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Table 2 Templates’ overview. Summary of the main characteristics of the patient information sheets

From: The CORBEL matrix on informed consent in clinical studies: a multidisciplinary approach of Research Infrastructures Building Enduring Life-science Services

Source Topics Layout Phrases, examples Information process
General Information Introduction Description of the study Study Participation Benefits and risks Other therapies Insurance Confidentiality Data sharing Economic aspects Specific targets, settings Example of C.I. form Language level Length Suggested Structured
European clinical research infrastructures network ECRIN  −   +   − 
Health Research Authority (UK) template and guidance  +   +   +   +   +   +   +   +   +   +   +   −   + 
Agency for Healthcare Research and Quality (UK) toolkit: information and questions to assess consent  −   +   −   +   +   −   + 
The Central Committee on Research Involving Human Subjects (Netherlands)  +   +   +   +   +     +   − 
World Health Organization Informed consent form template for clinical studies  +   −   − 
National Cancer Institute (USA) “Questions to ask your doctor about treatment clinical trials”  −   +   +   +     −   −   −   −   −   − 
Clinical Trials Transformation Initiative  −   +   +   +   +   +   −   −   −   −   + 
Regional committees for medical and health research ethics (Norway)  +   −   +   −   − 
European commission—“Ethical review in FP7”  −   +   −   −   −   −   − 
  1. √In general, briefly mentioned; + in detail; − not found