Portugal Healthy Volunteer Consent Requirements

Required document set

Mandatory. Prepare a Portuguese healthy-volunteer PIS and ICF. Do not reuse a patient form that describes treatment benefit or clinical alternatives that do not apply.

Conditional. Submit Portuguese recruitment advertisements, telephone scripts, online text, pre-screening materials, participant cards, restrictions, visit information and diaries. Include every item the volunteer will see or use.

Conditional. Add separate forms for optional future use of samples, pregnancy follow-up, genetic research or an impartial witness when those pathways apply.

The CEIC adult ICF model is optional and may be adapted. Portugal has not published a separate mandatory national healthy-volunteer ICF template.

Main differences from a patient PIS and ICF

No expected therapeutic benefit

State clearly that the volunteer is healthy for the study purpose and that the intervention is not intended to treat a condition. Do not describe general scientific value as a personal medical benefit.

First exposure and uncertainty

If this is first-in-human, early-phase or dose-escalation research, explain the uncertainty, sentinel dosing, cohort progression and stopping rules in plain language. Describe known class risks and relevant nonclinical uncertainty without copying the investigator's brochure.

Procedures and restrictions

Explain admission, confinement, fasting, diet, alcohol, nicotine, exercise, medicines, blood donation, contraception, pregnancy testing and washout requirements. State the volume and frequency of blood sampling. Explain how noncompliance may affect safety.

Screening and incidental findings

Explain the screening tests, what happens if the person is not eligible, whether clinically relevant findings will be communicated and how screening data or samples are retained. Avoid implying that screening is a health check.

Compensation and expenses

Describe reimbursement and any payment for participation separately. State the amount, calculation, schedule and prorated payment if the volunteer stops early. Portuguese CEIC guidance recognizes that payment may be made in healthy-volunteer trials. Payment must compensate time and burden without becoming pressure to accept risk or remain in the trial.

Keep the PIS and ICF consistent with the participant-compensation description and the site financial arrangements in CTIS folder P. The investigator should not have discretion to withhold earned payment because the volunteer withdraws.

Insurance and medical care

Explain the civil-liability insurance, how to report an injury and what trial-related medical care is available. Do not ask the volunteer to waive legal rights. Confirm that the policy covers the site, study activities and any external facility.

Reproductive precautions

Explain contraception, pregnancy testing, sperm or egg donation restrictions and the response to pregnancy. If the sponsor collects data from a pregnant partner, use her separate Portuguese information and consent. See the Portugal pregnancy follow-up guide.

Consent and signatures

The volunteer and the person conducting the consent interview sign and date the ICF when consent is obtained. Give the volunteer a signed copy. The submitted CTIS model remains blank.

Consent must be obtained before any trial-specific screening procedure. If pre-screening itself collects health data beyond normal recruitment, explain the data use and obtain the appropriate permission before collection.

Re-consent is needed when approved new information may affect willingness to continue. Withdrawal must remain possible at any time. Explain which safety follow-up may still be requested and how already collected trial data are handled.

Final review

Check that the Portuguese document:

• says no therapeutic benefit is expected
• describes uncertainty and serious risks without minimizing them
• states the total blood volume and confinement burden
• explains restrictions and washout periods
• separates payment from expense reimbursement
• prorates payment fairly after withdrawal
• explains screening-data and sample handling
• matches the protocol, insurance and financial documents
• includes a separate optional future-use decision where needed
• uses the correct witness, pregnancy or capacity variation where applicable

Use the Portugal patient-facing document QC checklist for the cross-document review. Return to the Portugal CTIS hub for the full series.