The purpose of this document is to describe guidelines for disclosure of possible conflicts of interest for (1) SVS/ISCVS executive councils, committee members, and appointees and (2) organized educational meetings. 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.

Background

Why important

Issues of conflict of interest have assumed greater focus in maintaining trust. With the establishment of these standards for disclosure of possible conflicts of interest, the overall goal is to protect the integrity of the decision-making processes of the councils and their committees; to assure the members that the selection, presentation, and publication of scientific work are not biased by competing financial issues; to maintain the public confidence in the Societies; and to protect the stature of the Societies.

Because decisions by the councils and their committees and the “integrity” of a presentation at our meetings may be biased by a member's 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 if an individual's primary responsibility (eg, obligations, actions, views, judgment, or decisions) might be influenced by secondary factors (eg, the potential for personal financial profit, professional competition, academic gain, or personal opinions or biases). There is nothing wrong with having secondary interests, and indeed, it is often desirable to select individuals for appointments or for presentations who have broad interests or relationships. However, problems arise if the secondary interests influence or appear to influence the primary responsibility (eg, the obligation for unbiased patient care, the integrity of research, or the importance of making impartial decisions on behalf of a society).

For pragmatic reasons, primarily financial conflicts of interest are considered. However, it is acknowledged that individuals may also be influenced by nonfinancial factors such as personal bias.

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 applies 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.1 Because absolute rules are not possible, an appropriate test of potential conflict is to evaluate whether a decision or actions 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 interest (eg, patient's welfare or integrity of research is paramount and should not be weakened); (2) the chance that the individual's obligation, action, views, judgment, or decisions will be influenced by secondary factors; and (3) the seriousness of the harm that might result if conflict of interest is present.

Existing approaches to providing a solution

Law and ethics interact and usually are mutually reinforcing; they are briefly discussed below.1

Law

The conduct of lawyers in the lawyer/client relationship, security traders, agents, and others is governed by a large body of legal opinions and disciplinary rulings by courts. 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. Applicable common law principles could include those related to fiduciary duty, informed consent, negligence, bad faith, kickbacks, and fraud. State statutes apply to officers of nonprofit corporations and to a corporate official's conflicts of interest.

Bioethics

Modern bioethics is based on the principles of beneficence (to do good), nonmaleficence (to do no harm), justice, and patient autonomy. Because of the imbalance of power between physicians and patients, preserving justice is an altruistic goal and a standard against which our efforts in dealing with conflicts of interest with regard to any patient matter can be measured. This could relate to the development of practice guidelines, the appointment of committees, and the presentation of scientific work.

Professional standards

Although many societies have codes of ethics, few have specific standards related to conflicts of interest or procedures for evaluating potential conflicts of interest or defined sanctions and appeal mechanisms for violations. Only in 1986 did the American Medical Association advise physicians to resolve all conflicts of interest in favor of patients, and more recently, the American Heart Association has published Conflict of Interest Standards.2

POLICY FOR SVS/ISCVS

Policy for dealing with conflict of interest in administrative matters

Principle

All council members, committee members, the editors of the Journal of Vascular Surgery, and other appointees or employees of the SVS/ISCVS shall avoid conflict of interest between the well-being of the Societies and their own personal financial gain in fulfilling their obligations, making decisions, and expressing their views on behalf of the Societies.

Two approaches

Two approaches are suggested.

Voluntary exemption

The Societies encourage each individual to exercise the character and good judgment to be aware that self-interests may unintentionally bias his or her decisions or actions and to voluntarily exempt himself or herself from discussion of these issues. At each committee meeting, the chair will remind the members of the importance of declaring any potential conflict of interest and note that they must exempt themselves from discussion on the agenda item.

Regulations regarding disclosure

The following regulations are not a substitute for openness and integrity but will be useful in managing complex situations that pose a conflict of interest. With regard to 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 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 identify potential problems. Note that disclosure does not provide the solution for addressing the potential problem. If the conflict is significant, the solutions include either abstention from involvement if the individual has substantial secondary interests or divestiture of the secondary interests.

Financial conflicts that should be disclosed

Because of the influence of their positions, council members, committee members, and editors 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 a bond holder (including immediate family)

•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 the 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 Societies' position on an issue that might have an impact on the company or a competitive company.

Procedure for avoiding conflict of interest, disclosure, and actions

On an annual basis, members of the SVS/ISCVS Council, members of committees, and editors of the Journal of Vascular Surgery 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 Council meetings and chairs of the committee meetings on a need-to-know basis.

At each 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. 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. If the chair is perceived to have a conflict of interest in relationship to an agenda item, the decision will be made by a vote of all members present. Members should refrain from accepting committee responsibilities if they have or are likely to have a financial relationship that might impair or appear to impair the member's objectivity.

In the case of editors of the Journal of Vascular Surgery, full disclosure of potential conflicts of interest is required before appointment, and annual disclosure is required. Because of their position, the editors must be particularly sensitive to the issue of actual or perceived conflicts of interest. It may be necessary for the individuals to divest themselves of certain investments or holdings or place them in a blind trust.

Sanctions

If an individual willfully fails to fully disclose the information requested, he or she will be disqualified from participation in administrative decisions of the SVS/ISCVS for a period of not less than 12 months.

Policy for dealing with conflict of interest in the educational program

Principle

At SVS/ISCVS–sponsored programs, the audience should be informed of the author's potential conflict of interest, which might have unconsciously biased decisions in the design, implementation, analysis, or discussion of the research. Through disclosure, competitive interests are made transparent; consequently, the readers can assess the magnitude of the competition and add this to their overall interpretation of the published work.

Organization of educational programs

The following comments relate to educational programs and not to specific training in the use of a medical device:

•Educational programs sponsored by the SVS/ ISCVS must be free from industrial interference and influence. Specifically, the Societies must have full control over the scientific content of any pro- gram and selection of the presenters. Explicit endorsement of a sponsor's product must be avoided.

•The individuals organizing a symposium that is sponsored by the SVS/ISCVS, but funded by a company, should not have a financial relationship with the company.

•Expenses and honoraria for specific individual speakers at SVS/ISCVS–sponsored meetings can- not be supported by a specific company.

•Negotiations for space at SVS/ISCVS–sponsored meetings should not be influenced by industry sponsorship.

Presenters' disclosure

For papers selected for presentation, the senior author is responsible for completing a conflict of interest statement on behalf of all authors. Similarly, invited presenters and discussants will complete a conflict of interest statement. The Societies require that the financial relations between presenters and companies be disclosed to the audience.3, 4, 5

Sanction

If an individual willfully fails to fully disclose the information requested, he or she will be disqualified from participation in educational programs sponsored by the SVS/ISCVS for a period of not less than 12 months.

Appeal on decision related to conflict of interest

As necessary, a committee consisting of the past two presidents from each Society (the chair will be decided by mutual agreement by the four individuals) will meet to address questions of conflict of interest. As necessary, it will review and suggest solutions to conflict of interest of potential appointees to Council, committees, and editorial positions on the Journal of Vascular Surgery 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 Joint Council.

References

1. 1 Shimm DS, Spece RG. Chapter 1, Introduction. In: Spece RG, Shimm DS, Buchanan AE editor. Conflicts of interest in clinical practice and research. New York: Oxford University Press; 1998;.

2. 2 Rodwin M. Medicine, money & morals: physicians' conflicts of interest. 1993;.

3. 3 Physicians and the pharmaceutical industry. American College of Physicians. Ann Intern Med. 1990;112:624–626. MEDLINE

4. 4 Guidelines for commercial support of continuing medical education. ACCME; March 16, 1991; approved.

5. 5 Gifts to physicians from industry. JAMA. 1991;265:501; AMA Council on Ethical and Judicial Affairs. MEDLINE

☆ J Vasc Surg 2000;32:213-5.

PII: S0741-5214(00)69260-1

doi:10.1067/mva.2000.107867

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