E1/E2a. Template Subject Information Sheet 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:
The templates provide researchers with tools and examples to create comprehensible information for children, including images specially developed for this purpose.
English translation
English translations of the templates are at your disposal, but can be used for information purposes only. A Dutch version has to be submitted to the review committee.
Developed by DCRF
The templates for research subjects under the age of 16 were developed by the Dutch Clinical Research Foundation (DCRF) in collaboration with children and their parents. Research nurses, researchers, lawyers, MRECs and the CCMO have also been involved in the development of these templates.