Spain CTIS Part II Healthy Volunteer Consent Requirements

Start with the main Spanish PIS/ICF

The healthy-volunteer document does not replace the standard Spanish requirements. It should be in Spanish, follow the AEMPS national structure and remain within the recommended 15-page limit including the ICF. Use Arial or Times New Roman at 11 points or larger, at least 1.5 line spacing and normal margins.

The Spain main patient information and consent guide covers identification, design, activities, risks, privacy, insurance, withdrawal, contacts and signatures that still apply.

Documents to prepare

Mandatory. Prepare one Spanish healthy-volunteer PIS/ICF for the main trial. Submit the blank version under “Subject information and informed consent form.” The volunteer and investigator sign and date it only when consent is obtained.

Conditional. Prepare distinct documents or clear optional sections for genetic testing, optional biopsies, future data or sample use, pregnancy follow-up, repeat screening or substudies. If the trial recruits through advertising, submit the Spanish recruitment materials and the recruitment process.

Mandatory. Include the AEMPS Annex VIIIA data-protection appendix. When biological samples are collected, align the PIS with AEMPS Annex VIIIB and the Part II sample-compliance information in Annex XIII.

Spain has no separate national healthy-volunteer PIS template. Adapt AEMPS Annex VIIIA and make the differences from a patient trial explicit.

Explain why a healthy person is being invited

State the scientific reason for using healthy volunteers and describe the eligibility criteria in plain language. Avoid suggesting that selection means the volunteer has no health risk. Screening may identify previously unknown findings, and the document should explain how clinically relevant results will be handled.

State the number of planned volunteers, cohorts, dose levels, sentinel dosing or dose escalation when applicable. Explain how assignment works and whether later groups may receive a different dose based on earlier safety results.

State that there is no expected therapeutic benefit

Mandatory. Tell volunteers clearly that they are not being treated for an illness and should not expect a health benefit. AEMPS advises that free medicines, tests, clinical monitoring and test results must not be presented as benefits of participation.

Any possible benefit to science or future patients should be described without exaggeration. Do not imply that participation provides a general health check unless that service is genuinely offered and approved.

Describe the full burden

Explain screening, washout requirements, admission and discharge, confinement, overnight stays, fasting, standardised meals, posture restrictions, repeated blood draws, urine collection, monitoring, outpatient visits and follow-up calls. State the total duration and the longest stay.

Quantify blood sampling and explain common effects such as bruising, pain, dizziness and the risk of anaemia when relevant. Describe cannula use, biopsies, lumbar puncture, challenge procedures or other invasive activities individually.

Explain restrictions on medicines, supplements, alcohol, nicotine, caffeine, exercise, driving, diet, donation of blood and participation in other studies. Match every restriction to the protocol and give a practical time period.

Risks and first-in-human uncertainty

Summarise the known risks of the study medicine and procedures. When human experience is limited, say so directly. Explain that unexpected reactions may occur and describe the safeguards used, such as sentinel dosing, observation, stopping rules and emergency care, without presenting them as eliminating risk.

For dose-escalation trials, explain that information from earlier participants may influence dosing of later groups. State circumstances in which dosing, a cohort or the whole trial may stop.

Compensation and reimbursement in Spain

Conditional. Compensation for time and inconvenience may be offered when approved by the CEIm and must not exert undue influence. State the amount, payment stages, method and any deductions or proportional calculation if participation ends early.

Spanish rules provide that an agreed payment is still due for the part completed when a participant withdraws. AEMPS also asks the PIS to state that compensation is treated as income for Spanish tax purposes and may affect the volunteer's income-tax return. If the volunteer can decline payment, explain how.

Separate compensation from reimbursement of reasonable expenses. Match both to the financial budget submitted in Part II. Do not leave payment terms only in the budget when they affect the participant's decision.

Pregnancy and reproductive precautions

Include the protocol's contraception, pregnancy testing, sperm or egg donation and breastfeeding restrictions. Explain the known reproductive risks or state that they are unknown.

Tell volunteers to report pregnancy promptly. If a male volunteer's partner becomes pregnant and the sponsor will collect her information, she needs a specific consent. Do not ask the volunteer to consent on the partner's behalf. The Spain pregnancy follow-up guide covers this pathway.

Data and samples

Explain whether screening data and samples from screen failures will be retained and why. Separate trial-required pharmacokinetic, pharmacodynamic and safety samples from optional future research.

If leftover samples will be stored after the trial, give a separate yes or no choice and identify the biobank, collection or repository arrangement. Refusal of future use should not prevent main-trial participation unless the sample use is scientifically essential and described as part of the trial.

Insurance, care and withdrawal

Explain the Spanish insurance or financial-guarantee route and the contact for a possible trial-related injury. State how medical care will be provided during confinement and after discharge.

Confirm that withdrawal is allowed at any time and does not require a signed revocation form. Explain safety follow-up that may still be requested after dosing and the handling of data and samples already collected.

Signature and submission check

At CTIS submission, the healthy-volunteer PIS/ICF is a blank Spanish document. When consent is obtained, the volunteer and investigator sign and date it and the volunteer receives a signed copy.

Before submission, compare the PIS with the protocol, pharmacy plan, schedule of activities, laboratory manual, compensation budget and insurance certificate. Use the Spain patient-facing QC checklist for the final review, then return to the Spain CTIS guide hub for the wider package.