E1/E2. Subject information sheet and informed consent form research subjects
To speed up the assessment process of the Subject Information Sheet (SIS) and Informed Consent Form (ICF), you are strongly advised to use (one of) the templates for adults and/or children (in Dutch). These templates have been developed to assist investigators in compiling concise, clear information and prevent omission of essential parts when drafting the sheet.
Please note: The templates are updated regularly. At all times, use the most recent versions of the templates as available on this website.
Language Subject Information Sheet
The reviewing committee (MREC or CCMO) only assesses the Dutch information sheet and consent form. However, every test subject must be able to make well-informed decisions about participating in a study. If a person not sufficiently proficient in Dutch, is asked to participate in a study, the subject information sheet must be available in a language that the person is proficient in. As a standard, the study's sponsor is responsible for a good translation. The review committee does not require the translated subject information sheet; however the corresponding translation certificate must be submitted. If a person who is not proficient in Dutch, is asked to participate in research unexpectedly and incidentally, a translation certificate is not required. In addition to providing adequate written information, the investigator must also ensure that oralinformation is provided (before and during the study) in a language that the subject is sufficiently proficient in.