Regulatory Aspects of Embryo Testing: An American View
Screening the Single Euploid Embryo: Molecular Genetics in Reproductive Medicine, E. Scott Sills, ed., Springer International Publishing, 2015
Posted: 10 Aug 2016
Date Written: September 30, 2015
The key sources of regulation impacting on the genetic testing of embryos in the United States include the United States Constitution, statutes and administrative regulations, medical malpractice law, and professional norms. Beyond rules that prohibit discrimination, that guarantee the privacy of patient information, and that govern molecular genetic testing in laboratories and the qualifications of genetic counselors, little in the Constitution, statutes, or administrative regulations bears directly on preimplantation genetic screening and preimplantation genetic diagnosis. This leaves medical malpractice law and the norms of professional societies as the primary regulatory mechanisms that define the standard of care and the requirements of informed consent in embryo testing for in vitro fertilization (IVF). Fertility societies may wish to bring their influence to bear on legislative initiatives to regulate insurance coverage for IVF so that the movement toward single-embryo transfer may be more fully realized.
Keywords: assisted reproduction, single-embryo transfer (SET), diploid embryo, preimplantation genetic screening (PGS), preimplantation genetic diagnosis (PGD), procreative liberty, regulation of biotechnology
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