Revised version of PIF template published
Today a revised version of the PIF template, the template subject information sheet (SIS), was published. This document is only available in Dutch, since the reviewing committees only assess the Dutch information sheet and consent form.
From 1 September 2025 you are required to implement the changes described below when submitting new dossiers. For ongoing studies it is up to the sponsor to assess whether it is useful to adjust the information letter. These amendments will then be considered non-substantial.
Subject is now participant
There are two PIF-versions, one for children between the ages of 12 and 16 and one for participants aged 16 years or older. In the document, the term ‘proefpersoon’ (‘subject’) has been replaced by ‘onderzoeksdeelnemer’ (‘participant’). This term, being more neutral, is considered more appropriate and emphasizes the active role of the person participating in research. This amendment is in line with the revision of the ICH GCP E6 guideline.
A project aiming to enhance the accessibility of the PIF is currently underway. Pending the results of this project, the Template subject information sheet (Proefpersoneninformatieformulier) is provisionally referred to as the Template information letter for participants (Model informatiebrief voor onderzoeksdeelnemers).
Amendment regarding sharing data
A second amendment relates to sharing data with countries outside the EEA. In section 10 (paragraph ‘We sturen gegevens naar landen buiten de EU’ - 'We send data to countries outside EU') and in the consent form, the legal basis ‘consent’ has been removed.
Although health data may be shared if participants have given their consent, from a legal perspective informed consent only exists if participants have been fully informed about the actual risks. In practice, these risks can hardly be defined in general terms. Firstly, they vary for each country, secondly, the actual risks cannot always be ascertained.
Furthermore, sharing data on the basis of consent is only possible in the case of incidental and limited data transfers. For further explanation, refer to this EPPD guideline.
Ground for exclusion removed
Finally, a ground for exclusion has been removed from Annex B. This concerns ‘Schade door een behandelmethode die al bestaat. Of door een onderzoek naar een behandelmethode die al bestaat’ - ‘Damage caused by an existing treatment method. Or by research into an existing treatment method’.