The Accreditation Council for Continuing Medical Education (ACCME) announced adjustments to their questions and answers around the standards for commercial support and how it relates to scientific presentations given by employees of pharmaceutical and device manufacturers at CME accredited educational activities.
They have issued new answers to questions posted on their website including:
What kinds of topics an industry employee can present
· Scientific discovery or the discovery process
· Reporting research results not connected to a product
· Presentations beyond the scope of the firms interest (disaster management…)
Under the following circumstances industry employees can present scientific data both orally and in writing:
· System of rigorous peer review is in place
· Mechanisms are in place to determine that the information is relevant and important to the learners
Several additional factors can include:
· No patient care recommendations
· On the level of biology, physiology or physics and far from a product discussion
· Discussion on the discovery process
· Early research results
· The targeted audience are scientists
There has also been some confusion about the use of rooms and facilities for CME and non CME events i.e. demonstrations of medical devices, the ACCME states that the provider has the option to exclude some presentations or abstracts from their accredited program or present this content in a track that is outside of but in conjunction with accredited CME. This option preserves the free flow of information.
According to a statement issued by Murray Kopelow, MD Chief Executive of the ACCME:
The ACCME policy in discussion is Standard 1 of the ACCME Standards for Commercial Support – and it is unchanged. Over the last 18 months, since the March 2009 addition to the ACCME’s Q&A, we have continued to provide guidance to providers on what constitutes INDEPENDENCE in CME – what meets the ACCME’s expectations for being compliant with SCS 1 of the ACCME SCS. In our ongoing discussions with accredited providers, we have worked with them to ensure the free flow of scientific information and safeguarding independence in accredited CME activities.
We have definitely not reversed course, but continued our flow in that direction. Accredited providers want to include the reporting of science within accredited CME activities according to the controls set by our standards for commercial support and other requirements. This is a challenge. We will continue to support accredited providers in this process.
The employees of ACCME-defined commercial interests still cannot control the content of accredited CME. In the case of reporting the results of scientific research there is a way for accredited providers to maintain absolute control of the content while allowing the industry scientists to present the results.
The ACCME is focused on ensuring that accredited CME contributes to improvements in patient care and quality. The inclusion of new science in accredited CME is critically important to that process.
The accreditation system is based on CME that addresses professional practice gaps. Professional practice gaps go beyond patient care, they include research, executive and educational practice gaps. Providers are expanding the scope of accredited CME so that it can include helping participants improve their practice of research.
This process of working together with accredited providers to broaden the range of accredited CME activities has been an important affirmation of the accredited CME system. All accredited providers support our goal of independence. Independence is what distinguishes accredited CME from other information exchanges.
These are welcome clarifications from the ACCME. The refined definitions are important in preserving the flow of scientific information.