ASHG CME Policies and Procedure

ASHG CME Policies and Procedure

As a joint provider with the American College of Medical Genetics and Genomics accredited by the Accreditation Council for Continuing Medical Education (ACCME), the American Society of Human Genetics plans and implements all of its educational activities in accordance with the ACCME Essentials and Areas and ACCME® Policies to ensure balance, independence, objectivity and scientific rigor. In accordance with the ACCME® Standards for Commercial Support, everyone (speakers, moderators, platform presenters, all authors, committee members, and staff) who is in a position to control the content of an educational activity certified for AMA PRA Category 1 Credit™ is required to disclose all financial relationships with any commercial interests (see definition below) within the past 12 months that creates a real or apparent conflict of interest. Individuals who do not disclose are disqualified from participating in a CME activity.

Individuals with potential for influence or control of CME content include:

  • planners, planning committee members, staff
  • authors
  • others who participate, e.g., facilitators and moderators

This disclosure pertains to relationships with pharmaceutical companies, biomedical device manufacturers, or other corporations whose products or services may be related to the subject matter of the presentation topic. Any real or apparent conflicts of interest related to the content of the presentations must be resolved prior to the educational activity. Disclosure of off-label, experimental or investigational use of drugs or devices must also be made known to the audience.

ASHG’s Policy and Procedure for Identifying and Resolving Conflict of Interest for CME Educational Activities

The ACCME Standards of Commercial Support (SCS) describe six Standards: (1) independence (2) resolution of personal conflicts of interest (3) appropriate use of commercial support (4) appropriate management of associated commercial promotion (5) content and format without commercial bias and (6) disclosures relevant to potential commercial bias. These updated Standards underscore continued voluntary self-regulation by the CME community, ensuring that physicians have opportunities to engage in commercially unbiased life-long learning facilitated by accredited providers. The purpose of this policy is twofold: [1] to establish guidelines and a mechanism for identifying and resolving conflicts of interest in CME educational activities as required in Standard 2 (see below), and [2] to be consistent with ASHG’s policy for resolving conflicts of commitment and interest. Regardless of role, disclosure forms for speakers, moderators, all authors, program committee and staff participating in a CME activity will collected reviewed.

Standard 2: Resolution of Personal Conflicts of Interest in the Standards for Commercial Support requires the following of ACCME accredited providers:

  • Documenting that everyone who is in a position to control the content of an education activity has disclosed to the provider all relevant financial relationships with any commercial interests in any amount within the past 12 months that creates a conflict of interest. (SCS 2.1)
  • Disqualifying individuals who do not disclose from participating in a CME education activity. (SCS 2.2)
  • Identifying and resolving all conflicts of interest prior to the education activity. (SCS 2.3)

Terms as Defined by the ACCME:

  1. Commercial Interest: 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. A commercial interest is not eligible for ACCME accreditation or participation in joint providership.
  2. 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 potential for maintaining or increasing the value of the financial relationship with the commercial interest creates an incentive to influence the content of the CME – an incentive to insert commercial bias. See also “relevant financial relationships.”
  3. Financial Relationship: The ACCME requires anyone in control of CME content to disclose relevant financial relationships to the accredited provider. Individuals must also include in their disclosure the relevant financial relationships of a spouse or partner. The ACCME defines relevant financial relationships as financial relationships in any amount that create a conflict of interest and that occurred in the twelve-month period preceding the time that the individual was asked to assume a role controlling content of the CME activity. The ACCME has not set a minimal dollar amount – any amount, regardless of how small, creates the incentive to maintain or increase the value of the relationship. Financial relationships are those relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria for promotional speakers’ bureau, ownership interest (e.g. stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit. Financial benefits are usually associated with roles such as employment, management position, independent contractor (including contracted research), consulting speaking and teaching, membership on advisory committees or review panels, board membership, and other activities from which remuneration is received or expected. See also “conflict of interest.”
  4. Individuals with potential for influence or control of CME content: Planners and planning committee members, authors, teachers, educational activity director(s), educational partners(s), and others who participate, e.g. facilitators and moderators.

Please note: The ACCME has not a minimum dollar amount for relationships to be significant. Inherent in any amount is the incentive to maintain or increase the value of the relationship.

ASHG’s Procedures to Identify/Resolve Conflict

  • All individuals with potential for influence or control of content (defined in #2 above) must complete an ASHG’s Disclosure Form prior to the education activity as a condition of invitation and acceptance to participate. ASHG staff, Program Committee members are also required to complete an annual disclosure form.
  • An independent and unbiased assessment of content will be documented by one of the following methods to identify and resolve COIs –
    • Content review by the program planning committee.
    • Peer review committee are not participating in the specific educational activity.
    • Disclosures of all individuals participating in the educational activity will be made known to the audience as required by the ACCME, in addition to a disclosure of any COIs that have been resolved with independence and without bias.
    • Speakers will be required to verbally and include a disclosure slide (1st slide) identifying commercial relationships/interests or if none. Additionally, they must inform the audience prior to the presentation of any discussion of off-label use.

Consequences of Non-adherence to ACMG’s Policy

  • Disqualified from speaking if no disclosure form is completed (SCS 2.2)
  • Warning letter if the activity evaluation by the audience and session monitor comments indicates conflicts are present (1st occurrence)
  • Not invited to speak or participate in any other role in a ASHG CME-certified educational activity (2nd occurrence)

Content Validation and Fair Balance

  1. ASHG follows the ACCME policy on Content Validation for CME activities, which requires:
    1. All recommendations involving clinical medicine must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients.
    2. All scientific research referred to, reported, or used in CME in support or justification of patient care recommendations must conform to the generally accepted standards of experimental design, data collection, and analysis.
  2. Activities that fall outside the definition of CME/CE, “Educational activities that serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession” (source: ACCME and AMA), will not be certified for credit. CME activities that promote recommendations, treatment, or manners of practicing medicine or pharmacy that are not within the definition of CME/CE or, are known to have risks or dangers that outweigh the benefits or, are known to be ineffective in the treatment of patients.
  3. Presentations and CME/CE activity materials must give a balanced view of therapeutic options; use of generic names will contribute to this impartiality. If the CME/CE educational materials or content includes trade names, where available, trade names from several companies must be used.

Off-Label or Unapproved Use of Drugs or Devices

It is the policy of the ASHG to require the disclosure of all references to off-label or unapproved uses of drugs or devices prior to the presentation of educational content. The audience is advised that this continuing medical education activity may contain reference(s) to off-label or unapproved uses of drugs or devices. Please consult the prescribing information for full disclosure of approved uses.

Disclosure Statement

In accordance with the Accreditation Council for Continuing Medical Education (ACCME) and the policy of the American Society of Human Genetics (ASHG), speakers and moderators presenting in sessions that offer CME and CEU credit must disclose, prior to the start of their presentations, the existence of any relevant financial interest and/or other relationship(s) they might have with the manufacturer(s) or provider(s) of any commercial product(s) or service(s), including diagnostic laboratories to be discussed during their presentation. These disclosures are included in the Online Program Planner.

Speakers with disclosures are required to provide a slide that states any relevant financial relationships (or lack thereof), and to state these to the audience at the start of their presentation. All disclosures have been peer reviewed by the ASHG Program subcommittee.

Diagnostic and Testing Labs and Commercial Interest

ASHG CME activities adhere to the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support. The ACCME has defined under its conflict of interest definition the types of industry interests that must be excluded from CME content delivery. This largely applies to manufacturers of pharmaceuticals and devices. Diagnostic laboratories, whether not-for-profit or for-profit, that are not owned by device manufacturers are exempted from this CME requirement. However, they are still expected to be fair and balanced in their presentations.

HIPAA Compliance by Speakers

The ASHG supports medical information privacy. While the ASHG is not a “covered entity” under HIPAA 1996 and therefore is not required to meet these standards, ASHG wishes to take reasonable steps to ensure that the presentation of individually identifiable health information at ASHG-sponsored events has been properly authorized. All presenters have completed a form indicating whether they intend to present any form of individually identifiable healthcare information. If so, they were asked either to attest that a HIPAA-compliant consent form is on file at their institution, or to send ASHG a copy of the HIPAA compliance form. This information is on record at the ASHG Administrative Office and will be made available upon request.

Disclaimer

The opinions and recommendations expressed by faculty, authors, and other experts whose input is included in this program are their own and do not necessarily represent the viewpoint of ASHG.

ACCME Accreditation Requirements and Guidelines

The ASHG Annual Meeting has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint providership of the American College of Medical Genetics and Genomics (ACMG) and ASHG. The ACMG is accredited by the ACCME to provide continuing medical education for physicians. All educational programming must be developed and presented in compliance with all ACCME requirements.

All speakers/authors must sign a disclosure statement regarding the existence of any relevant financial interest and/or other relationship(s) they and/or their spouse/legally recognized domestic partner might have with the manufacturer(s) or provider(s) of any commercial product(s) or service(s) or with commercial and academic laboratories that accept samples for testing or develop any laboratory test or test(s) to be discussed during their presentations.

The content or format of a CME activity or its related materials must promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial entity. Presentations must give a balanced view of therapeutic options. Use of generic names will contribute to this impartiality. If the educational material or content includes trade names, trade names from several companies should be used when available, not just trade names from a single company.

Authors/speakers must adhere to these guidelines as outlined below. Failure to do so may result in your presentation being excluded from the meeting.

  • For authors/speakers of abstracts, the disclosure information completed during abstract submission will be used automatically.
  • For speakers in invited sessions and invited workshops, you will be contacted by ASHG staff to complete a disclosure statement.
  • Disclosure of financial relationships will be listed in the online program.
  • Conflicts that may affect the content of presentations will be required to provide a copy of their slides in advance of the meeting so they can be peer-reviewed.
  • Authors/speakers must not engage in the marketing of product(s) in any way during the presentation.
  • Talks must be free of commercial bias for or against any product. If commercial products are discussed, the session must present objective information about those products, based on generally accepted scientific evidence.
  • Presentation Slides
    • To satisfy potential conflict-of-interest requirements, there are constraints regarding the use of any logos on presentation slides. The constraints include no logos on each slide. Further information will be posted in April.
    • Authors who disclosed a conflict may be contacted and asked to upload their slides in advance of the meeting so that the slides can be reviewed by members of the Program Committee. Once approved, the slides cannot be changed.
    • Authors/speakers must include a conflict-of-interest slide as part of their presentations to meet ACCME requirements, even when there is nothing to disclose. This ASHG-approved slide will be inserted automatically as the first slide in the presentation.
    • For abstract speakers/authors who indicated a conflict, the disclosure information completed during abstract submission will be used automatically. No further action is required by authors.

 

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