Acceptable Risk In Biomedical Research

Author : Sigmund Simonsen
Publisher : Springer Science & Business Media
ISBN 13 : 9400726783
Total Pages : 292 pages
Book Rating : 4.89/5 ( download)

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Download or read book Acceptable Risk in Biomedical Research written by Sigmund Simonsen and published by Springer Science & Business Media. This book was released on 2012-01-04 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309133386
Total Pages : 445 pages
Book Rating : 4.88/5 ( download)

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Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Author : Baruch Fischhoff
Publisher : Cambridge University Press
ISBN 13 : 9780521278928
Total Pages : 228 pages
Book Rating : 4.29/5 ( download)

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Download or read book Acceptable Risk written by Baruch Fischhoff and published by Cambridge University Press. This book was released on 1981 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: A framework for making decisions about risks, with recommendations for research, public policy, and practice.

Author : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher :
ISBN 13 :
Total Pages : 614 pages
Book Rating : 4.28/5 ( download)

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Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Deborah G. Mayo
Publisher : Oxford University Press
ISBN 13 : 0195358325
Total Pages : 305 pages
Book Rating : 4.22/5 ( download)

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Download or read book Acceptable Evidence written by Deborah G. Mayo and published by Oxford University Press. This book was released on 1994-02-17 with total page 305 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discussions of science and values in risk management have largely focused on how values enter into arguments about risks, that is, issues of acceptable risk. Instead this volume concentrates on how values enter into collecting, interpreting, communicating, and evaluating the evidence of risks, that is, issues of the acceptability of evidence of risk. By focusing on acceptable evidence, this volume avoids two barriers to progress. One barrier assumes that evidence of risk is largely a matter of objective scientific data and therefore uncontroversial. The other assumes that evidence of risk, being "just" a matter of values, is not amenable to reasoned critique. Denying both extremes, this volume argues for a more constructive conclusion: understanding the interrelations of scientific and value issues enables a critical scrutiny of risk assessments and better public deliberation about social choices. The contributors, distinguished philosophers, policy analysts, and natural and social scientists, analyze environmental and medical controversies, and assumptions underlying views about risk assessment and the scientific and statistical models used in risk management.

Author : Robin Cook
Publisher :
ISBN 13 :
Total Pages : 406 pages
Book Rating : 4.18/5 ( download)

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Download or read book Acceptable Risk written by Robin Cook and published by . This book was released on 1994 with total page 406 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 304 pages
Book Rating : 4.23/5 ( download)

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Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Author : Les Irwig
Publisher : Judy Irwig
ISBN 13 : 1905140177
Total Pages : 255 pages
Book Rating : 4.76/5 ( download)

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Download or read book Smart Health Choices written by Les Irwig and published by Judy Irwig. This book was released on 2008 with total page 255 pages. Available in PDF, EPUB and Kindle. Book excerpt: Every day we make decisions about our health - some big and some small. What we eat, how we live and even where we live can affect our health. But how can we be sure that the advice we are given about these important matters is right for us? This book will provide you with the right tools for assessing health advice.

Author : Robin Cook
Publisher : Wheeler Publishing, Incorporated
ISBN 13 : 9781568951737
Total Pages : 550 pages
Book Rating : 4.36/5 ( download)

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Download or read book Acceptable Risk written by Robin Cook and published by Wheeler Publishing, Incorporated. This book was released on 1995 with total page 550 pages. Available in PDF, EPUB and Kindle. Book excerpt: Robin Cook has always been on the cutting edge of the latestmedical controversies. In Acceptable Risk, he confronts one of themost provocative issues of our time: personality-altering drugs and thecomplex moral questions they raise. Neuroscientist Edward Armstrong hasmanaged to isolate a psychotropic drug with a strange and dark history--onethat may account for the public hysteria during the Salem witch trials. In abrilliant designer-drug transformation, it is developed into an antidepressantwith truly startling therapeutic capabilities. But who can be sure the drug issafe for consumers? Who defines the boundaries of "normal" humanbehavior? And if the drug's side effects are proven to be dangerous--eventerrifying--how far will the medical community go to alter their standardsof...Acceptable Risk.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309164257
Total Pages : 267 pages
Book Rating : 4.52/5 ( download)

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Download or read book Finding What Works in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.