Latvia Healthy Volunteer Consent Requirements

Documents to prepare

Mandatory. Submit a Latvian healthy-volunteer information and consent document. If screening involves research procedures or collection of data or samples before main enrollment, make the screening consent scope clear or prepare a separate screening consent.

Conditional. Submit Latvian advertisements, pre-screening scripts, invitation text, digital recruitment material, and doctor-facing referral material when used. Describe identification, first contact, record access, pre-screening, and the person approaching volunteers in the mandatory Recruitment and Informed Consent Procedure template.

Conditional. Prepare separate consents for optional genetic work, future sample or data use, pregnancy follow-up, recordings, or another activity that is not necessary for the main trial.

The blank forms are not signed at CTIS submission. At consent, the volunteer and the person conducting the interview sign and date the consent record before trial-specific screening or treatment procedures begin.

Healthy-volunteer information

State plainly that the trial is research and is not intended to treat an illness in the volunteer. Explain whether any personal health benefit is expected. Describe the investigational product, dose escalation, placebo, randomisation, sentinel dosing, stopping rules, and unknown risks where applicable.

Give a practical account of:

• screening tests and the possibility of screen failure
• admission, confinement, outpatient visits, observation, and follow-up
• fasting, diet, alcohol, nicotine, caffeine, exercise, driving, medication, supplement, and donation restrictions
• blood and other sample volumes, timing, storage, and analysis
• reproductive restrictions, pregnancy testing, contraception, and exposure reporting
• adverse-event care, emergency contacts, medical follow-up, insurance, and injury claims
• incidental findings and whether results will be returned or referred for care
• checks for simultaneous participation or required washout from another trial

Latvian rules require protocol-specified medicines, administration devices, other medicines, devices, and examinations to be provided free to participants. Keep this consistent with the payment and insurance sections.

Payments and reimbursement

Describe travel reimbursement, accommodation, meals, loss of earnings, monetary or non-monetary payments, recipients, amounts or calculation, timing, and any payment conditions. Match the participant document to the mandatory Compensation for Trial Participants template and the Latvia site budget.

Do not make payment contingent on finishing the trial in a way that discourages withdrawal. A proportionate schedule may reflect completed visits or burden. State what is payable after screen failure, early withdrawal, investigator discontinuation, or trial suspension.

Privacy and medical-record checks

Explain health-history collection, medical-record access, identity checks, trial-participation database checks if used, drug or alcohol tests, and communication with a general practitioner. State who receives the information and how long it is retained.

Include the study-centre, controller, ZVA, ethics-committee, and Data State Inspectorate details requested by Latvia. If recruitment uses identifiable patient lists or an outside pre-screening provider, align the information with the recruitment procedure and data-protection statement.

Special populations and exclusions

Healthy-volunteer status does not remove the need for a separate consent pathway. If the protocol includes minors, adults unable to consent, breastfeeding women, or emergency enrollment, assess whether that design is scientifically and ethically justified and prepare the relevant variation. Under the Clinical Trials Regulation, minors, incapacitated participants, and breastfeeding women may receive reimbursement of expenses and loss of earnings but no financial inducement.

Run the final set through the Latvia patient-facing document QC checklist and return to the Latvia CTIS guide hub for other consent pathways.