Shelly B. Rodrigues, CCMEP, CAE
We’re all professionals, right?
We always follow the rules, right?
We know when a speaker is a mouthpiece for a drug or product, right?
We get “conflict of interest,” right?
So, why do we need a whole set of standards for commercial support and pages of guidelines on how to identify, manage and resolve conflicts of interest?
Dr. X., a well-liked physician, who has been a residency director, society president, and frequent lecturer, stops practicing medicine to take up continuing medical education. He’s well-liked, charming, a good speaker and he has many contacts with industry folks who enjoy working with him. He begins contracting with medical associations for a percentage of grants to “make rain” or bring in dollars for CME activities. He helps develop the courses, prepares the slides, recruits the faculty, chairs and usually speaks at the sessions – and each time he speaks the slide says, “Dr. X. declares that he has no financial affiliation with any company providing support for this CME activity.”
Does he have an affiliation? Is there a conflict of interest? You decide –
Now granted, this situation is the exception, not the rule, but we have all experienced these exceptions. The problem is that we have also borne the brunt of major new regulations, standards, initiatives adopted to deal with the exceptions. That said, the ACCME’s Standards for Commercial Support – while appearing to be over-onerous – are our protective blanket. They protect us from the Dr. Xs of the world, from the perception of promotional bias, from undue influence by industry, and maybe even from some of the Senator Grassley fall-out.
Understanding and implementing the standards are not all that tough – they require education on the part of everyone in your organization – from the CEO and education specialist to the annual meeting planning committee and Board members. There are many topics covered in the Standards, but as a first step, they require each of us to begin on the highest ground by identifying conflict, then managing and resolving it.
Identify: Ask each person who has even the slightest opportunity to influence educational content to complete a financial disclosure statement – before they are in a position to influence content. For example: all committee members, curriculum development teams, staff, and potential faculty should have a financial disclosure statement on file with you. We collect them annually (in January), and then before inviting someone to speak in April ask them to “check here” if their statement has changed since the last filing.
Manage: A process to identify, manage and resolve the conflict is vital. An algorithm for action will help guide the process. “If this, then that … if yes, then.” Check the sample we’ve developed for you. Simply having a slide at the beginning of a presentation declaring the conflict is no longer enough. You need to tell learners how the conflict has been managed or resolved.
Resolve: If an individual who has potential influence reports a financial relationships, for example, a research grant from a pharmaceutical company, that just so happens to be on a therapy you plan to present, this constitutes a conflict and you need to begin a process to resolve the conflict. Ask the speaker to recuse herself; have the speaker present on a different topic; ask the speaker to present only evidence-based findings; or require peer review.
The good news is that there is plenty of help out there:
- Accreditation Council for CME: On the ACCME Web site you’ll find FAQs about not only the standards, but all the CME criteria. You’ll also find sample conflict of interest statements, and links to providers who have earned commendation in their work on the commercial standards.
- Alliance for CME: The ACME has many resources available on its Web site as well, and offers several educational sessions – live and web-based – on a wide array of CME topics, including conflict of interest.
- National Faculty Education Initiative: The NFEI is a new initiative launched by ACME and the Society for Academic CME to facilitate faculty and provider development. The first offering is a four-part case-based course on conflict of interest.
- NC-CME: The National Commission for Certification of CME Professionals Inc launched the exam to certify those of us to do CME. The designation CCMEP shows that a professional has passed an exam that tests the many aspects of CME – from the ACCME standards to the nuts and bolts of a program.
Here’s my conflict of interest – I’m lucky enough to chair AAMSE’s incredibly talented Council for Medical Education Leadership Forum– the Council members are all experts in CME and continuing professional development, and we promise the Council will work diligently to make your lives easier.
We’ve already:
- Completed a baseline needs assessment survey with AAMSE members
- Presented our first session at the 2008 Annual meeting
- Gathered Web resources and made them available on AAMSE’s site via links
- Launched this new blog
And we will continue to offer educational sessions at AAMSE meetings – all with your needs in mind.
Got questions? Got comments? Let’s hear them.