Noncompliance with ACCME’s Standards for Commercial Support 2 & 6

The ACCME received a complaint suggesting that an ACCME-accredited provider was conducting continuing medical education activities about the use of a health care product, “Product X.” The complaint described educational and business relationships that made it appear that the accredited provider stood to gain financially from the sale of Product X and that the manufacturer of Product X had the opportunity to influence the CME activity content. In addition, the complainant suggested that the accredited provider had an ACCME-defined relevant financial relationship with a commercial interest, and that the relationship was not addressed through the provider’s process for identifying and resolving conflicts of interest, and was not disclosed to learners.

The ACCME sent a Notice of Complaint to the accredited provider and asked for asked for its response to a series of questions, including the following:

1. Do you stand to gain financially from the sale of the Product X?
2. Describe and provide evidence of how your activities about Product X were planned and implemented free of the control of a commercial interest. Include a description of (a) identification of CME needs, (b) determination of educational objectives, (c) selection and presentation of content, (d) selection of all persons and organizations that were in a position to control the content of the CME, (e) selection of educational methods; and (f) evaluation of the activity.
3. Describe and provide evidence of how conflicts of interest were identified and resolved in your activities about Product X.
4. Describe and provide evidence of how relevant financial relationships were disclosed to learners in your activities about Product X.

In its response, the accredited provider communicated the following information:

  • The activity in question was done in joint provdership and the joint provider had assured the provider of its independence from any commercial interests.
  • The maker of Product X is an ACCME-defined commercial interest.
  • The provider had failed to collect information from the individuals in control of content about their relevant financial relationships with the commercial interest, and was therefore unable to identify or resolve conflicts of interest.
  • The presence or absence of relevant financial relationships for all individuals in control of content was not disclosed to learners. Instead, the provider reported that “faculty” had no relationships with any “funding source” and did not provide the names of faculty or others in control of content.
  • Based on the complaint and internal discussion, the provider discontinued its activities about Product X. In addition, it discontinued its relationship with the joint provider.

The provider’s response confirmed that it was not in compliance with Criterion 7 (Standard for Commercial Support 2: Resolution of Personal Conflicts of Interest and Standard 6: Disclosures Relevant to Potential Commercial Bias); therefore the ACCME issued the provider a Notice of Noncompliance. The ACCME did not require the provider to take any further action because it had informed the ACCME that it would no longer offer activities related to Product X. The ACCME reminded the provider that it is responsible for ascertaining the compliance of its educational partner(s) with ACCME’s accreditation policies, the content of its CME activities, and the independence of its activities. ACCME-accredited providers are accountable for the compliance of their educational activities, including those that are offered in joint providership.  The ACCME will include the information pertaining to the complaint in the provider's next reaccreditation review.

For more information
ACCME Policy: Joint Sponsorship
Ask ACCME Standards for Commercial Support, 2: Resolution of Personal Conflicts of Interest
Ask ACCME Standards for Commercial Support, 6: Disclosures Relevant to Potential Commercial Bias
Video FAQ: Avoiding Noncompliance with the Standards for Commercial Support: What Do I Need to Understand about Conflicts of Interest?
 

Published Date: 
Wednesday, June 19, 2013
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