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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.

Medical ethics. --- Medical laws and legislation -- Europe. --- Medical laws and legislation --- Biology --- Medicine --- Medical ethics --- Risk --- Risk Management --- Epidemiologic Measurements --- Biomedical Research --- Research --- Investigative Techniques --- Probability --- Organization and Administration --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Science --- Public Health --- Natural Science Disciplines --- Statistics as Topic --- Environment and Public Health --- Health Services Administration --- Disciplines and Occupations --- Health Care --- Epidemiologic Methods --- Health Care Evaluation Mechanisms --- Quality of Health Care --- Health Care Quality, Access, and Evaluation --- Risk Assessment --- Human Experimentation --- Law - Non-U.S. --- Health & Biological Sciences --- Law, Politics & Government --- Medical Ethics & Philosophy --- Law - Europe, except U.K. --- Medical Research --- Biology - General --- Human experimentation in medicine. --- Risk management. --- Research. --- Experimentation on humans, Medical --- Medical experimentation on humans --- Biomedical ethics --- Clinical ethics --- Ethics, Medical --- Health care ethics --- Medical care --- Biological research --- Biomedical research --- Medical research --- Moral and ethical aspects --- Medicine. --- Medical laws and legislation. --- Medicine & Public Health. --- Theory of Medicine/Bioethics. --- Medical Law. --- Biomedicine general. --- Bioethics --- Professional ethics --- Nursing ethics --- Social medicine --- Law, Medical --- Medical personnel --- Medical registration and examination --- Physicians --- Surgeons --- Medical policy --- Medical jurisprudence --- Clinical sciences --- Medical profession --- Human biology --- Life sciences --- Medical sciences --- Pathology --- Legal status, laws, etc. --- Law and legislation --- Medicine, Experimental --- Clinical trials --- Insurance --- Management --- Public health laws. --- Communicable diseases --- Public health --- Health Workforce --- Biomedicine, general.

Choose an application

• Reference Manager
• EndNote
• RefWorks (Direct export to RefWorks)

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.

Professional ethics. Deontology --- Medical law --- Human biochemistry --- medische biochemie --- biochemie --- deontologie --- patiëntenrechten --- gezondheidsrecht