New ACCME standards are now in effect as of January 1, 2022
Since 1992, the Accreditation Council for Continuing Medical Education (ACCME) has set standards governing interactions between CME and industry. These standards have been recognized by accrediting bodies representing multiple health care professions in the U.S. as well as by international accrediting and regulatory bodies, the government, and industry to protect the integrity of CME and ensure independence from inappropriate industry influence. They are the standards that we as a provider of Accreditation Continuing Education must uphold.
According to ACCME definitions, biomedical startups become ineligible companies (formerly commercial interests) when they begin a governmental regulatory approval process. In the U.S., the regulatory approval process operationally begins when an IND for drugs or PMA (premarket approval) for devices has been submitted; that is, before clinical trials have started.
Because owners and employees of ineligible companies are individuals who have a legal duty to act in the company’s best interests, which is considered an unmitigable conflict, they must be excluded from controlling content of an accredited continuing education (CE) activity as either a planner or speaker. There are only 3 circumstances in which owners or employees of ineligible companies can participate:
- when activity content is not related to business lines or products of the company,
- when activity content is limited to basic science research, and they do not make care recommendations, or
- when participating as technicians to teach safe and proper use of medical devices and do not recommend whether or when a device is used.
If you are an owner of an ineligible company, please do not agree to join a planning committee for or speak at an accredited CME activity that you think is related to your company’s business lines/products. If you’re not sure, ask us. If you do agree to participate in a CME activity, expect questions to determine whether your participation is permitted.
We are excited to announce Convey® as our new financial disclosure collection system! Beginning January 24, 2022, ACMG Education will be using Convey to collect all financial interest disclosures. Convey, a global disclosure system developed by the Association of American Medical Colleges (AAMC), will help us centralize and streamline the data collection and review process for our organization’s disclosure needs.
For more information on the ACCME Standards for Integrity and Independence in Accredited Continuing Education click here.