Table 2.

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

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”	−	√	√	√	√	√	√	√	√	√	+	−	√	−	−	−	−

√In general, briefly mentioned; + in detail; − not found