Norway Limited-Capacity Participant and Legal Representative Consent Requirements

When the pathway may be used

Conditional. Use this pathway only where the participant lacks capacity for the decision and the protocol includes incapacitated adults in compliance with Article 31 of the Clinical Trials Regulation. Do not use representative consent merely because communication is difficult or because a relative is present.

The trial must be essential for incapacitated participants and comparable data must not be obtainable from people able to consent or by other methods. Article 31 also limits permissible risk and burden and requires either a prospect of direct benefit outweighing risk and burden or the tightly limited group-benefit pathway in the Regulation.

Required Norwegian documents

Prepare:

• a Norwegian information and consent form addressed to the legally designated representative
• a Norwegian participant information or assent form adapted to the participant's comprehension
• a documented capacity-assessment and re-consent process in the protocol or consent procedure
• any standard recruitment materials in Norwegian

REK KULMU does not list a separate national limited-capacity template. Adapt the current Norwegian CTR template and make the consent-giver, participant and signature roles explicit.

Legal representative and consent logic

Identify the legally designated representative under the law applicable in Norway and document how the site confirms that authority. Do not assume that the nearest relative or an accompanying person automatically has authority to consent to research.

The representative receives the information required by CTR Article 29 and signs for the participant only within the scope of that authority. The person conducting the consent interview also signs. The blank version submitted in CTIS is not signed.

The representative should make the decision in the participant's interests and should take known wishes and values into account. Explain that the representative may refuse or withdraw consent without disadvantage to the participant.

Participant information, assent and dissent

Give the participant information in a form suited to their ability, using short text, conversation, images or another accessible method where appropriate. Involve the participant in the consent process as far as possible.

The investigator must respect an explicit wish to refuse participation or withdraw from a participant who can form an opinion and assess the relevant information. Representative consent does not override that dissent.

No incentives or financial inducements may be offered to the participant or representative beyond compensation for participation-related expenses and loss of earnings.

Capacity changes during the trial

Mandatory when capacity returns. Obtain the participant's own informed consent as soon as the person becomes able to consent. Do this before relying on the representative's consent for continued participation.

If capacity fluctuates, define how the investigator assesses it for the relevant decision, how changes are documented and when information or consent is repeated. New information that could affect willingness to continue may also require re-consent using an approved version.

Submission and conduct checks

In CTIS, submit blank Norwegian participant and representative documents with distinct titles, versions and dates. The recruitment and informed consent procedure should explain capacity assessment, representative verification, information delivery, dissent and re-consent.

Use the Norway patient-facing document QC checklist before submission. If incapacity arises in a sudden emergency and prior representative consent cannot be obtained within the treatment window, use the separate Norway emergency enrollment guide. Return to the Norway CTIS hub for all guides.