Ireland CTIS Healthy Volunteer Consent Requirements

When this guide applies

Use it for trials that enrol people because they are healthy rather than because they have the condition under study. It is particularly relevant to early-phase, first-in-human, bioavailability, bioequivalence and vaccine studies.

Ireland does not publish a separate mandatory national healthy-volunteer consent template. Use the accepted EU or NREC-aligned participant-information structure and adapt it to the actual protocol.

The required set normally includes the healthy-volunteer SIS and ICF, screening information and consent where screening is separate, recruitment materials, participant instructions and any optional sample or future-use consent that applies.

State the absence of therapeutic benefit

Say plainly that the volunteer is not being treated for an illness and is not expected to receive a direct health benefit. Do not describe medical screening, monitoring, payment or access to study staff as a therapeutic benefit.

If the study may contribute to future knowledge or treatment, present this as a possible societal benefit rather than a personal benefit.

Explain uncertainty and foreseeable risk

Describe:

• whether the medicine has been given to humans before
• what is known from laboratory, animal and previous human studies
• important known and theoretical risks
• uncertainty about dose, interactions and rare or delayed effects
• escalation, sentinel dosing or stopping rules in language the volunteer can understand
• emergency facilities and the action staff will take if harm occurs

Do not reassure beyond the evidence. For first-in-human or novel-mechanism studies, the unknown-risk statement should be prominent.

Describe screening and eligibility

Explain all screening procedures, including medical history, examination, blood and urine tests, infection testing, drug or alcohol testing, pregnancy testing and genetic testing where applicable. State what happens to screening samples and data if the person is not enrolled.

Tell volunteers whether clinically relevant incidental findings will be disclosed, by whom and whether follow-up care is part of the trial.

Set out practical burdens

Include the number and duration of visits, overnight stays, confinement, fasting, cannulation, sample volumes, biopsies, exercise testing and other burdens. State restrictions on medicines, alcohol, tobacco, recreational drugs, diet, driving, strenuous activity, blood donation and participation in other research.

Explain contraception, pregnancy testing and sperm or egg donation restrictions in a way that matches the protocol.

Payment and reimbursement

Separate reimbursement of reasonable expenses from compensation for time and inconvenience. State the amount, schedule, tax position if known and what is paid after early withdrawal.

Payment must not be presented as a trial benefit or be structured so that it undermines a free decision to withdraw. The NREC reviews payment and compensation arrangements as part of Part II.

Injury, insurance and care

Explain the insurance or indemnity arrangements, immediate medical care, how to report injury and how a compensation claim is handled. Keep this wording consistent with the insurance certificate, sponsor arrangements and any State indemnity position for the site.

Do not promise automatic compensation if the actual policy has conditions or exclusions.

Consent and withdrawal

Allow enough time for questions and reflection. Confirm that participation is voluntary and withdrawal is possible without penalty. Explain which safety follow-up may still be requested and what data or samples must be retained under law after withdrawal.

For repeat volunteers, explain how prior participation is checked and why simultaneous or closely spaced studies may be unsafe.

Submission checks

• The SIS and ICF match the protocol and investigator brochure.
• Unknown risk is not minimised.
• No therapeutic benefit is claimed.
• Screening failures are covered.
• Payment is itemised and not contingent on completing every procedure.
• Restrictions and reproductive precautions are complete.
• Insurance and emergency contacts are correct.
• Optional samples or future research have separate choices.

Return to the Ireland CTIS Part II guide hub for the national document set.