Here are 14 crucial questions about determining conflict of interest in continuing medical education. Do you have the answers?
In attempting to codify our conflict-of-interest vetting policies, we have encountered some situations for which there seems to be no official answer. Under our current policy, there are a few cases that are automatically rejected and a few that are automatically accepted for accreditation on the basis of disclosures and abstracts. For the remainder, we require review of the actual presentation by an officer of the accrediting agency (currently, that's me). I would like to present a few of these problem situations in the hope that we can agree on some guidelines for — or at least open it up for discussion about — vetting continuing medical education contributors and CME content.
All persons who have the potential to contribute to a CME program require vetting. The presenter must produce both names and affiliations. Regulations seem to indicate that that is sufficient. Will it remain so, or must we also seek independent sources to validate such lists?
How much latitude does the accrediting agency officer have in making accreditation decisions? How deep must he go into the tangle of interconnected biomedical companies to determine if the affiliations of the potential contributor are relevant to a particular product?
Some disclosures are incomplete — for example, they state one or more commercial interests, but do not indicate the nature or level of involvement. If time constraints forbid tracking down the details, how should this be handled?
We will automatically accredit presenters with no commercial affiliations whose abstracts do not include commercial products or mention commercial products only generically — e.g., fluoroquinolones, laser ablation, or total knee replacement. If a unique product is mentioned — such as a drug in a new class, or a new diagnostic test — and it has no competition and it must be identified as such for the presentation to be useful, can that be accredited? If this product does have competitors, but only one can serve as the focus of the presentation (as in a “how to use” practicum), how, if at all, can that presentation be made to comply with conflict-of-interest standards?
In a field with numerous competitors — e.g., antibiotics — what percentage of those competitors must be mentioned to constitute balanced representation?
If a presentation (by an otherwise accreditable potential contributor) demonstrates objectively that one product is clearly superior to its competitors, does that presentation qualify for accreditation if it is mentioned specifically? If it is described only generically?
If a presentation by potential contributors who have COI demonstrates that their product is inferior to its competitors, does it qualify for accreditation?
Can an activity given by an employee of a commercial concern be accredited if it contains no reference to any product?
We automatically reject any presentation in which a product is mentioned by an employee of the product manufacturer. But how removed from the manufacturer must a potential contributor be to be accepted for reviewing the presentation?
Could the applicant be a consultant, adviser, board member, owner of directly purchased stock, or grant recipient?
What about relatives? Apparently only spouses are now considered to have potentially inappropriate influence over educational content. Which relatives are being considered for inclusion in this category and are therefore in need of vetting at some future date?
How many different affiliations must a potential contributor list to be considered “balanced”?
It seems there is as yet no established dollar amount that would raise a red flag for significant conflict of the potential contributor. Should we set one? If so, what annual limit is reasonable?
Is there a difference between the principle presenter and the rest of the contributors in terms of the significance of their potential conflicts?
If a presentation by an employee of his company's product proves on review to be fair, balanced, and objective, can that presentation be accredited?
Is there a difference between a presentation that has been peer-reviewed by virtue of its being published in a recognized journal, and a presentation that has not yet been peer-reviewed? If so, how does that difference influence accreditation?
Some presentations extend a bit beyond basic science in the direction of building a foundation for the development of future products, although no product is yet in the pipeline. At what point does a presentation enter the commercial arena and constitute a COI?
What exactly can and cannot be included in a “save the date” card or brochure distributed by commercial-product representatives?
Can a provider of CME ask a commercial supporter for the names of experts who are hostile to their products?
Our position as accrediting agencies seems to be identical to that of physicians attempting to avoid malpractice litigation. For them, clinical guidelines are being established that at least set a standard that can serve as a defense. So far, the vetting guidelines for conflict-of-interest resolution have created only an unnavigable space where fear seems to dominate. If we could reach a consensus on these questions, it would begin to establish a solid footing on which to operate.
Please take some time to carefully consider these questions, then share your thoughts by e-mail with the editor at email@example.com. The results will be published in a future issue.
Ricker Polsdorfer, MD, is medical director with Professional Education Services Group, Sterling, Va.