Template Subject Information Sheet 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 is obligatory for both structure and (most of the) wording The template is the standard of assessment by the review committee (MREC or CCMO) of the submitted subject information sheet.

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. Als u niet wilt meedoen of wilt stoppen met het onderzoek (if you do not want to participate or would like to stop participating in the study);
  • 9. Einde van het onderzoek (end of the study);
  • 10. Gebruik en bewaren van uw gegevens [en lichaamsmateriaal] (use and storage (body material);
  • 11. Verzekering voor proefpersonen (insurance for subjects);
  • 12. Informeren [huisarts en/of behandelend specialist en/of apotheker] (informing general practitioner and or/ treating specialist and/or pharmacist
  • 13. [Geen] Vergoeding voor meedoen ([no] compensation for participation);
  • 14. Heeft u vragen? (do you have any questions);
  • Bijlage [Z] Toestemmingsformulier (consent form subject).

For the other (study-specific) components (see below), 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).

  • 2. Doel van het onderzoek (purpose of the study);
  • 3. Achtergrond van het onderzoek (background of the study);
  • 4. Wat meedoen inhoudt (what participation involves);
  • 5. Wat wordt er van u verwacht (what will be expected of you);
  • 6. Mogelijke [bijwerkingen/complicaties en andere/ nadelige effecten/ ongemakken] (possible side-effects/ complications and other adverse/ effects discomforts).;
  • 7. Mogelijke voor- en nadelen (Possible advantages and disadvantages).

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

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.