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Author: Sigmund Simonsen
Publisher: Springer Science & Business Media
ISBN: 9400726775
Category : Medical
Languages : en
Pages : 292
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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.
Author: Sigmund Simonsen
Publisher: Springer Science & Business Media
ISBN: 9400726775
Category : Medical
Languages : en
Pages : 292
Get Book Here
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.
Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Ethics, Medical
Languages : en
Pages : 614
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Book Description
Author: Graeme Laurie
Publisher:
ISBN: 1108576095
Category : Law
Languages : en
Pages : 444
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Book Description
The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues.
Author: Iwao Hirose
Publisher: Oxford University Press
ISBN: 0190273356
Category : Philosophy
Languages : en
Pages : 457
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Book Description
Value theory, or axiology, looks at what things are good or bad, how good or bad they are, and, most fundamentally, what it is for a thing to be good or bad. Questions about value and about what is valuable are important to moral philosophers, since most moral theories hold that we ought to promote the good (even if this is not the only thing we ought to do). This Handbook focuses on value theory as it pertains to ethics, broadly construed, and provides a comprehensive overview of contemporary debates pertaining not only to philosophy but also to other disciplines-most notably, political theory and economics. The Handbook's twenty-two newly commissioned chapters are divided into three parts. Part I: Foundations concerns fundamental and interrelated issues about the nature of value and distinctions between kinds of value. Part II: Structure concerns formal properties of value that bear on the possibilities of measuring and comparing value. Part III: Extensions, finally, considers specific topics, ranging from health to freedom, where questions of value figure prominently.
Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: World Health Organization
ISBN: 9789290360889
Category : Bioethics
Languages : en
Pages : 0
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Book Description
"In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.
Author: Sigmund Simonsen
Publisher: Springer Science & Business Media
ISBN: 9400726783
Category : Medical
Languages : en
Pages : 292
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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.
Author: Markus Dirk Dubber
Publisher:
ISBN: 019006739X
Category : Business & Economics
Languages : en
Pages : 896
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Book Description
This interdisciplinary and international handbook captures and shapes much needed reflection on normative frameworks for the production, application, and use of artificial intelligence in all spheres of individual, commercial, social, and public life.
Author: National Research Council
Publisher: National Academies Press
ISBN: 030918651X
Category : Medical
Languages : en
Pages : 163
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Book Description
Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.
Author: Sabine Roeser
Publisher: Springer Science & Business Media
ISBN: 9400714327
Category : Decision making
Languages : en
Pages : 1209
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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.
Author: Rafaela Hillerbrand
Publisher: Springer Science & Business Media
ISBN: 9400714335
Category : Science
Languages : en
Pages : 1209
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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.
