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.




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.




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.




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.




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.




Juridification In Bioethics: Governance Of Human Pluripotent Cell Research


Book Description

What is 'legal' about bioethics? What are the ideas and artefacts that bioethics encompasses, and how are they related to law? What is the role of law in bioethics? In this work, Calvin Ho attempts to address these questions in the context of the governance of human pluripotent stem cell research. In essence, he argues that the hybridization of law, through processes, devices and techniques of juridification, has helped to constitute bioethics as a public sphere and an emergent civic epistemology.Drawing on his multi-sited ethnographic fieldwork and on Actor-Network-Theory, Ho explains how the law has, through bioethics, contributed to the scientific and public understanding of human pluripotent stem cell research and its artefacts, particularly the embryo and human-animal combinations. Although the focus of his work is on bioethical developments in Singapore over a period of more than 15 years, parallel developments in key jurisdictions (especially the United States of America and the United Kingdom) and in international science policy are also evaluated. It is through appreciating how it has progressed that bioethics will be better able to engage with future challenges presented by advances in human embryo research and gene editing techniques, among others.




Responsible Research with Biological Select Agents and Toxins


Book Description

The effort to understand and combat infectious diseases has, during the centuries, produced many key advances in science and medicine-including the development of vaccines, drugs, and other treatments. A subset of this research is conducted with agents that, like anthrax, not only pose a severe threat to the health of humans, plants, and animals but can also be used for ill-intended purposes. Such agents have been listed by the government as biological select agents and toxins. The 2001 anthrax letter attacks prompted the creation of new regulations aimed at increasing security for research with dangerous pathogens. The outcome of the anthrax letter investigation has raised concern about whether these measures are adequate. Responsible Research with Biological Select Agents and Toxins evaluates both the physical security of select agent laboratories and personnel reliability measures designed to ensure the trustworthiness of those with access to biological select agents and toxins. The book offers a set of guiding principles and recommended changes to minimize security risk and facilitate the productivity of research. The book recommends fostering a culture of trust and responsibility in the laboratory, engaging the community in oversight of the Select Agent Program, and enhancing the operation of the Select Agent Program.




Stem Cell Therapy for Vascular Diseases


Book Description

Vascular diseases are the leading cause of death worldwide. Distinguished clinical and surgical approaches have attempted to overcome its morbidity and mortality; still 17.9 million people die every year due to vascular affections. Stem cell therapy has emerged as a promising therapeutic strategy. Stem cells synthesize and secrete cytokines that promote cell recruitment, immunomodulation, extracellular matrix remodeling, angiogenesis, and neuroregeneration, all of which promote regeneration. Besides that, stem cells are also capable of differentiating in various cell types, being employed in tissue engineering. Preclinical and clinical investigations have reported efficacy of stem cell therapy for various vascular diseases. Even though results are encouraging, the studies demonstrate variation in stem cell type and origin, route and protocol for administration, and concomitant use of other treatment strategies, impairing easy interpretation of results and clinical application. The purpose of this book is to compile and comprise the current state of the evidence regarding stem cell therapy for each vascular disease, elucidating possible clinical applications. More than an objective guide for readers on the use of this novel treatment strategy, this publication will advocate for stem cell therapy use and development and will be of significant interest to physicians in a wide range of disciplines as well as researchers.




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.




Chimeras, Hybrids, and Interspecies Research


Book Description

In his 2006 State of the Union speech, President George W. Bush asked the U.S. Congress to prohibit the "most egregious abuses of medical research," such as the "creation of animal–human hybrids." The president's message echoed that of a 2004 report by the President's Council on Bioethics, which recommended that hybrid human–animal embryos be banned by Congress. Discussions of early interspecies research, in which cells or DNA are interchanged between humans and nonhumans at early stages of development, can often devolve into sweeping statements, colorful imagery, and confusing policy. Although today's policy advisory groups are becoming more informed, debate is still limited by the interchangeable use of terms such as chimeras and hybrids, a tendency to treat all forms of interspecies alike, the failure to distinguish between laboratory research and procreation, and not enough serious policy justification. Andrea Bonnicksen seeks to understand reasons behind support of and disdain for interspecies research in such areas as chimerism, hybridization, interspecies nuclear transfer, cross-species embryo transfer, and transgenics. She highlights two claims critics make against early interspecies studies: that the research will violate human dignity and that it can lead to procreation. Are these claims sufficient to justify restrictive policy? Bonnicksen carefully illustrates the challenges of making policy for sensitive and often sensationalized research—research that touches deep-seated values and that probes the boundary between human and nonhuman animals.