Genetic and Genomic Testing Outside of Clinical Care: Changing Paradigms for Access, Application & Understanding - R. Rodney Howell Symposium
(Previewing required of presentations prior to webinar and learner engagement ~70 minutes)
*Click on the Course tab to review the recordings and click on Q&A to send in questions prior to the webinar.
Friday, June 5, 2020
1:00 pm – 2:00 pm ET
www.acmgeducation.net
The exponential growth in our ability to generate and analyze genetic data, combined with the demand for patient-driven medical care has raised a host of societal issues surrounding the use of genetic information. As with other types of medical care, genetic testing has traditionally occurred in the realm of medical genetic professionals trained to protect patients from harm that could arise from the misuse of their genetic information. Testing has been provided predominately in the form of diagnostic evaluations and screening grounded in the best available scientific data and evidence, and subject to prevailing standards of protection, such as doctor-patient confidentiality practices and medical regulations such as HIPPA and GINA.
Increasingly, however, other forms of testing have emerged that reside outside of the domain of the health care system. Examples of these emerging applications of genetic data outside of the physician-ordered historical norms include direct-to-consumer diagnostics, genetic entertainment/education, forensic testing, disability/life insurance and various emerging models for population genomic health and screening. The growing field of personalized medicine and the shift in the physician-patient relationship toward a more equal partnership is changing the climate of health care.
The growth of the medical genetics profession has been outpaced by both the expansion in available genetic testing and changes in modes of health care delivery. As the representative voice of the medical genetics profession, we must recognize the changing landscape of genetic testing, acknowledge the rights of individuals to access their own genetic data, address the ethical issues at hand, and work to facilitate the delivery of genetic information in the best possible manner to all individuals in the population.
This session will address four broad questions about the dynamic and complex social, ethical and legal landscape for genetic testing being done outside of the domain of established medical genetics and genetic counseling practice: 1) What is it about our current genetics health care system that is enabling or driving the demand for testing that resides outside of established practice? 2) Are there benefits to patients and their families that use less orthodox approaches to genetic testing in lowering barriers and increasing access to genetic information? 3) What harms accrue from such testing under less tight regulation and greater informality governing privacy protections with such testing? 4) How can we act to facilitate the democratization of these potentially powerful technologies in ways that maximize value and minimize harm in an ethical and socially just manner?
Speakers with deep levels of expertise have been chosen from differing perspectives to broadly represent the spectrum of social, ethical and legal considerations from current public and professional discourse.
Target Audience
All healthcare professionals interested in the diagnosis, management, treatment and prevention of genetic conditions and increasing their understanding of the genetic basis of common, chronic health problems affecting both children and adults will find the programming applicable to their practice.
Agenda
- Welcome and Introductions - Theresa A. Grebe, MD
- Competing Cultural Values Surrounding the Quest for Genetic Knowledge - Leslie G. Biesecker, MD
- Consumer Genomics, Then and Now- Jill Hagenkord, MD
- Consumer Directed Testing: a Clinician’s Perspective - John C. Carey, MD, MPH
- Individual Access to Genomic Data & Results: Ethical, Legal & Societal Issues - Susan M. Wolf, JD
- Health Justice in a Genomic Era: The Role of Democratic Deliberation - Erika Blacksher, PhD
- Closing Remarks - Robert G. Best, PhD
- Panel
Learning Objectives
At the conclusion of this session, participants should be able to:
- Identify the multiple types and applications of direct-to-consumer genetic testing options that exist in the public realm and the multiple settings in which they are utilized.
- Examine the gaps in gaps in prevailing protections for genetic privacy across the full spectrum of genetic data applications in our society.
- Identify ways to develop robust privacy protections where they are lacking.
- Discuss the rights of individuals in a democracy to receive their own genetic/genomic data outside of a traditional healthcare setting.
- Explain potential challenges of health practitioners in understanding HGVS nomenclature
- Recognize the limitations that current health care regulations/structures pose on genetics professionals that prevent them from playing a greater role in the dissemination of genetic information to the public.
- Develop open lines of communication between direct-to-consumer genetic testing companies and community of genetics providers to facilitate education of the public about genetic information.
- Analyze the role of genetics professionals with respect to wellbeing within the public sphere in the absence of a direct doctor-patient relationship.
- Discuss the role of genetics professionals in educating other health providers who utilize genetic testing in their practices.
Presenters
Theresa A. Grebe, MD
Phoenix Children's Hospital
Robert G. Best, PhD
Associate Dean for Faculty Affairs and Professional Development,
University of South Carolina School of Medicine
Leslie G. Biesecker, MD
Clinical and Molecular Geneticist, National Human Genome Research Institute
Jill Hagenkord, MD
Co-founder and Chief Medical Officer of MDisrupt
John C. Carey, MD, MPH, FACMGG, FAAP
Professor and formerly Vice Chair of Academic Affairs, Department of Pediatrics, at the University of Utah
Susan M. Wolf, JD.
McKnight Presidential Professor of Law, Medicine & Public Policy Faegre Baker Daniels Professor of Law; Professor of Medicine; and Chair of the University’s Consortium on Law and Values in Health, Environment & the Life Sciences, University of Minnesota
Erika Blacksher, PhD.
Associate Professor and Director of Undergraduate Studies in the Department of Bioethics and Humanities, University of Washington
Financial Disclosures
Disclosure Statement
It is the policy of the American College of Medical Genetics and Genomics to plan and implement 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, 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. Disclosure must include financial relationships of the individual and those of their spouse/partner. Individuals who do not disclose will be disqualified from participating in a CME activity.
This disclosure pertains to relationships with ACCME-defined commercial interests 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 managed prior to the educational activity. ACMG will identify, review and resolve all conflicts of interests prior to an educational activity being delivered to learners.
NOTE:
- ACMG will follow the ACCME’s expectation that no employees or owners of commercial interests will be involved as planners/faculty/presenters of a CME accredited activity.
- The ACCME definition of 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.
- Diagnostic laboratories are not considered commercial interests unless they are owned by or have a sister organization which is a commercial interest.
Theresa A. Grebe, MD
Has no relevant financial relationships to disclose.
Robert G. Best, PhD
Has no relevant financial relationships to disclose.
Leslie G. Biesecker, MD
Dr. Biesecker has disclosed that he has grant/research support from ArQule, non-remunerative positions of influence such as officer, board member, trustee, or public spokesperson from Illumina, Inc, Royalty (ies)/Honoraria from Cold Spring Harbor Press, Salary, Spouse/Legally recognized domestic partner; RTI International.
Jill Hagenkord, MD
Dr. Hagenkord has disclosed she was a former employee of Color Genomics, resigned June 2019.
John C. Carey, MD, MPH, FACMGG, FAAP
Dr. Carey has disclosed that he is a consultant/advisory board for FDNA/Face2Gene, and has consultant/consulting fees/other remuneration from John Wiley & Sons, Associate Editor American Journal of Medical Genetics.
Susan M. Wolf, JD.
Has no relevant financial relationships to disclose.
Erika Blacksher, PhD
Has no relevant financial relationships to disclose.
Educational Credit
Accreditation Statement
The American College of Medical Genetics and Genomics is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
Designation Statement
The American College of Medical Genetics and Genomics designates this live activity for a maximum of 2 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CE (Continuing Education for non-physicians): This activity has been approved for CE credits.
*The certificate is accepted by the ABMGG for certification.
Genetic Counselor Credit
The National Society of Genetic Counselors (NSGC) has authorized American College of Medical Genetics to offer up to 2 Category 1 contact hours for this activity. The American Board of Genetic Counseling (ABGC) will accept CEUs earned at this program for the purposes of genetic counselor certification and recertification.
ACMG will report completed accredited sessions to NSGC for credit certificates on December 4, 2020, December 3, 2021 and July 8, 2022. Submissions outside of these parameters may incur a processing fee of $35.
P.A.C.E.® CEUs- Laboratory Directors and Laboratory Personnel
ACMG is approved as a provider of continuing education programs in the clinical laboratory sciences by the American Society for Clinical Laboratory Science (ASCLS) Professional Acknowledgment for Continuing Education (P.A.C.E.®) Program. The American College of Medical Genetics and Genomics designates this OnDemand course for a maximum of 2 contact hours. ACMG is approved by the Florida Board of Clinical Laboratory Personnel as CE Provider #50-11878. This course is registered # 20-775394 with CEBroker. ACMG is approved by the California Department of Health Services through the ASCLS P.A.C.E.®
Claiming your Educational Credits
Complete the activity and carefully complete the evaluation form. Deadline to claim educational credits is within 30 days from the date of the webinar. ACMG will not accept any credit request for live meetings after that period.
HIPAA Compliance
The ACMG supports medical information privacy. While the ACMG is not a “covered entity” under HIPAA 1996 and therefore is not required to meet these standards, ACMG wishes to take reasonable steps to ensure that the presentation of individually identifiable health information at ACMG-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 ACMG a copy of the ACMG HIPAA compliance form. This information is on record at the ACMG Administrative Office and will be made available on request.
Content Validation
ACMG follows the ACCME policy on Content Validation for CME activities, which requires:
Content Validation and Fair Balance
- ACMG follows the ACCME policy on Content Validation for CME activities, which requires:
- 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.
- 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.
- 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.
- 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 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 accredited sponsor shall require 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.
Disclaimer
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 tests or exclusive of other procedures and tests that are reasonably directed at obtaining the same results. In determining the propriety of any specific procedure or test, a healthcare provider should apply his or her own professional judgment to the specific clinical circumstances presented by the individual patient or specimen.