Disclosure FAQ and Information
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.
WU employees should continue to disclose in the RMS COI system as they always have.
FREQUENTLY ASKED QUESTIONS
If I have research grants from ineligible companies but my institution manages the funds, do these need to be disclosed?
Yes, all financial relationships with ineligible companies within the prior 24 months need to be disclosed regardless of the amount or of your view of the relevance of a relationship to the education. This includes research support even if the money goes to the institution.
If I consult for an ineligible company on a product that is not relevant to my talk, do I need to disclose it?
Yes, all financial relationships with ineligible companies need to be disclosed. The regulation is that the relationship is relevant if any products developed or marketed by the company are relevant to the activity content, not just the product you are being consulted on or researching. So, for relationships with far-reaching pharmaceutical companies, there may be virtually no clinically based CE activity for which the relationship won’t be relevant even if the drug you are consulting on is still in preclinical studies.
I am planning a research symposium. Do I need to get disclosures from all authors on each abstract that is being presented or only from the individuals presenting?
Only the presenters. The individuals considered in control of content for a presentation on a research study are those who are involved in the planning, reviewing, and delivery of the actual CE presentation. Others who were involved in the research or who were authors of a published research paper would not be considered in control of the CE content if they were not involved in the presentation
If I own a biomedical startup that is developing technology for use in patients, but no products have FDA approval yet, can I plan a CE activity?
Not if you have submitted a premarket approval (PMA) for any devices. The point at which a biomedical startup becomes an ineligible company is when it has begun a governmental regulatory approval process. In the U.S., this is when an IND for drugs or a PMA for devices has been submitted. At that point, you may only control content of a CE activity if the activity content is not related to business lines or products of the company, activity content is limited to basic science research/no care recommendations will be made, or you will participate as a technician to teach safe and proper use of medical devices/will not recommend whether or when a device is used.
If I have ownership interest in a company that doesn’t produce, market, or sell healthcare products for patients but is a subsidiary of a one that does, can I speak at a CE activity?
No. For companies with subsidiaries, the exclusion of owners and employees applies both to subsidiaries of an ineligible parent company regardless of steps taken to firewall the subsidiaries and to those of an ineligible subsidiary of an eligible parent company.
Can an owner of an ineligible company participate as a speaker at a CE activity if the content of their talk is unrelated to the business lines or products of the company but other talks they have no role in may be related?
Yes, an owner of an ineligible company may control content unrelated to the products of their company as a speaker even if there are other sessions of the same activity (in which the owner is not involved) that are related to the products of their company