Finland Healthy Volunteer Consent Requirements

This is a variation of the main consent document

Start with the Finland Patient Information and Consent Requirements guide. Retain its language, privacy, insurance, withdrawal and signature structure. Replace patient and treatment assumptions with facts that match the healthy-volunteer protocol.

Mandatory. Use this variation whenever people without the condition under study are recruited. A separate document is also useful when a trial includes both patients and healthy volunteers because the invitation reason, expected benefit, procedures and alternatives differ.

Required healthy-volunteer documents

Prepare:

• a Finnish and/or Swedish Participant Information Sheet tailored to healthy volunteers
• a matching Informed Consent Form
• the Finnish and/or Swedish Recruitment and Informed Consent Procedure
• every recruitment advertisement, invitation, transcript or storyboard
• the GDPR information, in the main sheet or a linked annex
• separate optional future-use consent when samples or data may be used outside the protocol

No Finland-specific healthy-volunteer template replaces Tukija's general template. Adapt that template and the current EU procedure form.

Main differences from a patient consent form

No therapeutic expectation

State plainly that the volunteer is not being treated for an illness and is not expected to receive a direct medical benefit. Explain the scientific purpose without implying personal health gain. Describe whether any screening result or incidental finding will be returned and how clinical follow-up will work.

Exposure and procedures

Explain dose escalation, placebo probability, first-in-human uncertainty, sentinel dosing, confinement, repeat dosing and stopping rules when applicable. Give accurate blood volumes, sampling frequency, biopsies, imaging, telemetry, cannulation and other burdens. Describe washout, fasting, diet, alcohol, nicotine, exercise and medicine restrictions that affect daily life.

Reproductive precautions

List permitted contraception methods and the required duration for each sex or reproductive situation included by the protocol. Explain pregnancy testing, sperm or egg donation restrictions and the pregnancy-reporting pathway. Do not transfer pregnancy language from another country without adapting it to Finland.

Alternatives

The alternative is usually not to participate. Do not include patient-treatment alternatives unless the protocol recruits a group that also has a medical condition requiring care.

Compensation without undue influence

Explain travel reimbursement, loss of earnings and inconvenience payments, including how partial participation or early withdrawal affects payment. Finnish law permits reasonable inconvenience compensation for participants outside the protected categories, but EU rules still prohibit undue financial influence. Payment should reflect time and burden, not risk acceptance.

Do not make withdrawal financially punitive. State which expenses and completed visits remain payable if the volunteer leaves early.

Insurance and medical care

Describe the actual insurance or guarantee and the route for obtaining care after an adverse event. Retain Tukija's Finnish Pharmaceutical Injuries Insurance and patient-insurance wording where it applies. Amend it when the investigational medicine or facility is covered differently.

Consent and signatures

Before consent, a qualified study-team member must explain the trial, answer questions, allow enough decision time and verify understanding. Recruitment language must not minimise risk or present payment as the main reason to join.

At consent, the healthy volunteer and the person receiving consent sign and date the form. The original stays in the investigator archive and the volunteer receives a paper or electronic copy. If the volunteer cannot write, follow the Finland impartial witness guide.

If samples or related data will be used for research outside the protocol, the volunteer makes that decision separately. Refusal must not affect trial eligibility. See the Finland secondary-use consent guide.

Use the Finland patient-facing document QC checklist before submission and return to the Finland CTIS hub for the complete series.