Human Genome Editing


Book Description

Genome editing is a powerful new tool for making precise alterations to an organism's genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an explosion of interest from around the globe in the possible ways in which genome editing can improve human health. The speed at which these technologies are being developed and applied has led many policymakers and stakeholders to express concern about whether appropriate systems are in place to govern these technologies and how and when the public should be engaged in these decisions. Human Genome Editing considers important questions about the human application of genome editing including: balancing potential benefits with unintended risks, governing the use of genome editing, incorporating societal values into clinical applications and policy decisions, and respecting the inevitable differences across nations and cultures that will shape how and whether to use these new technologies. This report proposes criteria for heritable germline editing, provides conclusions on the crucial need for public education and engagement, and presents 7 general principles for the governance of human genome editing.




Final Report of the National Academies' Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research


Book Description

In 2005, the National Academies released the book, Guidelines for Human Embryonic Stem Cell Research, which offered a common set of ethical standards for a field that, due to the absence of comprehensive federal funding, was lacking national standards for research. In order to keep the Guidelines up to date, given the rapid pace of scientific and policy developments in the field of stem cell research, the Human Embryonic Stem Cell Research Advisory Committee was established in 2006 with support from The Ellison Medical Foundation, The Greenwall Foundation, and the Howard Hughes Medical Institute. As it did in 2007 and 2008, the Committee identified issues that warranted revision, and this book addresses those issues in a third and final set of amendments. Specifically, this book sets out an updated version of the National Academies' Guidelines, one that takes into account the new, expanded role of the NIH in overseeing hES cell research. It also identifies those avenues of continuing National Academies' involvement deemed most valuable by the research community and other significant stakeholders.




2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research


Book Description

In 2005, the National Academies released the report Guidelines for Human Embryonic Stem Cell Research, which offered a common set of ethical standards for a field that, due to the absence of comprehensive federal funding, was lacking national standards for research. In order to keep the Guidelines up to date, given the rapid pace of scientific developments in the field of stem cell research, the Human Embryonic Stem Cell Research Advisory Committee was established in 2006 with support from The Ellison Medical Foundation, The Greenwall Foundation, and the Howard Hughes Medical Institute. This letter report is the committee's first set of amendments to the Guidelines and clarifies earlier recommendations and conclusions, including the criteria for determining which stem cell lines it is acceptable to use. Future deliberations of the committee will address items for which additional information gathering and more extensive debate and discussion will be necessary.




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.




Fostering Integrity in Research


Book Description

The integrity of knowledge that emerges from research is based on individual and collective adherence to core values of objectivity, honesty, openness, fairness, accountability, and stewardship. Integrity in science means that the organizations in which research is conducted encourage those involved to exemplify these values in every step of the research process. Understanding the dynamics that support â€" or distort â€" practices that uphold the integrity of research by all participants ensures that the research enterprise advances knowledge. The 1992 report Responsible Science: Ensuring the Integrity of the Research Process evaluated issues related to scientific responsibility and the conduct of research. It provided a valuable service in describing and analyzing a very complicated set of issues, and has served as a crucial basis for thinking about research integrity for more than two decades. However, as experience has accumulated with various forms of research misconduct, detrimental research practices, and other forms of misconduct, as subsequent empirical research has revealed more about the nature of scientific misconduct, and because technological and social changes have altered the environment in which science is conducted, it is clear that the framework established more than two decades ago needs to be updated. Responsible Science served as a valuable benchmark to set the context for this most recent analysis and to help guide the committee's thought process. Fostering Integrity in Research identifies best practices in research and recommends practical options for discouraging and addressing research misconduct and detrimental research practices.




Stem Cells and the Future of Regenerative Medicine


Book Description

Recent scientific breakthroughs, celebrity patient advocates, and conflicting religious beliefs have come together to bring the state of stem cell researchâ€"specifically embryonic stem cell researchâ€"into the political crosshairs. President Bush's watershed policy statement allows federal funding for embryonic stem cell research but only on a limited number of stem cell lines. Millions of Americans could be affected by the continuing political debate among policymakers and the public. Stem Cells and the Future of Regenerative Medicine provides a deeper exploration of the biological, ethical, and funding questions prompted by the therapeutic potential of undifferentiated human cells. In terms accessible to lay readers, the book summarizes what we know about adult and embryonic stem cells and discusses how to go about the transition from mouse studies to research that has therapeutic implications for people. Perhaps most important, Stem Cells and the Future of Regenerative Medicine also provides an overview of the moral and ethical problems that arise from the use of embryonic stem cells. This timely book compares the impact of public and private research funding and discusses approaches to appropriate research oversight. Based on the insights of leading scientists, ethicists, and other authorities, the book offers authoritative recommendations regarding the use of existing stem cell lines versus new lines in research, the important role of the federal government in this field of research, and other fundamental issues.




Scientific and Medical Aspects of Human Reproductive Cloning


Book Description

Human reproductive cloning is an assisted reproductive technology that would be carried out with the goal of creating a newborn genetically identical to another human being. It is currently the subject of much debate around the world, involving a variety of ethical, religious, societal, scientific, and medical issues. Scientific and Medical Aspects of Human Reproductive Cloning considers the scientific and medical sides of this issue, plus ethical issues that pertain to human-subjects research. Based on experience with reproductive cloning in animals, the report concludes that human reproductive cloning would be dangerous for the woman, fetus, and newborn, and is likely to fail. The study panel did not address the issue of whether human reproductive cloning, even if it were found to be medically safe, would beâ€"or would not beâ€"acceptable to individuals or society.




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.




Vibrant and Healthy Kids


Book Description

Children are the foundation of the United States, and supporting them is a key component of building a successful future. However, millions of children face health inequities that compromise their development, well-being, and long-term outcomes, despite substantial scientific evidence about how those adversities contribute to poor health. Advancements in neurobiological and socio-behavioral science show that critical biological systems develop in the prenatal through early childhood periods, and neurobiological development is extremely responsive to environmental influences during these stages. Consequently, social, economic, cultural, and environmental factors significantly affect a child's health ecosystem and ability to thrive throughout adulthood. Vibrant and Healthy Kids: Aligning Science, Practice, and Policy to Advance Health Equity builds upon and updates research from Communities in Action: Pathways to Health Equity (2017) and From Neurons to Neighborhoods: The Science of Early Childhood Development (2000). This report provides a brief overview of stressors that affect childhood development and health, a framework for applying current brain and development science to the real world, a roadmap for implementing tailored interventions, and recommendations about improving systems to better align with our understanding of the significant impact of health equity.




2008 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research


Book Description

In 2005, the National Academies released the report Guidelines for Human Embryonic Stem Cell Research, which offered a common set of ethical standards for a field that, due to the absence of comprehensive federal funding, was lacking national standards for research. In order to keep the Guidelines up to date, given the rapid pace of scientific developments in the field of stem cell research, the Human Embryonic Stem Cell Research Advisory Committee was established in 2006 with support from The Ellison Medical Foundation, The Greenwall Foundation, and the Howard Hughes Medical Institute. As it did in 2007, the Committee identified issues that warranted revision, and this book addresses those issues in a second set of amendments. Most importantly, this book addresses new scientific developments in reprogramming of somatic cells to pluripotency by adding a new section and revising other relevant sections of the Guidelines.