Using ACCME’s Flowchart for the Identification and Resolution of Personal Conflicts of Interest A tutorial and flowchart to help you navigate the identification.

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Presentation transcript:

Using ACCME’s Flowchart for the Identification and Resolution of Personal Conflicts of Interest A tutorial and flowchart to help you navigate the identification of relevant financial relationships and the resolution of conflicts of interests in CME activities.

About This Tool ACCME requirements are designed to ensure that accredited continuing medical education (CME) provides a safe place for learning—independent of commercial interests and commercial influence. We prepared this tutorial and flowchart to help you navigate the identification of relevant financial relationships and the resolution of conflicts of interests in CME activities. It’s optional: Use of these resources is optional. Please note that the tutorial and flowchart do not address all of the expectations of ACCME requirements for independence from commercial interests. Get the flowchart and step-by-step tutorial on the ACCME website at www.accme.org/coiflowchart.

Ensuring Independence ACCME expects accredited organizations to ensure independence by: Identifying relevant financial relationships between commercial interests and those who plan, teach, and implement CME Resolving conflicts of interest that arise when those with relevant financial relationships with commercial interests have the opportunity to control CME content related to the products or services of those commercial interests Disclosing to learners the (identified) relevant financial relationships for those in control of CME content prior to the educational activity or disclosing that there were no relevant financial relationships.

Key Terms Commercial Interest ACCME defines a commercial interest as any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. The ACCME does not consider providers of clinical service directly to patients to be commercial interests - unless the provider of clinical service is owned, or controlled by, an ACCME-defined commercial interest. Relevant Financial Relationship Relevant financial relationships are financial relationships in any amount, which occurred in the twelve-month period preceding the time that the individual was asked to assume a role controlling content of the CME activity, and which relate to the content of the educational activity, causing a conflict of interest. The ACCME considers financial relationships to create 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.

Key Terms (Cont) Who is “in control of content”? If someone in connection to the activity has the opportunity to affect the content, they are “in control of content.” Those individuals in a position to control the content of an educational activity might include (but are not limited to) planners, faculty, authors, committee members, content reviewers, editors, and staff depending on the accredited provider’s processes for developing educational activities.

Let’s Get Started Start early! Use this flowchart early in your planning process to make sure you can implement your approaches to ensure independence during the planning process and before the educational activity occurs.

Start at A Begin on the upper left corner of the flowchart at the A. Is the content of the CME activity related to the products or business lines of an ACCME-defined commercial interest?   If your answer is “yes,” proceed to B. If your answer is no, there are no relevant financial relationships to identify. Before the CME activity, disclose to learners that there are no relevant financial relationships with ACCME-defined commercial interests for anyone who is in control of the content of the activity. The flowchart ends here—you’re done!

Beginning at B, use the flowchart for each person in control of the content of the CME  activity. These may include planning committee members, staff, authors, content reviewers, and faculty.   Is the person an employee/owner of an ACCME-defined commercial interest? If the answer is “no,” proceed to C. If the answer is “yes,” proceed no further. Employees of ACCME-defined commercial interests are prohibited from having any role in the planning or implementation of CME activities related to the commercial interest’s business lines or products. (There are a few special-use cases where employees may have a specific, limited role. For more information, see http://www.accme.org/commercialemployees

Does the person have a relevant financial relationship with an ACCME-defined commercial interest?   The flowchart provides a four-question checklist to determine whether a relevant financial relationship exists—per ACCME expectations —therefore creating a conflict of interest. A relevant financial relationship exists only if you affirm all four statements. Relevant financial relationship between person in control of content (or their spouse/partner) and an ACCME-defined commercial interest To better understand how the ACCME defines relevant financial relationships, see http://www.accme.org/ask-accme/what-financial-relationships-need-be-disclosed-accredited-provider. Remember that the financial relationships of the person’s spouse or partner count. (Please note that the ACCME’s definition of relevant financial relationships does not include faculty honoraria, even if the activity is commercially supported, since the financial relationship is between the faculty and the CME provider, not between the faculty and the commercial interest.) Any amount ($) A financial relationship of any value counts — there is no minimum threshold. For more explanation, see this Ask ACCME FAQ . In the past 12 months ACCME requirements are concerned with relevant financial relationships of the person in control of content (and/or or their spouse/partner) that existed within the 12 months prior to the CME activity. Products/business lines of the ACCME-defined commercial interest (with which they have the relationship) are related to the content of the CME activity Check this box if the content of the CME is related to the products and/or business lines of the ACCME-defined commercial interest with which the person in control of content has a financial relationship. It doesn’t matter what type of relevant financial relationship exists — what matters is whether the content of the CME is related to the products and/or business lines of the commercial interest. The ACCME considers financial relationships to create 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 business lines of that commercial interest. If you affirm all four statements, proceed to D. If you are not able to affirm all four statements, there is no relevant financial relationship for the person in control of CME content. Before the CME activity, disclose to learners that the person has no relevant financial relationships with ACCME-defined commercial interests. There is nothing more that you need to do.

You’ve determined that the person in control of content for the CME activity has a relevant financial relationship that creates a conflict of interest. The next step—before the CME activity takes place—is to take an active role to resolve the conflict of interest and disclose to learners the name of the individual, the name of the ACCME-defined commercial interest with which they have a relevant financial relationship, and the nature of the financial relationship.   There are a number of approaches you can use to resolve conflicts of interest. The flowchart includes several examples, but you can find more practice-based examples from accredited providers on the ACCME website page Examples of Compliance and Noncompliance for Criterion 7. Helpful Tip: Be sure to use a process that is appropriate for the person’s role. Approaches to resolve conflicts for speakers may not be applicable to planners  and vice-versa.

Visit www.accme.org for… Ask ACCME Frequently-Asked-Questions Practice-based examples of Compliance and Noncompliance with ACCME Requirements Educational Tutorial Pages Interviews with CME Leaders & Stakeholders