Definitions Relevant to Disclosure and Commercial Support

Agent: A company acting for a manufacturer in a promotional activity is an agent. An accredited ACCME provider is not an agent for a manufacturer.

Commercial interest: Any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.

Commercial support: Any financial or in-kind contributions given by a commercial interest which is used to pay all or part of the costs of a CME activity. Funds paid by commercial interests for exhibits and advertisements are separate promotional activities, and are not CME. Therefore they must be kept separate from the funding of CME and are not considered to be “commercial support.”

Conflict of interest (COI): Circumstances create a COI when a planner, speaker or author or spouse/partner has both a current financial relationship with a commercial interest and the opportunity to affect content relevant to products or services of that commercial interest. The conflict occurs when there is a divergence between an individual's private interests and his or her professional obligations such that an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal gain, financial or otherwise. A conflict of interest depends on the situation, and not on the character or actions of the individual.

Content of Continuing Medical Education (CME): Content of CME about the products or services of a commercial interest includes content about specific agents/devices, but not necessarily about the class of agents/devices, and not necessarily content about the whole disease class in which those agents/devices are used.

Expert testimony is any testimony in a legal or regulatory setting, such as a malpractice case or FDA hearing, relating to the drugs, products, or services that are the subject of the content of CME under consideration.

Financial relationships are those relationships in which you, your spouse/partner, or your organization benefit 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.

Honoraria received in the past 12 months from relevant entities should be included. Honoraria paid by independent institutions or organizations, not by the commercial entity, do not have to be disclosed if the institution or organization selection process was independent of the financial support.

Other leadership positions such as Officer or Director, consultant, review panel member and advisory positions for an entity relevant to the content of CME under consideration are included and should be disclosed.

Other remuneration includes trips, travel, gifts, or other in-kind payments not directly related to research activities and were received from a relevant entity.

Relevant financial relationships are financial relationships in any amount occurring within the past 12 months that create a conflict of interest. Any entities having an investment, licensing, or other commercial interest in any drugs, products, patents, or services that are the subject of the matter under consideration are relevant. For further information, see: honoraria, stock ownership, research funding, other leadership positions, expert testimony, and other remuneration.

Research funding includes any payments in connection with the conduct of the clinical research projects in question provided by the trial sponsor or any agents employed by the trial sponsor. This includes contracted research in which the institution receives the grant and manages the funds and for which you or your partner are the principal or named investigator on the grant. Authors of studies funded by the tobacco industry or a foundation funded by the tobacco industry must declare such support.

Spouse/life partner is defined as someone with whom you have a relationship involving the sharing of income or assets.

Stock ownership includes any ownership interest in a start-up company, the stock of which is not publicly traded, or in any publicly traded company (except when invested in a diversified fund not controlled by you or a spouse/life partner) where the entity has an investment, license, or other commercial interest in any drugs, products, or services that are the subject of the content of CME under consideration.