@article{686513c78ca64eb2a8fdbd7ec524ec6d,
title = "Low risk pragmatic trials do not always require participants{\textquoteright} informed consent",
abstract = "Clinical trial regulations should remove unnecessary obstacles for the conduct of pragmatic trials assessing the comparative effectiveness of medicines posing no or minimal risk to participants, say Rafael Dal-R{\'e} and colleagues",
keywords = "CLINICAL-TRIALS",
author = "Rafael Dal-Re and Cristina Avenda{\~n}o-Sol{\`a} and Brigitte Bloechl-Daum and {de Boer}, Anthonius and Stefan Eriksson and Uwe Fuhr and S{\o}ren Holm and James, {Stefan K.} and Mentz, {Robert J.} and Emilio Perucca and Rosendaal, {Frits R.} and Shaun Treweek",
note = "Acknowledgments We thank Cristina G{\'o}mez Piqueras (general subdirectorate of data inspection, Spanish Data Protection Agency) and Alessandro Spina (data protection officer, European Medicines Agency) for their comments on our interpretation of the provisions of the GDPR regarding participants{\textquoteright} informed consent in medical research, and Jan P Vandenbroucke (Leiden University) for his advice. We also thank A de longh, N Ivers, M, Zwarenstein, and The BMJ editors for their comments and suggestions. ",
year = "2019",
month = mar,
day = "27",
doi = "10.1136/bmj.l1092",
language = "English",
volume = "364",
journal = "BMJ",
issn = "0959-8146",
publisher = "BMJ Publishing Group",
}