Finland Limited-Capacity Participant and Legal Representative Consent Requirements

This is a variation of the main consent set

Use the Finland Patient Information and Consent Requirements guide for the shared trial, privacy, insurance and signature content. Modify the language and decision pathway rather than merely replacing the participant signature with a representative signature.

Conditional. Use this variation only after a documented assessment shows that the adult cannot understand enough to consent independently. Diagnosis, disability or residence in care does not by itself prove incapacity.

Who is the legally designated representative in Finland

Finnish law identifies the person's legal representative as the first option. If there is no legal representative, a close family member or another person close to the participant may give informed consent.

The submission should explain how the site will identify the correct person and document the relationship. The representative must act for the participant and receive the information needed to decide. A convenient companion is not automatically the representative.

Required documents

Prepare:

• a representative Participant Information Sheet
• a representative Informed Consent Form
• an adapted participant information sheet suitable for the person's capacity
• a participant assent or acknowledgement form when the person can meaningfully express a view and the protocol uses written documentation
• the Finnish and/or Swedish Recruitment and Informed Consent Procedure describing capacity assessment, representative selection, participant involvement, dissent and later re-consent

Tukija advises separate documents for representatives and for groups recruited because of cognitive ability. An easy-language version may be appropriate.

Information and consent process

The representative receives the Article 29 information and enough time to consider participation. A qualified member of the study team conducts the prior interview, answers questions and documents consent.

Give the participant information in a form the person can understand. This may require shorter text, easy language, pictures or supported discussion. Participation in the conversation should be real, even when the representative provides the legal consent.

The trial must meet the protection criteria in Article 31. It must be essential for the population, relate directly to the participant's condition and satisfy the applicable benefit, minimal-risk and minimal-burden conditions. Do not use representative consent to bypass those scientific and ethical requirements.

Objection and dissent

The explicit wish of a participant who can form an opinion and evaluate the information to refuse or withdraw must be respected at any time. A representative cannot override that refusal.

Describe how staff will recognise verbal, behavioural or supported-communication dissent. Separate a temporary reaction to a procedure from a clear wish to leave the trial, then prioritise safety and the person's expressed preferences.

Signatures and later capacity changes

At consent, the representative and the qualified person receiving consent sign and date the approved form. If the participant signs an assent or acknowledgement document, it supplements rather than replaces representative consent. Archive the original and provide a copy to the representative and, in an accessible form, to the participant.

If the participant later becomes able to give informed consent, obtain the participant's own consent before continued participation. The protocol and Part II procedure should define who reassesses capacity, when reassessment occurs and how previously collected data are handled if the participant declines.

If a participant who previously had capacity has already given or refused consent before losing capacity, evaluate that prior decision under Article 31 and the protocol. Do not assume a representative can reverse a documented refusal.

For emergency situations where prior representative consent is impossible within the therapeutic window, use the separate Finland emergency enrollment guide. For a participant who can consent but cannot write, use the Finland impartial witness guide.

Run the final set through the Finland patient-facing document QC checklist and return to the Finland CTIS hub for the complete series.