Germany CTIS Limited-Capacity Participant and Legal Representative Consent Requirements

When this pathway applies

Use this document set when an adult lacks trial-specific consent capacity because of a permanent, progressive, fluctuating, or temporary condition and the emergency exception is not being used.

Capacity is decision-specific. A diagnosis, disability, guardianship order, or clinical severity does not by itself prove incapacity. The K1 procedure should state who assesses capacity, the criteria used, how fluctuations are handled, and when reassessment occurs.

Conditions for including adults without capacity

Mandatory. The trial must satisfy Article 31. This includes representative consent, adapted information, respect for refusal, no improper incentives, and a scientific reason why the research cannot be carried out with capable participants or by another method.

The trial must either offer a justified prospect of direct benefit that outweighs risks and burdens, or meet the narrower conditions for research expected to benefit the represented population with minimal risk and burden.

Germany's special rule for group-benefit research

Germany adds a major condition for an adult trial that offers only a benefit to the represented population under Article 31(1)(g)(ii).

Mandatory. The adult must previously, while capable, have stated in writing after medical information that they consent to specified types of group-benefit clinical trials that were not yet imminent. The court-appointed representative then checks whether that advance statement applies to the current situation. The statement can be withdrawn informally at any time.

Do not rely on representative consent alone for this German group-benefit pathway. The application should explain and document the legal basis and how applicability of the advance statement will be verified.

Required documents

Legal-representative information and consent

Mandatory. Provide a full German information sheet addressed to the legally designated representative. Explain the trial, why adults without capacity must be included, benefit category, risks, burden, alternatives, participant objection, data, samples, insurance, withdrawal, and capacity reassessment.

The form should record the representative's authority and relationship to the participant. A general contact person or relative does not automatically have legal authority to consent.

Adapted participant information

Mandatory. Give the participant information suited to their ability to understand. Explain the immediate procedures, discomforts, choices, and right to refuse without relying only on the representative document.

Participant response or assent record

Conditional. Use a separate assent or acknowledgment section when it helps document the participant's involvement. It does not replace representative consent and must not be used to override objection.

Advance statement for group-benefit research

Conditional but essential when the German group-benefit pathway is used. Explain what evidence will show that the participant made the required prior written statement after medical information and how the representative verifies its application. Avoid uploading unnecessary personal information to CTIS.

Consent and signature process

The blank forms are submitted unsigned in Part II. Before participation, the legally designated representative and the investigator responsible for this protected-population process sign and date the approved consent form. The participant is involved to the greatest extent possible.

The AKEK investigator FAQ treats the protected-population consent process as an investigator responsibility rather than a task that can be delegated to a non-investigator trial-team member. Reflect that allocation in K1 and site training.

Germany requires express written or electronic consent by the representative for processing the participant's personal and health data.

Objection and dissent

An explicit wish by a participant who can form an opinion and assess the information to refuse or withdraw must be respected. German law also treats a refusal expressed by a person without full understanding as the explicit wish protected by Article 31.

Behavioral or non-verbal resistance can therefore matter. Define how the team recognizes, records, and responds to objection. Do not continue a non-essential research procedure against active resistance.

Regained or changing capacity

Mandatory. Reassess capacity when the condition can improve or fluctuate. If the participant becomes capable, provide the current adult information and obtain the participant's own informed consent before continued trial participation.

Explain what happens if the newly capable participant declines, including treatment, safety follow-up, data already collected, and samples.

Country-specific templates

AKEK does not list a dedicated current CTR model text for adults without capacity on its medicinal-product trial page. Use the current capable-adult CTR model only as a content baseline. Build the legal-representative, adapted participant, objection, advance-statement, and re-consent logic specifically for this protocol.

Use the Germany patient-facing document QC checklist before submission.

Return to the Germany CTIS hub

The Germany CTIS submission guide hub contains every English guide in this series.

Other language versions

Read this guide in German.