Lithuania CTIS Healthy Volunteer Consent Requirements

When a healthy-volunteer variation is needed

Use a healthy-volunteer version when the protocol enrolls people who do not have the disease or condition under investigation.

The document should not simply rename the standard patient ICF. It should change the benefit, risk, alternatives, reimbursement and screening explanations so they accurately describe the healthy-volunteer context.

Required document set

Mandatory. Prepare the Lithuanian participant information and ICF used before the volunteer decides whether to join.

Mandatory. Make sure the recruitment and informed consent procedure explains how healthy volunteers will be identified, screened and consented.

Conditional. If advertising is used to recruit healthy volunteers, submit the advertisements and the supporting information requested by the Lithuanian Bioethics Committee, including why advertising is needed, where it will be placed, how ineligible respondents are handled, reimbursement and any personal data collected from respondents.

No separate national healthy-volunteer form was identified in the Lithuanian Part II recommendations checked for this guide.

Main differences from a patient ICF

Do not imply therapeutic benefit

The document should make clear that the volunteer is not being treated for an illness and that direct medical benefit may be absent.

If health checks could identify an incidental finding, explain what will happen if something clinically relevant is found and whether the volunteer will be referred for care.

Explain research risks in practical terms

Healthy volunteers may have a lower tolerance for uncertainty because there is no therapeutic need. Explain:

• known and unknown investigational product risks
• dose escalation where applicable
• first-in-human uncertainty where applicable
• blood sampling burden
• fasting, confinement or activity restrictions
• reproductive precautions
• rescue procedures and medical monitoring
• stopping rules that affect the volunteer

Avoid reassuring language that goes beyond the evidence.

Make reimbursement and compensation transparent

Lithuania requires financial information in Part II and regulates compensation for time spent in biomedical research. The Lithuanian Bioethics Committee recommends stating an approximate hourly compensation amount in the ICF where compensation for time is paid.

Distinguish:

• reimbursement of actual expenses
• compensation for time
• any payment schedule
• what happens to payment if screening fails or the volunteer withdraws
• which procedures remain payable when the study is discontinued early

Payment should not be described in a way that obscures the volunteer's right to withdraw.

Explain free trial procedures

Recommended. Lithuanian Bioethics Committee guidance recommends stating in participant-facing documents that the investigational medicinal product and trial health checks are free of charge where this applies.

This is especially useful for healthy volunteers because screening and study procedures can otherwise be mistaken for a paid healthcare service.

Contraception and pregnancy prevention

If the protocol requires contraception, pregnancy testing or restrictions on sperm or egg donation, describe them clearly and use the same time periods as the protocol.

Current Lithuanian FAQ guidance states that contraceptive costs should be compensated when contraception is specifically required because of participation in the research.

If the protocol includes pregnancy follow-up, prepare the relevant participant or partner documentation described in the Lithuania pregnancy follow-up guide.

Screening and screen failures

If potential healthy volunteers provide health data before formal trial enrollment, explain who collects the data, why, how long they are kept and what happens if the person is not eligible.

Where advertising is used, the Lithuanian Bioethics Committee specifically asks sponsors to explain how respondents found ineligible at the first visit will be handled and whether reimbursement is available to eligible and ineligible respondents.

Signatures

At the initial CTIS submission, submit the blank Lithuanian ICF version with the correct signature and date fields.

When consent is obtained, the volunteer and the person conducting the consent interview sign and date the consent record. Give the volunteer a copy.

If the volunteer cannot write, do not improvise a signature substitute. Use the consent pathway described in the Lithuania impartial witness guide.

Final healthy-volunteer QC

Before submission, confirm that the ICF:

• does not promise treatment benefit
• uses the actual dose and escalation plan
• states the true confinement and follow-up burden
• matches protocol reproductive restrictions
• explains reimbursement and compensation clearly
• explains free IMP and trial health checks where applicable
• covers screen-failure data handling
• is in Lithuanian
• uses the correct version and signature blocks

The Lithuania patient-facing QC checklist can be used for the final cross-document review.