Obligations légales dans la mise en place d'un essai clinique portant sur un médicament en France

In France, biomedical research practiced on human beings is surrounded by ethical and legal issues. For these issues, there are specific laws applied directly to clinical research which are based on the respect of the person, the relevance and quality of research. Those laws are : " Loi Huriet " concerning the protection of the person participating in biomedical research, the "Loi informatique et libertés " which applies to projects allowing personal identification, and the Law " anti-cadeaux " whose aim is to insure a greater transparency into the financial reports. Because of the new European directive 2001/20/CE on the clinical trials of drugs, the regulation of clinical trial is currently changing. This will imply a revision of the Huriet Law.TOULOUSE3-BU Santé-Centrale (315552105) / SudocTOULOUSE3-BU Santé-Allées (315552109) / SudocSudocFranceF