Disclosure Policy
The American College of Medical Genetics and Genomics (ACMG) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide Accredited Continuing Education (ACE) for physicians. ACMG is an organization committed to improvement of patient care and general health by the incorporation of genetics and genomics into clinical practice. ACMG requires that all ACE activities are scientifically based, accurate, current, and objectively presented. All recommendations for patient care must be based on current science, evidence, and clinical reasoning, while giving a fair and balanced view of diagnostic and therapeutic options. All scientific research referred to, reported, or used in accredited education in support or justification of a patient care recommendation must conform to the generally accepted standards of experimental design, data collection, analysis, and interpretation. Education may not advocate for, or promote, practices that are not, or not yet adequately based on current science, evidence, and clinical reasoning, such as new and evolving topics.
ACMG is committed to provide accredited continuing medical education that offer healthcare professionals with a protected space to learn, teach, and engage in scientific discourse free of the influence from organizations that may have an incentive to insert commercial bias into the education. Education must be free of the influence or control of ineligible entities, and protect learners from promotion, marketing, and commercial bias. Presentation materials may not include logos or product messaging from ineligible companies and shall use generic names, rather than trade names, when referencing pharmaceutical or medical device products. Owners and employees of ineligible companies are considered to have unresolvable financial relationships and shall have no role in accredited continuing education.
Financial relationships held with ineligible companies have the potential to influence and create bias in the content of accredited education. Ineligible companies are defined as those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. Financial relationships are defined as any relationship held with an ineligible company within the prior 24 months, regardless of the amount and whether relevant to the education. Examples of such relationships include employee, researcher, consultant, advisor, speaker, independent contractor (including contracted research), royalties or patient beneficiary, executive role, ownership interest, individual stock and stock options, institutional research funding if principal or named investigator.
ACMG education and designated content experts without any relevant conflicts will identify and review all financial relationships held by planners, faculty, and others who would be in position to control the content of accredited education, and determine which relationships are relevant. Relevant financial relationships will be mitigated prior to individuals assuming their roles in the activity. Persons who fail or refuse to disclose all financial relationships, or do not cooperate with mitigation strategies implemented, will be disqualified. Relevant financial relationships will be disclosed to learners prior to their engagement with the accredited education and include information about the names of ineligible companies and nature of relationships. All activities will be evaluated to determine if the content was free of commercial bias and met acceptable scientific standards.
The following reported disclosures and none are relevant to the content of this course. All of the relevant financial relationships listed for these individuals have been mitigated.
Content Validation Policy
The ACMG is responsible for ensuring that all Accredited Continuing Education (ACE) is fair balanced and that any clinical content presented supports safe, effective patient care
This is accomplished by:
- All recommendations for patient care in accredited continuing education must be based on current science, evidence, and clinical reasoning, while giving a fair and balanced view of diagnostic and therapeutic options.
- All scientific research referred to, reported, or used in ACE is in support or justification of a patient care recommendation must conform to the generally accepted standards of experimental design, data collection, analysis, and interpretation.
- Although ACE is an appropriate place to discuss, debate, and explore new and evolving topics, these areas need to be clearly identified as such within the program and individual presentations. It is the responsibility of accredited providers to facilitate engagement with these topics without advocating for, or promoting, practices that are not, or not yet, adequately based on current science, evidence, and clinical reasoning.
- ACMG requests activity faculty/presenters to disclose to learners any description of unlabeled use or investigational use of pharmaceutical/device products. Faculty must use scientific or generic names (not trade names) in referring to products; and, if necessary, when using a trade name, to use the names of similar products or those within a class.
- ACMG ACE activities cannot advocate for unscientific approaches to diagnosis or therapy, or if their education promotes recommendations, treatment, or manners of practicing healthcare that are determined to have risks or dangers that outweigh the benefits or are known to be ineffective in the treatment of patients.
Off-Label Uses of Products
When an off-label use of a product, or an investigational use not yet approved for any purpose, is discussed during an educational activity, the ACMG requires the speaker to disclose that the product is not labeled for the use under discussion, or that the product is still investigational. Discussions of such uses shall focus on those uses that have been subject of objective investigation.
HIPAA Compliance by Faculty
The American College of Medical Genetics and Genomics ("ACMG") supports medical information privacy. While the ACMG is not a "covered entity" under the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and its implementing regulations (the "HIPAA Privacy Rules") and, therefore, is not required to meet the standards set forth in the HIPAA Privacy Rules, ACMG takes reasonable steps to attempt to ensure that any presentation of individually-identifiable health information at ACMG-sponsored events has been properly authorized.
Disclaimer
ACMG educational programs are designed primarily as an educational tool for health care providers who wish to increase their understanding of the application of genomic technologies to patient care. The ACMG does not endorse or recommend the use of this educational program to make patient diagnoses, particular by individuals not trained in medical genetics. Adherence to the information provided in these programs does not necessarily ensure a successful diagnostic outcome. The program should not be considered inclusive of all proper procedures and or exclusive of other procedures and that are reasonably directed at obtaining the same results. In determining the propriety of any specific procedure or, a healthcare provider should apply his or her own professional judgment to the specific clinical circumstances presented by the individual patient or specimen.
Questions regarding CE credit should be directed to education@acmg.net