title: The legal protection of test subjects in clinical trials of medicinal products for human use in the European Union.
abstract: 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 has been developed. 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.
authors.affiliation: Department of Health Law, Faculty of Health Sciences, University of Maastricht, The Netherlands.
authors.forename: Nicole P Y M
authors.initials: NP
authors.lastname: de Bijl
mesh_terms: D000328:Adult; D002986:Clinical Trials as Topic / Q000379:methods*; D005062:European Union; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D016743:Mental Competency / Q000331:legislation & jurisprudence; D004364:Pharmaceutical Preparations; D018570:Risk Assessment
chemical_list: D004364:Pharmaceutical Preparations