Sweden CTIS Part II Limited-Capacity and Legal Representative Consent Requirements

When the pathway can be used

Conditional. Use this pathway only when the participant cannot give valid informed consent and the trial satisfies Article 31.

The trial must be essential for the incapacitated population and directly related to the participant's medical condition. Comparable data must not be obtainable from participants able to consent or by other research methods. The expected benefit and risk conditions in Article 31 must also be met.

Required participant and representative documents

Prepare a Swedish information and consent form for the legally designated representative. Also prepare information for the participant that is adapted to the person's ability to understand.

The participant must be involved in the consent process as far as possible. A representative's signature does not remove the obligation to explain the trial to the participant at an appropriate level.

No separate national LAR form was identified in the official Swedish sources reviewed. Adapt the main Swedish participant information and consent set to the legal representative pathway and identify the representative's capacity clearly.

Consent and signature logic

The legally designated representative provides the formal consent on behalf of the participant. The person providing the information also signs and dates the consent under the normal Article 29 procedure.

The Swedish professional-role rule for obtaining consent still applies. The normal consent interviewer is a licensed physician or licensed dentist unless Läkemedelsverket permits another healthcare professional for special reasons.

The CTIS submission contains the blank Swedish forms. The representative signs when consent is obtained.

Objection and dissent

The participant's own wishes remain decisive in one important respect. If an incapacitated participant can form an opinion and assess the information, an explicit wish to refuse participation or to withdraw must be respected by the investigator.

Do not draft the representative form to imply that the representative can override a participant's explicit refusal.

Compensation

Article 31 does not permit incentives or financial inducements to the incapacitated participant or representative. Compensation for expenses and loss of earnings directly related to participation is permitted.

The participant-facing wording must match the Part II compensation arrangements.

If capacity changes during the trial

The approved consent procedure should explain how capacity is reassessed when the underlying condition may change. If the participant becomes able to make an informed decision, the site should move to direct participant involvement and document consent according to the approved protocol and applicable Article 29 process.

The verified Swedish sources reviewed for this guide do not prescribe a separate national re-consent form for recovery of capacity. Avoid inventing one. Define the transition in the protocol and participant documents in a way that allows the participant to make their own decision as soon as they are able.

Return to the Sweden CTIS Part II hub and use the patient-facing QC checklist before submission.