Regulating Preimplantation Genetic Diagnosis in the United States


Book Description

Reproductive technology allows us to test embryos' genes before deciding whether to transfer them to a woman's uterus. Embryo selection raises many ethical questions but is virtually unregulated in the United States. This comprehensive study considers the ethical, medical, political, and economic aspects of developing appropriate regulation.




Regulating Pre-implantation Genetic Diagnosis


Book Description

The successful achievement of pregnancies following pre-implantation genetic diagnosis (PGD) was first reported in April 1990. The technology is often used for patients who are at substantial risk of conceiving a pregnancy affected by a known genetic disorder, however from this technology other more controversial uses have arisen such as HLA typing to save the life of a sibling, gender selection for social reasons, the prevention of late onset diseases, or the prevention of diseases which may be genetically predisposed to developing such as breast cancer. The technology surrounding PGD is constantly developing, giving rise to new and unexpected consequences that create fresh ethical and legal dilemmas. Featuring internationally recognized experts in the field, this book critically explores the regulation of PGD and the broader legal and ethical issues associated with it. It looks at the regulatory situation in a number of jurisdictions including New Zealand, Australia and the United Kingdom, but it also explores a number of themes of wide significance including a historical consideration of PGD and its part in the creation of the "genetic embryo" as a political tool, the over regulation of PGD and the ethical difficulties in handling additional unexpected medical information yielded by new technologies. This book will be of particular interest to academics and students of law, medicine and ethics.




Heritable Human Genome Editing


Book Description

Heritable human genome editing - making changes to the genetic material of eggs, sperm, or any cells that lead to their development, including the cells of early embryos, and establishing a pregnancy - raises not only scientific and medical considerations but also a host of ethical, moral, and societal issues. Human embryos whose genomes have been edited should not be used to create a pregnancy until it is established that precise genomic changes can be made reliably and without introducing undesired changes - criteria that have not yet been met, says Heritable Human Genome Editing. From an international commission of the U.S. National Academy of Medicine, U.S. National Academy of Sciences, and the U.K.'s Royal Society, the report considers potential benefits, harms, and uncertainties associated with genome editing technologies and defines a translational pathway from rigorous preclinical research to initial clinical uses, should a country decide to permit such uses. The report specifies stringent preclinical and clinical requirements for establishing safety and efficacy, and for undertaking long-term monitoring of outcomes. Extensive national and international dialogue is needed before any country decides whether to permit clinical use of this technology, according to the report, which identifies essential elements of national and international scientific governance and oversight.




Regulating Preimplantation Genetic Diagnosis in the United States


Book Description

Reproductive technology allows us to test embryos' genes before deciding whether to transfer them to a woman's uterus. Embryo selection raises many ethical questions but is virtually unregulated in the United States. This comprehensive study considers the ethical, medical, political, and economic aspects of developing appropriate regulation.




Mitochondrial Replacement Techniques


Book Description

Mitochondrial replacement techniques (MRTs) are designed to prevent the transmission of mitochondrial DNA (mtDNA) diseases from mother to child. While MRTs, if effective, could satisfy a desire of women seeking to have a genetically related child without the risk of passing on mtDNA disease, the technique raises significant ethical and social issues. It would create offspring who have genetic material from two women, something never sanctioned in humans, and would create mitochondrial changes that could be heritable (in female offspring), and therefore passed on in perpetuity. The manipulation would be performed on eggs or embryos, would affect every cell of the resulting individual, and once carried out this genetic manipulation is not reversible. Mitochondrial Replacement Techniques considers the implications of manipulating mitochondrial content both in children born to women as a result of participating in these studies and in descendants of any female offspring. This study examines the ethical and social issues related to MRTs, outlines principles that would provide a framework and foundation for oversight of MRTs, and develops recommendations to inform the Food and Drug Administration's consideration of investigational new drug applications.




Genetic Dilemmas


Book Description

What limits the genetic choices parents make for their children? Is it okay to select the sex of our children, or for deaf parents to select deaf children? In this second edition of Genetic Dilemmas, Davis argues that parental reproductive autonomy should be limited by respect for the future autonomy of the children created by these measures. Praise for the first edition: "A thoughtful, timely and comprehensive look at genetics in the modern era by a recognized scholar of both their legal and humanistic implications. An excellent read!" -R. Alta Charo, Professor of Law and Medical Ethics, University of Wisconsin- Madison. "Dena Davis has been the most consistent and important voice insisting that we take seriously the concept of each child's right to an open future, and what respecting that right would mean for new technologies in genetics and reproduction. This engaging new book is the work of a thoughtful and humane scholar, and deserves a broad readership." -Thomas H. Murray, President of The Hastings Center "Dena Davis offers an engaging, informative and provocative argument in Genetic Dilemmas. Her primary accomplishment is to draw much-needed attention to the interests of the child in reproductive decision-making...she has succeeded admirably." -Mary Terrell White, Medical Humanities Review "People now face a dizzying array of choices about reproduction-from sex selection to cloning, from prenatal screening to genetic enhancement. In this engaging and path-breaking book, Dena Davis intelligently and compassionately explores the often-ignored impact of these choices on the children that are created and the society in which they will be raised." -Lori Andrews, Professor of Law, Chicago-Kent College of Law




Born and Made


Book Description

'Born and Made' examines the case of preimplantation genetic diagnosis (PGD), the procedure used to prevent serious genetic disease by embryo selection, and the so-called 'designer baby' method. It shows that far from being a runaway technology, the regulation of PGD provides an example of precaution and restraint.




Assessing Genetic Risks


Book Description

Raising hopes for disease treatment and prevention, but also the specter of discrimination and "designer genes," genetic testing is potentially one of the most socially explosive developments of our time. This book presents a current assessment of this rapidly evolving field, offering principles for actions and research and recommendations on key issues in genetic testing and screening. Advantages of early genetic knowledge are balanced with issues associated with such knowledge: availability of treatment, privacy and discrimination, personal decision-making, public health objectives, cost, and more. Among the important issues covered: Quality control in genetic testing. Appropriate roles for public agencies, private health practitioners, and laboratories. Value-neutral education and counseling for persons considering testing. Use of test results in insurance, employment, and other settings.




Choosing Between Possible Lives


Book Description

To what extent should parents be able to choose the kind of child they have? The unfortunate phrase 'designer baby' has become familiar in debates surrounding reproduction. As a reference to current possibilities the term is misleading, but the phrase may indicate a societal concern of some kind about control and choice in the course of reproduction. Typically, people can choose whether to have a child. They may also have an interest in choosing, to some extent, the conditions under which they do so, such as whether they have a child with a serious disability or disease. The purpose of this book is to explore the difficult and controversial question of the appropriate ethical and legal extent of reproductive autonomy in this context. The book examines ethical, legal and public policy issues in prenatal screening, prenatal diagnosis (PND), selective abortion and preimplantation genetic diagnosis (PGD). It explores the ethics of these selection practices and the ability of current ethical guidelines and legal mechanisms, including the law on selective abortion and wrongful birth, to deal with advances in genetic and other knowledge in these areas. Unlike in the United States, in England the relevant law is not inherently rights-based, but the impact of the Human Rights Act 1998 inevitably raises questions about the proper scope of reproductive autonomy in this context. The implications of the analysis are considered for the development of relevant law, public policy and ethical guidelines and will be of interest to academics in medical law and ethics, health professionals, lawyers, those working on public policy and students with an interest in these issues.




Human Germline Genome Modification and the Right to Science


Book Description

The advent of the CRISPR/Cas9 class of genome editing tools is transforming not just science and medicine, but also law. When the genome of germline cells is modified, the modifications could be inherited, with far-reaching effects in time and scale. Legal systems are struggling with keeping up with the CRISPR revolution and both lawyers and scientists are often confused about existing regulations. This book contains an analysis of the national regulatory framework in eighteen selected countries. Written by national legal experts, it includes all major players in bioengineering, plus an analysis of the emerging international standards and a discussion of how international human rights standards should inform national and international regulatory frameworks. The authors propose a set of principles for the regulation of germline engineering, based on international human rights law, that can be the foundation for regulating heritable gene editing both at the level of countries as well as globally.