Ireland CTIS Limited-Capacity and Legally Designated Representative Consent Requirements

Assess and support capacity

Do not treat a diagnosis, disability, age or communication difficulty as proof of incapacity. Assess whether the person can understand, retain, use or weigh the relevant trial information and communicate a decision, with appropriate support.

Use accessible information, extra time, communication aids and trusted support where appropriate. Record the assessment, the decision-maker, the date and the support used. Reassess when capacity may change.

Ireland's legally designated representative route

Under Ireland's 2022 clinical-trial regulations, the legally designated representative is first a person who, because of a family or other personal relationship, is suitable and available to represent the participant. That person must act according to their best interpretation of the participant's will and preferences.

If no suitable person is available, the representative may be the medical practitioner primarily responsible for the participant's treatment, provided that practitioner is not involved in conducting the trial.

The representative should receive the full information required for informed consent and enough time to decide. Verify the relationship, availability and absence of conflict. The representative is not a witness and the witness cannot substitute for the representative.

Involve the participant

Give the participant information in a form they can understand and involve them as far as possible. Respect an explicit wish to refuse participation or withdraw. The representative's agreement does not override the participant's resistance.

The trial must meet the additional safeguards in Article 31 of the Clinical Trials Regulation, including direct relation to the participant's condition and the required benefit or minimal-risk and minimal-burden basis.

Personal data requires a separate Irish analysis

The Health Research Regulations generally use the individual's explicit consent as a safeguard for processing health data. An Irish legally designated representative for trial participation cannot ordinarily give that explicit data-processing consent for an adult lacking capacity.

Before submission, determine and document the lawful route for data processing. This may require an application to the Health Research Consent Declaration Committee unless a specific legal exception applies. Ethics approval and representative consent to participation do not by themselves replace this data-protection step.

The participant information, NREC data statement, DPIA and protocol must describe the same route. Do not describe pseudonymised trial data as anonymous.

Regaining capacity and re-consent

If the participant regains capacity, give them the current participant information and seek their own consent to continued participation without undue delay. Explain the activities already completed and the data already collected. Record their decision and apply the approved withdrawal process if they decline.

For fluctuating capacity, define when reassessment occurs and which activities pause while consent is uncertain.

Consent-document structure

Prepare:

• an accessible participant information or summary suitable for the person's abilities
• a full representative information sheet and consent form
• a documented capacity-assessment and reassessment process
• participant re-consent documents for regained capacity
• data-protection wording that reflects the approved Irish legal route

Ireland has no dedicated mandatory national representative SIS or ICF template. Adapt an accepted EU or NREC-aligned structure and ensure it reflects the Irish representative hierarchy and approved data-protection route.

Signature blocks should identify the representative, their relationship or role, the person taking consent and the date. Include a witness block only when the separate witness pathway applies.

Submission checks

• Inclusion of adults lacking capacity is scientifically necessary and justified.
• Article 31 conditions are addressed in the protocol and participant documents.
• Capacity is supported, assessed and reassessed.
• The Irish representative hierarchy is followed.
• The participant's will, preferences and dissent are respected.
• Trial participation consent is separated from data-processing safeguards.
• Any HRCDC declaration is obtained or clearly planned before the processing that needs it.
• Re-consent after capacity returns is operational.
• Compensation does not include an incentive for an incapacitated participant.

Return to the Ireland CTIS Part II guide hub for the full national guide series.