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

Affiliations

• 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.