Romania CTIS Part II Limited-Capacity Participant and Legal Representative Consent Requirements

Start with the main consent guide

This pathway is a variation of the Romania patient information and consent requirements.

Mandatory. Participant-facing documents should be in Romanian and should be understandable to the person who will receive them.

When the pathway applies

Use the limited-capacity pathway when a potential participant cannot provide valid informed consent under the applicable legal framework.

The Clinical Trials Regulation allows such participants to be included only under defined conditions, including consent by the legally designated representative and scientific justification for inclusion.

Romania's national recruitment and informed-consent procedure asks the sponsor to justify recruitment of adults lacking capacity and explain the nature of the condition that causes the incapacity and its relevance to the trial.

Capacity assessment

Mandatory. The Part II procedure should state who assesses and confirms whether a potential participant has capacity to consent.

If capacity may fluctuate or be borderline, explain how the participant will be involved in the decision and how information will be adapted so the participant can understand as much as possible.

Do not describe capacity as a permanent administrative label if the clinical condition may change.

Legal representative

Mandatory. Explain how the legally designated representative will be identified and in what capacity that person acts.

The study team should verify the representative's authority under Romanian law before relying on the signature. Do not assume that a relative automatically has legal authority.

Participant involvement and signatures

The participant should be involved in the decision as far as possible.

Mandatory. Where the participant can form an opinion and assess the information. Romania requires both the participant and the legal representative to sign the informed-consent form.

If the participant expresses an objection or refusal protected under the Clinical Trials Regulation, the study team should respect that decision.

Re-consent if capacity returns

Conditional. If the participant regains capacity during the trial, the national recruitment form expects the sponsor to explain how the participant will be asked to consent to continued participation.

Plan the re-consent process in the protocol and participant documents. The participant should be re-informed and asked to sign the standard adult consent when legally required.

Information for the participant and representative

The representative document should explain the study and the representative's role.

Where the participant can understand some information, provide adapted participant information rather than communicating only with the representative.

The documents should cover study procedures, burdens, risks, potential benefit, alternatives, privacy, samples, compensation, withdrawal and contact points.

Compensation

For adults lacking capacity and their legal representatives, financial inducements are not permitted beyond compensation for expenses and loss of earnings directly related to trial participation.

Romania's compensation form should match the participant and representative information.

Recruitment and data protection

If potential participants are identified through medical records or other sources, the national recruitment form asks the sponsor to explain how access to identifying data complies with applicable rules.

Recruitment, consent and communication should also respect Union data-protection law.

Submission package

Prepare the representative information and consent document, adapted participant information where appropriate, the national recruitment and informed-consent procedure, compensation information and the standard site and investigator documents.

If a participant cannot write, combine this pathway with the Romania impartial-witness requirements where applicable.

Use the Romania Part II checklist for the full dossier and return to the Romania CTIS hub for related guides.