To speed up the assessment process, you are strongly advised to use (one of) the information sheet 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.
For research involving adults (aged 16 and older), the use of the IRP (Information Sheet for Research Participants) will be mandatory as of 1 January 2027. Until that date, the SIS (Subject Information Sheet) may still be used. Using the IRP already speeds up the processing of research proposals.
Language Subject Information Sheet
The reviewing committee (MREC or CCMO) only assesses the Dutch information sheet and consent form. However, every research participant 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 participant is sufficiently proficient in.