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Acceptable Risk In Biomedical Research

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Acceptable Risk in Biomedical Research

Acceptable Risk in Biomedical Research Book
Author : Sigmund Simonsen
Publisher : Springer Science & Business Media
Release : 2012-01-04
ISBN : 9400726783
Language : En, Es, Fr & De

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Book Description :

This book is the first major work that addresses a core question in biomedical research: the question of acceptable risk. The acceptable level of risks is regulated by the requirement of proportionality in biomedical research law, which state that the risk and burden to the participant must be in proportion to potential benefits to the participant, society or science. This investigation addresses research on healthy volunteers, children, vulnerable subjects, and includes placebo controlled clinical trials. It represents a major contribution towards clarifying the most central, but also the most controversial and complex issue in biomedical research law and bioethics. The EU Clinical Trial Directive, the Council of Europe’s Oviedo Convention (and its Additional Protocol), and national regulation in member states are covered. It is a relevant work for lawyers and ethicists, and the practical approach makes a valuable tool for researchers and members of research ethics committees supervising biomedical research.

Acceptable Risk in Biomedical Research

Acceptable Risk in Biomedical Research Book
Author : Sigmund Simonsen
Publisher : Springer Science & Business Media
Release : 2012-01-05
ISBN : 9400726775
Language : En, Es, Fr & De

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Book Description :

This book is the first major work that addresses a core question in biomedical research: the question of acceptable risk. The acceptable level of risks is regulated by the requirement of proportionality in biomedical research law, which state that the risk and burden to the participant must be in proportion to potential benefits to the participant, society or science. This investigation addresses research on healthy volunteers, children, vulnerable subjects, and includes placebo controlled clinical trials. It represents a major contribution towards clarifying the most central, but also the most controversial and complex issue in biomedical research law and bioethics. The EU Clinical Trial Directive, the Council of Europe’s Oviedo Convention (and its Additional Protocol), and national regulation in member states are covered. It is a relevant work for lawyers and ethicists, and the practical approach makes a valuable tool for researchers and members of research ethics committees supervising biomedical research.

Handbook of Risk Theory

Handbook of Risk Theory Book
Author : Sabine Roeser
Publisher : Springer Science & Business Media
Release : 2012
ISBN : 9400714327
Language : En, Es, Fr & De

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Book Description :

Risk has become one of the main topics in fields as diverse as engineering, medicine and economics, and it is also studied by social scientists, psychologists and legal scholars. But the topic of risk also leads to more fundamental questions such as: What is risk? What can decision theory contribute to the analysis of risk? What does the human perception of risk mean for society? How should we judge whether a risk is morally acceptable or not? Over the last couple of decades questions like these have attracted interest from philosophers and other scholars into risk theory. This handbook provides for an overview into key topics in a major new field of research. It addresses a wide range of topics, ranging from decision theory, risk perception to ethics and social implications of risk, and it also addresses specific case studies. It aims to promote communication and information among all those who are interested in theoetical issues concerning risk and uncertainty. This handbook brings together internationally leading philosophers and scholars from other disciplines who work on risk theory. The contributions are accessibly written and highly relevant to issues that are studied by risk scholars. We hope that the Handbook of Risk Theory will be a helpful starting point for all risk scholars who are interested in broadening and deepening their current perspectives.

Nordic Health Law in a European Context

Nordic Health Law in a European Context Book
Author : Elisabeth Rynning,Mette Hartlev
Publisher : BRILL
Release : 2011-12-21
ISBN : 9004223819
Language : En, Es, Fr & De

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Book Description :

This anthology aims to provide Nordic perspectives on the young and evolving field of health law – or biomedical law – by reflecting on issues that have been explored within the activities of the Nordic Network for Research in Biomedical Law. In the emergence of this fairly new legal discipline, it has become very clear that the Nordic region forms a part of Europe that has been strongly influenced by both hard and soft law initiatives from the European Union and the Council of Europe, but also that Nordic identity, culture, and collaboration clearly remain an important factor in the legal development of this particular region.

Biomedical Research

Biomedical Research Book
Author : Anonim
Publisher : Council of Europe
Release : 2004
ISBN : 9287154627
Language : En, Es, Fr & De

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Book Description :

This publication, the fifth in the Ethical Eye series, contains contributions from a multidisciplinary group of authors from different countries in Europe which examine a range of ethical issues arising from the use of biomedical research. Topics discussed include: the problems of obtaining consent, standards for the selection and recruitment of participants for research, the use of placebos, clinical trials of new medicines or experimental treatments for cancer sufferers, industry-sponsored clinical trials, the internationalisation of medical research, and gender aspects. The publication looks at various international and European standards governing this field including the Helsinki Declaration of the World Medical Association, EU DIrective 2001/20 on pharmaceutical research, and the Council of Europe's Convention on Human Rights and Biomedicine.

Law and Ethics in Biomedical Research

Law and Ethics in Biomedical Research Book
Author : Duff William Ramus Waring,Trudo Lemmens
Publisher : University of Toronto Press
Release : 2006
ISBN : 0802086438
Language : En, Es, Fr & De

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Book Description :

When a young man named Jesse Gelsinger died in 1999 as a result of his participation in a gene transfer research study, regulatory agencies in the United States began to take a closer look at what was happening in medical research. The resulting temporary shutdown of some of the most prestigious academic research centres confirmed what various recent reports in the United States as well as Canada had claimed; that the current system of regulatory oversight was in need of improvement. Law and Ethics in Biomedical Research uses the Gelinger case as a touchstone, illustrating how three major aspects of that case - the flaws in the regulatory system, conflicts of interest, and legal liability - embody the major challenges in the current medical research environment. Editors Trudo Lemmens and Duff R. Waring, along with a host of top scholars in the field, demonstrate why existing models of research review and human subject protection are in need of improvement, and how more stringent regulatory and legal means can be used to strengthen the protection of research subjects and the integrity of research. The contributors also address conflicts of interest, paying particular attention to the growing commercialization of medical research, as well as the legal liability of scientific investigators, research institutions, and governmental agencies. Legal liability is a growing concern in medical research and this fascinating study is, in the international context, one of the first to explore the liability of various parties involved in the research enterprise.

The Ethics of Biomedical Research

The Ethics of Biomedical Research Book
Author : Baruch A. Brody,Leon Jaworski Professor of Biomedical Ethics Director of the Center for Medical Ethics and Health Policy Baruch A Brody
Publisher : Oxford University Press, USA
Release : 1998
ISBN : 9780195090079
Language : En, Es, Fr & De

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Book Description :

Examines the many ethical issues related to biomedical research, including the use of animals in research, research on human subjects, clinical trials, international research ethics policies, and other related topics.

Ethics in Psychiatry

Ethics in Psychiatry Book
Author : Hanfried Helmchen,Norman Sartorius
Publisher : Springer Science & Business Media
Release : 2010-08-05
ISBN : 9789048187218
Language : En, Es, Fr & De

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Book Description :

Ethics in Psychiatry: (1) presents a comprehensive review of ethical issues arising in psychiatric care and research; (2) relates ethical issues to changes and challenges of society; (3) examines the application of general ethics to specific psychiatric problems and relates these to moral implications of psychiatry practice; (4) deals with recently arising ethical problems; (5) contains contributions of leading European ethicists, philosophers, lawyers, historians and psychiatrists; (6) provides a basis for the exploration of culture-bound influences on morals, manners and customs in the light of ethical principles of global validity.

The Physical Measurement of Bone

The Physical Measurement of Bone Book
Author : C.M. Langton,C.F. Njeh
Publisher : CRC Press
Release : 2016-04-19
ISBN : 1420033344
Language : En, Es, Fr & De

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Book Description :

Bone is a complex biological material that consists of both an inorganic and organic phase, which undergoes continuous dynamic biological processes within the body. This complex structure and the need to acquire accurate data have resulted in a wide variety of methods applied in the physical analysis of bone in vivo and in vitro. Each method has it

Foundations of Global Health Human Rights

Foundations of Global Health   Human Rights Book
Author : Lawrence O. Gostin,Benjamin Mason Meier
Publisher : Oxford University Press
Release : 2020-07-15
ISBN : 0197528317
Language : En, Es, Fr & De

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Book Description :

Human rights are essential to global health, yet rising threats in an increasingly divided world are challenging the progressive evolution of health-related human rights. It is necessary to empower a new generation of scholars, advocates, and practitioners to sustain the global commitment to universal rights in public health. Looking to the next generation to face the struggles ahead, this book provides a detailed understanding of the evolving relationship between global health and human rights, laying a human rights foundation for the advancement of transformative health policies, programs, and practices. International human rights law has been repeatedly shown to advance health and wellbeing - empowering communities and fostering accountability for realizing the highest attainable standard of health. This book provides a compelling examination of international human rights as essential for advancing public health. It demonstrates how human rights strengthens human autonomy and dignity, while placing clear responsibilities on government to safeguard the public's health and safety. Bringing together leading academics in the field of health and human rights, this volume: (1) explains the norms and principles that define the field, (2) examines the methods and tools for implementing human rights to promote health, (3) applies essential human rights to leading public health threats, and (4) analyzes rising human rights challenges in a rapidly globalizing world. This foundational text shows why interdisciplinary scholarship and action are essential for health-related human rights, placing human rights at the center of public health and securing a future of global health with justice.

Emergency Research Ethics

Emergency Research Ethics Book
Author : A.M. Viens
Publisher : Routledge
Release : 2017-03-02
ISBN : 1351940635
Language : En, Es, Fr & De

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Book Description :

The essays selected for this volume focus on issues that arise when attempting to design, review and undertake research involving human participants who are experiencing a private or public emergency. The main themes discussed by the essays are: the distinctive and significant ethical questions as to how research participants can be treated during emergency settings; the ethical challenges raised by emergencies for researchers undertaking research and its effects on the nature of research pursued; and procedural obstacles raised by emergencies which can affect the quality of good research ethics review. The volume is unique in that it is the first collection to exclusively deal with all of the central ethical aspects of conducting human subject research in the context of emergency.

Nonhuman Primates in Biomedical Research Two Volume Set

Nonhuman Primates in Biomedical Research Two Volume Set Book
Author : Christian R. Abee,Keith Mansfield,Suzette D. Tardif,Timothy Morris
Publisher : Academic Press
Release : 2012-12-31
ISBN : 0124159729
Language : En, Es, Fr & De

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Book Description :

The 2e of the gold standard text in the field, Nonhuman Primates in Biomedical Research provides a comprehensive, up-to-date review of the use of nonhuman primates in biomedical research. The publication emphasizes the biology and management, diseases, and biomedical models for nonhuman primate species most commonly used in research. Each chapter contains an extensive list of bibliographic references, photographs, and graphic illustrations to provide the reader with a thorough review of the subject. The Biology and Management volume provides basic information on the natural biology of nonhuman primates and the current state of knowledge regarding captive management. The Diseases volume provides thorough reviews of naturally occurring diseases of nonhuman primates, with a section on biomedical models reviewing contemporary nonhuman primate models of human diseases. Now in four color throughout, making the book more visually stimulating to enhance learning and ease of use Fully revised and updated, providing researchers with the most comprehensive review of the use of nonhuman primates in biomedical research Addresses commonly used nonhuman primate biomedical models, providing researchers with species-specific information

Ethical and legal debates in Irish healthcare

Ethical and legal debates in Irish healthcare Book
Author : Mary Donnelly,Claire Murray
Publisher : Manchester University Press
Release : 2016-02-01
ISBN : 1784996580
Language : En, Es, Fr & De

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Book Description :

This is an in-depth study of the contentious issues in Irish healthcare and deals with issues such as assisted suicide, abortion, adolescent treatment refusal, end of life care, retention of biological samples, involuntary admission to care and the regulation of stem cell research.

Ethical Considerations for Research Involving Prisoners

Ethical Considerations for Research Involving Prisoners Book
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research
Publisher : National Academies Press
Release : 2007-02-22
ISBN : 0309101190
Language : En, Es, Fr & De

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Book Description :

In the past 30 years, the population of prisoners in the United States has expanded almost 5-fold, correctional facilities are increasingly overcrowded, and more of the country's disadvantaged populations—racial minorities, women, people with mental illness, and people with communicable diseases such as HIV/AIDS, hepatitis C, and tuberculosis—are under correctional supervision. Because prisoners face restrictions on liberty and autonomy, have limited privacy, and often receive inadequate health care, they require specific protections when involved in research, particularly in today's correctional settings. Given these issues, the Department of Health and Human Services' Office for Human Research Protections commissioned the Institute of Medicine to review the ethical considerations regarding research involving prisoners. The resulting analysis contained in this book, Ethical Considerations for Research Involving Prisoners, emphasizes five broad actions to provide prisoners involved in research with critically important protections: • expand the definition of "prisoner"; • ensure universally and consistently applied standards of protection; • shift from a category-based to a risk-benefit approach to research review; • update the ethical framework to include collaborative responsibility; and • enhance systematic oversight of research involving prisoners.

Medical Law and Ethics

Medical Law and Ethics Book
Author : Jonathan Herring
Publisher : Oxford University Press
Release : 2016
ISBN : 0198747659
Language : En, Es, Fr & De

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Book Description :

Medical Law and Ethics covers the core legal principles, key cases, and statutes that govern medical law alongside the key ethical debates and dilemmas that exist in the field to ensure that the law is firmly placed in context.Carefully constructed features highlight these debates, drawing out the European angles, religious beliefs, and feminist perspectives which influence legal regulations. Other features such as 'a shock to the system', 'public opinion' and 'reality check' introduce further socio-legal aspects andcontribute to the lively and engaging manner in which the subject is approached.Online Resource CentreThis book is accompanied by an Online Resource Centre which includes:Bibliography and further readingLinks to key casesAuthor video podcastWeb linksLinks to key sites with information on medical law and ethics

International Law from a Baltic Perspective

International Law from a Baltic Perspective Book
Author : Ineta Ziemele
Publisher : BRILL
Release : 2020-11-04
ISBN : 9004433155
Language : En, Es, Fr & De

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Book Description :

Celebrating the 20th anniversary of the Baltic Yearbook of International Law, this volume contains a selection of articles chosen by the editors to showcase the Yearbook’s important contribution to international legal scholarship and practice. It thus offers ground-breaking articles on diverse legal areas, including international humanitarian law, international human rights law, peaceful settlement of disputes, European Union law, and the history of international law. Naturally, issues relevant to the international legal status of the Baltic States and the consequences of their occupation by the Soviet Union are also explored, as well as to transitional justice and the collapse of communism. Finally, articles on new areas, such as bioethics and cyperspace, are also included, showing where the development of science prompts the need for legal regulation. This wide-ranging selection reflects the Yearbook’s aim to offer a unique forum among international legal periodicals - where the past meets the future.

Ethics and Epidemiology

Ethics and Epidemiology Book
Author : Steven S. Coughlin,Angus Dawson
Publisher : Oxford University Press
Release : 2021
ISBN : 0197587054
Language : En, Es, Fr & De

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Book Description :

"This chapter considers the history of the rise of ethical concerns in the public health movement and epidemiology, which is the study of the distribution and determinants of disease in human populations. Epidemiology is a basic science in public health. This chapter provides an overview of early developments in public health and ethics. More recent developments are also discussed, including the origins of bioethics, regulatory safeguards for human subjects research, public health ethics, and contemporary epidemiologic ethics"--

Nonhuman Primates in Biomedical Research

Nonhuman Primates in Biomedical Research Book
Author : Christian R. Abee
Publisher : Academic Press
Release : 2012
ISBN : 0123813654
Language : En, Es, Fr & De

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Book Description :

The second edition of the gold standard text in the field, Nonhuman Primates in Biomedical Research provides a comprehensive, up-to-date review of the use of nonhuman primates in biomedical research. The Biology and Management volume provides basic information on the natural biology of nonhuman primates and the current state of knowledge regarding captive management.Each chapter contains an extensive list of bibliographic references, photographs, and graphic illustrations to provide the reader with a thorough review of the subject. * Fully revised and updated, providing researchers with the most comprehensive review of the use of nonhuman primates in biomedical research * Addresses commonly used nonhuman primate biomedical models, providing researchers with species-specific information * Includes four color images throughout