Romania CTIS Part II Minor Consent and Assent Requirements

Start with the main Romania consent requirements

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

Mandatory. Participant-facing documents used in Romania should be in Romanian. The consent process should also be described in Romania's national recruitment and informed-consent procedure.

Who provides legal consent

Mandatory. A legally designated representative provides consent for a minor unless the young person has acquired full legal capacity under Romanian law.

Romania's Civil Code states that full legal capacity normally begins at age 18. It also contains limited exceptions, including marriage and court-recognised full capacity from age 16 in certain circumstances. Do not build the routine trial pathway around an exception unless the participant's legal status is confirmed.

Romanian family law generally places parental authority jointly and equally with both parents. The study team should verify who has legal authority to act for the child in the individual case rather than assuming that a particular family member can sign.

The capable minor's agreement

Mandatory. When the minor can form an opinion and assess the information. Order 3390/2022 requires the minor's agreement in addition to the representative's consent.

The national methodology does not give a fixed assent age. Use age-appropriate information and a process that reflects the child's maturity and ability to understand.

For younger children, a short child information or assent document may be appropriate. For adolescents, a more detailed age-adapted information and assent form may be needed.

What the pediatric documents should explain

The child or adolescent should receive information adapted to age and mental maturity about what will happen, what may be uncomfortable, what choices they have and whom they can ask for help.

The representative information should explain the full study, risks, potential benefits, alternatives, procedures, privacy, samples, compensation, withdrawal and any pregnancy-related requirements relevant to adolescents.

If future sample use or other optional research is planned, make the optional choice clear. The Romania secondary-use guide covers those choices.

Refusal and dissent

The Clinical Trials Regulation requires the explicit wish of a minor who is capable of forming an opinion and assessing the information to refuse participation or withdraw to be respected.

Representative consent does not remove the need to consider the capable minor's own decision.

Re-consent when legal capacity is reached

Conditional. If a participant enrolled as a minor reaches legal competence during the trial, new informed consent is required before further protocol-related actions continue.

For Romania, the normal age of full legal capacity is 18. Prepare the adult information and consent form early enough that the participant can be re-informed and sign without disrupting the trial.

Consent interview and signatures

The person conducting the consent interview in Romania must be a physician, member of the investigation team and appropriately trained on the protocol and good clinical practice.

The representative signs and dates the consent when consent is obtained. Where an age-appropriate assent form is used, the capable minor should document agreement in a way consistent with the approved form and the national requirement for their agreement.

Compensation

For minors and their legally designated representatives, no financial inducement is permitted beyond compensation for expenses and loss of earnings directly related to participation.

Romania's national compensation form asks for the type and beneficiary of reimbursement or payment. Align the form with the representative and participant information.

Pediatric study team

Order 3390/2022 requires a pediatrician to be part of the investigator team when the clinical trial involves the pediatric population.

This is a national operational requirement that should be reflected in site planning even though it is not a participant-document signature rule.

Submission package

Prepare the representative consent document, age-appropriate child or adolescent information, assent documentation where appropriate, the national recruitment and consent procedure, compensation information and the standard site and investigator documents.

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