The American Society for Surgery of the Hand (“ASSH”) is committed to complying with ACCME’s Standards for Commercial Support for all of its continuing medical education (CME) eligible activities. ASSH’s CME Conflict of Interest Policy and Disclosure Form is intended to comply with ACCME’s requirements and is in addition to ASSH’s General Conflict of Interest Policy and Disclosure Form, which is also applicable. The responsibility for managing ASSH’s CME Conflict of Interest Policy is under the control of the CME Advisory Group (CME-AG) which (i) reports to Council (the ASSH’s governing board); (ii) establishes ASSH’s rules, responsibilities and processes with respect to compliance with ACCME’s requirements for identification, disclosure and resolution of COI; and (iii) has the authority to implement, apply, and interpret ASSH’s CME Conflict of Interest Policy and ASSH’s General Conflict of Interest Policy as it may apply to CME related activities. The CME-AG is chaired by ASSH’s Education Division Director.
Every person who has the potential to affect the content of a CME activity must complete a Disclosure of Relevant Financial Relationships for Continuing Professional Education form (CME Financial Disclosure Form) and submit it to ASSH prior to their invitation to participate in a CME related activity, where practical, and in all cases, as follows:
• For Planners, the CME Financial Disclosure Form must be returned prior to planning the activity.
• For faculty/moderators/presenters/authors, the CME Financial Disclosure Form must be returned prior to developing their course materials.
• For Reviewers, the CME Financial Disclosure Form must be returned prior to the commencement of content review.
Persons who perform CME related duties on a regular and ongoing basis must complete Disclosure Forms annually. All other persons must complete forms in the course of their becoming involved in CME related activity. Everyone must provide updates if a change in relevant financial relationships has occurred.
All persons who have the potential to affect the content of a CME activity must ensure that:
• All recommendations involving clinical medicine in a CME activity are based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients.
• All scientific research referred to, reported or used in a CME activity or in support of a patient care recommendation conform to generally accepted standards or experimental design, data collection and analysis.
• Content is linked to the learning objectives for the activity, pertinent to the target audience and free of commercial bias.
Resolution of Personal Conflicts of Interest
It is ASSH’s intent that all relevant financial relationships with commercial interests are identified in a timely manner and any resulting conflicts of interest (“COI”) are resolved appropriately. A “commercial interest” is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.
A “relevant financial relationship” is any amount occurring within the past 12 months that creates a conflict of interest. Please note that ASSH’s General Conflict of Interest Policy defines financial relationships more broadly. ASSH will review and assess disclosed commercial interests and the identification of relevant financial relationships at the earliest possible occasion with the goal of determining and resolving any potential or relevant COI (as defined by either ASSH’s General or CME Conflict of Interest Policies) prior to the commencement of any affected CME related activity.
All CME Disclosure Forms will be reviewed by ASSH’s Vice President of Professional Development to ensure (i) compliance with ASSH’s CME Conflict of Interest Policy; (ii) resolution of COI consistent with ACCME’s requirement occurs as necessary; (iii) any potential COI matters under ASSH’s General Conflict of Interest Policy are identified and addressed; and (iv) any questions or issues requiring follow-up are referred to the CME-AG. ASSH may from time to time adopt additional procedures for implementing this policy and for handling CME related COI matters.
If the Vice President of Professional Development has any initial questions or concerns regarding a CME Financial Disclosure Form, she will send the CME Financial Disclosure Form(s) in question to the applicable course chair(s) for their review and for them to provide guidance on whether a relevant financial relationship with a commercial interest creates a COI that must be resolved.
In general, if the Vice President of Professional Development identifies a relevant financial relationship, the following occurs:
No one will be allowed to plan, present, or affect the content of an ASSH CME activity related to that person’s relevant financial relationship with a commercial interest. Anyone with such a COI must recuse themselves from participating in the affected activity. In the alternative, ASSH will not invite them to participate, will preclude them from participating, or, as necessary, will remove them from participation. In special circumstances, persons with unresolvable conflicts may be considered a critical source of expertise for CME planning purposes. In such cases, ASSH’s CME-AG will appoint one of its members to review and oversee the planning process to ensure that the CME activity is fair, balanced, and without commercial bias.
Where COI can reasonably and appropriately be resolved, ASSH will work with the affected parties to take steps to resolve their conflicts. For example:
• Planners/reviewers will not be allowed to plan/review the content relevant to their reported COI or another planner/reviewer will be required to participate to ensure fair balance.
• Planners/reviewers should not have any relevant COI. Where relevant COI is present, another reviewer should be selected with no relevant COI. In the rare circumstance where every potential reviewer has one or more conflicts and there is no qualified reviewer without relevant COI, then two reviewers should be utilized as a check-and-balance and/or a member of the CME-AG shall perform the review.
• Faculty/presenters will have their CME content independently reviewed to ensure that the faculty presenter: (i) does not make recommendations or topics related to their COI; (ii) makes any recommendations for patient care on peer reviewed data; or (iii) re-submits and limits the scope of their presentation as needed to resolve the COI as determined by ASSH’s Professional Development Office.
• Faculty/presenters who have a relevant COI with any grantors of the CME activity, or with content to be discussed during their presentation that is related to their COI, will have their content reviewed prior to presentation by the assigned non-conflicted reviewer for the activity and/or a member of the CME-AG. Any content determined by the reviewer to have commercial bias, lack of fair balance or other concerns, may not be presented until it is limited/corrected and re-reviewed by the CME-AG or the course chair.
To avoid having the process for managing resolvable conflicts interfere with the timely development and implementation of CME activities, all persons with a resolvable conflict must present their relevant presentation/materials to ASSH for review no later than three weeks prior to the CME activity. Whenever corrections or changes are required, the affected person must make those changes/corrections within three business days and re-submit their presentation/materials to the assigned reviewer for final approval. A person with a resolvable conflict can only participate in the affected CME activity after review and final approval by the ASSH under this policy.
Documentation, Interpretation and Final Adjudication
All actions and decision implementing this policy must be documented and made a part of the CME activity file.
Any questions concerning whether a COI exists, whether it is unresolvable, or whether it is properly resolved and/or otherwise managed will be determined in the sole discretion of the CME-AG. In addition, the CME-AG has the authority to determine how to manage any potential conflicts that are disclosed, or that should have been disclosed, under ASSH’s General Conflict of Interest Policy and Disclosure Form.
ASSH will provide all learners (i.e., CME Participants) with information about the relevant financial relationships of all persons that affect the content of CME related activities pursuant to this policy and with other information that ASSH determines should be disclosed pursuant to ASSH’s General Conflict of Interest Policy. All such information will be positioned in course materials and/or opening slides such that it is easily seen by learners prior to the commencement of the CME activity (e.g., at the beginning of course handouts or the beginning of each presentation).
Any questions about this policy should be directed to the attention of ASSH’s Vice President of Professional Development at firstname.lastname@example.org
AMERICAN SOCIETY FOR SURGERY OF THE HAND Conflict of Interest Disclosure Form