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Clinical Education
Financial Disclosure, Conflict of Interest, and Bias

Anyone who is in a position to influence content (speakers, planners, reviewers, and faculty) must complete a financial disclosure form.

To assist with this process, the Academy will review a potential joint sponsor's financial disclosure and conflict of interest policies. (Suggested forms and policy guides are available below in "Tools and Resources".) It is important for all activities to have a method to eliminate commercial bias. Bias is an undue influence promoting the proprietary interests of a Commercial Interest.

The following ACCME criteria govern the influence of industry, and speakers, on educational content, as detailed in the ACCME Standards for Commercial Support (SCS).

ACCME Criteria 7: The provider [the Academy] develops activities/educational interventions independent of commercial interests (SCS 1, 2 and 6).

ACCME Criteria 10: The provider actively promotes improvements in health care and NOT proprietary interests of a commercial interest (SCS 5).

Q: When do relationships create "conflicts of interest? (COI)" (SCS 2.1)

A: The ACCME considers financial relationships to create actual conflicts of interest in CME when individuals have both a financial relationship with a commercial interest and the opportunity to affect the content of CME about the products or services of that commercial interest.

If, upon review by activity planners or reviewers, a conflict of interest is thought to exist, a Conflict of Interest Resolution and Management form will need to be completed. This form documents how the COI was discovered, and what methods were used to achieve resolution.

Definitions related to Financial Disclosure, COI, and Bias
  • Commercial Bias: An undue influence promoting the proprietary interests of a Commercial Interest
  • Commercial Interest: [From the ACCME] A commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.  (Revised August 2007) The ACCME does not consider providers of clinical service directly to patients to be commercial interests.
  • Conflict of Interest (COI): The ACCME considers financial relationships to create actual conflicts of interest in CME when individuals have both a financial relationship with a commercial interest and the opportunity to affect the content of CME about the products or services of that commercial interest.
  • Financial Disclosure (FD): The process of providing public access to financial information
  • Standards for Commercial Support (SCS): 1) The ACCME Standards for Commercial Support (SCS). 2) Standards to ensure the independence of CME activities from Commercial Interests.

 
Tools and Resources

The following information is provided assist with collecting Financial Disclosures, and managing Conflict of Interest to prevent bias.

Tools:

Resources:

Regulations:

  • ACCME Standards for Commercial Support (SCS)
  • CMSS Code for Interactions with Companies
  • Societies will commit that their educational activities, scientific programs, products, services and advocacy positions are independent of Company influence, and will develop and adopt policies and procedures that foster independence.

    As an initial signor of the CMSS Code, the American Academy of Ophthalmology abides by the recommendations herein. Principles for interaction begin on page 11.

 
Actions Perceived by Health Care Professionals as Commercial Bias

 Study conducted by Jean K. Cornish, Rph; and James C. Leist, EdD, FACME (see suggested reading for more in-depth analysis)

  • Focusing on 1 agent, device, or procedure when others exist
  • Not providing a balanced presentation of the benefits and adverse effects for all agents, methods, or procedures in an activity
  • Most of the faculty have relationships with the grantor sponsoring the activity
  • References to inappropriate studies (promotional, bad design, etc.)
  • Inconsistent use of brand names
  • Misleading title
  • Lack of appropriate scientific references
  • Misleading learning objectives
  • Misleading overview statement
  • Endorsement of a particular product or practice by a respected and well-known expert in the field
 
Tips and Recommendations
  • If content will focus on only one agent, device, or procedure, acknowledge competing options and explain how & why they fall outside of this activity.
  • Have policies in place not only for the collection of financial disclosures, but for review of the submitted forms: Review these materials relevant to the content of the activity, and any commercial supporters providing resources to the activity. [SCS 1.1, 2.1, 2.2, 2.3, 6.1, 6.2, 6.5]
  • The person completing a financial disclosure does not get to determine if a relationship is 'relevant'. A determination of 'relevancy' is made by the reviewer(s).[SCS 2.1, 2.2, 2.3, 6.1, 6.2, 6.4]
  • Relevant disclosures must be made to learners prior to the start of the activity. [SCS 6.1, 6.2, 6.5] This is often accomplished by publishing disclosures in activity-accompanying material, and listing relationships on the first slide of presentations.