Standard 3: Identify, Mitigate, and Disclose Relevant Financial Relationships
Standard 3 applies to all accredited continuing education.
Many healthcare professionals have financial relationships with ineligible companies. These relationships must not be allowed to influence accredited continuing education. The accredited provider is responsible for identifying relevant financial relationships between individuals in control of educational content and ineligible companies and managing these to ensure they do not introduce commercial bias into the education. Financial relationships of any dollar amount are defined as relevant if the educational content is related to the business lines or products of the ineligible company.
Accredited providers must take the following steps when developing accredited continuing education. Exceptions are listed at the end of Standard 3.
1. Collect information: Collect information from all planners, faculty, and others in control of educational content about all their financial relationships with ineligible companies within the prior 24 months. There is no minimum financial threshold; individuals must disclose all financial relationships, regardless of the amount, with ineligible companies. Individuals must disclose regardless of their view of the relevance of the relationship to the education. Disclosure information must include:
a. The name of the ineligible company with which the person has a financial relationship.
b. The nature of the financial relationship. Examples of financial relationships include employee, researcher, consultant, advisor, speaker, independent contractor (including contracted research), royalties or patent beneficiary, executive role, and ownership interest. Individual stocks and stock options should be disclosed; diversified mutual funds do not need to be disclosed. Research funding from ineligible companies should be disclosed by the principal or named investigator even if that individual’s institution receives the research grant and manages the funds.
2. Exclude owners or employees of ineligible companies: Review the information about financial relationships to identify individuals who are owners or employees of ineligible companies. These individuals must be excluded from controlling content or participating as planners or faculty in accredited education. There are three exceptions to this exclusion—employees of ineligible companies can participate as planners or faculty in these specific situations:
a. When the content of the activity is not related to the business lines or products of their employer/company.
b. When the content of the accredited activity is limited to basic science research, such as pre-clinical research and drug discovery, or the methodologies of research, and they do not make care recommendations.
c. When they are participating as technicians to teach the safe and proper use of medical devices, and do not recommend whether or when a device is used.
3. Identify relevant financial relationships: Review the information about financial relationships to determine which relationships are relevant. Financial relationships are relevant if the educational content an individual can control is related to the business lines or products of the ineligible company.
4. Mitigate relevant financial relationships: Take steps to prevent all those with relevant financial relationships from inserting commercial bias into content.
a. Mitigate relationships prior to the individuals assuming their roles. Take steps appropriate to the role of the individual. For example, steps for planners will likely be different than for faculty and would occur before planning begins.
b. Document the steps taken to mitigate relevant financial relationships.
5. Disclose all relevant financial relationships to learners: Disclosure to learners must include each of the following:
a. The names of the individuals with relevant financial relationships.
b. The names of the ineligible companies with which they have relationships.
c. The nature of the relationships.
d. A statement that all relevant financial relationships have been mitigated.
Identify ineligible companies by their name only. Disclosure to learners must not include ineligible companies’ corporate or product logos, trade names, or product group messages.
Disclose absence of relevant financial relationships. Inform learners about planners, faculty, and others in control of content (either individually or as a group) with no relevant financial relationships with ineligible companies.
Learners must receive disclosure information, in a format that can be verified at the time of accreditation, before engaging with the accredited education.
Exceptions: Accredited providers do not need to identify, mitigate, or disclose relevant financial relationships for any of the following activities:
1. Accredited education that is non-clinical, such as leadership or communication skills training.
2. Accredited education where the learner group is in control of content, such as a spontaneous case conversation among peers.
3. Accredited self-directed education where the learner controls their educational goals and reports on changes that resulted, such as learning from teaching, remediation, or a personal development plan. When accredited providers serve as a source of information for the self-directed learner, they should direct learners only to resources and methods for learning that are not controlled by ineligible companies.