potential ownership or investment interest in, or compensation arrangement with, any entity or individual with which the Organization is negotiating a transaction or agreement.
- A potential ownership or investment interest in, or compensation arrangement with, any entity or individual with which the Organization has scientific interactions where the individual with the claim is in a position to have potential influence on the exchange in a capacity in which they act on behalf of the Society (examples of the potential impact on interactions include review/approval of scientific content for an ISCTM function, determination of participants in a scientific process, and decisions by a Society committee or working group, etc.)
Compensation includes direct and indirect remuneration and gifts or favors that are not insubstantial. Compensation may be monetary or non-monetary.
A financial interest is not necessarily a conflict of interest. Under Article III, Section 2. a person who has a financial interest may have a conflict of interest only if the appropriate governing board or committee decides that a conflict of interest exists.
Article III Procedures
- When a concern about possible conflicts of interest is referred to the executive committee, the executive committee shall determine if there is reasonable cause to believe there has been a serious violation of the conflict of interest. In such cases, the executive committee or a committee appointed by the executive committee will act as the governing board charged with reviewing the alleged conflict of interested.
- Duty to Disclose: In connection with any actual or possible conflict of interest, an interested person must disclose the existence of the financial interest and be allowed to disclose all material facts to the directors and members of committees with governing board delegated powers considering the proposed transaction or arrangement. Disclosure statements for members of the Executive, Scientific, Finance, and Poster Committees and Working Group Chairs shall be provided by the Secretariat to the appropriate committee chair.
- Determining Whether a Conflict of Interest Exists: After disclosing the financial interest and all material facts, and after any discussion with the interested person, they shall leave the governing board meeting when the determination of a conflict of interest is being discussed and voted upon. The remaining governing board members shall decide if a conflict of interest exists.
- Procedures for Addressing the Conflict of Interest:
- An interested person may present the perceived conflict at the governing board meeting. After the presentation, they shall leave the meeting during the discussion of, and the vote on, the transaction or arrangement involving the possible conflict of interest.
- The chairperson of the governing board shall, if appropriate, appoint a disinterested person or committee to investigate alternatives to the proposed transaction or arrangement.
- After exercising due diligence, the governing board or committee shall determine whether the Organization can obtain with reasonable efforts a more advantageous transaction or arrangement from a person or entity that would not give rise to a conflict of interest.
- If a more advantageous transaction or arrangement is not reasonably possible under the circumstances not producing a conflict of interest, the governing board or committee shall determine by a majority vote of the non-conflicted directors whether the transaction or arrangement is in the Organization’s best interest, for its benefit, and whether it is fair and reasonable. In conformity with the above determination, it shall decide whether to enter into the transaction or arrangement.
- Conflict of interest or potential conflict of interest may, following disclosure, also be addressed by recusal from a potentially conflicted process or decision.
- If the governing board has reasonable cause to believe a member has failed to disclose actual or possible conflicts of interest: In that case, it shall inform the member of the basis for such belief and allow the member to explain the alleged failure to disclose.
- When the governing board has reasonable cause to believe there has been a violation of the conflict of interest: In that case, it shall inform the member of the basis for such belief and allow the member to explain the alleged infringement. Violations may include any action which might result in or create the appearance of:
- giving preferential treatment to any organization or person
- using one’s office or position for personal gain
- adversely affecting the confidence of the Organization’s membership, regulatory agencies, patients, patient advocacy organizations, or the public in the Organization
- If, after hearing the member’s response and after making further investigation as warranted by the circumstances, the governing board determines the member has failed to disclose a material actual or possible conflict of interest or has violated the conflict of interest policy, it shall take appropriate disciplinary and corrective action, up to or including termination of membership and notification of other concerned parties.
Article IV Records of Proceedings
The minutes of the governing board meeting and meetings of all committees with board delegated powers shall contain:
- The names of the persons who disclosed or otherwise were found to have a financial interest in connection with any actual or possible conflict of interest, the nature of the financial interest, any action taken to determine whether a conflict of interest was present, and the governing board’s decision as to whether a conflict of interest existed.
- The names of the persons present for discussions and votes relating to the transaction or arrangement, the content of the meeting, including any alternatives to the proposed transaction or arrangement, and a record of any votes taken in connection with the proceedings.
Article V Compensation
- A voting member of any committee who receives compensation, directly or indirectly, from the Organization for services is precluded from voting on matters related to that member’s compensation.
- A voting member of any committee whose jurisdiction includes compensation matters and who receives compensation, directly or indirectly, from the Organization for services is precluded from voting on issues about that member’s compensation.
Article VI Annual Statements
Each director, principal officer, and member of a committee with governing board delegated powers shall annually sign a statement that affirms such person:
- Has received a copy of the conflicts of interest policy,
- Has read and understands the policy,
- Has agreed to comply with the policy, and
- Understands the Organization is charitable. To maintain its U.S. federal tax exemption, it must engage primarily in activities that accomplish one or more of its tax-exempt purposes.
Article VII Periodic Reviews
To ensure the Organization operates consistently with charitable purposes and does not engage in activities that could jeopardize its tax-exempt status, periodic reviews shall be conducted. The systematic reviews shall, at a minimum, include the following subjects:
- Whether ISCTM’s compensation arrangements and benefits are reasonable, based on competent survey information, and the result of arm’s length bargaining.
- Whether partnerships, joint ventures, and arrangements with management organizations conform to ISCTM’s written policies, are properly recorded, reflect reasonable investment or payments for goods and services, further charitable purposes, and do not result in inurement, impermissible private benefit, or an excess benefit transaction.
Article VIII Use of Outside Experts
When conducting the periodic reviews as provided for in Article Vll, the Organization may, but need not, use outside advisors. If outside experts are used, their use shall not relieve the governing board of its responsibility for ensuring periodic reviews are conducted.
Acceptance and Disclosure Form (to be completed by Executive, Scientific, Finance and Poster Committee members and Working Group Chairs)
Revised 20 June 2022