Ireland CTIS Patient Information and Consent Requirements

Language and document presentation

Mandatory. Submit the Irish SIS and ICF in English. Ireland requires the application and all documents and communications before, during and after the trial to be in English.

Write for the intended participants, not for regulatory specialists. Explain technical terms, abbreviations, study arms, randomisation, placebo, genetic analyses and uncommon procedures in plain language. Use short sections, readable type, adequate spacing and clear tables or diagrams when they make visits or treatment groups easier to understand.

Submit accessible, searchable source files or original PDFs. NREC-CT has repeatedly stated that image-only scanned documents cannot be optimised for assistive technology. Check navigation, selectable text, headings, lists and meaningful reading order.

Core information the SIS should contain

The document set should explain the following in a trial-specific way:

• the study purpose, phase and why the person is being invited
• the investigational treatment, comparator, placebo and chance of receiving each arm
• screening, treatment, follow-up, visit frequency, visit duration and procedures
• which procedures are research-specific and which are standard care
• foreseeable risks, burdens, discomforts and precautions in understandable terms
• expected benefit, including a clear statement where direct benefit is not expected
• available alternatives to participation and the effect of declining
• pregnancy, breastfeeding, contraception and pregnancy-reporting requirements
• collection, analysis, storage and transfer of biological samples
• optional genetics, photographs, recordings, apps, devices or third-party services
• data controllers, data categories, purposes, recipients, transfers, retention and rights
• reimbursement, expenses, insurance, research injury and complaint routes
• the right to refuse or withdraw without affecting ordinary care
• what happens to data and samples collected before withdrawal
• investigator, study-team, Data Protection Officer and complaint contacts
• where participants can find public trial information and results

Do not refer participants to the protocol, Investigator's Brochure or Summary of Product Characteristics to discover material risks. Put the information needed for consent in the participant document itself.

Consent choices and optional activities

Mandatory. Separate agreement to the main trial from optional elements. Each optional activity should be described before the corresponding consent statement. Use one clear choice for each distinct activity, such as future sample research, genomic analysis, photographs, recordings, recontact, or use of a reimbursement provider.

Declining an optional activity must not block main-study participation unless that activity is genuinely necessary to answer the trial's scientific question or protect safety. If it is mandatory, explain why and do not present it as optional.

Ireland's Health Research Regulations treat explicit consent as a safeguard for processing personal data in health research, even where consent is not the controller's GDPR legal basis. The SIS and ICF must therefore distinguish ethical consent to take part from the data-protection information and safeguards that support processing.

Data-protection information for Ireland

Explain who determines the purposes and means of processing, which Irish and international entities receive data, whether data are coded, where transfers occur and which safeguards apply. Pseudonymised or coded data remain personal data.

State realistic retention periods and the legal or scientific reason for them. Avoid open-ended phrases such as retention for as long as necessary without further explanation. Keep the period consistent with the NREC Statement of Compliance or DPIA, protocol and biological-samples form.

Explain rights accurately. A participant may withdraw from future trial activities, but legal duties may require retention of data already collected to protect trial integrity and safety. Do not imply that all data can always be erased, and do not imply that withdrawal has no effect. Explain the practical result and the legal basis.

Biosamples, genetics and future use

Describe each sample, amount, collection procedure, purpose, storage location, retention, coding, recipients and destruction. Explain whether results or incidental findings will be returned and whether commercial organisations may use samples or derived data.

Conditional. If samples or data may be used beyond the current protocol, provide a distinct optional information and consent pathway. Irish broad consent must remain informed and linked to a stated disease, health or research area. Unspecified blanket consent is not acceptable. Future research must receive appropriate ethics review when defined. The Ireland secondary-use consent guide explains the detailed pathway.

Signature and dating process

The submitted Irish SIS and ICF are blank and unsigned. At enrollment, the participant or legally designated representative signs and dates the approved ICF. The authorised person taking consent also signs and dates it. Give the participant a copy and retain the original in the investigator site file as required by the approved process.

Under Irish legislation, the pre-consent interview and consent may be handled by the investigator or an appropriate registered medical practitioner, registered dentist or registered nurse designated by the investigator. The recruitment and consent procedure should identify the role, training, setting, timing and steps used to check understanding.

If a participant can consent but cannot read or write, prepare the approved witness pathway and witness signature field described in the Ireland impartial witness guide.

Population-specific document variations

Healthy volunteers

Healthy volunteers need the main SIS and ICF adapted to explain the lack of therapeutic intent, first-in-human uncertainty where relevant, confinement, intensive sampling, restrictions and payment. See the Ireland healthy volunteer consent guide.

Participants under 16

For regulated Irish trials, a person under 16 is a minor. A parent or guardian provides consent, while a capable child provides assent using age-appropriate information. Re-consent is needed when the participant reaches 16. See the Ireland minor consent and assent guide.

Adults lacking decision-making capacity

An Irish legally designated representative may consent to trial participation. Separate analysis is needed for personal-data processing because a representative generally cannot give the participant's explicit data consent. See the Ireland limited-capacity consent guide.

Emergency enrollment

Emergency inclusion without prior consent is allowed only when every condition in Article 35 is met. The protocol and Part II documents must provide a rapid subsequent consent pathway. See the Ireland emergency enrollment guide.

Pregnancy follow-up

Use a separate consent document when pregnancy follow-up data will be collected from a trial participant or from the pregnant partner of a participant. The pregnant partner is a separate data subject and must consent for herself. See the Ireland pregnancy follow-up guide.

Final review before CTIS upload

Confirm that the SIS and ICF match the protocol, recruitment procedure, Irish data statement, compensation form and sample form. Check treatment arms, doses, procedure counts, visit length, contraception, storage, retention, recipients, transfers, injury wording and contacts. The Ireland patient-facing document QC checklist provides the final cross-document review.

Return to the Ireland CTIS Part II guide hub for every population-specific consent pathway.