AMERICAN SOCIETY OF NUCLEAR CARDIOLOGY
DISCLOSURE POLICY

Volunteers of the American Society of Nuclear Cardiology (ASNC) contribute to the mission of the organization in various ways. They participate on the Board of Directors, committees, and programs, and deal with issues that have far-reaching implications. ASNC is well served by the fact that many of those involved have diverse interests and are involved in a number of activities outside ASNC. This interest and involvement enhances the expertise these individuals bring to the various roles they fill in representing ASNC.

On occasion, however, situations arise in which an individual serving ASNC in an elected or appointed position has a relationship that could be perceived as a relevant or potential conflict of interest. Generally, a relevant conflict of interest could be said to exist when individuals have material interests outside ASNC that could influence them or could be perceived as influencing them to act contrary to the interests of ASNC and to influence ASNC’s programmatic activity for either their own personal benefit or that of a family member or a business associate. Most often, a relevant conflict of interest is financial, such as when an individual has an employment relationship, a stock ownership interest, a consultative or advisory arrangement, or receives a grant or stipend. In some situations a conflict of interest may exist even though the conflict does not arise out of financial considerations.

A key element in monitoring relevant conflicts of interest, and in avoiding potential conflicts of interest, is a system in which those serving ASNC provide disclosure of their interests. By disclosing such interests to ASNC, ASNC can determine if a conflict is relevant and can determine the steps that should be taken to minimize the likelihood that a conflict would arise. The types of conflicts of interest that should be reported include all of the ones mentioned below. It is the responsibility of each individual to notify ASNC of any changes to his or her annual disclosure. ASNC will re-confirm disclosure information of members who are selected to serve on the planning committee or as a faculty member for an activity.

Disclosure Policy in Relation to Continuing Medical Education Activities

As an Accreditation Council for Continuing Medical Education (ACCME) accredited continuing medical education (CME) provider, ASNC must insure balance, independence, objectivity, and scientific rigor in all of its continuing medical education activities. In order to achieve these goals, we require everyone who is in a position to control the content of an educational activity to disclose to us all relevant financial relationships with any commercial interest. These relationships are those in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (e.g. stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit. Financial benefits are usually associated with roles such as employment, management position, independent contractor (including contracted research), consulting, speaking and teaching, membership on advisory committees or review panels, board membership, and other activities from which remuneration is received or expected. We also consider relationships of the person involved in the CME activity to include financial relationships of a spouse or partner. With respect to personal financial relationships, ‘contracted research’ includes research funding where the institution receives the grant and manages the funds and the person is the principal or named investigator on the grant. Relevant financial relationships are financial relationships with commercial interests in the 12-month period preceding the time that the individual is being asked to assume a role controlling content of the CME activity. In addition, should it be determined that a conflict of interest exists as a result of a financial relationship a planner or a speaker may have, this will need to be resolved prior to the activity.

Dissemination of Disclosure Information

All disclosure information for planners and speakers will be included in the agendas of Education Committee meetings and/or conference calls as well as the agendas of planning conference calls for educational activities. Furthermore, disclosure information for the planners and faculty of educational activities will be shared with the activity’s audience.

In addition, every speaker should begin a formal presentation with a title slide, including speaker name and lecture topic, indicating at the bottom whether or not a relationship exists that might be considered a conflict of interest. This statement must be in appropriate size and color font to be clearly visible at the back of the auditorium.  The statement may be very simple, with wording such as:

            “A relationship [or No relationship] exists that represents a possible conflict of interest with respect to the content of this presentation.”

Resolving Conflicts of Interest

ASNC requires full disclosure of all faculty and committee members who are in a position to control course content before course planning begins. If a conflict is discovered during disclosure, mechanisms are in place to resolve the conflict. Resolution mechanisms may include advance peer review of slides (which will be documented), re-assignment of lecture, limitation of discussion (e.g. no recommendations), speaker attestation of a balanced presentation based on best available evidence, etc.

In rare emergency situations where a last minute speaker substitute is required, and advance disclosure analysis is not possible, ASNC will assign an appropriate person (e.g., moderator) to request this information at the time of presentation, and document that the relevant information was disclosed. The resulting verification documentation will be placed in the activity’s file and must:

(a)    Reflect that verbal disclosure occurred; and
(b)    Include a list of the disclosed information, including disclosure of no relevant relationships

Off-label Indications of Non-FDA approved products

When an unlabeled use of a commercial product, or an investigational use not yet approved for any purpose is discussed during an educational activity, the faculty must disclose that the product is not labeled for the use under discussion or that the product is still investigational.  This information should be included on the slide referenced above and/or mentioned at the time of discussion.

Commercial Bias

It is essential for ASNC and its educational activities to reflect product neutrality. Hence, all ASNC educational activities must reflect balanced content with respect to commercial products. Presentations which discuss commercial products should, to the extent possible, reflect neutrality. Therefore, during presentations, faculty should adhere to the following guidelines to avoid the appearance of commercial bias:

• When referring to pharmaceuticals, cameras and other commercial products, use generic terms and refrain from using trade names, wherever possible. If a single commercial product is highlighted, alternative products should also be discussed.
• Refrain from identification of specific products and/or distributors unless essential to the educational objective.
  

Consequences of Noncompliance

Because this disclosure, either having a relationship or having none, is a requirement of the ACCME, the lack of filing such a statement with ASNC will disqualify a person from participating in an activity either as a planner or a speaker.

Any individual refusing to provide adequate disclosure consistent with this policy will be prohibited from participation in any future ASNC educational activities.

Audit Process

Audience members will be asked to evaluate educational activities for bias. If more than 3 percent of the participants of an activity report perceived bias, a review committee will convene to recommend mechanisms for eliminating the perception of bias in the future. A faculty member’s failure to resolve the perception of bias will result in disqualification from future participation.

ASNC may conduct random post meeting audits, by topic, to ensure presentations were balanced and on site verbal disclosures did not create a perception of bias or a conflict of interest.