Greece Minor Consent and Assent Requirements

Age bands and documents

Children under 10

Mandatory. Provide the child with information adapted to age and maturity whenever the child can understand it. Seek the child's agreement and respect a capable child's clear refusal. Greek law does not impose the same automatic written-assent rule below age 10, but a child-facing sheet or assent form should be prepared when the protocol population can understand one.

Mandatory. Obtain written, signed and dated consent from both parents who exercise parental responsibility, or from a court-appointed guardian where applicable.

Children and adolescents aged 10 to 17

Mandatory. Prepare a Greek age-appropriate information and written assent form for the minor. The child is informed by the principal investigator, an investigator or an authorized study-team member trained or experienced in working with children. The minor signs and dates the assent after clear information about the trial, expected benefits and risks.

Mandatory. Obtain separate written, signed and dated consent from both parents exercising parental responsibility, or from the court-appointed guardian. The minor's signature does not replace adult legal consent.

At age 18

Mandatory during conduct. When a participant reaches 18 while participation continues, obtain the participant's own adult informed consent for continued participation. Use the approved adult Greek form and document the transition promptly.

Joint parental consent

Greek law requires the parents who exercise parental responsibility to consent jointly. Prepare signature and full-date fields for both parents on the submitted form.

One parent may consent alone when the other parent's parental responsibility has ended through death, declaration of absence or legal removal. One parent may also act alone when the other is demonstrably unable to exercise parental responsibility for factual reasons or lacks the relevant legal capacity. If factual inability is relied on, the consenting parent provides a formal declaration that is attached to the consent form.

An award of day-to-day custody to one parent does not by itself prove that the other cannot exercise parental responsibility. If parents disagree, or the supervisory council objects where the child has a guardian, the court decides with the child's wishes and interests in mind.

Child information and assent

Use separate versions when one form cannot serve the full age range. The child document should explain why the study is being offered, what will happen, discomforts, foreseeable risks, possible benefit, alternatives, privacy, samples, and the right to say no or stop. Avoid relying on the parent document to inform the child.

The child's categorical wish to refuse or withdraw is binding when the child can form an opinion and evaluate the information. Explain any medical risks of stopping without using those risks to pressure the child.

Signature and submission logic

At CTIS submission, upload blank Greek child, adolescent and parent or guardian forms. They are not signed at submission. Include future fields for:

• the minor, for the age band and capacity in which written assent applies
• both parents exercising parental responsibility, or the court-appointed guardian
• the investigator or authorized study-team member obtaining consent
• full dates for every signer

During conduct, the Greek in-person paper-consent process applies. Give the parents and the minor appropriate time to ask questions. Provide a signed copy of the relevant documents.

Optional research and pregnancy-related forms

If a genetic substudy, future sample use or another activity is optional, obtain the child's age-appropriate agreement and the required parental permission separately from main-trial consent. Use the Greece secondary-use guide.

If pregnancy follow-up could collect information about an infant born to a minor participant, plan the pregnancy and infant permissions separately. The Greek guidance requires both parents or guardians of the child whose information will be collected to consent. Use the Greece pregnancy follow-up guide.

QC before submission

• The protocol, CTIS age ranges and every document agree.
• The assent language is appropriate for the intended age and maturity.
• The form does not treat parental permission as a substitute for the child's information.
• The 10th and 18th birthday transitions are operationally defined.
• Both-parent signature fields and the permitted exception evidence are correct.
• Refusal, dissent and withdrawal are described without pressure.
• Greek translations, versions, dates and pagination are aligned.

Use the Greece patient-facing QC checklist and return to the Greece CTIS guide hub for the connected guides.