The following policy is a revision of that first published in 2000. (Johnston KW, Hertzer NR, Rutherford RB, Smith RB 3rd, Yao JS. Joint Council guidelines for disclosure of conflict of interest. J Vasc Surg. 2000 Jul;32(1):213-5.)
The purpose of this document is to provide guidelines for the management of possible conflicts of interest for the SVS leadership. In this document, the “Leadership of the SVS” includes the individuals serving on the Board, Executive Committee of the Board, Councils, committees, task forces, employees, or any other position of leadership.
We review the background principles and suggest approaches that will be helpful in recognizing, avoiding, and dealing with situations that may represent a conflict of interest.
The Importance of a Statement of Ethical Standard
Issues of conflict of interest have assumed greater focus in maintaining trust. The overall goal of establishing standards for managing possible conflicts of interest is to maintain the public confidence in the Society and to protect the stature of the Society by ensuring that the integrity of the decision-making processes by the Leadership of the SVS is not biased by financial or professional interests. It is appropriate to consider how to minimize the influence of real or perceived self-interest.
Definition
Conflict of interest is a circumstance or situation that is present when an individual's primary responsibility of providing unbiased and impartial decisions, judgments, or opinions on behalf of the SVS might be influenced by a secondary factor. There is nothing wrong with having secondary interests, and indeed, it is often desirable to select individuals for appointments who have broad interests or relationships. However, problems arise if the secondary interests (eg, the potential for personal financial profit, professional gain, or academic gain) influence or appear to influence the primary responsibility.
Individuals may be influenced by financial relationships, responsibilities on other Boards or in other organizations, or personal bias. For pragmatic reasons, financial conflicts of interest are often considered to be the most important problem but other responsibilities or personal biases are equally important.
Is conflict of interest present?
Although it may not be possible to precisely identify conflict of interest, the following factors are important to consider in judging if conflict of interest is present: (1) it exists with respect to a specific circumstance or situation; (2) conflict of interest exists in relationship to a role and the duties and moral requirements attached to the role; (3) the greater the potential for personal gain, the greater the concern about the significance of the conflict of interest; and (4) the greater the potential harm, the greater the concern.
Because absolute rules are not possible, an appropriate test of potential conflict is to evaluate whether a decision or actions of the SVS would be considered to be trustworthy and credible if the potential conflict were made known.
Seriousness of the conflict
The severity of a conflict depends on multiple factors. The factors include (1) the importance of the individual's primary role (e.g., the fiduciary responsibility of providing unbiased advice to the SVS); (2) the likelihood that the individual's obligation, actions, views, judgment, or decisions for the SVS will be influenced by secondary factors; and (3) the seriousness of the harm that might result if undue influence is present.
Existing approaches to providing a solution
Law and ethics interact and usually are mutually reinforcing; they are briefly discussed below.
Bioethics
Modern bioethics is based on the principles of beneficence (to do good), non-maleficence (to minimize harm), justice, and patient autonomy.With regards to the actions of the Leadership of the SVS, the principle of justice is the standard against which our efforts in dealing with conflicts of interest can be best be measured.
Law and Guidelines
In establishing a culture for preventing and detecting ethical violations, guidelines have been established by the U.S. Federal Sentencing Guidelines for Organizations (http://www.ussc.gov/1997guid/tabcon97.htm).
It is the responsibility of the Board of the SVS to be certain that mechanisms are in place to create and sustain an ethical environment in the SVS as an organization and within the Board. This would include as a minimum a statement of ethical standards, effective implementation and application of the standards, and regular monitoring, communication, and re-assessment of ethical issues.The conduct of security traders, agents, lawyers in the lawyer/client relationship, and others is governed by a large body of legal opinions and disciplinary rulings by courts and other bodies. In law, the principles of conflict of interest grew out of fiduciary law, specifically the law of trusts where trustees are required to act solely in the interests of the beneficiary. Analogous common law principles could include those related to fiduciary duty, informed consent, negligence, bad faith, kickbacks, and fraud. In many states, statutes apply to the duties of directors and officers of nonprofit corporations. For example, under the Illinois corporation statute governing the SVS, a transaction directly between a corporation and one of its directors is permissible, as long as the substance of the transaction is fair to the corporation at the time it is approved. With respect to the process for establishing fairness, a key element under the Illinois statue is whether the material facts of the transaction and the nature of the director’s separate interest are disclosed to the decision-making body before the decision is made. Another key element is that the vote of the interested director is not to be counted when the decision is made.
In serving the SVS, the Leaders have certain fiduciary obligations: specifically, they must (1) act in the best interest of the SVS, (2) avoid conflict of interest that might bias their decisions, and (3) not compete with the SVS with regards to corporate opportunities.
Principle
The Leadership of the SVS shall avoid conflict of interest between the well-being of the SVS and their own personal financial gain or other responsibilities. This shall apply in fulfilling their obligations, making decisions, and expressing their views on behalf of the SVS.
Two approaches are suggested.
Voluntary recusal
The SVS encourages each individual to exercise character and good judgment to be aware that self-interests may unintentionally bias his or her decisions or actions on certain issues and to voluntarily withdraw himself or herself from discussion of these issues. At each Board, Council, or Committee meeting, the chair will remind the members of the importance of declaring any potential conflict of interest and note that they must recuse themselves from discussion on the relevant agenda item if a conflict exists.Disclosure - Principles regarding disclosure
The following principles (regulations) are not a substitute for openness and integrity but will be useful in managing complex situations that might pose a conflict of interest. With regard to the principles (regulations), the following comments are of note.First, in the development of an approach to prevent a circumstance where there is the perception of a conflict of interest in relationship to an individual carrying out his or her SVS duties, it must be recognized that there may be disagreement on the baseline standard of behavior beyond which it would be considered unsatisfactory. Second, because of the complexity of the ethical situation, categorical rules are not possible: only principles can be established, and they must be applied with discretion. Third, the rules are based on the assumption that disclosure of potential conflicts will help to avoid potential problems. Note that disclosure does not necessarily provide the solution for addressing the potential problem. If the conflict is significant because the individual has substantial secondary interests, the solutions include either abstention from involvement or divestiture of the secondary interests.
Financial interests that should be disclosed
Because of the influence of their positions, the Leadership of the SVS must be particularly sensitive to the issue of actual or perceived conflict of interest. Financial conflict of interest may be present if an individual (or family member) has any of the following relationships with biomedical companies, device manufacturers, or pharmaceutical companies:
- officer, board member, trustee, owner or employee of a company
- owner of stock, stock options, or bonds of a company.
- paid consultancy, scientific advisory committee membership, or lecturer for a company in the last 12 months (Note: Disclosure is not required for an honorarium paid by a university, hospital, or medical society that extends the invitation for a lecture and has received unrestricted funding)
- investigator for a company, including holding research grants from the company
- holder of patent
As noted above, there is nothing wrong if an individual has a major financial interest in a company. However, it is not appropriate for the individual with a financial interest in a company (or a competitive company) to influence the SVS’s position on an issue involving such companies.
Other conflicts that should be disclosed
In practice, non-financial conflicting interests may be equally important e.g., loyalty to more that one organization. Responsibilities to other organizations (e.g., other vascular society or organization) may represent a conflict of interest related to decisions made on behalf of the SVS. Significant personal biases should be acknowledge and disclosed.
Procedure for avoiding conflict of interest, disclosure, and actions
On an annual basis, each member of the Leadership of the SVS will complete a conflict of interest form and submit it to the executive director. The form will ask individuals to list their possible conflicts of interest. During the year, the individual should voluntarily update the information as necessary. The compiled disclosures will be available to the chairs of the Board, Executive Committee, Councils, and Committees on a need-to-know basis.
At each Board, Council, or Committee meeting, the chair will request that all members disclose if they have any potential conflict of interest with items on the agenda. Those with a conflict of interest will not participate in the discussion or vote on the matter. It will usually be appropriate for the individual to leave the room during the discussion and the vote or recuse themselves from a conference call if the meeting is conducted through that method. The minutes will reflect the action taken.
If there is a question on an individual's potential conflict of interest, the chair will make the decision as to recusal. If the chair is perceived to have a potential conflict of interest in relationship to an agenda item, the decision on recusal will be made by a majority vote of all other members present. Members should refrain from accepting SVS responsibilities if they have or are likely to have a financial or other relationship that might impair or appear to impair the member's objectivity.
Sanctions and Appeal
If an individual willfully fails to fully disclose the information requested, he or she will be disqualified from participation in decisions of the SVS for a period of not less than 12 months.
If an appeal is lodged, regarding a conflict of interest decision, a committee consisting of the three most recent past presidents (the chair will be decided by mutual agreement by the three individuals), that have no conflict of interest regarding the issue or the individual in question, will meet to address and suggest solutions to the conflict of interest and will answer an individual's complaints or requests for appeal on a decision related to conflict of interest. This committee's decision may be appealed to the SVS Board.
K. Wayne Johnston MD
Anton N. Sidawy MD
Revised May , 2006