CME Policy and Procedures for Disclosure of Conflicts of Interest
The following policy governs all Louisiana Academy of Family Physicians (LAFP) produced CME activities of all types, including live, performance improvement in practice, point of care, enduring materials and medical journals. The intent of this policy is not to prevent individuals from participating, but rather is to identify and resolve any conflict of interest. Should resolution be impossible, a replacement for the individual must be chosen.
1. COLLECTION OF ALL FINANCIAL RELATIONSHIPS
All individuals in a position to control content must disclose online to the LAFP the existence of any financial relationships they or their spouse or domestic partner have had with ineligible companies within the previous 24 months (36 months for journal editors and editorial board members) or might have within the foreseeable future. An ineligible company is defined as one whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. Individuals must disclose all financial relationships with ineligible companies, regardless of the amount or the potential relevance to the education.
Examples of financial relationships include employee, researcher, consultant, advisor, speaker, independent contractor (including contracted research), royalties or patent beneficiary, and ownership interest. Ownership of individual stocks and stock options should be disclosed; ownership of diversified mutual funds does not need to be disclosed. Research funding from ineligible companies should be disclosed by the principal or named investigator even if that individual’s institution receives the research grant and manages the funds.
Disclosure information must be received and reviewed by the LAFP prior to confirmation of the individual’s participation. The disclosure will be reviewed and, should a conflict be identified, additional information or dialogue may be required. Failure or refusal to disclose online by the due date, false disclosure, or the inability to work with the LAFP to mitigate an identified financial relationship will result in withdrawal of the invitation to participate and replacement of the individual. It is necessary to update disclosure information should the status change during the course of the CME activity.
2. IDENTIFICATION OF RELEVANT FINANCIAL RELATIONSHIPS
The LAFP will have read-only access to all disclosure forms and will review the submitted information to determine which relationships are relevant to the education. The intent of this policy is not necessarily to prevent individuals from participating, but rather to identify and mitigate any relevant financial relationships to prevent commercial bias.
Owners and employees of ineligible companies must be excluded from controlling content or participating as planners or faculty in accredited education. Three exceptions to this exclusion outlined in ACCME Standard 3.2 may be considered by the LAFP.
3. MITIGATION OF RELEVANT FINANCIAL RELATIONSHIPS
Should no conflicts of interest be identified, the individual may be confirmed in his or her role in the activity. Should a relevant financial relationship be identified a mitigation strategy will be assigned and discussed with the individual prior to assuming their role in the activity. Should resolution be impossible, a replacement for the individual must be chosen. Resolution methods will be determined based on the individual’s role in the activity and may include, but not be limited to, one or more of the following:
a. Conduct peer review of the content prior to the activity to ensure it is based on the best available, highest strength evidence available. The activity faculty or authors must be responsive to revision requirements.
b. Assign a different topic for the individual.
c. Limit the scope of the topic the individual may control.
d. Terminate the relationship with the individual.
All mitigation strategies must be implemented prior to the activity. The mitigation process and outcome will be documented in the activity file, with a copy forwarded to the LAFP for tracking and reporting purposes.
On-site and post-activity audits will be conducted at random to ensure that LAFP CME activities are unbiased and offered in compliance.
4. DISCLOSURE OF UNLABELED/INVESTIGATIONAL USES OF PRODUCTS
LAFP believes that it is important for faculty and authors to clarify for 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. 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.
For live activities, should an unplanned discussion of unlabeled or investigational uses of a product occur (usually in the course of a question and answer session), 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.
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.
5. DISCLOSURE TO LEARNERS
Acknowledgement of all relevant disclosures as determined by the LAFP —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 influence/control content of the educational activity must be presented in writing to the learners prior to presentation.
Before a learner engages in the education, the LAFP will disclose all relevant financial relationships, or lack thereof, for all individuals in a position to control content. When disclosing a relevant financial relationship, the following will be shared:
a. Names of the individuals
b. Names of the ineligible companies with which they have relationships
c. The nature of the relationships
d. The topic areas involved
e. A statement that all relevant financial relationships have been mitigated
