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Author: Sigmund Simonsen Publisher: Springer Science & Business Media ISBN: 9400726783 Category : Medical Languages : en Pages : 296
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: 9400726783 Category : Medical Languages : en Pages : 296
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: Institute of Medicine Publisher: National Academies Press ISBN: 0309133386 Category : Medical Languages : en Pages : 445
Book Description
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: Deborah G. Mayo Publisher: Oxford University Press ISBN: 0195358325 Category : Science Languages : en Pages : 305
Book Description
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: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Publisher: ISBN: Category : Human experimentation in medicine Languages : en Pages :
Author: Graeme Laurie Publisher: ISBN: 1108576095 Category : Law Languages : en Pages : 444
Book Description
The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues.
Author: Robin Cook Publisher: Wheeler Publishing, Incorporated ISBN: 9781568951737 Category : Fiction Languages : en Pages : 550
Book Description
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: 0309164257 Category : Medical Languages : en Pages : 267
Book Description
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.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309164923 Category : Social Science Languages : en Pages : 216
Book Description
Ethical Considerations for Research on Housing-Related Health Hazards Involving Children explores the ethical issues posed when conducting research designed to identify, understand, or ameliorate housing-related health hazards among children. Such research involves children as subjects and is conducted in the home and in communities. It is often conducted with children in low-income families given the disproportionate prevalence of housing-related conditions such as lead poisoning, asthma, and fatal injuries among these children. This book emphasizes five key elements to address the particular ethical concerns raised by these characteristics: involving the affected community in the research and responding to their concerns; ensuring that parents understand the essential elements of the research; adopting uniform federal guidelines for such research by all sponsors (Subpart D of 45 CFR 46); providing guidance on key terms in the regulations; and viewing research oversight as a system with important roles for researchers, IRBs and their research institutions, sponsors and regulators of research, and the community.
Author: Sigmund Simonsen
Author: Sigmund Simonsen
Author: Baruch Fischhoff
Author: Institute of Medicine
Author: Deborah G. Mayo
Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Author: Robin Cook
Author: Graeme Laurie
Author: Robin Cook
Author: Institute of Medicine
Author: Institute of Medicine