Additional Protocol To The Convention On Human Rights And Biomedicine Concerning Biomedical Research

This protocol covers the full range of research activities in the health field that involve interventions on human beings. It aims to protect the dignity and identity of everyone involved, without discrimination.

The Convention on Human Rights and Biomedicine, also referred to as the "Oviedo Convention", celebrated the 10th anniversary of its entry into force in 2009. This legally binding instrument aims to protect the integrity, dignity and identity of all human beings and guarantees everyone, without discrimination, the respect for their rights and fundamental freedoms with regard to the application of biology and medicine. It shares with the European Convention on Human Rights the same underlying approach and many ethical principles, and provides a general framework for the protection of fundamental rights and freedoms in the field of biomedicine. The Oviedo Convention also addresses new challenges in biomedicine that are brought about by technological and scientific developments, making it a reference text for patient rights at the European level. The principles laid down in the Oviedo Convention were further developed and complemented in additional protocols in specific fields: prohibition of cloning of human beings, transplantation of organs and tissues of human origin, and biomedical research and genetic testing for health purposes.

In 1997, the Council of Europe established the Convention on Human Rights and Biomedicine. It is generally regarded as an important addition to the general human rights laid down in the European Convention for the Protection of Human Rights and Fundamental Freedoms (1950), in particular with a view to the developments in modern biology and medicine. The Biomedicine Convention, which entered into force in 2000, is a framework treaty, meaning that a number of issues have to be dealt with or will be elaborated in additional Protocols; at this moment, three such Protocols have already been opened for signature. This volume of essays, written in honour of Henriette Roscam Abbing upon her retirement as Professor of Health Law at the University of Utrecht, gives an overview of some of the most important issues raised by the Convention. In six parts, this volume discusses the basic concepts and leading principles; the provision of services; the rights of patients; research; human tissue and genetics; and the implementation of the Convention.

Parallel text in English & French. - Opposite pages bear duplicate numbering

This is a comprehensive reference text that examines the current state of Legal Medicine, which encompasses Forensic Medicine, in the 21st century. It examines the scope of both legal and forensic medicine, its application and study and has adopted a wide ranging approach including multinational authorship. It reviews the differences between and similarities of forensic and legal medicine, the need for academic qualification, the applications to many and varied fields including international aid, military medicine, health law and the application of medical knowledge to both criminal law and tort/civil law, sports medicine and law, gender and age related factors from obstetrics through to geriatrics and palliative care as well as cultural differences exploring the Christian/Judeo approach compared with that within Islamic cultures, Buddhism and Hinduism. The book looks at practical applications of legal medicine within various international and intercultural frameworks. This is a seminal authoritative text in legal and forensic medicine. It has a multi-author and multinational approach which crosses national boundaries. There is a great interest in the development of health law and legal medicine institutes around the world and this text comes in on the ground floor of this burgeoning discipline and provides the foundation text for many courses, both undergraduate and postgraduate. It defines the place of legal medicine as a specialized discipline.​

A survey of the regulation of human germline genome modification in eighteen countries and the emerging international standards.

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.