For reference purposes at this meeting, all participants are advised of the FDA’s policy governing the disclosure of conflicts of interest. The policy and the written disclosure form are attached to your agenda.
Article I
Purpose
Interested persons (as defined in Article II) shall, at all times, exercise diligent care and unbiased judgment in assuring that no detriment to the FDA results from conflicts between their personal or business interests and those of the FDA. Interested persons act in a representative and fiduciary capacity requiring that they place loyalty to the FDA’s interests above their own personal or business interests.
Another purpose of the conflict of interest policy is to protect the FDA’s status as an IRS tax-exempt organization when it considers a transaction or arrangement that might benefit the private interests of an association leader or result in a possible excess-benefit transaction. This policy supplements but does not replace state and federal laws governing conflict of interest applicable to nonprofit and charitable organizations.
Article II
Definitions
1. Interested Person
Interested persons include any FDA representative and key employee who has a direct or indirect financial interest as defined below.
2. Financial Interest
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 but only if the association Board of Trustees decides after deliberation that one exists. A person has a financial interest that should be disclosed to the Board of Trustees if the person has, directly or indirectly, through business, investment, or family:
a. An ownership or investment interest in any entity with which the association has a transaction or arrangement,
b. A compensation arrangement with the association or with any entity or individual with which the association has a transaction or arrangement, or
c. A potential ownership or investment interest in, or compensation arrangement with, any entity or individual with which the association is negotiating a transaction or arrangement.
For example, a doctor’s participating provider agreement with a managed care organization would not present a potential conflict of interest because the FDA itself does no business with the managed care organization.
3. Compensation
Compensation includes direct and indirect remuneration as well as gifts or favors that are not insubstantial as determined by the Board of Trustees. The Board of Trustees hereby determines that travel reimbursements, stipends and honorariums paid in accordance with the association’s annual budget are not compensation, gifts or favors. If the interested person is in doubt as to whether he or she receives compensation from an entity with which the association does business, he or she should err on the side of caution and disclose the remuneration when completing the annual conflict of interest disclosure form.
Article III
Procedures
1. 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 given the opportunity to disclose all material facts to the Board of Trustees considering the proposed transaction or arrangement. The Board of Trustees shall review interested person’s annual statements as required in Article VI to determine whether an actual or potential conflict of interest exists such that a determination under Article III, paragraph 2 (immediately below) must occur.
2. Determining Whether a Conflict of Interest Exists
After disclosure of the financial interest and all material facts, and after any discussion with the interested person, he/she shall leave the Board of Trustees meeting while the determination of a conflict of interest is discussed and voted upon. If the interested person is a trustee or alternate trustee, the remaining board members shall decide if a conflict of interest exists.
3. Procedures for Addressing the Conflict of Interest
a. An interested person may make a presentation to the Board of Trustees, but after the presentation, he/she shall leave the meeting during the discussion of, and the vote on, the transaction or arrangement involving the possible conflict of interest.
b. The chair of the Board of Trustees shall, if appropriate, appoint a disinterested person or committee to investigate alternatives to the proposed transaction or arrangement involving the interested person.
c. After exercising due diligence, the Board of Trustees shall determine whether the association 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.
d. If a more advantageous transaction or arrangement is not reasonably possible under circumstances not producing a conflict of interest, the Board of Trustees shall determine by a majority vote of the disinterested trustees whether the transaction or arrangement is in the association’s best interest, for its own 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.
4. Violations of the Conflicts of Interest Policy
a. If the Board of Trustees has reasonable cause to believe an interested person has failed to disclose an actual or possible conflict of interest, it shall inform the interested person of the basis for such belief and afford him/her an opportunity to explain the alleged failure to disclose.
b. If, after hearing the interested person’s response and after making further investigation as warranted by the circumstances, the Board of Trustees determines the interested person has failed to disclose an actual or possible conflict of interest, it shall take appropriate disciplinary and corrective action.
Article IV
Records of Proceedings
The minutes of the Board of Trustees shall contain:
a. The names of the persons who disclosed or otherwise were found to have a financial interest that is or may be a conflict of interest, the nature of the financial interest, any action taken to determine whether a conflict of interest was present, and the board’s decision as to whether a conflict of interest in fact existed.
b. The names of the persons who were present for discussions and votes relating to the transaction or arrangement, the content of the discussion, 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 member of the Board of Trustees who receives compensation, directly or indirectly, from the association for services shall not vote on matters pertaining to that member’s compensation.
Article VI
Annual Statements
Each interested person shall annually sign a statement which affirms such person:
a. Has received a copy of the conflicts of interest policy,
b. Has read and understands the policy,
c. Has agreed to comply with the policy, and
d. Understands the association is a tax-exempt organization that must, in order to maintain its federal tax exemption, engage primarily in activities that accomplish one or more of its tax-exempt purposes.
Article VII
Periodic Reviews
To ensure the association operates in a manner consistent with its tax-exempt purpose and does not engage in activities that could jeopardize its tax-exempt status, periodic reviews shall be conducted. The periodic reviews shall, at a minimum, include the following subjects:
a. Whether compensation arrangements and benefits are reasonable, based on competent survey information, and the result of arm’s length bargaining.
b. Whether partnerships, joint ventures, and arrangements with management organizations conform to the association’s written policies, are properly recorded, reflect reasonable investment or payments for goods and services, further tax-exempt purposes and do not result in inurement, impermissible private benefit or in an excess-benefit transaction.
Article VIII
Use of Outside Experts
When conducting the periodic reviews as provided for in Article VII, the association 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.