Disclosure Policy

Disclosure of Relationships Policy
As part of the Society's commitment to transparency and accountability, and to attain the highest standards of excellence, HRS maintains independence, objectivity, and scientific rigor in all of its activities. HRS requires Volunteers, Faculty, and Authors, as defined in Section 4.1 of the Code of Ethics, to disclose and manage relationships with personal, professional, financial, or business interests when engaged in Society activities. Interests include relationships with commercial interests** and non-commercial interests, with activities related to heart rhythm care and apply as well to an individual's spouse/partner. While not all relationships are prohibited or harmful, full disclosure of such relationships is required and mechanisms are in place to identify and resolve potential or perceived conflicts of interest. Any relationships from the preceding 12-months are to be disclosed and should be updated as required at the time of consideration for participation in any Society's activities, and at least annually.

Disclosure for CME Purposes
The Heart Rhythm Society is committed to the provision of Continuing Medical Education (CME) that is balanced, objective, and evidence-based. The Heart Rhythm Society adheres to the Standards for Commercial Support (SCS) of the Accreditation Council for Continuing Medical Education (ACCME) which requires that those individuals in a position to control the content of an educational activity (including 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 refuses to disclose financial relationships will be disqualified from participating in HRS educational activities.

Owners and employees of ACCME-defined commercial interests may have no role in the planning or implementation of CME activities without a special exception from the HRS Chief Learning Officer that will be granted only in specific circumstances that meet ACCME requirements:

  • when the content of the individual's role in the CME activity is not related to the business lines or products of the employer
  • when the content of the individual's role in the accredited CME activity is limited to basic science research
  • for technicians that teach the safe and proper use of medical devices

ACCME Definitions:
*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.
***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. The ACCME considers content of CME about the products or services of that commercial interest to include content about specific agents/devices, but not necessarily about the class of agents/devices, and not necessarily content about the whole disease class in which those agents/devices are used.

One Disclosure: Many Uses
To reduce the administrative burden for HRS volunteers and staff, the disclosure process includes a requirement for annual disclosure. The data from that disclosure will be reviewed for multiple uses, including governance activities, document development and CME accreditation compliance. Because the HRS disclosure requirements are broader and more comprehensive than ACCME requires, volunteers will be offered an opportunity to identify those disclosures that meet ACCME definitions both to identify commercial interests and to identify relevant conflicts of interest for individual roles in educational activities. Disclosure data for all CME activities will be filtered to remove:

(1) Financial amounts associated with the relationships
(2) Disclosures for non-financial or non-commercial interest relationships
(3) Any other disclosures required by HRS but not required by the ACCME

COI Resolution
For all accredited education activities, disclosures will be reviewed for potential conflict of interest (COI). Conflicts must be resolved prior to the activity. 

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).
  • 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).
  • If a planner, reviewer or staff member has a COI, they must recuse themselves for all planning related to the relevant content.

CME COI Resolution if Bias is Reported
In rare circumstances, despite COI resolution, bias may be reported by learners. For each of those 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 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 would be 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 sanctions. An appeals process is provided via an independent appeals panel, appointed by the Ethics Committee, whose decision on sanctions is final.

If a conflict cannot be adequately resolved as prescribed, then the Ethics Committee or the Board of Trustees (upon recommendation from the Ethics Committee) may require different or additional resolutions in order to eliminate or remedy the conflict.

 

Relationship Category Descriptions

For each of the following categories, respondents will be asked to identify if the relationship is with an ACCME-defined commercial interest (relationships with non-commercial interests will be filtered out for CME disclosure purposes):

Salary from Employment (Commercial Interests): Salary from employment with a commercial interest.
Ownership/Partnership/Principal (Commercial Interests): Status or position of Ownership/ Partnership/ Principal in a commercial interest.
Honoraria/Speaker Fee/Consulting Fee: Honoraria, gifts or in-kind compensation for consulting, lecturing, speaking engagements, advisory board, or membership, legal testimony or consultation (e.g., expert witness), or other purpose. 
Intellectual Property Rights: Patent or other intellectual property rights in a for-profit corporation, manifested in a tangible form that can be legally protected whether or not such rights are currently commercialized via a license agreement or other means (e.g., patent, trademark, or copyright).
Research Grants (PIs and Named Investigators only): For Primary Investigators and named investigators only, including grants received OR submitted. Includes coverage for partial support of salary, receipt of drugs, supplies, equipment, or other in-kind support over which you have direct decision-making responsibility.
Royalty Income: The right to receive current or future royalties under a license or copyright.
Stock or Stock Options – Non-Public (including start-up companies): Includes any stock or stock options for a non-publicly traded commercial interest including a start-up company *.
Stock or Stock Options – Public: Includes any stock or stock options for a publicly traded commercial interest*.
Other Financial Relationships: Other relevant relationships related to heart rhythm care not described above must be disclosed.
Travel/Entertainment: Disclosure of travel, entertainment, food, beverage, and education expenses as reported by industry for Open Payments Program.
Fellowship Support: Support for Fellowship
Speaker's Bureau: When a company has the right to dictate or control the content of the presentation or talk, and/or the company creates the presentation material and has final approval of the content and edits, and/or you are expected to act as a company's agent or spokesperson for the purpose of disseminating company or product information.

Additional categories not required for CME:

Other Non-Financial Relationships: Other relevant non-financial relationships not described above.
For Board Members Only: Family Relationships with another member of the Board
For Board Members Only: Business Relationships with another member of the Board
Officer, Trustee, Director, Committee Chair, or Any Other Fiduciary Role: Officer, Trustee, Director, Committee Chair, or Any Other Fiduciary Role of a relevant for-profit or non-profit organization, whether or not remuneration is received for service.
Ownership/Partnership/Principal (Non-Commercial Interests): Status or position of Ownership/Partnership/Principal in a non -commercial interest.

Note: Owners of commercial interests and individuals who receive a salary due to employment with a commercial interest§ are ineligible to participate as faculty or planners for CME-certified activities.

§Intellectual property is defined as property from original thought protected by law: original creative work.