The Legal Protection of Test Subjects in Clinical Trials of Medicinal Products for Human Use in the European Union
de Bijl, Nicole P.Y.M.
Medicine and Law: World Association for Medical Law 2004; 23(1): 1-7
On the international as well as on the level of the European Union a legal framework has been developed on the protection of test subjects. In 2000, the Declaration of Helsinki, issued by the World Medical Association, was revised and the previous distinction between therapeutic and non-therapeutic trial situations has been eliminated. Non-therapeutic trials that only aim at the progress of scientific knowledge and do not benefit the patient are now admissible. This is not to the benefit of the position of the test subject and most certainly not when the test subject should be given special protection. The question arises what this recent revision means for the group of incompetent adult patients in clinical trials on medicinal products (hereinafter called drugs) in the European Union (EU). This group needs special protection. Also relevant are national and international legal frameworks and the protection offered by informed consent procedures and screening by ethics committees and member states' competent authorities.
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Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to the Implementation of Good Clinical Practice in The Conduct of Clinical Trials on Medicinal Products for Human Use Unknown author (European Union. European Parliament and Council of Europe, 2001-05-01)