"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.
In the past, the European institutions have repeatedly addressed the information rights of patients and the resulting ethical issues, as laid down 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 The conduct of clinical trials with human medicinal products, 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, 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.
This book provides a comprehensive overview of the legal and ethical issues related to "informed consent".
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