Identification, Mitigation, and Disclosure of Relevant Financial Relationships in CME
The Standards for Integrity and Independence in Accredited Continuing Education are designed to ensure that accredited continuing education serves the needs of patients and the public, is based on valid content, and is free from commercial influence. The Standards were released in December 2020, replacing the Standards for Commercial Support: Standards to Ensure Independence in CME Activities.
What We Require Our Activity Director's To Do
As an ACCME accredited provider of CME, the UConn CME program is committed to ensuring fair balance, independence, objectivity, and scientific rigor in all its sponsored programs. As such, Activity Directors of all UConn CME activities are required to ensure the identification and resolution of any concerns with regard to integrity and independence.
Key Steps in Identification, Mitigation, and Disclosing
Collect information from all planners, faculty, and others who will be in positions to control content. Ask them to provide information about all their financial relationships with ineligible companies over the previous 24 months; Review the disclosed relationships; Determine which financial relationships are relevant to the content of the continuing education activity, mitigate those relevant financial relationships.
Refer to: Key Step Info Sheet
Speaker Presentation Slides or Materials
Presentations must not use logos or trademarks, although factual references to companies, products and services in generic font are permitted; however, educational materials that are part of a continuing medical education activity cannot contain any advertising, trade names or product group messages. This especially applies to speakers who are from an ineligible company (as defined below).
Owners and Employees of ineligible companies
ACCME clearly defined that you must 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:
- When the content of the activity is not related to the business lines or products of their employer/company.
- 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.
- 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.
Refer to: ACCME Standard 3
CRITERIA FOR DISCLOSURE OF FINANCIAL RELATIONSHIPS
UConn School of Medicine considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner. Conflict of interest applies to any speaker, moderator, facilitator, activity director, peer reviewer, planner, activity administrator or any other individual who are involved in the planning, implementation, or evaluation of the CME activity.
In accordance with ACCME and UConn CME guidelines, instructors, planners, and managers who affect the content of a CME activity are required to disclose financial relationships they have with ineligible companies. Circumstances create a conflict of interest when an individual has an opportunity to influence continuing medical education (CME) content about products or services of a commercial interest (e.g., pharmaceutical company, medical device manufacturer) with which she/he has a financial relationship.
An “Ineligible company” is any entity producing, marketing, selling, re-selling, or distributing healthcare products/services used by or on patients. (For specific examples of ineligible companies visit acme.org/standards) 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. When a person divests her/himself of a relationship with an ineligible company, it is no longer considered a conflict of interest, but it must be disclosed to the learners for 24 months. Relationships with governmental agencies (e.g., the NIH) and organizations that do not fit the above definition do not have to be disclosed. In accordance with ACCME requirements, failure, or refusal to provide disclosure information in a timely manner will result in the disqualification of any CME approvals.
Resources for you to use
Resource: UConn Declaration of Disclosure Form
For questions regarding this new standard, please contact the CME Office at 860-679-4590 or email@example.com.