Public preferences on written informed consent for low-risk pragmatic clinical trials in Spain.

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作者： Rafael,Dal-Ré ^[1] ; Antonio J,Carcas ^[2] ; Xavier,Carné ^[3] ; David,Wendler ^[2]

作者单位： Clinical Research, BUC (Biosciences UAM+CSIC) Program, International Campus of Excellence, Universidad Autónoma de Madrid, Ciudad Universitaria de Cantoblanco, Einstein 3, 28049, Madrid, Spain. ^[1] Chair on Bioethics 'Grifols Foundation', University of Vic-Central University of Catalonia, Miquel Martí i Pol 1, Campus Miramarges, 08500, Vic, Barcelona, Spain. ^[2] Clinical Pharmacology Department, La Paz University Hospital, IdiPaz, School of Medicine, Universidad Autónoma de Madrid, Paseo de la Castellana 261, 28046, Madrid, Spain. ^[3] Clinical Pharmacology Department, Clínic Hospital, August Pi i Sunyer Biomedical Research Institute (IDIBAPS); Clinical Fundamentals Department, Universidad de Barcelona, Carrer de Villarroel 170, 08036, Barcelona, Spain. ^[4] Chair on Bioethics 'Grifols Foundation', University of Vic-Central University of Catalonia, Miquel Martí i Pol 1, Campus Miramarges, E-08500, Vic, Barcelona, Spain. ^[5] Section on Research Ethics, Department of Bioethics, NIH Clinical Center, 10 Center Drive, Bethesda, MD, 20814,, USA. ^[6]

关键词 clinical trial regulation general notification low-risk pragmatic trials verbal informed consent written informed consent