کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
7522633 1487030 2012 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Sécurité des patients et développement des recherches : de la loi Bertrand à la loi Jardé
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی پزشکی و دندانپزشکی (عمومی)
پیش نمایش صفحه اول مقاله
Sécurité des patients et développement des recherches : de la loi Bertrand à la loi Jardé
چکیده انگلیسی
The legislator has successively adopted two laws amending deeply the legal framework of research. The first one is the law “Bertrand” no. 2011-2012 of 29 December 2011 on strengthening the safety of the drug and health products, which emphasizes the need for transparency of links of interest and opens wider opportunities for using post-marketing authorization trials. The second one is the law “Jardé” no. 2012-300 of March 5, 2012 on researches involving the human person, reforming all the rules governing researches and which establishes a national commission of researches involving the human person. If the first one is a clear move towards strengthening the protection of patients in research, it is possible to be more reserved about the effects of the latter, which seems more oriented towards an easing of constraints on researchers.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Médecine & Droit - Volume 2012, Issue 117, November–December 2012, Pages 163-169
نویسندگان
, ,