Disclosure

Disclosure Policy

Background

It is the policy of ImproMED to ensure balance, independence, objectivity, and scientific rigor in all of our individually sponsored educational activities. All faculty members participating in ImproMED sponsored activities are expected to disclose all relevant financial relationships with any commercial interest. The Accreditation Council for Continuing Medical Education (ACCME) defines relevant financial relationships as “financial relationships in any amount occurring within the past 12 months that create a conflict of interest.” The ACCME considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner.

Policy

Any individual who refuses to disclose relevant financial relationships will be disqualified from being a planning committee member, a teacher/faculty member, advisor, or an author of CME, and cannot have control of, or responsibility for, the development, management, presentation, or evaluation of the CME activity. False disclosure or inability to work with ImproMED to resolve an identified conflict of interest will result in withdrawal of the invitation to participate and replacement of the individual for the activity.

Faculty members need to disclose relationships with a commercial interest if both:

The relationship is financial and occurred within the past 12 months and
The individual has the opportunity to affect the content of CME about the products or services of that commercial interest.

Financial relationships are those relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (eg, 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 for which remuneration is received or expected. The ACCME considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner. The ACCME has not set a minimum dollar amount for relationships to be significant. Inherent in any amount is the incentive to maintain or increase the value of the relationship.

Our intent is not to prevent individuals from participating, but rather is to identify and resolve any potential conflicts of interest. It is intended that any relationship(s) should be identified openly so that the learners may form their own judgments about the presentation with full disclosure of the facts. It remains for the audience to determine whether the speaker’s relationship(s) may reflect a possible bias in either the exposition or the conclusions presented. Please note: disclosure information will be printed on participant/enduring material.

Disclosure of Unlabeled/Investigational Uses of Products

Policy

Discussion of off-label uses is allowed in CME activities. Faculty must disclose to ImproMED and the learners when an unlabeled use of a commercial product, or an investigational use not yet approved for any purpose, is discussed during an educational activity. Faculty must disclose that the product is not labeled for the use under discussion or that the product is still investigational.

The intent of this policy is not to prohibit or limit the exchange of views in scientific and educational discussions, including discussions of unapproved uses, but to ensure that faculty discloses to learners that such discussion will take place.

Should an unplanned discussion of unlabeled or investigational uses of a product occur (usually in the course of a question and answer session), it is the responsibility of the faculty member to inform the learners that the use under question/discussion is unlabeled or investigational prior to answering the question or responding to the discussion point.

Acknowledgement of planned discussion of unapproved or investigational uses of products must be presented in writing to the learners prior to the start of the activity, or (for enduring materials) at the point that first mention is made of the unapproved/investigational use in the activity.

The ACCME adopted content validation statements in 2002 that outline expectations of providers with regard to any recommendations for clinical care. Specifically, “all the recommendations involving clinical medicine in a CME activity [are] based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients. All scientific research referred to, reported or used in CME in support or justification of a patient care recommendation [conforms] to the generally accepted standards of experimental design, data collection and analysis.” ImproMED requires its faculty to adhere to these content expectations.