How do we Identify and Mitigate Relevant Financial Relationships?

Content courtesy of the ACCME

An important part of FCM’s process to protect the integrity of accredited continuing education (CE) is determining when those who can control the content of CE have financial relationships that would allow them to insert commercial bias or influence into the education.  We take steps to prevent all those with relevant financial relationships from inserting commercial bias into content.  This is called mitigation.

CONSIDER EVERYONE WHO CAN CONTROL THE CONTENT

Review financial relationship disclosures before those who can control the content of accredited continuing education assume their role.  This includes:

• Planners: planning committee, CE staff, editors and /or activity directors
• Faculty presenters: speakers, panelists, instructors, trainers, coaches or educational consultants
• Authors: writers, editors, instructional designers, content developers, educational researchers, CE staff
• Reviewers: peer reviewers, editors or CE staff

EXCLUDE OWNERS AND EMPLOYEES

First we exclude owners and employees of ineligible companies from controlling content or participating as planners or faculty in accredited continuing education.

Owners and employees of ineligible companies have a legal duty to act in their company’s best interests.  They are considered to have unresolvable financial relationships and must not be allowed to influence of control planning, delivery or evaluation of accredited CE.

3 EXCEPTIONS THAT ALLOW OWNERS AND EMPLOYEES TO PARTICIPATE AS PLANNERS OR FACULTY

1. The content of the CE is not related to the business lines or products of their employer/company
2. Content of the CE is limited to basic science research (e.g. pre-clinical research and drug discovery), methodologies of research, and no care recommendations are given
3. Participating as technicians to teach the safe and proper use of medical devices, do not recommend whether or when a device is used.

IS THE FINANCIAL RELATIONSHIP RELATED TO THE CONTENT

Determine if the educational content the person can control is related to the business lines or products of the ineligible company with whom they have a financial relationships.

Would the person’s role in the CE activity allow them to insert commercial bias into the content?

Is the content of the CE activity that the person can control related to the products or business lines of the ineligible company?

MITIGATE RELEVANT FINANCIAL RELATIONSHIPS

Before a person assumes their role in the CE activity, take steps to mitigate by preventing all those with relevant financial relationships from inserting commercial bias into the content.

PLANNERS AND REVIEWERS

Making decisions related to the scope and direction of the content, educational goals, identification of practice gaps and needs, selecting speakers, authors, reviewers.  If a planner or reviewer discloses a financial relationship, here are options that can be considered to mitigate the relationship.

• End the financial relationship (including having ended the relationship within 24 months)
• Recuse individual from controlling aspects of planning and content with which there is a financial relationship
• Peer review planning decisions and review determinations by persons without relevant financial relationships

FACULTY, TEACHERS, AUTHORS

This is teaching, writing, producing and delivering education

• End the financial relationship (including having ended the relationship within 24 months)
• Recuse individual from controlling aspects of planning and content with which there is a financial relationship
• Peer review of content by persons without relevant financial relationships
• Attest that clinical recommendations are evidence-based and free of commercial bias (e.g., peer-reviewed literature, adhering to evidence-based practice guidelines)

DISCLOSE TO LEARNERS

Before learners engage in the accredited CE, disclose all relevant financial relationships to learners

Disclosure to learners includes:

• The names of the individuals with relevant financial relationships
• The names of the ineligible companies with which they have relationships
• The nature of the relationships
• A statement that all relevant financial relationships have been mitigated
• The absence of relevant financial relationships (if applicable)