SHM Policy for the Identification, Resolution and Disclosure of Conflict of Interest in the Creation of CME

1. DEFINITION OF TERMS

Commercial Interest
The ACCME defines commercial interest as any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.

The ACCME does not consider providers of clinical service directly to patients to be commercial interests - unless the provider of clinical service is owned, or controlled by, an ACCME-defined commercial interest.

Source: http://www.accme.org/requirements/accreditation-requirements-cme-providers/policies-and-definitions/definition-commercial-interest

Financial Relationships
Financial relationships are those relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria for promotional speakers’ bureau, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit. Financial benefits are usually associated with roles such as employment, management position, independent contractor (including contracted research), consulting, speaking and teaching, membership on advisory committees or review panels, board membership, and other activities from which remuneration is received, or expected. ACCME considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner.

The ACCME has not set a minimum dollar amount for relationships to be significant. Inherent in any amount is the incentive to maintain or increase the value of the relationship.

With respect to personal financial relationships, contracted research includes research funding where the institution gets the grant and manages the funds and the person is the principal or named investigator on the grant.

Source: http://www.accme.org/requirements/accreditation-requirements-cme-providers/policies-and-definitions/financial-relationships-and-conflicts-interest

Conflict of Interest (COI)
Circumstances create a conflict of interest when 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.

The ACCME considers financial relationships to create actual conflicts of interest in CME when individuals have both a financial relationship with a commercial interest and the opportunity to affect the content of CME about the products or services of that commercial interest. The ACCME considers “content of CME about the products or services of that commercial interest” to include content about specific agents/devices, but not necessarily about the class of agents/devices, and not necessarily content about the whole disease class in which those agents/devices are used.

With respect to financial relationships with commercial interests, when a person divests themselves of a relationship it is immediately not relevant to conflicts of interest but it must be disclosed to the learners for 12 months.

Source: http://www.accme.org/requirements/accreditation-requirements-cme-providers/policies-and-definitions/financial-relationships-and-conflicts-interest


2. PROCEDURE FOR THE IDENTIFICATION OF COI

  1. Disclosure of Financial Relationships to SHM: SHM is committed to developing balanced, objective, scientifically rigorous continuing medical education that is free from the control or influence of commercial interests. Everyone who is in a position to control the content of a CME activity (e.g., planners, speakers, authors, etc.) must disclose all relevant financial relationships with a commercial interest to the SHM by completing our Conflict of Interest Disclosure Form prior to the education activity being delivered to learners.
  2. Individuals who refuse to disclose relevant financial relationships will be disqualified from being a planning committee member, a teacher or an author of CME, and cannot have control of, or responsibility for, the development, management, presentation or evaluation of the CME activity.
  3. Identification of COI: SHM staff will review submitted COI Disclosure forms upon submission. Should a potential conflict of interest be identified, the individual will be contacted and asked for clarification or additional information. Should no conflict of interest be identified, the individual may be confirmed in his or her role in the activity. If relevant financial relationships are confirmed, staff will notify the full planning committee of the relevant financial relationship and provide links to the ACCME standards for commercial support: http://www.accme.org/requirements/accreditation-requirements-cme-providers/standards-for-commercial-support.

Staff will also initiate one of the below mechanisms for the resolution of COI as appropriate.


3. MECHANISMS FOR THE RESOLUTION OF COI

In the case a conflict of interest is identified with a course director, activity director or program chair responsible for developing agenda and proposing presenting faculty, a review and feedback by the SHM Education Committee will be provided and in some instances peer review outside of the institution may be sought.

In the case a conflict of interest is identified with a faculty, author, speaker, planning committee member, or any individual control of the content of individual presentations, lectures, and enduring online activities, the following mechanisms may be employed:

  1. The scope of the conflicted individual’s role may be restricted so that he/she may no longer control the content, or he/she may be asked to refrain from providing clinical recommendations within a given CME activity.
  2. An individual without a conflict of interest may replace the conflicted individual.
  3. Any content created by the individual will have to be reviewed by an independent party, including an SHM Education committee member, SHM Hospital Quality & Patient Safety Committee member, SHM Board member and/or qualified SHM staff. 
    • Reviewers will not have a relevant financial relationship with respect to educational content or CME activity.
    • If reviewers find bias in the content, the content will be removed or edited until the independent reviewer agrees that it is free of bias.
  4. If disagreement arises related to the nature of bias and the individual with a relevant financial relationship disagrees and is unwilling to edit content, content will be removed from the educational activity. The individual may be removed from the CME planning committee and/or activity creation and all of that individuals content may also be removed if the independent party believes that content created if deemed appropriate by the independent review.
  5. While not a mechanism to protect against bias, we do also utilize retrospective analysis: in all cases, final feedback related to the content and potential perceived commercial bias in individual presentations as well as the CME activity in general will be requested from learners immediately following the educational activity. Results will be shared with individual presenters, course directors, and planning committee members.

4. DISCLOSURE TO LEARNERS

Relevant financial relationships of those with control over CME content will be disclosed to learners prior to the continuing medical education activity in a “Disclosure Statement”. When commercial support is “in-kind,” the nature of the support must be disclosed as well.

For online enduring activities, this disclosure statement will appear as the front matter, requiring learners to mark a checkbox acknowledging they have read the disclosure. For live activities, a full list of COI data will be included in the program book and as the first slide of each speaker/author/presenters presentation

Disclosure statements will include: name of individual, name of commercial interest, & nature of the relationship will be provided without trade names, logos, product messages, or any similarly promotional type content.



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