Ethics: First Human Trials and Genetic Screening Coverage
Mitochondrial pathogenic DNA mutations are responsible for pathological mutations in one out of 5,550 live births, and there are few effective treatment options for people living with these genetic diseases. Consequently, scientists have been developing interventions such as mitochondrial replacement technologies (MRT) whereby mitochondrial DNA (mtDNA) from a healthy donor is used to replace mutated host mtDNA in order to create an embryo that would result in an offspring who would not suffer from mtDNA diseases. Genomic medicine such as this has the capacity to revolutionize clinical practice. However, these rapidly emerging technologies are ethically fraught and lead to concerns about risks and uncertainty for potential offspring created through these techniques, for the donors and prospective parents involved, and for society. In addition, regulators must identify steps for review and approval of such novel reproductive technologies, and payers must determine appropriate approaches for reimbursement decisions — all complicated by limited data on which to make assessments.
During this presentation, Dr. Kahn will describe the issues associated with these new technologies and explore the ethical and policy concerns associated with these rapidly developing biotechnological interventions.
At the end of this educational activity, participants should be able to
- Explain the potential for genomic medicine and its role in clinical practice, through the case of MRT
- Discuss current ethical and regulatory concerns associated with initial investigations and eventual introduction of novel reproductive technologies
- Describe and discuss the issues and concerns associated with health insurance coverage for experimental treatments and novel reproductive technologies
Jeffrey P. Kahn, PhD, MPH
Andreas C. Dracopoulos Director
Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy
Johns Hopkins Berman Institute of Bioethics;
Professor, Department of Health Policy and Management
Bloomberg School of Public Health
Johns Hopkins University
Disclosures of Relevant Financial Relationships
In accordance with the ACCME Standards for Commercial SupportSM, OptumHealth Education requires all those involved in the development of activity content to disclose their relevant financial relationships. An individual has a relevant financial relationship if such person (or their spouse/partner) has a financial relationship in any amount occurring in the last 12 months with a commercial interest whose products or services are discussed in the activity content over which the individual has control.
OptumHealth Education ensures that the content is independent of commercial bias.
Jeffrey P. Kahn, PhD, MPH has indicated that he has no relevant financial relationships.
Sarah Chart, RN
Eden Prairie, MN
Rebecca Gleason, RN, CCM
Eden Prairie, MN
Tina Rydland, PharmD
Crystal Clear Rx
V. Silverstein, MD
Eagle Creek Medical Communications
Activity Planner Disclosures
Drs Rydland and Silverstein have indicated that they have no relevant financial relationships.
Ms Chart and Ms Gleason have indicated that they are employees of and own stock in UnitedHealth Group.
To ensure fair balance and avoid bias, the content for this activity has been reviewed by an independent medical expert with no relevant financial relationships.
Method of Participation
There are no fees for participating in or receiving credit for this activity.
For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board.
Participants will receive a certificate upon successful completion of the activity, which includes the following:
- Completing the entire activity
- Completing the Pre- and Post-Activity Assessments, Activity Evaluation, and Application for Certificate of Credit forms
You must be logged into your account to participate in this activity. Get started by clicking “Begin” and viewing the “CE Info”; then follow the prompts at the bottom of the screen. At the end of the activity, you will be able to view, save, or print your certificate of participation. The Area of Practice you indicated in your profile corresponds with your certificate type. A complete listing of all of your activities can be found under “My Account”, “My Activities.”
Method for Calculating CE Credit
CE credit was calculated by the complexity of content.
In support of improving patient care, OptumHealth Education is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the health care team.
Credit Designation Statements
OptumHealth Education designates this enduring activity for a maximum of 1.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
The American Academy of Physician Assistants (AAPA) accepts credit from organizations accredited by the ACCME.
The participant will be awarded up to 1.00 contact hour(s) of credit for attendance and completion of supplemental materials.
The American Academy of Nurse Practitioners Certification Program (AANPCP) accepts credit from organizations accredited by the ACCME and ANCC.
The Commission for Case Manager Certification has approved this program for a maximum of 1.00 clock hour(s) for Certified Case Managers (CCM). (Please reference the 10th Annual Medical Director Forum when contacting CCMC to claim credit for this activity.)
This activity is approved for 1.00 contact hour(s) ([0.1] CEU) in states that recognize ACPE.
Attending the full program will earn 1.00 contact hour(s).
Unique Activity Number(s): 0860-0000-16-027-H01-P/0860-0000-16-027-H01-T
A certificate of attendance will be provided to learners upon completion of activity requirements, enabling participants to register with licensing boards or associations that have not been pre-approved for credits. To apply for credit types not listed above, participants should use the procedure established by the specific organization to which you wish you apply credit.
This activity is provided by OptumHealth Education.
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This activity is designed to meet the educational needs of case managers, nurses, pharmacists, pharmacy technicians, physicians and other health care professionals who are interested in health and wellness.
This activity consists of recorded presentations from the "10th Annual Medical Director Forum" held in Las Vegas, NV on November 3, 2016.
- 1.00 ACPE - Pharmacists
- 1.00 ACPE - Pharmacy Technicians
- 1.00 AMA - Physicians
- 1.00 ANCC - Nurses
- 1.00 Attendance - General Attendance
- 1.00 CCMC - General - Case Managers