Approved by the AOFAS Board of Directors May 10, 2022, Revised September 19, 2023
As an ACCME accredited provider, the AOFAS must be able to show that all individuals in a position to control the content of an educational activity have disclosed to the Society all relevant financial or other relationships with any ineligible company.
The ACCME defines an "Ineligible Company" as one who’s primary purpose is the producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. Examples of such organizations include:
Advertising, marketing, or communication firms whose clients are ineligible companies
Bio-medical startups that have begun a governmental regulatory approval process
Compounding pharmacies that manufacture proprietary compounds
Device manufacturers or distributors
Diagnostic labs that sell proprietary products
Growers, distributors, manufacturers or sellers of medical foods and dietary supplements
Manufacturers of health-related wearable products
Pharmaceutical companies or distributors
Pharmacy benefit managers
Reagent manufacturers or sellers
Ineligible companies do not include privately held companies who have not yet completed certain regulatory approval processes. For a private drug company, ACCME considers the Investigational New Drug Application (IND) the starting point
for the regulatory process. For a private device company, ACCME considers the Premarket Approval (PMA) process as the starting point. Pre-clinical (i.e., animal testing) or before status does not meet the definition of an ineligible company and therefore
ownership interest in or employment by the same will not require exclusion.
A "relevant financial relationship" is defined as a relationship in any amount for the individual (i.e., self) occurring within the 24-month period preceding the time that the individual is asked to assume a role in controlling the content
of a CME activity – including planners, faculty, and staff. AOFAS has responsibility for the educational process and an obligation to ensure the delivery of education that is balanced and free of commercial bias. Attendees at CME activities
must have the opportunity to properly evaluate information, analysis, and opinions presented during the activity. It is important that the audience be informed of any aspect of a presenter’s personal or professional interests and relationships
from which the perception of a conflict or bias might arise.
All educational activities under the auspices of AOFAS require that the clinical content be valid and that presentation(s) be based on evidence that is accepted within the profession of medicine as adequate justification for indications and contraindications
in the care of patients. All scientific research referred to, reported, or used in support or justification of a patient care recommendation must conform to the generally accepted standards of experimental design, data collection and analysis.
The ACCME defines Owners and Employees of a Company as follows:
Employees are individuals who have a legal duty to act in a company's best interests. These individuals are hired and compensated to work for this business, and are subject to the employer’s direction as to how to perform their jobs.
Owners are individuals who own any stock (not through a mutual fund or pension plan) in a privately held (i.e., not publicly traded) company. Note: holders of patent royalties or stock options are not considered
owners.
Owners and employees of ineligible companies are considered to have unresolvable financial relationships and must be excluded from participating as planners or faculty and must not be allowed to influence or control any aspect of the planning, delivery, or evaluation of accredited continuing education, except when these individuals fall into any of the limited circumstances outlined below.
When the content of the CME activity is unrelated to the business lines or products of their employer/company.
When the content of the accredited activity is limited to basic science research, such as pre-clinical research and drug discovery, or the methodologies of research, and they do not make care recommendations.
When they are participating as technicians to teach the safe and proper use of medical devices, and do not recommend whether or when a device is used.
AOFAS Disclosure Program
Orthopedics is a specialty that relies heavily on devices, and it is recognized that many AOFAS planners and speakers may have multiple financial relationships with commercial interests that might potentially create conflicts. AOFAS does not view the
existence of disclosed interests or commitments as necessarily implying bias or decreasing the value of an individual’s participation in this activity. Further, AOFAS understands that financial commercial relationships do not automatically preclude
the ability to provide a balanced, objective, and scientifically rigorous perspective and/or presentation.
The AOFAS requires all instructors, authors, planners, reviewers, staff and other individuals in a position to control or influence the content of an activity to disclose all relevant financial relationships or affiliations with ineligible companies.
All identified conflicts of interest must be mitigated and the education content thoroughly vetted through peer review by AOFAS for fair balance, scientific objectivity, and appropriateness of patient care recommendations. The AOFAS also requires faculty/authors to disclose when off label/unapproved uses of product are discussed in a CME activity or included in related materials or discussion.
Disclosures are maintained by the AOFAS office. Disclosures must be dated within one year of the date of presentation or planning activity with AOFAS. Individuals complete an online disclosure form which must be updated on an annual basis or when information
changes. AOFAS staff review the disclosure information and ensure that all required disclosures are submitted. AOFAS requires that all faculty, planners, authors, and relevant staff members comply with the ACCME Standards for Integrity and Independence
in Accredited Continuing Education.
Education Conflict of Interest Subcommittee
AOFAS has established a subcommittee within the Education Committee to review and mitigate all conflicts of interest identified by AOFAS staff who review submitted disclosures. The subcommittee is comprised of AOFAS Active Member or Candidate
Members, who volunteer to provide abstract review, disclosure review, and content review for educational programming. This pool of volunteers is maintained by the Education Staff and is updated yearly. Staff randomly select 5-8 individuals who have
no conflicts of interest to report, and they review and mitigate all disclosures and content for each educational activity or course. These disclosures and all content must be submitted sufficiently ahead of time for the Education Subcommittee to
have enough time for their review and mitigation process to be completed before the CME event. Additionally, volunteers are used for larger events like the Annual Meeting or Winter Meeting. This subcommittee is responsible for reviewing in advance
of the educational activity all disclosures, mitigating all conflicts of interest, and reviewing PowerPoint slides, references, resources, or other materials provided in advance of the activity. The subcommittee reports all findings directly to the
Education Committee Chair.
Identification of Conflicts
AOFAS relies upon two mechanisms to resolve conflicts of interest: recusal and disclosure/content review by the Education Conflict of Interest Subcommittee.
Planners recuse themselves from controlling CME content when the content relates to a relevant financial relationship. For committee meetings and conference calls, all AOFAS committee members with COIs must refrain from discussion and voting when their
COIs are relevant. Planner recusals are recorded in the meeting/call minutes. Within the planning of individual CME activities, when a moderator (webinar) or chair (course) has a relevant financial relationship(s), s/he would continue to be expected
to recuse him/herself from decisions where his/her COI is relevant. In such situations, the Education Conflict of Interest Subcommittee would be advised and consulted.
The Education Conflict of Interest Subcommittee reviews all disclosures that require further discovery for participation, including any presenters who are employees or owners of ineligible companies. Additional information may be required from the presenters
to determine whether participation will be allowed.
Mitigation Process
Due Process
The Education Conflict of Interest Subcommittee will review the individual’s disclosures, along with the content in question, and address and document the handling of the potential violation for each educational activity. Any individual who refuses
to disclose or provides partial or incomplete disclosure of relevant relationships cannot be permitted to have control of or responsibility for the development, management, presentation, or evaluation of a CME activity.
After identification and investigation of a potential violation, the subcommittee will confer with the Chair of the Education Committee. All documentation efforts shall be reflected on the Resolution of Identified Conflict of Interest Form. Should it
be determined that the individual is in violation of the COI Policy the following steps shall be taken to resolve the issue:
First Violation
Education Conflict of Interest Subcommittee shall investigate the potential violation and contact the planner or faculty member to identify, discuss and document the nature of the violation, and report to the Chair of the Education Committee. Documentation
of steps taken to resolve issue shall be reported to the AOFAS Board of Directors.
Subsequent Violations
Education Conflict of Interest Subcommittee and Education Committee Chair shall address the nature of the violation in writing with the planner or faculty member. Documentation of steps taken to resolve the issue shall be reported and saved as a matter
of official record. A subsequent third or greater violation determination by the Education Conflict of Interest Subcommittee may result in suspension from future planner or faculty for a period of 1-3 years, depending upon the severity of the violation.
Resolution
Pending resolution of identified COI, compliance with AOFAS policies shall be mandated.
Grievance
The Education Conflict of Interest Subcommittee will make penalty recommendations pertaining to any violation directly to the AOFAS Board of Directors for final approval. Written notice will be sent to the planner or faculty member within 30 days of receipt
of a complaint or information the Subcommittee deems meritorious or credible. Individuals will have 30 days to respond in writing to the notice. Decisions of the Subcommittee may be appealed in writing to the Board of Directors.
AOFAS posts the Society’s conflict of interest policies on the AOFAS website to make them available to members and the public.
Educational Presentation Requirements
All presentations must be free of commercial bias and any implication of an endorsement of specific products or services.
Faculty must not actively promote or sell products or services that serve their professional or financial interests during accredited education.
Abstract presentations must include disclosures for all authors. AOFAS disseminates disclosures of all authors prior to the educational activity via electronic or print mechanisms.
Slides and handouts should be free of trade names.
Company logos and company generated animations or videos are prohibited.
Mention of trade names is not allowed during your presentation except for the two situations listed below.
If the nature of the presentation necessitates the identification of trade names for scientific or comparative purposes, it is mandatory that balance be provided through identification of the majority of available alternatives.
Factual statements made regarding those specific products must be based on generally accepted scientific methods.
If a trade name is used and it is the product available, this first time it appears in print or is stated verbally, the generic name should be used followed by the trade name in parenthesis in print or can be mentioned verbally. After
that that generic term should be used.
Disclosure Slide
Each presenter must include a separate disclosure slide to follow the initial title slide of the presentation. Disclosure slides inform the audience of any financial relationship which exists between the presenter, a co-author
and any ineligible company. The nature of all financial relationships in any amount occurring within the past 24 months must be disclosed. The AAOS slide should not be used as the disclosure slide.
The disclosure slide should be displayed to the audience long enough for them to read it and the speaker should not comment unless it is to positively point out a relevant conflict.
Potential conflicts of interest for co-authors of a presentation must be included in the program disclosure section and should be referenced in a separate disclosure slide immediately following the presenter’s title slide.
All conflicts relevant to the presentation within the faculty disclosure should be verbally reported from the podium.
Financial interests include and should be reported in this order:
Slide Decks/Handouts/Written Material
Slide Decks/Visual Presentations are required for each presentation and must be uploaded by the deadline provided when faculty confirm participation, to allow moderators, staff, and content reviewers sufficient time to review documents by the established
deadline. The Education Conflict of Interest Subcommittee will review all handouts for potential bias or conflict of interest and may require corrections be made. Manufacturers, exhibitors and other commercial enterprises are prohibited from sponsoring
or providing course handouts. In addition, the name of a manufacturer and/or exhibitor may not appear on any page or product used as a handout except when used for scientific or comparative purposes. All faculty are required to revise content based
on recommendations from the Education Conflict of Interest Subcommittee.
Labs
Faculty instructing in laboratory courses may express personal preferences (ideally with reasoning provided for same) for specific instruments, implants and techniques but must balance the discussion with the identification of specific alternatives. Opinions
must not constitute a commercial endorsement. Faculty members should indicate if they lack familiarity with comparable alternatives. Derogatory comments regarding any vendor or product is not allowed.
Program Evaluation
AOFAS learner evaluations address the presence of commercial bias in all its educational activities, and those evaluations are monitored by the planning committee for that program. Feedback from evaluations reporting bias in presentations are sent to
the Education Committee for review and investigation, and feedback given to present hers, when appropriate.
Disclosure to Learners
Based on the activity format, the AOFAS employs different mechanisms for disclosure. Regardless of the mechanism, disclosure information always includes:
names of the individuals in a position to control CME content along with their role in the CME activity
the name of the commercial interest(s),
the nature of the relationship(s), and
names of all individuals in a position to control CME content who disclosed they had no relevant financial relationships.
For live courses, including the Annual Meeting, Winter Meeting, and all in-person courses, disclosure information is communicated to learners in the printed program agenda materials, in addition to online information, and/or the meeting app (if
used). Speaker disclosure information is included on the second slide of every presentation. When an app is used, speaker disclosure information is available in the “speaker” section. Planner disclosure information is available
in the "information" section.
In webinars, disclosure information for all individuals in control of CME content is available for download in the CME Program information document that is accessible once learners connect to the webinar and are waiting for the webinar to begin.
These relationships are also on the "waiting wall" that learners see while they wait the start of the webinar. Speaker disclosures are included within the slide deck of their presentations as slide 2.
For the FAI CME Exam, the FAI CME Exam Committees’ disclosure information is communicated to learners on the main landing page of the journal as a downloadable handout and in the CME Exam information, which has a specific tab within the
exam platform. This information is viewable and available for download before the user initiates participation in the CME activity.
For Manuscript Review, AOFAS discloses the Journal's Editorial Board's relationships within the CME Program Information materials posted on the publisher's website, and via email in the instructions provided to manuscript reviewers before they
begin their review. AOFAS does not consider the manuscript authors to control CME content of the activity. However, manuscript authors' relationships, but not names, are disclosed to manuscript reviewers in our blinded review process.