What are the rules and underlying values governing biomedical research in Europe? What form do these values take and where do they originate? Does biomedical research pose a threat to individuals and their rights? What balance should be struck between freedom of research and protection of the individual? All these questions are examined in this book from a pan-European perspective.The authors look at various international and European standards, including the Helsinki Declaration of the World Medical Association, EU Directive 2001/20 on pharmaceutical research and the Council of Europe's Convention on Human Rights and Biomedicine. The last named was signed in Oviedo in 1997 and is the first binding international treaty on the subject, with a special chapter on scientific research on human beings. The Convention establishes a common minimum level of protection of fundamental rights throughout Europe. It will soon be supplemented by an additional protocol specifically concerned with biomedical research.The book contains a glossary and a list of relevant international conventions and treaties, web sites and publications. It is aimed at both specialists and a wider public interested in this subject.
Preface
Introduction by Claude Huriet
History and definitions by Povl Riis
ETHICAL DILEMMAS IN RESEARCH
Uses and abuses of biomedical research by Jan Helge Solbakk
Selection and recruitment of participants: European standards by Herman Nys
Placebo: its action and place in health research by Andrzej Górski
Cancer clinical trials by Maxime Seligmann
Some ethical considerations in industry-sponsored clinical trials by Tom Gallacher and N. Sreeharan
Women in biomedical research by Outi Leena L. Hovatta
BIOMEDICAL RESEARCH IN EUROPE
Germany: current legislation by Jochen Taupitz
Central and eastern Europe: research-related problems for transition countries by Eugenijus Gefenas
Italy: some shortcomings of biomedical research by Stéphane Bauzon
United Kingdom: data protection and confidentiality by Vivienne Harpwood and Michel Coleman
EUROPE AND BIOMEDICAL RESEARCH
European law and biomedical research by Pēteris Zilgalvis
APPENDICES
Selected websites
Draft protocol on biomedical research, Council of Europe
The Helsinki Declaration, World Medical Association
What are the rules and underlying values governing biomedical research in Europe? What form do these values take and where do they originate? Does biomedical research pose a threat to individuals and their rights? What balance should be struck between freedom of research and protection of the individual? All these questions are examined in this book from a pan-European perspective.The authors look at various international and European standards, including the Helsinki Declaration of the World Medical Association, EU Directive 2001/20 on pharmaceutical research and the Council of Europe's Convention on Human Rights and Biomedicine. The last named was signed in Oviedo in 1997 and is the first binding international treaty on the subject, with a special chapter on scientific research on human beings. The Convention establishes a common minimum level of protection of fundamental rights throughout Europe. It will soon be supplemented by an additional protocol specifically concerned with biomedical research.The book contains a glossary and a list of relevant international conventions and treaties, web sites and publications. It is aimed at both specialists and a wider public interested in this subject.
