The medical educational system is full of passionate and knowledgeable clinician educators developing and delivering thoughtful and effective CME content. As a result, practitioners have numerous choices when choosing a CME activity.
CME conference attendees benefit from the transparency and support provided by the ACCME in their mission to ensure practitioner access to high-quality CME. Their Standards for Integrity and Independence, aim to, among other objectives, protect clinician learners from biased and inaccurate educational materials that can sometimes find their way into CME activities at the hands of unscrupulous presenters.
Why Do the Standards for Integrity and Independence Matter?
Within the ethical guidelines and components of its accreditation criteria put forth in the Standards of Integrity and Independence, conditions under which a clinician or healthcare organization can create, organize and distribute ACCME accredited CME activities are established.
An important portion of the ACCME’s Standards for Integrity and Independence is devoted to defining ineligible companies—the individuals and organizations who are prohibited from leading CME activities. This designation helps to prevent conflicts of interest within the continuing medical education industry.
It is vital that commercially motivated content does not impact—or appear to impact—the integrity of CME activity materials meant to be objective. It is vital to practitioners, their employers and patients that materials are unbiased and free of promotional messaging and intent. It is simply too important to the integrity of continuing education, the ACCME and CME providers everywhere, as well as the public perception of a CE system designed on trust and transparency.
How Do the Eligibility Criteria Promote Quality CME Experiences?
The eligibility criteria established by the ACCME work in the following ways to promote the creation of high-quality CME materials that provide impartial, balanced, empirically based and pertinent medical information:
- Information is accurate, relevant and supported in peer reviewed research
- Materials aren’t promotional, marketable or commercialized in their intent or substance
What is an Ineligible Company?
The ACCME defines ineligible companies as “those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.”
Those who meet the criteria are ineligible to be accredited by the ACCME and cannot author or deliver materials meant for inclusion in any CME activities. This includes live and in-person CME activities such as destination CME conferences, or enduring materials such as online CME courses.
This criterion does not only apply to the ineligible company itself but also to those who own or are employed by an ineligible company. Furthermore, clinician educators who may have otherwise been eligible to produce or distribute CME materials may become ineligible due to their involvement with a commercial entity.
The ACCME provides several resources on ineligibility to help clinicians understand when their involvement with an entity, even if on the surface does not appear to be commercially motivated, can make them ineligible. Relatedly, clinicians and organizations with financial interests in CME content are unable to gain joint eligibility by partnering or collaborating with an otherwise eligible entity. The ACCME does allow joint accreditation with unaccredited eligible companies in order to promote the development of high-quality CME materials from diverse, interdisciplinary sources, however, it still requires those who are non-accredited to be free of financial conflicts of interest. Subsidiaries of parent companies with relevant financial interests are also ineligible, even if the subsidiary’s day-to-day operations and overall direction are free of parent company input and interference.
What Should Practitioners be Aware Of?
Company ineligibility impacts more than those who create educational content. It behooves practitioners to understand the framework the ACCME uses to evaluate a content provider’s potential conflicts of interest. Presenters are required to report a potential change in their status as a member of a commercial entity or another relationship that can potentially cause a conflict of interest.
Who’s Job is it Prevent Conflicts of Interest?
There are a number of safeguards to protect learners from exposure to biased and unobjective content. The first is the ACCME’s Standards for Integrity and Independence, which establishes the organization’s ethical stance on financially motivated relationships with CME providers. Next is the accreditation process, which pragmatically implements what the Standards for Integrity and Independence stand for. Third is the ineligibility criteria, which provide clear guidelines to CME providers as to who is eligible and who isn’t. The fourth is disclosure criteria, which is required of every planner, producer and distributor of content.
Conflicts of Interest and Disclosures
When exceptions to the ineligibility criteria are made, content authors must disclose the existence and nature of commercial relationships to CME conference participants. The first is to provide transparency so participants can make their own fully-informed judgments about the content’s substance. Disclosures also create a record of conflicts of interest the ACCME can refer to at any time during the course of an audit.
With disclosures, participants have a fuller understanding of what information is included in an activity and why. Conflict of interest disclosures aim to inform activity participants of any potential conflicts and raise their awareness of potential biases so they can evaluate the information presented to them within its full context.
Exceptions to the Ineligibility Criteria
The purpose of CME is to bring the most up-to-date medical information to practitioners to positively impact care and support career advancement. In some of the most advanced corners of the medical world, those with a commercial stake in a drug, device or technique are also those who are uniquely suited to teach about related issues in healthcare. It is therefore important for these individuals to contribute to the medical education sphere.
CME providers can make distinctions between those with conflicts of interest that can be resolved through the disclosure process and those that introduce biased content into the CME ecosystem.
The ACCME outlines a system of exceptions for providers to consider. In sum, these exceptions entail differentiating between commercial motivations and unique clinical expertise. For exceptions to apply, the content must:
- Not be related to the lines of business the content’s planner, author or distributor is associated with. This means that a researcher in genetics could provide an overview of recent advances in genetics, without specifically highlighting their work or any commercial advancements stemming from these medical developments.
- Be related to basic research, including the foundational causes of diseases and their potential cures. These do not have commercial intent because they do not relate directly to specific medical techniques or methodologies.
- Reflect the role creators of medical devices have as technicians to teach the safe use of their tool, without making any direct medical or commercial recommendations.