Estonia CTIS Healthy Volunteer Consent Requirements

Start from the main Estonia PIS and ICF

Use the Estonia Patient Information and Consent Requirements guide as the baseline.

Mandatory. Participant-facing information must be in Estonian and carry the EU CT number. If another language will be used, provide that participant-language version as well.

Recommended. Use the Estonia Subject Information and Informed Consent Form template as the national drafting baseline and adapt it to the healthy-volunteer protocol.

What changes for a healthy volunteer

The volunteer should be able to understand that participation is research and is not treatment for an existing disease.

Explain clearly:

• why healthy volunteers are needed
• whether direct medical benefit is expected
• investigational product exposure and dose escalation when relevant
• screening procedures and reasons a volunteer may be excluded
• confinement or residential periods
• fasting, diet, activity, alcohol, nicotine or medicine restrictions
• blood-draw frequency and total burden
• cardiac, laboratory or other safety monitoring
• contraception and pregnancy-testing requirements
• washout and follow-up
• what happens if clinically relevant incidental findings are detected
• withdrawal and any safety follow-up required after withdrawal

Do not soften risk language because the participant is healthy. Risk information should match the Investigator's Brochure, protocol and current safety information.

Reimbursement and compensation in Estonia

Mandatory. Unavoidable expenses directly caused by trial participation must be reimbursed under Estonia's ethics guidance. Explain the approved reimbursement principles in the ICF.

Conditional. A competent healthy volunteer may receive compensation for inconvenience and burdensome procedures when the need and amount are justified in the clinical trial application and approved by the Ethics Committee for Medicinal Products.

Ravimiamet states that compensation should reflect the participant's contribution and time. The amount for time should be based on the minimum wage in force in Estonia in the year the trial was initiated.

Compensation must not be payment for taking risk and must not depend on the risk level.

Do not offer an additional completion bonus, make full payment conditional on completing the trial, or hold back a large share of compensation to encourage continued participation.

Information about compensation belongs in the ICF and not in recruitment materials.

Consent and signatures

The consent discussion follows the same Estonia rules as other adult trials.

Before consent, the participant must speak with an appropriately knowledgeable trial-team member who is a doctor, nurse or pharmacist and can explain the trial and investigational medicinal product.

The consent is dated and signed by the participant and the person conducting the consent interview. Estonia permits legally valid digital signatures.

If remote consent is planned, the process must meet the national video-call and e-identification conditions and be justified and approved by the Ethics Committee before use.

Data and sample choices

Healthy-volunteer studies commonly collect dense pharmacokinetic, genetic or biomarker data and repeated biological samples. Describe the collection and retention precisely.

Estonia asks sponsors to explain data protection in detail in the ICF and recommends separate consent choices for trial participation and use of pseudonymised health data or biological samples.

If future use is optional, do not make it a condition of joining the main study unless the protocol and legal basis genuinely require it. See the Estonia secondary use consent guide.

When a separate healthy-volunteer document is useful

A dedicated healthy-volunteer PIS/ICF is useful when the trial has both patient and healthy cohorts, or when the procedures, risk-benefit explanation, payment structure or screening pathway differ materially from a standard patient cohort.

Do not reuse a patient ICF with only the disease name removed. The expected benefit, alternatives, recruitment context and burden explanation are different.

The Estonia patient-facing QC checklist can be used before submission.

Return to the Estonia CTIS hub for the full guide library.