Standard 3: Identify, Mitigate, and Disclose Relevant Financial Relationships

Key Concept: Verbal Disclosure of financial relationships to provider

Providers may accept verbal disclosure of financial information from those in control of content in accredited CE. Providers must be able to verify for the ACCME that the individual was given the ACCME definition of an ineligible company and was informed that they must disclose all financial relationships with ineligible companies over the 24-month period prior to their involvement in accredited CE.

Definition: Spontaneous case conversations among peers

Spontaneous learning opportunities that previously might not have been considered accredited CE. A few examples are team huddles, well-being check-ins, and impromptu leadership-learning discussions.

Key Concept: Standard 3, exception 2

The exception does not apply to conferences or rounds that have set times and dates and have traditionally been planned as accredited CE. Activities such as regularly scheduled series, department rounds, morbidity and mortality rounds, and tumor boards do not fall under the exceptions. Providers are expected to comply with Standard 3 when planning those activities.

Definition: Nature of the relationship

Related to providing disclosure to learners in Standard for Independence and Integrity 3.5c. The nature of the relationship means the role played or service provided by a person potentially in control of CE content, in exchange for some form of compensation from an ineligible company (e.g., independent contractor including contracted research, consulting, promotional speaking and teaching, membership on advisory committees or review panels and board membership). ACCME has not set a minimum dollar amount for relationships to be disclosed. Inherent in any amount is the incentive to maintain or increase the value of the relationship therefore the dollar value of the relationship does not need to be disclosed.

Definition: “Others in control of educational content” as referenced in Standard 3.1

If someone in connection to the activity has the opportunity to affect the content, they are “in control of content.” Those individuals in a position to control the content of an educational activity might include (but are not limited to):

• Planners
• Faculty
• Authors
• Committee members
• Content reviewers
• Editors
• Staff (depending on the accredited provider’s processes for developing educational activities)
• Providers sometimes make the mistake of only collecting information about financial relationships from faculty or authors but do not collect that information from others, such as committee members, who may be in control of content. This would be a cause of noncompliance.in control of educational content”” as referenced in Standard 3.1 “

Key Concept: Delegation

The provider cannot delegate the responsibility for identifying relevant financial relationship solely to the person with the financial relationship.

Key Concept: Attestation to take action to mitigate a relevant financial relationship

The ACCME considers faculty to be agents of the accredited provider. So, when the provider, after identifying that a financial relationship is relevant, directs teachers/authors to take actions to assist in the mitigation of relevant financial relationships, a provider’s mechanism is implemented. The provider might then monitor the effectiveness of the actions taken by the teachers/authors to mitigate these relationships. Keep in mind that simply monitoring the CME content for commercial bias at the time of presentation is not an acceptable mitigation mechanism.

Key Concept: Approaches to mitigate relevant financial relationships based on role in activity

Some mechanism(s) that providers employ to mitigate relevant financial relationships for authors and speakers do not address the role(s) that planners have in controlling decisions that occur before content is developed for a CME activity. This influence may include choosing topics and faculty for the CME activity. To mitigate the relevant financial relationships of individuals involved in the planning of CME activities, the provider needs to implement mechanisms that ensure independence in the planning process, itself, prior to the development of educational content and instruction. See the Standards for Integrity and Independence in Accredited Continuing Education Toolkit for guidance on mitigating relevant financial relationships.

Key Concept: Mechanisms to obtain disclosure

The ACCME does not require that providers use a disclosure form to collect information about financial relationships of all persons in control of content of an educational activity. A disclosure form is one mechanism that providers may use to obtain (and show that they possess) this information. Signatures of the individual providing information on financial relationships with ineligible companies are not required . Other methods to collect this information could include:

Collecting the information verbally and recording it in a spreadsheet, table, or database
Collecting disclosure information electronically (for example, via e-mail, web-based form, or database)
The ACCME requires accredited providers to obtain information about the financial relationships of all persons in control of content. The obtaining of this information is a key component of the process to ensure the independence of educational activities (see Standard 3). Providers may choose the mechanism(s) to obtain this information that best suit their organizational needs and can be used to demonstrate compliance to the ACCME.

Key Concept: Journal-based CME: Control of content and disclosure

If you are creating a journal-based CME activity, the ACCME does not expect you to identify, mitigate, and disclose to learners the relevant financial relationships of the article’s authors and editors. That process is handled by the journal editors. Disclosure by authors is a standard component of published articles, and the editorial review process manages the mitigation of relevant financial relationships. The accredited provider does, however, need to identify, mitigate, and disclose relevant financial relationships for those involved in planning the journal-based CME activity, e.g., the person(s) choosing the article(s) and/or writing the evaluation mechanism.

The ACCME has two expectations about the publication that issued the article:

The publication cannot be owned by an ACCME-defined ineligible company.
The publication must have in place a process that manages the disclosure of authors, editors, and peer reviewers involved in the process of reviewing and publishing the article. The process must be accepted within the scientific publication community. For example, the publication follows the International Committee of Medical Journal Editors’ (ICMJE) Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (http://www.icmje.org/recommendations/).”

Key Concept: Managing the relationship of an individual who reports stock options with ineligible companies

Individuals who may be in a position to control accredited continuing education are expected to disclose all their financial relationships with ineligible companies within the past 24 months to the provider, including contracts to purchase stock at an agreed-upon price (stock options).

As described in Standard 3, the provider is expected to determine if the relationship, in this case, stock options, is relevant to the educational content. If so, the provider needs to take steps to mitigate the relationship and disclose the relationship to learners.
An individual who holds stock options in an ineligible company is not considered an owner or employee of that ineligible company.

Key Concept: Managing the relationship of an individual who reports stock ownership in an ineligible company

Individuals who may be in a position to control accredited continuing education are expected to disclose all their financial relationships with ineligible companies within the past 24 months to the provider.

Individuals who own stock (not through a mutual fund or pension plan) in privately held ineligible companies are considered owners or employees and therefore must be excluded from controlling content or participating as planners or faculty in accredited CE, unless they meet the exceptions to the exclusion described in Standard 3.2.
Individuals who own stock in publicly traded ineligible companies are not considered owners or employees. As described in Standard 3, the provider is expected to determine if the relationship is relevant to the educational content. If so, the provider needs to take steps to mitigate the relationship and disclose the relationship to learners.