Disclosure Policy

HRS is committed to the provision of Accredited Continuing Education (ACE, formerly known as Continuing Medical Education (CME)) that is balanced, objective, and evidence based. HRS adheres to the Standards for Integrity and Independence in Accredited Continuing Education 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 financial relationships with an ACCME-defined ineligible company* within the 24 months prior to the disclosure.

Any individual who fails to disclose financial relationships will be disqualified from participating in HRS ACE certified activities.

Owners and employees of ACCME-defined ineligible companies may have no role in the planning or implementation of ACE 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 and financial relationships may be mitigated as necessary.

Disclosures are reviewed for multiple HRS purposes, including ACE 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 regarding relevant financial relationships for individual roles in educational activities and for ineligible companies will undergo the COI resolution process.

Disclosure data for all ACE activities will be filtered to remove:

1. Financial amounts associated with the relationships
2. Disclosures for non-financial or non-ineligible company relationships

ACCME Definitions

*An ineligible company is one whose primary business is 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 or health-related wearable products
• Pharmaceutical companies or distributors
• Pharmacy benefit mangers
• Reagent manufacturers or sellers

¹ https://accme.org/sites/default/files/2021-06/884_20210624_New%20Standards%20Standalone%20Package.pdf

For all certified education activities, disclosures will be reviewed for relevant financial relationships. Financial relationships are relevant if the educational content an individual can control is related to the business lines or products of the ineligible company.

If a relevant financial relationship is identified, HRS will take one of the following steps to prevent bias by mitigating the relationship(s) prior to the individual assuming his/her role(s):

• Mitigation 1: Replace the presenter.
• Mitigation 2: Assign different content to presenter to avoid conflict of interest.
• Mitigation 3: Limit the presentation to report without recommendations.
• Mitigation 4: Utilize peer review of content prior to the program (default for select enduring products when content is available prior to the activity).
• Mitigation 5: Limit sources of recommendations to scientifically peer-reviewed, evidence-based, and unbiased literature and guidelines (default for Annual Meeting and other live activities when slides are not obtained in advance).
• Mitigation 6: Recuse from reviewing/planning content related to the specific agents/devices of disclosed affiliations (For Abstract Reviewers and Planners).
• Mitigation 7: Recuse yourself when the topic under discussion relates to business lines and products or services of ineligible companies with which they have a relationship (Committee Members/Planners).

Session Chairs (for Annual Meeting 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.

ACE COI Resolution if Bias is Reported

In rare circumstances, despite the mitigation steps above, bias may be reported by learners. For these cases, whenever captured content of the presentation/session is available, the content will be reviewed by at least two members of the ACE 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 ineligible company 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.