Subject information, informed consent and informed consent procedure
All information given to the subjects (or, where applicable, to their legally designated representatives) before their decision to participate or abstain from participation shall be submitted together with the form for written informed consent, or other alternative means according to Article 29(1) CTR for recording informed consent.
In the Netherlands, several templates for the subject information sheet and informed consent form have been developed. Sponsors and/or investigators are strongly advised to use these templates. The CCMO and MREC will use this model as basis for their review. Only the Dutch version of the subject information sheet and informed consent form should be submitted in CTIS.
Subject Information Sheet template for research subjects > 16 years of age (adults)
The template Subject Information Sheet (including informed consent forms and the insurance text template) for research subjects aged 16 and over (adults) is not non-binding. This means that this template is used as a criterion in the assessment by the review committee of the information sheet submitted. This concerns both the structure and the wording of the information sheet.
An English translation of the template is at your disposal, but can be used for information purposes only.
Subject Information Sheet templates for research subjects <16 years of age (children)
Two templates (in Dutch) are available for medical research on subjects under the age of 16:
- A simplified template for children up to the age of 12.
- A template subject 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 subjects (and their legally designated representatives, if applicable) shall be described in the protocol.