Dal-Re, RafaelAvendaño-Solà, CristinaBloechl-Daum, Brigittede Boer, AnthoniusEriksson, StefanFuhr, UweHolm, SørenJames, Stefan K.Mentz, Robert J.Perucca, EmilioRosendaal, Frits R.Treweek, Shaun2019-03-282019-03-282019-03-27Dal-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, vol. 364, 1092. https://doi.org/10.1136/bmj.l10920959-8146Mendeley: 9c0c1533-23ca-3a0e-a663-320c2e89f744ORCID: /0000-0002-7239-7241/work/186968400http://hdl.handle.net/2164/12090Acknowledgments 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.8384203engCLINICAL-TRIALSR Medicine (General)General MedicineR1Journal article10.1136/bmj.l1092http://www.scopus.com/inward/record.url?scp=85063604396&partnerID=8YFLogxKhttp://www.mendeley.com/research/low-risk-pragmatic-trials-not-always-require-participants-informed-consent364