Informed consent. The document must be in Norwegian or other languages that potential study participants understand. It is recommended to use REK’s template for informed consent for drug trials under CTR (in Norwegian only), which is available at rekportalen.no.
- The information in the informed consent must be adapted to the person from whom consent is to be obtained from, e.g., prepare and adapt the informed consent if the legal representative is to give consent on behalf of the study participant. Use a comprehensible language, please see Språkrådets website for further guidance.
- The informed consent must clearly state the expected date for “end of clinical trial”, i.e., the last patient visit or the date defined and justified as the end of study in the protocol, the expected date/year when all research-related activity within the clinical trial is assumed to have ended (including publication), as well as the expected date/year for when the data must be deleted (at least 25 years after “end of clinical trial”). The dates must be related to a realistic period in order to meet the trial’s endpoints as defined and justified in the protocol.
- The informed consent must also clearly state what kind of biological material is to be collected, how it will be analysed, and for how long time the samples will be stored. It must be stated whether the material is to be stored in a study-specific research biobank, where it is located and who is responsible for the biobank.
- If samples are to be sent out of the country for analyses to answer the trial’s endpoints or stored in a biobank abroad, it must be stated to which country and for how long the samples are to be stored there. It must be stated whether the material is to be destroyed or returned after the research active period, as well as the date/year for when the samples and any residual material will be destroyed.
- The informed consent must also contain information about any conflicts of interest/bindings for those who are responsible for the study.
- If biological material or personal health data is to be included in other and/or future research beyond the study, this can be briefly described in the main informed consent, but it must be stated that participation in other and/or future research is voluntary and not a condition to participate in the main trial. Consent must be given for such use, and detailed information about what is to be collected, and the purpose of the collection must be provided in a separate broad informed consent and not in the main informed consent. Such use must be linked to specific, broadly defined research purposes. In order to obtain consent for the collection of biological material to be included in a Norwegian general biobank, the REK-approved general biobank’s informed consent must be used. For more information, please see the section below regarding broad consent.
- For enrolment of minors, please see section INCLUSION OF MINORS IN RESEARCH.
For your information, NorTrials offers a review of the Information Consent Form(s) prior to submission to CTIS. Please note that REK KULMU is not involved in this service. The sponsor is responsible for content of submitted Information Consent Form(s).
