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

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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

Bibliographical note

Acknowledgments
We thank Cristina Gómez 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’ 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.

Keywords

CLINICAL-TRIALS

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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

Cite this

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AU - Avendaño-Solà, Cristina

AU - Bloechl-Daum, Brigitte

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AU - Eriksson, Stefan

AU - Fuhr, Uwe

AU - Holm, Søren

AU - James, Stefan K.

AU - Mentz, Robert J.

AU - Perucca, Emilio

AU - Rosendaal, Frits R.

AU - Treweek, Shaun

N1 - Acknowledgments We thank Cristina Gómez 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’ 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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Low risk pragmatic trials do not always require participants’ informed consent

Abstract

Bibliographical note

Keywords

Access to Document

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