Revised version of model PIF published

Revised version of model PIF published
An updated version of the model for subject information (PIF) has been published by the CCMO. The changes must be implemented in new applications from 1 September 2025 onwards. For ongoing research, it is up to the sponsor to assess whether it is needed to update the information letter. These changes are then considered non-substantial.

In brief, the changes are as follows:
- The term “subject” has been replaced by “participant”.
- In paragraph 10 and in the consent form, the legal basis “consent” has been removed.
- A ground for exclusion has been removed from Appendix B: “Damage caused by an existing treatment method. Or by research into an existing treatment method”.

For the time being, the new model is referred to as the “Model information letter for research participants” and is available in two versions: for adults (participants aged 16 and over) and for children (participants aged 12 to 16).

For more information, see the CCMO announcement: Revised version of PIF template published | News item | The Central Committee on Research Involving Human Subjects