International Institute for Restorative Reproductive Medicine

 

Policy and Procedures for Managing Conflicts of Interest

The following policy governs all IIRRM produced CME activities: Any individual in a position to control content must disclose, in writing to the CME Provider, the existence of any financial relationships with a commercial interest within the past 24 months. A commercial interest is defined as any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. Disclosure information must be received and reviewed by IIRRM prior to confirmation of the individual’s participation. Any conflicts of interest must be identified and resolved by the IIRRM prior to the individual’s confirmation as an activity planner, faculty author, or other content controlling role. 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. It is necessary to update disclosure information should the status change during the course of the CME activity.

The intent of this policy is not to prevent individuals from participating, but rather to identify and resolve any conflict of interest. Should resolution be impossible, a replacement for the individual must be chosen.

The review, identification, and resolution process must take place prior to the activity; 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 withdrawal of the invitation. The disclosure information will be reviewed, and should a potential conflict be identified, additional information or dialogue may be required.

Acknowledgement 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 content of the educational activity must be presented to the learners in writing prior to presentation or publication.

Failure or refusal to disclose, false disclosure, or inability to work with the IIRRM to resolve an identified conflict of interest will result in withdrawal of the invitation to participate and replacement of the individual.

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, un-biased content using best available, 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 IIRRM
  • Cancellation of the presentation and/or publication of the material with IIRRM

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 IIRRM 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 the 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 or responding to the discussion point.  If this occurred during a recorded session we ask you declare this to IIRRM on your faculty statement (disclosure form) so we can provide this information to learners before they view the session online or before the recorded presentation is viewed.

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 presentation .