1. Low risk pragmatic trials do not always require participants' informed consent.
- Author
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Dal-Ré R, Avendaño-Solà C, Bloechl-Daum B, de Boer A, Eriksson S, Fuhr U, Holm S, James SK, Mentz RJ, Perucca E, Rosendaal FR, and Treweek S
- Subjects
- Canada, European Union, Humans, Informed Consent ethics, Pragmatic Clinical Trials as Topic ethics, Randomized Controlled Trials as Topic ethics, Risk Factors, United States, Informed Consent legislation & jurisprudence, Pragmatic Clinical Trials as Topic legislation & jurisprudence, Randomized Controlled Trials as Topic legislation & jurisprudence
- Abstract
Competing Interests: 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.
- Published
- 2019
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