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2: Resolution of Personal Conflicts of Interest


QUESTIONS RELATED TO SCS 2.1
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1) What financial relationships need to be disclosed to the accredited provider? (SCS 2.1)
Individuals need to disclose relationships with a commercial interest if both (a) the relationship is financial and occurred within the past 12 months and (b) the individual has the opportunity to affect the content of CME about the products or services of that commercial interest.
Financial relationships are those relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit. Financial benefits are usually associated with roles such as employment, management position, independent contractor (including contracted research), consulting, speaking and teaching, membership on advisory committees or review panels, board membership, and other activities for which remuneration is received or expected. ACCME considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner. The ACCME has not set a minimum dollar amount for relationships to be significant. Inherent in any amount is the incentive to maintain or increase the value of the relationship.

2) When do relationships create ‘conflicts of interest?’ (SCS 2.1)
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.

3) Where is the ‘conflict?’ (SCS 2.1)
When the provider’s interests are aligned with those of a commercial interest the interests of the provider are in ‘conflict’ with the interests of the public. The interests of the people controlling CME must always be aligned with what is in the best interests of the public.

4) How do these circumstances create a conflict of interest? (SCS 2.1)
The potential for increasing the value of the financial relationship with the commercial interest creates an incentive to influence the content of the CME – an incentive to insert commercial bias. Commercial bias is prohibited in CME.

5) If at the first planning meeting for a CME activity, all committee members are asked to disclose, and each member responds that he/she has nothing to disclose (or disclose something), and this information is reflected in the minutes of the meeting – is that enough documentation that disclosure was sought? (SCS 2.1)
Yes. That documentation would help verify that the first step of a mechanism for identifying conflicts of interest is in place. That would document for ACCME that the Provider knew the relevant financial relationships of the Committee members.

6) Following up on that question, do we need committee members to sign a disclosure statement at every meeting while planning the same activity? (SCS 2.1)
No. Compliance with SCS2.1 requires that disclosure is made. Disclosing the same information repeatedly to the same Provider is not necessary. With the original disclosure information, the Provider is able to implement its mechanism to resolve any conflicts of interest.

QUESTIONS RELATED TO SCS 2.2
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1) What do we do when we appoint a person to speak at the last minute and when the person arrives at the activity they refuse to disclose relationship information? (SCS 2.2)
You must not carry on with the activity under these circumstances. The person cannot participate if they refuse to disclose because conflicts of interest can neither be identified nor resolved.

QUESTIONS RELATED TO SCS 2.3
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1) What do we do when we appoint a person to speak at the last minute and we have not had time to analyze disclosure information – never mind try to resolve any conflicts of interest? (SCS 2.3)
It is reasonable to expect that providers would have plans to manage this contingency as part of their institutional mechanisms for resolving conflicts of interest. Each provider is free to develop the strategy that best suits their circumstances.

2) What if, based on the disclosure information that we collect, we believe there is a conflict of interest? Does ACCME have any other examples of mechanisms for resolving conflict of interests that go beyond the five examples in “Identifying and Resolving Conflicts of Interest in Continuing Medical Education?” (SCS 2.3)
Yes. Please keep in mind that these are only suggested mechanisms. Each provider will want to design and adopt a mechanism that works best for its structure and type of activities. The intent of the Updated Standards is that any content about products is aligned with the best interest of the physician learners and their patients.
  1. “Peer review” of CME is often already in place and is a mechanism to resolve conflict of interest: Scientific abstracts or free-standing papers or articles in enduring materials are often already peer reviewed or judged against predetermined criteria to ensure the data supports the conclusions before they are accepted for presentation or publication. When people have relationships but are presenting the abstract or paper within a peer review process, the conflict may well be resolved by that peer review process. Similarly, groups of people working together to do reviews of activity content prior to publication can resolve conflicts of interest by ensuring the content is valid and aligned with the interest of the public. Multiple levels of peer review to validate content are also effective mechanisms for resolving conflict of interest.
  2. In the presence of some form of oversight by the provider, referencing the ‘best available evidence’ is also an important mechanism for resolving conflict of interest. Consider the situation where a person who does promotional education on a particular drug for a commercial interest is asked to analyze an important, very new, clinical trial report on that drug and present recommendations for how to use that drug in clinical practice. The content of the activity (in this case the teacher’s recommendations) can be aligned with what is in the best interests of the public by the teacher referencing the best available evidence in the literature, the grade or level of that evidence and by identifying the conclusions that the evidence support. Through integrating what this best available evidence supports with what the new study has revealed the person can go on to draw conclusions or formulate recommendations. When nested within some form of peer-review or oversight process there is even external validation of the conclusions.


3) How does a provider implement a mechanism for resolving conflicts of interest? It all seems very abstract and daunting, and seems to imply that experts with financial relationships must be excluded. (SCS 2.3)
What follows is an example of how several tactics can be tied together by the Provider into a mechanism to resolve conflicts of interest that could demonstrate the Provider’s compliance with the ACCME requirements, and preserve participation of experts with financial relationships.
  1. Determine through disclosure mechanisms if those involved in planning or presenting content within a CME activity have financial relationships related to that content.
  2. If planners, presenters or authors have financial relationships that create conflict of interest,

a. The conflict can be resolved by an effective peer review of content prior to presentation or publication to ensure the content is valid and aligned with the interest of the public. Various methods of peer review to validate content can be effective mechanisms for resolving conflict of interest. One way to resolve the conflict of interest is to have scientific abstracts or free-standing papers or articles, peer reviewed or judged by commercially disinterested peers before they are accepted for presentation or publication.

b. In addition, requiring that all financial relationships be disclosed prior to an activity will alert participants (audience, readers) of the potential for conflict of interest and commercial bias. Participants could be asked to evaluate the objectivity of the presentation or publication, and to identify any perceived commercial bias.

c. Also, presenters, authors, planners and reviewers could be instructed to reference the best available evidence.



4) If disclosure information cannot be analyzed in a timely fashion, is it appropriate for the activity or presentation to go on without formal CME credit? (SCS 2.3)
ACCME has never recommended withholding CME credit at the last minute as an alternative to producing CME that is in compliance with accreditation requirements. It does not seem fair to the physician learners. Assuming that in this scenario there is financial relationship information to disclose to the learners, a mechanism to resolve conflicts of interest could still be put in place. For example, the participants could be asked to evaluate the objectivity of the presentation and the Provider could make it clear to the teacher that there is an expectation that the presentation would be compliant with the ACCME content validation statements, which state that…

(a) All the recommendations involving clinical medicine in a CME activity [are] based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients.

(b) All scientific research referred to, reported or used in CME in support or justification of a patient care recommendation [conforms] to the generally accepted standards of experimental design, data collection and analysis.Providers are not eligible for accreditation if they present activities that promote recommendations, treatment or manners of practicing medicine that are not within the definition of CME, or known to have risks or dangers that outweigh the benefits, or known to be ineffective in the treatment of patients.

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