E1/E2. Information leaflet and consent form research subjects
To speed up the reviewing process, you are strongly advised to use the Template Subject Information (including Subject Consent Forms) (in Dutch). This template will help investigators to write in a clear and concise manner and prevents that investigators will overlook essential parts of the information when writing the leaflet. The use of the text of paragraph 10 of the template is mandatory. An English translation of the template is available.
The template is in line with the General Data Protection Regulation (GDPR) that will become effective on May 25, 2018. See the explanation (only in Dutch).
The Template Subject Information is a product of the DCRF-working group Study subjects. It is supported by the CCMO, NVMETC, NFU, STZ, Association Innovative Medicines, Acron and the department research professionals of the V&VN. Patient organizations also participated in the development of the Template.
When needed, you can use the checklist research subject information (Dutch). There may also be additional instructional documents. Ask the MREC to where the research is being submitted for review for further information.
You are advised to provide the research subjects and patients and/or their parents or representatives with the General brochure for research subjects (also available in Dutch). This brochure can also be ordered free of charge via email@example.com.