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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26 Citations (Scopus)
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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 languageEnglish
Article number1092
Number of pages8
JournalBMJ
Volume364
DOIs
Publication statusPublished - 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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