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BMJ. 2019 Mar 27;364:l1092. doi: 10.1136/bmj.l1092.

Low risk pragmatic trials do not always require participants' informed consent.

Author information

1
Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Avda Reyes Católicos 2, E-28040 Madrid, Spain.
2
Clinical Pharmacology Service, Puerta de Hierro University Hospital, Majadahonda, Madrid, Spain.
3
Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.
4
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, Netherlands.
5
Centre for Research Ethics and Bioethics, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.
6
Universityof Cologne Faculty of Medicine and University Hospital Cologne Centre of Pharmacology,Department I of Pharmacology, Clinical Pharmacology Unit, Cologne, Germany.
7
Centre for Social Ethics and Policy, School of Law, University of Manchester, Manchester, UK.
8
Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
9
Department of Medicine, Duke University Medical Centre and Clinical Research Institute, Durham, NC, USA.
10
Department of Internal Medicine, University of Pavia, Pavia, Italy.
11
Department of Clinical Epidemiology C7-P, Leiden University Medical Center, Leiden, The Netherlands.
12
Health Services Research Unit, University of Aberdeen, Aberdeen , UK.

Erratum in

PMID:
30917969
DOI:
10.1136/bmj.l1092
[Indexed for MEDLINE]

Conflict of interest statement

Competing interests: We have read and understood BMJ policy on declaration of interests and declare the following: SKJ reports grants and personal fees from AstraZeneca, Bayer, Boston Scientific, and Abbott; and grants from Jansen and Ted Med Co, outside the submitted work. RJM reports grants and personal fees from Amgen, Novartis, Merck, and Luitpold; grants from AstraZeneca, GSK, and Bayer; and personal fees from Boehringer Ingelheim during the conduct of the study. EP reports personal fees from UCB Pharma, Eisai Inc, GW Pharma, Mylan, Livanova, Sun Pharma, Sanofi, Takeda, and Medichem; and other from Wiley and Elsevier, outside the submitted work. The Health Services Research Unit, University of Aberdeen, receives core funding from the chief scientist office of the Scottish Government Health Directorates. FRR is a recipient of the NOW Spinoza award.

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