Oversight of Assisted Reproductive Technology
Oversight of Assisted Reproductive Technology is a summary of information presented and recommendations offered at a recent meeting convened by ASRM attended by medical professionals, legal experts, patient advocates and government representatives.
This summary provides a comprehensive overview of state and federal regulation specific to the field of reproductive medicine, including professional self-regulation practices. It also discusses changes to consider concerning oversight of the technologies used to treat infertility. A significant finding is that assisted reproductive technology (ART) is one of the most highly regulated of all medical practices in the U.S.
The different types of regulations covered are:
State regulation including medical licensing requirements, requirements for continuing medical education, and discipline for physician misconduct.
Federal regulation including the Fertility Clinic Success Rate and Certification Act (FCSRCA); mandatory reporting of ART cycle data to the Centers for Disease Control (CDC); Food and Drug Administration (FDA) regulation of drugs, devices and donor tissues; and the Clinical Laboratory Improvement Act (CLIA).
Professional self-regulation including the work of the professional societies ASRM and SART to develop ethical and practice guidelines and membership requirements; programs for laboratory accreditation through the College of American Pathologists (CAP) and the Joint Commission; and physician board certification through the American Board of Obstetrics and Gynecology (ABOG) and American Board of Urology (ABU).