As of 1 Juni 2026 a new version of the Information Sheet for Research Participants, IRP, has become available. The template is more concise than the former Subject Information Sheet (SIS, in Dutch PIF) and written in comprehensible language. As of 1 January 2027, this template will become mandatory for all clinical research involving people aged 16 and older.
Until 1 January 2027, an information sheet based on the SIS template can still be submitted. For children aged 12 to 16, only the SIS template is currently available. For children under 12, there is a simplified template.
Using the IRP offers advantages over the SIS in terms of comprehensibility for research participants and is therefore strongly recommended. The template complies with legal and regulatory requirements, including the General Data Protection Regulation (GDPR). Using the IRP expedites the processing of research proposals.
Instructions for drafting the information letter and the explanations regarding the required information are included with the template. It is key that these instructions are strictly followed. General information applicable to every study is provided separately on this website: General information on taking part in research (IRP).
Consultation period
This template was developed by IKNL and Pharos on behalf of CCMO, in collaboration with and in consultation with all relevant stakeholders: research participants, language ambassadors (from the ABC Foundation), researchers and their support staff, sponsors, grant providers, and evaluators.
The period from 1 Juni 1 through 1 November 2026 will be used to collect any comments or suggestions for improving the IRP. Suggestions for changes to or additions to the IRP may be submitted via e-mail: ccmo@ccmo.nl. Please include “Information Sheet for Research Participants (IRP)” in the subject line.