General recommendations
- Use the wording suggested in the REK templates for information documents and consent forms.
- Avoid repetitions of the same information in multiple places within the document.
- Check the language for clarity, grammar, and word breaks.
- Legal basis for the processing of data: The requirement is to inform participants about their rights related to the collected data, but not to consent to data processing. The institution’s and sponsor’s processing basis is regulated by the General Data Protection Regulation (GDPR). Ref. Art. 6, para. 1, letter e; archival purposes in the public interest, purposes related to scientific or historical research, or statistical purposes.
- Additional Requirements for Minors and Future Research (CTR Article 32, MDR Article 65, and IVDR Article 61):
- Children up to 15 years old should receive age-appropriate information documents. For younger children (e.g., under 12 years), several versions may be necessary. The child may sign to express their willingness to participate, but this is not a requirement.
- Youth 16–18: Participants must provide their own consent in a separate form, in addition to parental consent. If participants are included before the age of 16, consent must be re-obtained when they turn 16.
- Future research (broad consent): Participants aged 16 and older can provide their own consent when the study does not involve medical procedures. However, minors are generally excluded from future research studies. Each case will be evaluated individually by the ethics committee.
- A separate information document is required when samples are collected for future use, beyond the main study.
- Tip: Instead of «Invitasjon til deltakelse ..» benyttes «Forespørsel om deltakelse».
Recommendations per section in the REK template for Informed Consent Form according to Clinical Trials Regulation (CTR)
What data is collected about you and what happens to your data
- Information about where the data will be stored
- Information about what the data will be used for and how long it will be stored (at least 25 years after the study ends)
What samples will be collected from you and what happens to your samples
- Biological samples: Information about which country or countries the biological samples will be sent to for analysis and storage
- Information about what the material will be analyzed for and when it will be destroyed
Insurance
- Explain which law(s) apply to research: "You are insured by the Drug Liability Association through the Product Liability Act, and the Patient Injury Act.”
Consent
- Signature of guardians: One or both parents must consent if health information about the child is to be collected. Therefore, space must be provided for both parents to sign.
- Signature of legal guardian: This only applies in exceptional cases where the research involves individuals who are not legally competent to consent. If only legally competent individuals are included, the field for a guardian’s signature should be removed.
- Checkboxes are not ideal and should only be used if the study participant wants feedback on genetic findings. If there is a need to confirm what the participant is consenting to, it should be indicated with a separate signature line.
The article was translated from Norwegian to English using ChatGPT and edited by Signe Fretland.
Last updated 3/12/2025