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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: 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 : 614
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: 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: Les Irwig Publisher: Judy Irwig ISBN: 1905140177 Category : Health & Fitness Languages : en Pages : 255
Book Description
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: 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: Institute of Medicine Publisher: National Academies Press ISBN: 0309316324 Category : Medical Languages : en Pages : 304
Book Description
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: Sigmund Simonsen
Author: Sigmund Simonsen
Author: Institute of Medicine
Author: Baruch Fischhoff
Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Author: Deborah G. Mayo
Author: Graeme Laurie
Author: Les Irwig
Author: Institute of Medicine
Author: 
Author: Institute of Medicine