Norway CTIS Secondary-Use Consent Requirements

When separate broad consent is required

Mandatory when proposed. Submit a separate broad-consent form if the sponsor seeks to use identifiable data or biological samples for other or future research beyond the objectives of the applied clinical trial.

If samples will enter a general biobank in Norway, submit the consent already approved by REK for that general biobank. If samples will be transferred to a biobank abroad for storage and research beyond the trial, describe this in the biological-samples compliance document and obtain separate broad consent.

Do not label endpoint analyses, protocol-required safety testing or required archiving as optional future research. Keep the trial-use and future-use purposes distinct.

Required document set

Where future use is proposed, prepare:

• the Norwegian REK KULMU future-research information and broad-consent form, adapted to the project
• a separate consent choice that can be refused without affecting main-study participation
• the English Part II compliance document for biological samples, where material is involved
• the GDPR compliance statement and participant privacy information covering the relevant controllers and processing
• the general biobank's REK-approved consent if material will be included in a Norwegian general biobank

The blank consent is submitted in CTIS. The participant and the person conducting the consent interview sign and date it when broad consent is obtained.

What the future-use form should explain

Describe the research field or scope in terms a participant can understand. Avoid language so broad that the person cannot tell what they are accepting.

Explain:

• whether the consent covers data, biological material or both
• the types and sources of data and samples
• the types of future research and any important exclusions
• whether genetic or genomic analysis is possible
• the responsible organization and biobank, where relevant
• storage locations and duration
• sharing with academic, public or commercial researchers
• transfers outside Norway or the European Economic Area
• coding, security and re-identification controls
• whether participants will receive individual findings
• withdrawal procedures and the limits once material or data have been anonymized or used

If the future project later falls outside the approved scope, do not rely on the original broad consent without a new ethics and legal assessment.

Biological material in Norway and abroad

For samples linked to the clinical trial endpoints, Norway expects storage to end when analyses and the active research period are complete. If material is also retained for future use, declare that separate purpose in the Part II biological-samples document.

All use of material placed in a Norwegian general biobank must be approved by REK. For storage abroad beyond the study, state the destination, future-use purpose and applicable safeguards. REK KULMU expressly links this pathway to section 14 of the Norwegian Health Research Act and GDPR-equivalent privacy requirements.

Withdrawal and independence from the main trial

The participant must be able to refuse or withdraw future-use consent without losing access to the clinical trial or ordinary care. Use separate initials, tick boxes or signature logic so the optional choice is unmistakable.

Explain what can still be done with information or material already used in completed analyses. Avoid promising retrieval or destruction after irreversible anonymization. Keep the explanation consistent with the biobank's withdrawal process and the controller's data-protection notice.

Minors and changing capacity

REK KULMU states that minors should not generally be included in future research and assesses this case by case. From age 16, a minor may give broad consent without guardian consent where participation does not involve bodily intervention.

For younger children or participants lacking capacity, do not assume that main-trial representative consent automatically authorizes future research. Define any representative pathway, participant information, dissent and re-consent as capacity or age changes. The Norway minor consent guide explains the age-specific rule.

Use the Norway patient-facing document QC checklist before submission. Return to the Norway CTIS hub for all guides.