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What is a disclosure?
What is a disclosure?
A disclosure is the collection of information regarding all relevant financial relationships with ineligible entities (includes companies, non-profits, associations, etc.) over the previous 24 months. This information is required of all planners, faculty and others who would be in positions to control content. These roles may also include: teacher, instructor, author, faculty, writer, reviewer etc.
What are the types of relationships?
What are the types of relationships?
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
Diversified mutual funds do not need to be disclosed.
Research funding from ineligible entities should be disclosed by the principal or named investigator even if that individual’s institution receives the research grant and manages the funds.
This helpful visual aid will assist you in understanding eligibility.
What is the ACCME's definition of an ineligible entity?
What is the ACCME's definition of an ineligible entity?
Entities that are ineligible to be accredited in the ACCME System (ineligible companies) are those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.
Examples of such organizations include:
Examples of such organizations include:
Advertising, marketing, or communication firms whose clients are ineligible companies
Bio-medical startups that have begun a governmental regulatory approval process
Compounding pharmacies that manufacture proprietary compounds
Device manufacturers or distributors
Diagnostic labs that sell proprietary products
Growers, distributors, manufacturers or sellers of medical foods and dietary supplements
Manufacturers of health-related wearable products
Pharmaceutical companies or distributors
Pharmacy benefit managers
Reagent manufacturers or sellers
Q: How do I determine if the relationship is relevant?
A: The accredited provider is tasked by the ACCME to determine relevance. Please disclose all financial relationships with ineligible entities.
All financial relationships with ineligible entities must be disclosed regardless if you feel it is relevant or not
A financial relationship, in any amount, exists between the person in control of content and an ineligible entity.
The financial relationship existed during the past 24 months, even if the relationship has ended
After the collection of all disclosures, the Accredited Provider must exclude owners or employees of ineligible companies from participating as planners or faculty. These types of relationships are not considered eligible for mitigation by the ACCME.
Q: What happens if there is a relationship between an individual or ineligible entity that is not that of an employee or owner?
A: Mitigation
Mitigation steps for planners:
Mitigation steps for planners:
✓ Divest the financial relationship
✓ Recusal from controlling aspects of planning and content with which there is a financial relationship
✓ Peer review of planning decisions by persons without relevant financial relationships
Mitigation steps for faculty and others:
Mitigation steps for faculty and others:
✓ Divest the financial relationship
✓ Peer review of content by persons without relevant financial relationships
What doesn’t need to be disclosed?
What doesn’t need to be disclosed?
Relationships with universities, other CME providers, professional medical associations, publishers such as: Medscape, Up-to-Date, American College of Physicians, Springer Health. These types of organizations should not be disclosed. We will ask that they be removed on disclosure slides.
Disclosure Examples
Disclosure Examples
Use the reference below as a model for your disclosure slides. There are examples here for faculty with and without relationships to disclose, as well as required PIM relationship disclosures, and important points to remember.
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