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Compliance Corner: Exceptions to Standard 3

November 13, 2023


Standard 3, which applies to all accredited continuing medical education (CME), requires identification, mitigation, and disclosure of relevant financial relationships with ineligible companies. Apply Standard 3 to the planners, reviewers, speakers, editors, moderators, facilitators and others controlling the content of your educational activities.

While accredited providers may always apply the five elements of this standard, there are exceptions when you do not need to apply Standard 3. Below are some helpful clarifications and nuances to consider.

Exceptions: Accredited providers do not need to identify, mitigate or disclose relevant financial relationships for any of the following activities:

  1. Accredited education that is non-clinical, such as leadership or communication skills training.

TIPS:

  • The exception is meant to apply when the content of an activity would not cause any planners/speakers to have relevant financial relationships (examples include a business meeting, legislative update or awards ceremony), and is not controlled by ineligible companies or includes individuals with unmitigated, relevant financial relationships.
     
  • An accredited activity is considered non-clinical when there is no opportunity in that activity for an individual to insert commercial bias.
  1. Accredited education where the learner group is in control of content, such as a spontaneous case conversation among peers.

TIPS:

  • The exception does not apply to conferences or rounds that have set times and dates and have traditionally been planned as accredited CME. Activities such as regularly scheduled series, department rounds, morbidity and mortality rounds, and tumor boards do not fall under the exceptions. Providers are expected to comply with Standard 3 when planning those activities.
     
  • The exception is meant to apply to spontaneous learning opportunities that previously might not have been considered accredited CME. A few examples are team huddles, well-being check-ins, and impromptu leadership-learning discussions. In those cases, with the guidance of the CME department, learners can describe the learning opportunity (problem-in-practice and change that resulted) without having to take the steps outlined in Standard 3. Many of you applied this during the early COVID-19 pandemic. The Accreditation Council for Continuing Medical Education (ACCME) Quick Tool provides a good framework for spontaneous learning opportunities.
  1. Accredited self-directed education where the learner controls their educational goals and reports on changes that resulted, such as learning from teaching, remediation or a personal development plan.

TIPS:

  • When accredited providers serve as a source of information for the self-directed learner, they should direct learners only to resources and methods for learning that are not controlled by ineligible companies.
     
  • Self-directed learning is when a learner controls their education goals and reports on changes that resulted, like learning from teaching, remediation or a personal development plan. A common error is that enduring materials do not fit in this exception, even though the learner determines if and when to complete an activity, and Standard 3 must be applied.
     
  • Whenever another individual besides the learner is involved in the planning or creation of clinical content, their financial relationships with ineligible companies should be identified, mitigated and disclosed, since these individuals may have the opportunity to consciously or unconsciously insert commercial bias into the activity.

There are several helpful Standards for Integrity and Independence Resources found on the ACCME website for application of the Standards. We encourage you to use the Planning Guide and Toolkit templates among others.

As always, reach out with any questions to cme@cmadocs.org.

 

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