E1/E2b. Template Subject Information Sheet for research subjects > 16 years of age (adults)

Non-study-specific components

For non-study-specific components, deviations in the subject information sheet are not accepted without adequate justifications. These consist of the following components:

• Inleiding (Introduction)
• 1. Algemene informatie (General information)
• 8. Wanneer stopt het onderzoek? (When does the study stop?)
• 9. Wat gebeurt er na het onderzoek? (What happens after the study?)
• 10. Wat doen we met uw gegevens [en lichaamsmateriaal]? (What do we do with your data [and body material]?)
• 11. Krijgt u een vergoeding als u meedoet aan het onderzoek? (Will you receive compensation if you participate in the study?)
• 12. Bent u verzekerd tijdens het onderzoek? (Are you insured during the study?)
• 13. We informeren uw [huisarts en/of behandelend specialist en/of apotheker] (We will inform your [general practitioner and/or treating specialist and/or pharmacist])
• 14. Heeft u vragen? (Do you have any questions?)
• 15. Hoe geeft u toestemming voor het onderzoek? (How do you consent to the study?)

Study-specific components

For the other (study-specific) components, the recommendations in the template for conciseness (focus on relevant information for the subject on the decision to participate) and appropriate language use (avoidance of medical jargon) play an important role in the assessment by the review committee (MREC or CCMO). These consist of the following components:

• 2. Wat is het doel van het onderzoek? (What is the purpose of the study?)
• 3. Wat is de achtergrond van het onderzoek? (What is the background of the study?)
• 4. Hoe verloopt het onderzoek? (How does the study proceed?)
• 5. Welke afspraken maken we met u? (What arrangements will we make with you?)
• 6. Van welke bijwerkingen, nadelige effecten en ongemakken kunt u last krijgen? (What side effects, adverse effects and discomforts may you experience?)
• 7. Wat zijn de voordelen en de nadelen als u meedoet aan het onderzoek? (What are the advantages and disadvantages of taking part in the study?)

General Data Protection Regulation

The template is in line with the rules of the General Data Protection Regulation (GDPR). See the questions and answers (Q&A).

Sample information sheet

To help investigators write a short and clear information sheet, a sample information sheet for subjects 16 years of age and older (adults) is available. This example is intended to give you an idea of what an information letter should look like in terms of language and length.

Please note: This example does not comply with the current template subject information sheet. An updated version will be available as soon as possible.

English translation

An English translation of the template is at your disposal, but can be used for information purposes only. A Dutch version has to be submitted to the review committee.

Product of DCRF

The Template Subject Information Sheet is a product of the DCRF working group Study subjects and the result of a careful consideration process. The template is supported by the CCMO, NVMETC, NFU, STZ, Association Innovative Medicines, Acron and the department research professionals of the V&VN. Patient organisations also participated in the development of the template.