Washington University School of Medicine in St. Louis
Disclosure of Financial Relationships Policy & Procedures
Statement of Intent
As a provider accredited by the Joint Accreditation for Interprofessional Continuing Education, Washington University must ensure balance, independence, objectivity, and scientific rigor in all Continuing Education (CE) activities that it provides and credits. The content or format of CE activities and related materials must be crafted to promote improvements in quality of healthcare and not to promote proprietary business or commercial interest.
All persons in a position to influence the content of a CE activity are expected to adhere to the highest standards of academic integrity. Recommendations for medical practice must be based on evidence that is accepted within the profession as adequate justification for their indications. Investigational approaches should be identified as such. Furthermore, all scientific research referred to, reported, or used in CE in support or justification of patient care recommendations must conform to the generally accepted standards of biomedical research. Whenever possible, planners, presenters, and authors of CE activities should reference the best available evidence and describe the level of evidence supporting a particular diagnostic or management strategy.
The intent of disclosure is to ensure that Washington University CE-accredited activities are in the best interest of the public, promote quality and safety, and present unbiased, valid content.
Definition of Relevant Financial Relationship
In accordance with ACCME criteria, the accredited provider is responsible for identifying relevant financial relationships between individuals in control of educational content and ineligible companies and managing these to ensure they do not introduce commercial bias into the education. Financial relationships of any dollar amount are defined as relevant if the educational content is related to the business lines or products of the ineligible company.1 Financial relationships include the following: advisor, consultant, independent contractor, speaker, employee, executive role, ownership interest, royalties or patent beneficiary, individual stock and/or stock options, researcher (even if the institution receives the grant/manages the fund), and any other financial benefit. All financial relationships with ineligible companies within the previous 24 months must be disclosed regardless of the individual's perception of the relevance of the relationship to the content of the CE activity. There is no minimum financial threshold.
An individual who has ownership interest (equity) in or is employed by an ineligible company has a legal duty to act in the company's best interests, which is considered an unmitigable conflict; thus these individuals are prohibited from being involved in the planning or presentation of a CE activity. Note that this rule includes those whose ownership interest is in the form of stock and/or stock options in a non-publicly traded company who have not yet received any payment. There are three exceptions in which such an individual can have a limited role:
- when activity content is not related to the business lines or products of their employer/company2
- when activity content is limited to basic science research, and they do not make care recommendations
- when participating as technicians to teach safe and proper use of medical devices and do not recommend whether or when a device is used
Procedures for Identifying and Mitigating Relevant Financial Relationships/Potential Conflicts of Interest
All individuals in a position to control the content of a CE activity (chairperson, planning committee member, speaker, moderator, author, etc.) must complete a Disclosure of Financial Relationships and a Washington University Standards of Content Agreement in which they attest that all patient care recommendations will be based on the best available evidence and that a balanced view of therapeutic options will be provided. Disclosure and mitigation of relevant financial relationships must occur as follows:
|Role in activity||When disclosure and mitigation must occur|
|Activity chairpersons, planning committee members||Beginning of activity planning before topics and speakers are chosen|
|Activity speakers, moderators, or authors||Before presentations are given or enduring materials finalized|
Anyone who fails to disclose will be disqualified from participating as planner or faculty in the CE activity.
Toolkit for Identification, Mitigation, and Disclosure of Relevant Financial Relationships (PDF)
- Activity chairpersons and planning committee members:
- Complete the Disclosure of Financial Relationship and Standards of Content Agreement at the beginning of the planning process
- The CME department will review these disclosures and the content agreements
- If NO financial relationships exist, no action is required. Faculty letters will instruct the presenters on the rules for developing CE content.
- If relevant financial relationships are identified, the methods of mitigation listed below for planners should be followed and documented.
- Activity speakers, moderators, or authors:
- CE activity chair/planners/coordinators, in conjunction with the CME department, have primary responsibility for collecting and reviewing disclosures of interest for speakers, moderators, and authors.
|IF ANY relationships are disclosed:||IF NO relationships are disclosed:|
|If the companies with which there are relationships offer any products/services for the condition being presented, a slide review must be completed prior to the presentation to mitigate any relevant financial relationships/potential COI||No review/mitigation is needed|
|The steps that should be taken to mitigate any relevant financial relationships are outlined below and the Financial Relationship Mitigation Form provided on the CME website must be completed prior to the presentation start and submitted to CME for verification||The lack of relationships must be announced to the audience verbally, in print, or in the PowerPoint presentation|
* The CME department should be consulted when the eligibility of a company or a mitigation strategy is unclear. The CME department and the chair of the proposed CE activity will discuss and mitigate relevant financial relationships where necessary
Mechanisms to Mitigate Relevant Financial Relationships/Potential COI Prior to Activity Delivery
Note that these mechanisms do not apply to owners/employees of ineligible companies since such relationships are considered by the ACCME to be unmitigable conflicts.
Options for planners having relevant financial relationships/potential COI:
- Divest the financial relationship
- Recusal from controlling aspects of planning and content with which there is a financial relationship
- Peer review of planning decisions by persons without relevant financial relationships
The CME department will review how topics and faculty were chosen and obtain evidence that the topics represented are balanced and are supported by the best available evidence.
Options for speakers, moderators, and authors having relevant financial relationships/potential COI:
- Divest the financial relationship
- Peer review of content by persons without relevant financial relationships to verify that all recommendations involving clinical medicine are based on evidence accepted within the profession of medicine as adequate justification for their indications; that all scientific research conforms to the generally accepted standards of experimental design, data collection, and analysis; and that no bias is present. Revise content as deemed necessary.
- Substitute an individual with no relevant financial relationships
- Assign the individual with relevant financial relationships a role in which therapeutic options will not be recommended
- If relevant financial relationships cannot be mitigated and content is to be presented, eliminate CE credit for that portion of the activity. Note, however, that an interval of at least 30 minutes must separate accredited from non-accredited education delivered in the same physical or virtual (e.g., Zoom room) space.
Transparency to Learners
Financial interests of all individuals involved with the CE activity, including planners, speakers, moderators, and authors, must be disclosed to the learners. All disclosures, even when there is "nothing to disclose," need to be reported and documented. After all financial disclosures are received, reviewed, and mitigated, a listing of disclosures should be provided to learners prior to the start of the activity or in handout materials and must include the following statement:
“All relevant financial relationships have been mitigated."
Regularly Scheduled Series
The above policies and procedures also apply to regularly scheduled series (RSS). The time frame should be as follows: At the beginning of the fiscal year, the activity chair and planning committee members must complete a Disclosure of Financial Relationships and Standards of Content Agreement. If the activity chair or planners disclose a potential conflict, a member of the CME department will follow the mitigation guidelines for planners.
Disclosure of Support from Ineligible Companies
All support from ineligible companies for a CE activity must be made known to learners prior to the education activity. See Ineligible Company Policy for further information.
Non-Clinical CE Activities
The policies and procedures described above apply to all patient care-related CE activities. For non-clinical CE activities on such topics as faculty development, communication, ethics, law, office management, and teaching, disclosure of financial relationships is not required.
PDF of page content: Disclosure of Financial Relationships Policy & Procedures
1 Ineligible company (formerly referred to as commercial interest) is defined as any entity producing, marketing, re-selling, or distributing healthcare goods or services consumed by, or used on, patients. This does not include providers of clinical services directly to patients, government organizations, or non-healthcare related companies. A biomedical startup becomes an ineligible company when a governmental regulatory approval process is begun, i.e., when an IND for drugs or PMA (premarket approval) for devices has been submitted. This occurs before clinical trials commence.
2 For owners or employees of ineligible companies, it does not matter whether the individual is working on a product relevant to the topic being discussed or whether any of the company’s products will be discussed at the activity. The key element is whether the company is developing or marketing any product for use in the condition being discussed. For example, if the topic of a planned CE activity is hypertension, an individual who is an owner/employee of a company that markets or is developing an antihypertensive agent may not participate, even if the he/she does not directly work on that product.
Reviewed/revised 5/13, 2/14, 8/15, 11/17, 5/21, 1/22, 6/22