E1/E2. Information leaflet and consent form research subjects
Template Subject Information
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. An English translation of the template is available.
The Template Subject Information has no non-committal character. This means that this template is used as a criterion for the review by the review committee (MREC or CCMO) of the submitted information letter. This concerns both the structure and the wording in the information letter.
For non-study-specific components, deviations in the submitted information letter are not accepted without adequate justifications. These are the following components:
- 1. Algemene informatie;
- 8. Als u niet wilt meedoen of wilt stoppen met het onderzoek;
- 9. Einde van het onderzoek;
- 10. Gebruik en bewaren van uw gegevens [en lichaamsmateriaal];
- 11. Verzekering voor proefpersonen;
- 12. Informeren [huisarts en/of behandelend specialist en/of apotheker];
- 13. [Geen] Vergoeding voor meedoen;
- 14. Heeft u vragen?;
- Bijlage [Z] Toestemmingsformulier.
For the other (study-specific) components, the recommendations in the template for conciseness (focus on relevant information for the subject for the decision to participate) and appropriate language use (avoidance of medical jargon) play an important role in the review by the review committee (MREC or CCMO). These are the following components:
- 2. Doel van het onderzoek;
- 3. Achtergrond van het onderzoek;
- 4. Wat meedoen inhoudt;
- 5. Wat wordt er van u verwacht;
- 6. Mogelijke [bijwerkingen/complicaties en andere/ nadelige effecten/ ongemakken];
- 7. Mogelijke voor- en nadelen.
The template is in line with the General Data Protection Regulation (GDPR). See the questions and answers.
The Template Subject Information 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 organizations also participated in the development of the Template.
Examples of subject information letters
Two example information letters are available for inspiration to help investigators write a short and clear information letter: one for a study with mesenchymal stromal cells in patients with colitis ulcerosa and one for a study on a malaria vaccine in healthy volunteers. These examples are available to get an idea of what an information letter should look like in terms of language use and length. Both examples are written in accordance with the Template Subject Information.
Increasing the readability of the information letter deserves continuous attention. As part of this improvement process, one of the example letters was further simplified to language level B1 at the request of the CCMO by an external party. This simplified example is not written in accordance with the current Template Subject Information, but can help to further improve the template in the future.
General brochure for research subjects
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.