Yes, as long as the CME activity complies with the ACCME's Accreditation Criteria, including the ACCME® Standards for Commercial SupportSM. It is understood and accepted that industry conducts its own research and that industry partners, as a collaborator, in research. An important step in the translation of discovery to practice is the dissemination of the results of this research. There are several layers of internal and external controls already in place to manage the conduct of research (e.g., Institutional Review Boards, Government agencies) and the dissemination of results (e.g., editors, peer review, international standards.) The ACCME does not intend to interfere with these carefully managed phases.
However, when a provider chooses to base its CME content on research, the provider assumes responsibilities related to CME, including compliance with the ACCME® Standards for Commercial SupportSM. The CME content (not the research that has already taken place or is taking place) cannot be controlled by a commercial interest.
The ACCME recognizes that it is important for accredited CME to include reporting about the discovery phase of product development. We also realize that employees of commercial interests are often involved in research and discovery. We appreciate that providers face complex challenges when determining how to integrate discovery and research into accredited CME while safeguarding independence and complying with ACCME requirements. The ACCME and accredited providers have worked together to develop strategies that facilitate the appropriate flow of new information, while at the same time preserving accredited CME's independence.
Together, the ACCME and accredited providers have recognized that there are circumstances where an employee of an ACCME-defined commercial interest can make a scientific presentation within accredited CME about their company's research - and be compliant with the ACCME Standards for Commercial Support.
Industry employees cannot deliver oral presentations and cannot author enduring materials that are accredited CME if the CME content relates to business lines or products of their employer - unless the accredited provider takes complete control of the content of the oral or written presentation through the following mechanisms.
1. The provider implements and monitors a rigorous process of external validation and (peer) review of the research to ensure the validity of the research process, the results and the conclusions. Provider mechanisms are in place to review, evaluate and possibly change the content of all presentations, abstracts or posters and to ensure the appropriate balance within the larger CME activity so that the content is not biased towards any proprietary interests and the provider is in control of the content of the presentation and the CME activity; and
2. Provider mechanisms are in place to ensure the selection of content for presentation is based on its relevance and importance to the learners and that persons free of relevant financial relationships handle topic selection oversight.
Many providers have these mechanisms in place now and thus allow employees of ACCME-defined commercial interests to make presentations inside accredited CME.
The following are some examples of important additional factors for providers and the ACCME to consider in determining an appropriate role of an ACCME-defined commercial interest employee in planning or presenting accredited CME. The facts and circumstances of each individual provider will vary. The following is not a checklist of things that all must be present. It is not a set of mandatory requirements that must all be followed. Rather it is a list of factors that taken together or in combinations contribute to ensuring the independence of accredited CME that involves the employees of ACCME-defined commercial interests.
1. The content does not include patient care recommendations.
2. The content is at the level of biology, physiology or physics and far from a discussion of products that are prescribed to patients.
3. The content is about the discovery process itself and not about treatment or diagnostics.
4. The content covers research results so early in the discovery process that there is no product developed yet.
5. The target learners are scientists who are also participating in the discovery process.
In making their decisions and determining strategies, providers should always defer to independence and the free flow of information - and act in the best interest of the public.
The ACCME expects that the providers will fulfill their obligations to ensure independence. Each provider will choose their own strategy. As always, the ACCME accreditation and monitoring processes will evaluate on a case-by-case basis whether providers have met the appropriate standards for independence, taking into consideration the factors described above and the provider's specific circumstances.
The ACCME will continue to support accredited providers through this process.