Below you will find questions and answers about the Information Sheet for Research Participants (IRP, Dutch: IVO) aged 16 and older.
General
As of January 1, 2027, the use of the IRP (Dutch: IVO) will be mandatory in the Netherlands. Until that date, the SIS (Subject Information Sheet; Dutch: PIF) may still be submitted. It is preferable to start using the IRP now. It is written in plain language, which makes it easier to inform prospective research participants. Using the IRP also speeds up the processing of the submission.
If the SIS has been used for ongoing research, it is not necessary to replace the consent form with the IRP. When submitting substantial amendments for ongoing research, such a replacement is not necessary either.
Yes, provided that the instructions accompanying the document are strictly followed.
If the SIS has been used for ongoing research, it is not necessary to replace the consent form with the IRP. When submitting substantial amendments for ongoing research, such a replacement is not required either.
The IRP, including the general terms and conditions, may contain a maximum of 4,000 words. For complex studies, this maximum may be exceeded. The reason for exceeding the limit must be explained in the cover letter to the reviewing MREC. The MREC will assess whether the excess is acceptable.
Appendix E
If a child turns 16 during ongoing research, nothing changes, because the child has already given consent. Read more about Consent in research involving participants under 16 years of age. No additional section needs to be added to the IRP regarding re-signing.