Society Disclosure of Relationships
The Heart Rhythm Society (the Society or HRS) is committed to upholding the highest ethical values and encouraging professional and principled behavior by its staff and volunteers. As part of commitment to transparency and accountability, and to attain the highest standards of excellence, HRS requires disclosure of relationships to maintain independence, objectivity, and scientific rigor in all activities.
The Code of Ethics and Professionalism outlines the requirements that all individuals engaged in HRS- related activities must disclose and manage personal, professional, financial and nonfinancial relationships while engaged in Society activities. The types and description of relationships requiring disclosure are summarized in Table 1. Table 2 lists the disclosure requirements by role.
Disclosure statements (completed online) are filed and/or updated at the time of consideration for participation in any Society activity, and at least annually, by volunteers and staff.
HRS maintains a Code of Ethics and Professionalism, an Ethics Committee, and a CME Compliance Subcommittee of the Education Committee that oversee implementation of the CME Disclosure Policy and the Conflict of Interest (COI) Resolution policy to safeguard the credibility and reputation of the Society.
CME Disclosure Policy
HRS is committed to the provision of Continuing Medical Education (CME) that is balanced, objective, and evidence based. HRS adheres to the Standards for Commercial Support (SCS) of the Accreditation Council for Continuing Medical Education (ACCME)1 which require that those individuals in a position to control the content of an educational activity (including, but not limited to, planners, faculty, authors, committee members, content reviewers, editors, and staff) disclose all relevant* financial relationships (for self and for spouse/partner) with an ACCME-defined commercial interest** within the 12 months prior to the disclosure.
Any individual who fails to disclose financial relationships will be disqualified from participating in HRS CME certified activities.
Owners and employees of ACCME-defined commercial interests may have no role in the planning or implementation of CME activities without a special written exception from the HRS Chief Learning Officer that will be granted only in specific circumstances that meet ACCME requirements.
Disclosure Frequency and Purposes
HRS volunteers must update their HRS disclosures annually. Volunteers are instructed to inform an HRS staff member if disclosures change after submission (but prior to an activity) so disclosures may be reviewed for COI and updated as necessary.
Disclosures are reviewed for multiple HRS purposes, including CME accreditation compliance, governance activities and clinical document development. Because the Society disclosure requirements are broader and more comprehensive than ACCME requirements, only disclosures that meet the ACCME definitions (above) regarding relevant financial relationships for individual roles in educational activities and for commercial interests will undergo the COI resolution process and be reported to participants.
Disclosure data for all CME activities will be filtered to remove:
- Financial amounts associated with the relationships;
- Disclosures for non-financial or non-commercial interest relationships; and
- Any other disclosures required by HRS but not required by the ACCME.
*Relevant financial relationships are financial relationships in any amount, which occurred in the twelve-month period preceding the time that the individual was asked to assume a role controlling content of the CME activity, and which relate to the content of the educational activity, causing a conflict of interest. The ACCME considers financial relationships to create 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.
**A commercial interest is 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.
CME COI Resolution Policy
For all certified education activities, disclosures will be reviewed for potential COI. Conflicts must be resolved prior to the activity being delivered to learners.
Individuals who are employees or owners of commercial interests may not participate in any certified activity, with the exception of rare circumstances allowed by the ACCME. Other conflicts of interest may be resolved by one of the following COI resolution mechanisms:
- Resolution 1: Replace the presenter.
- Resolution 2: Assign different content to presenter to avoid conflict of interest.
- Resolution 3: Limit the presentation to report without recommendations.
- Resolution 4: Utilize peer review of content prior to the program (default for select enduring products and Board Review when content is available prior to the activity).
- Resolution 5: Limit sources of recommendations to scientifically peer-reviewed, evidence-based, and unbiased literature and guidelines (default for Scientific Sessions and other live activities when slides are not obtained in advance).
- Resolution 6: Recuse from reviewing/planning content related to the specific agents/devices of disclosed affiliations. (For Abstract Reviewers and Planners)
Session Chairs (for Scientific Sessions) and Activity Chairs/Directors (for other educational activities) will be required to ensure that content is balanced and not biased toward a product or manufacturer.
CME COI Resolution if Bias is Reported
In rare circumstances, despite COI resolution, bias may be reported by learners. For these cases, whenever captured content of the presentation/session is available, that content will be reviewed by at least two members of the CME Compliance Subcommittee. If the charge of bias is substantiated upon review, the faculty member will be advised in writing of the finding and prohibited from participating in a session/ presentation that covers a topic related to the product or service of the commercial interest for one year. The individual is eligible to participate in sessions/presentations covering other topics during that period.
Requests for appeal will be directed to the HRS Ethics Committee. The Ethics Committee has the authority to set and enforce all decisions. An appeals process is provided via a three-person independent appeals panel, appointed by the Ethics Committee. A written request for an appeal must be within 30 days of the date of the notification of the Ethics Committee's determination. The appeals panel's decision on sanctions is final. If a conflict cannot be adequately resolved, mitigated, or managed, then the Ethics Committee or the Board of Trustees (upon recommendation from the Ethics Committee) may require the person to limit or curtail certain activities with HRS, and/or ask the individual to eliminate or remedy the conflict if they want to continue participation in HRS activities.