Questions and answers on the template IRP

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. 

The complete IRP - that is, the explanation of the study and the signed consent form - is considered to be the source document and must be included and retained in the investigator site file (ISF)/trial master file (TMF).

Please note: The checkboxes and text fields for questions at the end of each section are an integral part of the informed consent form, even if they are empty. By including checkmarks and questions, participants' questions are documented, together with the way they are dealt with during the informed consent discussion. If no checkmarks have been placed or questions noted, this indicates that there were no questions.

The following is recorded in the EPD or in another digital participant database:
-    The research participant had no questions; or
-    The research participant had questions that were properly addressed (including how these questions were answered and by whom) before consent was documented.

The checkboxes with the text fields below them at the end of each section are intended for noting questions. The prospective participant can check a box and/or ask a question in the field below it. These questions must be discussed with the study participant.

The following is recorded in the EPD or another digital participant database:
-    The research participant had no questions; or
-    The research participant had questions that were properly addressed (how these questions were answered, and by whom) before consent was documented.

Both checkboxes and text fields (even if they are empty) are considered an integral part of the IRP. The complete IRP - that is, the explanation of the study and the signed consent form - serves as the source document and must be included and retained in the investigator site file (ISF) or trial master file (TMF). By including checkmarks and questions, it is documented which questions the participant had and that these were answered during the informed consent process. If no checkmarks were placed or questions were noted, this indicates that there were no questions.

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.