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” | − | √ | √ | √ | √ | √ | √ | √ | √ | √ | + | − | √ | − | − | − | − |