Low risk pragmatic trials do not always require participants’ informed consent

Rafael Dal-Re; Cristina Avendaño-Solà; Brigitte Bloechl-Daum; Anthonius de Boer; Stefan Eriksson; Uwe Fuhr; Søren Holm; Stefan K. James; Robert J. Mentz; Emilio Perucca; Frits R. Rosendaal; Shaun Treweek

doi:10.1136/bmj.l1092

Low risk pragmatic trials do not always require participants’ informed consent

Rafael Dal-Re (Corresponding Author), Cristina Avendaño-Solà, Brigitte Bloechl-Daum, Anthonius de Boer, Stefan Eriksson, Uwe Fuhr, Søren Holm, Stefan K. James, Robert J. Mentz, Emilio Perucca, Frits R. Rosendaal, Shaun Treweek

Research output: Contribution to journal › Article

7 Citations (Scopus)

12 Downloads (Pure)

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-Ré and colleagues

Original language	English
Article number	1092
Number of pages	8
Journal	BMJ
Volume	364
DOIs	https://doi.org/10.1136/bmj.l1092
Publication status	Published - 27 Mar 2019

Keywords

CLINICAL-TRIALS

ASJC Scopus subject areas

Medicine(all)

Access to Document

10.1136/bmj.l1092Licence: Unspecified

Accepted Manuscript
© BMJ Publishing Group Ltd, 2019. This article has been accepted for publication in BMJ, 2019 following peer review, and the Version of Record can be accessed online at https://doi.org/10.1136/bmj.l1092.
Accepted author manuscript, 375 KBLicence: Unspecified

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Dal-Re, R., Avendaño-Solà, C., Bloechl-Daum, B., de Boer, A., Eriksson, S., Fuhr, U., Holm, S., James, S. K., Mentz, R. J., Perucca, E., Rosendaal, F. R., & Treweek, S. (2019). Low risk pragmatic trials do not always require participants’ informed consent. BMJ, 364, [1092]. https://doi.org/10.1136/bmj.l1092

Low risk pragmatic trials do not always require participants’ informed consent. / Dal-Re, Rafael (Corresponding Author); Avendaño-Solà, Cristina; Bloechl-Daum, Brigitte; de Boer, Anthonius; Eriksson, Stefan; Fuhr, Uwe; Holm, Søren; James, Stefan K.; Mentz, Robert J.; Perucca, Emilio; Rosendaal, Frits R.; Treweek, Shaun.

In: BMJ, Vol. 364, 1092, 27.03.2019.

Research output: Contribution to journal › Article

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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. ",

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