Policy and Procedures for Managing Conflicts of Interest (VitaeCME )
The following policy governs all ViateCME produced CME activities:
1. Any individual in a position to control content must disclose, in their faculty form to VitaeCME, the existence of any financial relationships with a commercial or conflict of interest within the past 24 months. We define a conflict of interest as an individual has an opportunity to affect CME content about products or services of a commercial interest with which he/she has a financial relationship. Disclosure information must be received and reviewed by VitaeCME prior to confirmation of the individual’s participation or use of content in the delivery of ongoing [endured] continuing education on the platform.
2. An online faculty disclosure form is sent either:
a) to presenters and faculty, along with other speaker correspondence, prior to the activity taking place (live webinars and courses)
b) to faculty and those involved in content delivery of courses and endured content while the transition of content to VitaeCME is taking place
3. Any conflicts of interest must be identified and resolved by the VitaeCME prior to the individual’s confirmation as a presenter, or educator and before the content can be used for courses (endured learning) on the VitaeCME platform. We define a conflict of interest as an individual that has an opportunity to affect CME content about products or services of a commercial interest with which he/she has a financial relationship. For live-delivered CME, it is necessary to update disclosure information should the status change during the course of the CME activity, before the live activity takes place.
4. Relevant relationships disclosed by presenters do not necessarily disqualify the presenter or their presentation but will be identified in writing, to allow the audience to determine whether they believe that such a relationship may have any influence on the speaker’s presentation or conclusions. If the presenter refuses to make full disclosure, makes false disclosure, or the disclosure raises issues that in the judgment of VitaeCME are irreconcilable with the presentation to be made, the VitaeCME may elect to identify a different presenter or decide the material submitted cannot be used for the purposes of CME delivery.
5. The review, identification, and resolution process must take place prior to the activity or publishing of course material with VitaeCME; all individuals in a position to control content must return the disclosure information by the due date. Failure to disclose within the necessary timeframe will result in the withdrawal of the invitation. The disclosure information will be reviewed, and should a potential conflict be identified, additional information or dialogue may be required.
6. Acknowledgment of all relevant disclosures—i.e., nothing to disclose or existence of affiliation(s), and/or financial relationship(s) or interest(s)—for every individual who serves in a position to control the content of the educational activity must be presented to the learners in writing prior to the presentation or publication. For live presenting faculty (webinar presenters) this includes either a written statement to be included with the learning objectives distributed before the webinar, or makes a verbal statement at the beginning of the webinar along with a non-disclosure slide, as the second slide of your presentation which includes a non-disclosure statement (sample below)
Sample statements:
SAMPLE STATEMENT #1
This speaker has indicated that (s)he has no relationships to disclose with any manufacturer of any commercial product or services that may be mentioned in (her) his presentation, nor with any commercial supporter of this meeting (if applicable).
SAMPLE STATEMENT #2
This speaker has indicated that (s)he has the following relationships with commercial or proprietary entities that may be related to (her) his presentation:
[describe relationships]
Resolution of Conflicts of Interest
A. Should no conflict of interest be identified, the individual’s role in the activity may be established.
B. Should a conflict of interest be identified, the individual will be contacted and asked for clarification or additional information. Upon receipt and review of this additional information, methods of resolution will be identified and discussed with the individual. Resolution methods may include, but not be limited to, one or more of the following:
- Peer review of content prior to the activity to ensure evidence-based, unbiased content using best available, the highest strength of evidence. The activity faculty must be responsive to revision requirements.
- Modifications or edits of the material agreed upon between the speaker/faculty involved and VitaeCME
- Cancellation of the publication of the material with VitaeCME
C. The resolution process and outcome will be documented in the CME activity file
Disclosure of Unlabeled/Investigational Uses of Products
All speakers/faculty must disclose to VitaeCME and learners when an unlabeled use of a commercial product, or an investigational use not yet approved for any purpose, is discussed during an educational activity. Speakers/Faculty must disclose that the product is not labeled for use under discussion or that the product is still investigational.
The intent of this policy is not to prohibit or limit the exchange of views in scientific and educational discussions, including discussions of unapproved uses, but to ensure that faculty discloses to learners that such discussion will take place.
Should an unplanned discussion of unlabeled or investigational uses of a product occur, it is the responsibility of the faculty member to inform the learners that the use under question/discussion is unlabeled or investigational prior to answering the question of responding to the discussion point. If this occurred during a recorded session we ask you declare this to VitaeCME on your faculty statement (disclosure form) so we can provide this information to learners before they view the session online.
Acknowledgement of planned discussion of unapproved or investigational uses of products must be presented in writing to the learners prior to the start of the activity, or (for enduring materials) at the point that first mention is made of the unapproved/investigational use in the activity.
