Prior to participating in medical research, people must sign a consent form. Article 29(1) of the CTR sets out the requirements for this informed consent.
On the Consent page you will find information about the persons authorized to give consent and how this should be done. All information provided to potential participants (or their legal representatives) prior to their decision to participate must be submitted together with the consent form.
In the Netherlands, templates have been developed for information for research participants and consent forms. For adults (participants aged 16 and older), the Information Sheet for Research Participants (IRP) has been available since June 1, 2026.
Template Information Sheet for research participants aged 16 years and older
Effective January 1, 2027, the use of this form will be mandatory in the Netherlands. Even now, it is strongly recommended that you use this information sheet. It speeds up the processing of research proposals. Furthermore, the IRP is written in accessible language, which makes it easier to provide information to potential participants. This English-language version of the consent form cannot be submitted in the Netherlands. Only the Dutch version (IVO) may be submitted.
The use of the standard Subject Information Sheet (SIF) will remain permitted until January 1, 2027. However, it is strongly recommended that you use the IRP (see above).
Participant Information Sheet templates for research participants <16 years of age (children)
Two templates (in Dutch) are available for medical research on participants under the age of 16.
- A simplified template for children up to the age of 12:
- A template participant information sheet for children between the ages of 12 and 16:
A manual (in Dutch) is available for both templates:
A description of procedures relating to informed consent for all participants (and their legally designated representatives, if applicable) shall be described in the protocol.
Language Participant Information Sheet
The reviewing committee (MREC or CCMO) only assesses the Dutch information sheet and consent form. Therefore, only the Dutch information sheet and consent form need to be submitted. However, every 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 participant information sheet must be available in a language that the person is proficient in. This also applies to ICF appendices or other documents that are used as part of the informed consent process. The study's sponsor is responsible for adequate information provision and a good translation.
Only in case of foreseen inclusion of participants not sufficiently proficient in the Dutch language, the translation certificate of the ICF must be submitted in CTIS with the first Substantial Modification on Part II.
For unexpected incidental cases, no translation certificate needs to be submitted. If there are modifications to the authorised Dutch-language ICF, it is not necessary to submit another translation certificate. No translation certificate is required either for recruitment material and other documents shown to participants.
In addition to providing adequate written information, the investigator must ensure in all situations that also oral information is provided (before and during the study) in a language that the participant is sufficiently proficient in and that the process is adequately documented in the patient’s dossier.