The Content of Subject Information and Consent Form
Recommendations for the Contents of the Study Subject Information and Informed Consent Form
It is recommended that the Study Subject Information addresses research subjects directly avoiding passive tenses. The information document should not exceed five pages (A4) and it should be written in layman’s terms using plain language as well as appropriate font size for ease of reading.
If consent is requested from a research subject’s representative the text should be adjusted accordingly. Information documents aimed at vulnerable subjects such as children or incapacitated adults must always be specifically tailored to the needs of the target group, bearing in mind that the language used is also understandable. A separate information leaflet can be made to provide further information, instructions, or guidance on any procedures performed as part of the trial.