Assessing Genetic Risks

Assessing Genetic Risks

Author: Institute of Medicine

Publisher: National Academies Press

Published: 1994-01-01

Total Pages: 353

ISBN-13: 0309047986

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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.


Industrialization of Biology

Industrialization of Biology

Author: National Research Council

Publisher: National Academies Press

Published: 2015-06-29

Total Pages: 158

ISBN-13: 0309316553

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The tremendous progress in biology over the last half century - from Watson and Crick's elucidation of the structure of DNA to today's astonishing, rapid progress in the field of synthetic biology - has positioned us for significant innovation in chemical production. New bio-based chemicals, improved public health through improved drugs and diagnostics, and biofuels that reduce our dependency on oil are all results of research and innovation in the biological sciences. In the past decade, we have witnessed major advances made possible by biotechnology in areas such as rapid, low-cost DNA sequencing, metabolic engineering, and high-throughput screening. The manufacturing of chemicals using biological synthesis and engineering could expand even faster. A proactive strategy - implemented through the development of a technical roadmap similar to those that enabled sustained growth in the semiconductor industry and our explorations of space - is needed if we are to realize the widespread benefits of accelerating the industrialization of biology. Industrialization of Biology presents such a roadmap to achieve key technical milestones for chemical manufacturing through biological routes. This report examines the technical, economic, and societal factors that limit the adoption of bioprocessing in the chemical industry today and which, if surmounted, would markedly accelerate the advanced manufacturing of chemicals via industrial biotechnology. Working at the interface of synthetic chemistry, metabolic engineering, molecular biology, and synthetic biology, Industrialization of Biology identifies key technical goals for next-generation chemical manufacturing, then identifies the gaps in knowledge, tools, techniques, and systems required to meet those goals, and targets and timelines for achieving them. This report also considers the skills necessary to accomplish the roadmap goals, and what training opportunities are required to produce the cadre of skilled scientists and engineers needed.


Rethinking Health Care Ethics

Rethinking Health Care Ethics

Author: Stephen Scher

Publisher: Springer

Published: 2018-08-02

Total Pages: 177

ISBN-13: 9811308306

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​The goal of this open access book is to develop an approach to clinical health care ethics that is more accessible to, and usable by, health professionals than the now-dominant approaches that focus, for example, on the application of ethical principles. The book elaborates the view that health professionals have the emotional and intellectual resources to discuss and address ethical issues in clinical health care without needing to rely on the expertise of bioethicists. The early chapters review the history of bioethics and explain how academics from outside health care came to dominate the field of health care ethics, both in professional schools and in clinical health care. The middle chapters elaborate a series of concepts, drawn from philosophy and the social sciences, that set the stage for developing a framework that builds upon the individual moral experience of health professionals, that explains the discontinuities between the demands of bioethics and the experience and perceptions of health professionals, and that enables the articulation of a full theory of clinical ethics with clinicians themselves as the foundation. Against that background, the first of three chapters on professional education presents a general framework for teaching clinical ethics; the second discusses how to integrate ethics into formal health care curricula; and the third addresses the opportunities for teaching available in clinical settings. The final chapter, "Empowering Clinicians", brings together the various dimensions of the argument and anticipates potential questions about the framework developed in earlier chapters.


Global Health Law

Global Health Law

Author: Lawrence O. Gostin

Publisher: Harvard University Press

Published: 2014-03-31

Total Pages: 461

ISBN-13: 0674369882

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The international community has made great progress in improving global health. But staggering health inequalities between rich and poor still remain, raising fundamental questions of social justice. In a book that systematically defines the burgeoning field of global health law, Lawrence Gostin drives home the need for effective global governance for health and offers a blueprint for reform, based on the principle that the opportunity to live a healthy life is a basic human right. Gostin shows how critical it is for institutions and international agreements to focus not only on illness but also on the essential conditions that enable people to stay healthy throughout their lifespan: nutrition, clean water, mosquito control, and tobacco reduction. Policies that shape agriculture, trade, and the environment have long-term impacts on health, and Gostin proposes major reforms of global health institutions and governments to ensure better coordination, more transparency, and accountability. He illustrates the power of global health law with case studies on AIDS, influenza, tobacco, and health worker migration. Today's pressing health needs worldwide are a problem not only for the medical profession but also for all concerned citizens. Designed with the beginning student, advanced researcher, and informed public in mind, Global Health Law will be a foundational resource for teaching, advocacy, and public discourse in global health.


FDA in the Twenty-First Century

FDA in the Twenty-First Century

Author: Holly Fernandez Lynch

Publisher: Columbia University Press

Published: 2015-09-08

Total Pages: 499

ISBN-13: 0231540078

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In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.


Beyond the HIPAA Privacy Rule

Beyond the HIPAA Privacy Rule

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2009-03-24

Total Pages: 334

ISBN-13: 0309124999

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In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.


Genetically Engineered Crops

Genetically Engineered Crops

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2017-01-28

Total Pages: 607

ISBN-13: 0309437385

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Genetically engineered (GE) crops were first introduced commercially in the 1990s. After two decades of production, some groups and individuals remain critical of the technology based on their concerns about possible adverse effects on human health, the environment, and ethical considerations. At the same time, others are concerned that the technology is not reaching its potential to improve human health and the environment because of stringent regulations and reduced public funding to develop products offering more benefits to society. While the debate about these and other questions related to the genetic engineering techniques of the first 20 years goes on, emerging genetic-engineering technologies are adding new complexities to the conversation. Genetically Engineered Crops builds on previous related Academies reports published between 1987 and 2010 by undertaking a retrospective examination of the purported positive and adverse effects of GE crops and to anticipate what emerging genetic-engineering technologies hold for the future. This report indicates where there are uncertainties about the economic, agronomic, health, safety, or other impacts of GE crops and food, and makes recommendations to fill gaps in safety assessments, increase regulatory clarity, and improve innovations in and access to GE technology.


The Business of Healthcare Innovation

The Business of Healthcare Innovation

Author: Lawton R. Burns

Publisher: Cambridge University Press

Published: 2005-08-25

Total Pages: 400

ISBN-13: 9780521838986

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The first wide-ranging analysis of business trends in the manufacturing segment of the health care industry.