(From the Continuing Medical Education Policy Manual)
In order for the AAFPRS Foundation to further its academic and educational mission, its continuing medical education (CME) activities must be in compliance with the AAFPRS Foundation policy on Disclosure. No program or event should be unduly influenced by any special interest of individuals associated with the activity. Therefore, it has always been and continues to be important to identify actual or potential conflicts of interest that might improperly affect CME activities. Individuals involved in the CME activities of the AAFPRS Foundation also have significant roles in other professional, business, and personal settings and relationships. As these settings and relationships become increasingly varied and complex, informal means of identifying actual or potential conflicts of interest become increasingly inadequate. Therefore, a more formal system for the disclosure and evaluation of possible conflicts of interest has been adopted by the AAFPRS Foundation.
These procedures seek to address interests in commercial companies that may conflict with responsibilities associated with CME activities. Responsibilities associated with CME activities include: (1) the determination of educational activities to be offered; (2) the selection of specific topics and individuals to present or author information; (3) the actual presentation of information that is objective, complete, and balanced. Financial relationships with commercial companies could conflict with these responsibilities when the company’s products or services are related to the content of the CME activity. Types of potentially conflicting relationships with such companies include (but are not limited to): receiving payment from the company to plan the CME activity or present information at the CME activity, receiving payment from the company to participate in other educational activities, directly receiving research funds from the company, receiving fees from the company for consulting, owning directly purchased stock (rather than independently managed stock portfolios) in the company, receiving items of value from the company, and other financial or material ties to such a company. The procedures are primarily concerned with potential conflicts of interest directly involving individuals responsible for aspects of CME activities. However, these individuals may also be placed in potential conflict of interest when they benefit from jointly shared income from spouses, business partners, or others who have financial relationships with companies whose products or services are related to the CME activity.
The cornerstone of the procedures regarding possible conflicts of interest is the principle that, in most cases, disclosure of the conflicting or potentially conflicting interest will itself suffice to protect the integrity of CME activities. In other words, once such an interest is fully disclosed to the other participants in the CME activity, the other participants will generally be able to evaluate and adjust for the possible influence of the disclosed interest. In the few situations where mere disclosure does not appear adequate to deal with actual or potential problems, additional action may be necessary.
Individuals associated with a CME activity include the course faculty (or authors of enduring materials), the course director and planning committee, and the director of CME. The Disclosure Policy requires that individuals be informed of the policy at or shortly following the time of their initial involvement with a CME activity. The individuals will be asked to disclose interests with commercial companies that potentially conflict with their participation in the CME activity.
Disclosure declarations will be made in advance of the activity to the Office of CME. All participants in the planning and implementation of a CME program must disclose possible conflicts of interest. At the activity, disclosure will also be made to people attending the activity (or using the educational materials) through either written information or verbal announcement, the specific procedure to be determined in planning the CME activity.
Full disclosure is expected to resolve most problems of conflict of interest. A few situations may call for action beyond disclosure. For example, the remuneration received from a company may be so much greater than norms for professional services that the propriety of the relationship and the speaker’s ability to present information objectively is doubtful. No special procedures for handling unusual situations have been adopted. Rather, the course director, director of CME, and supervisor(s) of the director of CME have the basic authority to initiate special procedures appropriate to special situations disclosed to them by individuals they supervise in regard to the CME activity.
Failure of an individual associated with a CME activity to provide a statement regarding conflict of interest violates this policy and will require the Office of Continuing Medical Education to request a replacement be identified and/or deny certification of the program for Category 1 credit. Providing a false or misleading statement regarding conflict of interest is a serious violation of professional ethics. Occurrence or allegations will be handled through the established procedures for dealing with issues of professional misconduct. If an important conflict of interest is identified following a CME activity, the director of CME will determine whether participants should be informed of this conflict of interest by mail.
To function satisfactorily, this system will depend on everyone associated with the AAFPRS Foundation’s CME activities understanding the purpose of proper disclosure and the types of circumstances that call for disclosures. The purpose of the procedure is not to discourage individuals associated with CME activities from involvement in activities that might produce actual or potential conflicts with CME activities. Neither is the objective to intrude into aspects of an individual’s professional nor personal life that are, realistically, unlikely to have any significant bearing on CME activities. One reasonable test to guide all decisions about what to disclose is whether a particular circumstance, interest, or relationship, if made known to other professionals or to the general public, would be likely to cause embarrassment to the AAFPRS Foundation and/or the individual involved or evoke suspicion about motives affecting the content of the CME activity.