Ethics Committee Submission and Informed Consent Form

For industry sponsored trials, the sponsor will usually contribute with submission text as well as the subject information/informed consent form. Please note, however, that the quality of the sponsor's contribution may vary widely. Companies that have operations in Norway and are well acquainted with national routines usually deliver good quality texts in Norwegian, so that the NC only needs to ensure the quality of the information. In other cases, the sponsor may provide English master documents, often long and complicated, which must be translated and adapted to the Norwegian application portal and consent form templates.

As a rule, the REK application and subject information/informed consent form should be written in Norwegian. Attachments other than consent forms may be submitted in the original language, if this is English or a Scandinavian language. Some companies may want the Norwegian consent back-translated into English if the changes from their original text are extensive.

It is important to clarify in advance the expected workload for the NC in connection with the preparation of applications and consent forms, in order for this to be included in the budget negotiations.

Be sure to use the correct template for the consent forms, there are dedicated templates for clinical trials.