Managing Conflicts of Interest

It is vital that Continuing Medical Education is free from commercial bias. Consequently, all individuals involved in planning or presenting educational content must undergo full conflict of interest management. Financial conflicts with commercial interests must be identified, managed, then shared with participants. Supporting documentation must be maintained by the Office of CME and Lifelong Learning. Fortunately, MiCME automates and simplifies these steps, ensuring Educational Planners can easily meet CME requirements.

What is a Conflict of Interest?

A Conflict of Interest arises when an individual has a relevant financial relationship with a commercial interest (i.e., a pharmaceutical company or medical device manufacturer) whose products or services are used on (or consumed by) patients and will be discussed at a CME activity.

Financial Relationships that do not create a conflict of interest include those:

  • With non-profit organizations or government entities.
  • With companies that don't produce health care goods or services, including companies whose sole business is basic science or research, artificial intelligence, electronic health records, or health information/technology.
  • Where payment is not received directly by an individual (eg. distributed to the institution or department).

Who cannot plan or present educational content at a CME activity?

  • Individuals who refuse to complete the Conflict of Interest Management process.
  • Individuals who are employees or owners of a commercial interest, except in very rare instances. Note: Consultants are not considered employees.

Who Manages Conflicts of Interest?

The Conflict of Interest Manager is responsible for managing all potential conflicts for the activity. The Educational Planner is automatically assigned as the Conflict of Interest Manager for the activity if they have no financial relationships relevant to their role in the proposed educational activity. If the Educational Planner has relevant financial relationships(s), they must designate another individual (without conflicts) to conflict of interest management for all individuals involved in the activity.

How are Conflicts of Interest Managed?
4 Easy Steps: Identify, Manage, Share and Document

We've created a tool to help you navigate the process: Conflict of Interest Flowchart

Step 1. Identify Individuals with Conflicts of Interest

All individuals able to influence the educational content of an activity (eg. the educational planner, educational co-planners, and content presenters) must record and review their personal financial relationships (and those of their spouse or partner). They must then identify financial relationships that are relevant to the content of the educational activity using the conflict of interest management tool. If relevant, these financial relationships are true conflicts of interest and must be managed before the conflicted individual is able to influence any educational content.

The timing of financial relationship review and management of conflicts depends upon the ability to influence educational content:

Educational Planners and Co-Planners (including the Conflict of Interest Manager) must identify the presence (or absence) of any relevant financial relationships during the application process.

Content Presenters must identify the presence (or absence) of any relevant financial relationships before the start of an activity with enough time for conflicts to be reviewed and managed by the Conflict of Interest Manager.

NEW in MiCME: All Michigan Medicine Faculty have an annual requirement to document their financial relationships in the M-Inform database. MiCME uses this data to complete required financial relationship information for faculty, resulting in improved accuracy and less duplication of effort.

Step 2. Manage All Conflicts of Interest

The Conflict of Interest Manager uses the MiCME tool to manage all Conflicts of Interest for planners and presenters.

The COI Manager should review financial relationships relative to each individual's proposed role in the activity to ensure the relationships have no influence on the CME activity. Decisions made by individuals engaged in educational planning (i.e., activity design, topic choice, and speaker selection), as well as the educational content proposed by presenters, should be considered during this review.

The COI Manager should perform this review in advance, decided on a management plan, and then whenever possible, monitor all aspects of the activity to ensure compliance.

Conflict of Interest Management Options:

After reviewing educational content, the Conflict of Interest Manager will select one of four options to manage the conflict of interest.

After careful review the Identified Relevant Financial relationship was found to be:

  • Inactive: The financial relationship ended more 12 months ago.
  • Not relevant: Activity plans and/or proposed content were reviewed and found not to be relevant to the identified financial relationship(s).
  • Relevant but can be managed: Activity plans and/or proposed content were reviewed and found to be relevant to the identified financial relationship(s). Conflicted educational planners will recuse themselves from all planning decisions related to conflicted content, and non-conflicted planners will make all final planning decisions. Content presenters will discuss products/services in generic terms only, with no discussion or recommendation of specific products.
  • Relevant and can't be managed: Activity plans and/or proposed content were reviewed, found to be relevant to the financial relationship(s), and the conflict unable to be resolved. The individual can have no role in the activity (educational planning or presentation of content).

For planners and co-planners, all relevant financial relationships must be managed (resolved) during the application process.

For content presenters, all relevant financial relationships must be managed (resolved) prior to the start of the educational activity.

Presentations should be monitored by activity personnel to ensure adherence to the agreed conflict of interest management plan (e.g., the presenter will not discuss a particular drug or device.)

After the activity, participant evaluations should be reviewed by the Educational Planner to confirm the activity was free of commercial bias. Educational Planners should contact the Office of CME and Lifelong Learning if there is evidence of bias so that appropriate action can be taken for future activities.

Step 3. Share Everything with Participants

MiCME generates a summary of the presence or absence of conflicts of interest for all individuals in control of educational content (i.e., planners, co-planners, presenters) for an activity. When conflicts have been identified, MiCME will also indicate the method used to manage the conflict. Educational Planners must share this summary with participants before the activity begins, usually via an email or by including it in course materials or slides.

Step 4. Documentation

MiCME automatically stores all required documentation. If other methods are used to document the conflict of interest process, these documents must be sent to the Office of CME and Lifelong Learning within 30 days of the end of the activity during the Activity Close Out process.