Ireland CTIS Minor Consent and Assent Requirements

Legal consent and the child's assent

For a participant under 16, obtain informed consent from the person legally entitled to act for the child under the applicable Irish framework. Verify and document that person's authority. Do not assume authority from attendance at the visit or from an informal caregiving role.

Give the child information suited to their age, maturity and experience. Seek affirmative assent where the child can form an opinion and assess the information. The investigator must respect an explicit wish by a capable minor to refuse participation or withdraw.

Assent supports but does not replace the required guardian consent. Guardian consent does not remove the duty to listen to the child.

Age-appropriate document set

Prepare the smallest set of versions that covers the enrolled population clearly. A common approach is a parent or guardian SIS and ICF plus one or more child or adolescent assent sheets. The legal rules do not prescribe fixed assent age bands. Choose bands based on the protocol population and developmental needs, then justify them.

Each assent sheet should explain:

• why the study is being done
• what will happen to the child
• which procedures may hurt, worry or inconvenience them
• that questions are welcome
• that they may say no or change their mind
• whom to tell if they want to stop

Do not ask a young child to sign adult legal or data-protection declarations that they cannot understand.

Ireland has no dedicated mandatory national paediatric SIS, ICF or assent template. Use an accepted EU or NREC-aligned structure, then create and justify the age-appropriate versions needed by the protocol.

Guardian information and consent

The guardian document should contain the full information required for informed consent, including trial purpose, procedures, risks, possible benefit, alternatives, data, samples, injury arrangements and withdrawal. It should also explain how the child will be informed and how dissent will be handled.

Confirm the required guardian signature process for the participant's circumstances and the site's legal verification procedure. Record any supporting documentation without collecting more identity information than necessary.

Re-consent at age 16

Plan for participants who reach 16 while trial activities, follow-up or identifiable data processing continue. Provide the participant with the current adult information and obtain their own consent without undue delay. The protocol and submission should describe this transition.

If the participant does not consent after reaching 16, stop optional future activities and follow the approved withdrawal and safety process. Explain what information must still be retained under legal obligations.

Data protection and samples

Keep trial participation consent and data-protection information distinct. Explain the data processed about both the child and guardian. At age 16, obtain the participant's own consent where explicit consent is the applicable Health Research Regulations safeguard.

Optional future use of samples or data needs a separate, comprehensible choice. Broad consent must be limited to a described disease, health or research area. See the Ireland secondary-use guide.

Payment and reimbursement

Reimburse reasonable expenses without creating pressure on the guardian or child. Under the EU compensation template, minors should not receive incentives. Legitimate expenses and lost earnings can be described, and any token of appreciation requires ethics approval.

Explain whether payment goes to the guardian or participant and what happens after withdrawal.

Submission checks

• The protocol's age range matches every SIS, ICF and assent version.
• The legal guardian route is operational at each site.
• Assent is sought according to capacity, age and maturity.
• The child's refusal and withdrawal are respected.
• Re-consent at 16 is described.
• Risks and burdens are written for both the guardian and child.
• School, family and social impacts are addressed where relevant.
• Data, samples and optional future research are separated.
• Signature blocks match the actual consent pathway.

Return to the Ireland CTIS Part II guide hub for all national consent pathways.