This book provides a comprehensive overview of the legal and ethical issues related to informed consent. Informed consent as a declaration of consent after previous medical education is a central component of human self-determination. For the patient, this means the right to make his decisions on the basis of comprehensive information. The information process must be as clear, precise and personalised as possible. The EU have legislated for the information rights of patients and the resulting ethical issues in Directive 2001/20 / EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the application of good clinical practice. Clinical trials are subject to Directive 2005/28 / EC laying down the principles and detailed guidelines of good clinical practice for the use in humans of investigational medicinal products and requirements for the granting of an authorisation for the manufacture or importation of such products and Directive 2001 / 83 / EC on the establishment of a Community code for medicinal products for human use, and several guidelines on various aspects of clinical trials. All are analysed in this authoritative guide to informed consent in Europe.
Author Biography
Nikolaus Forgo is Professor of Law at the University of Hannover, Germany.
