Finland Patient Information and Consent Requirements

What the Finnish consent set must achieve

The Participant Information Sheet and Informed Consent Form are the written record supporting informed consent. They do not replace the prior discussion. A qualified member of the investigating team must explain the trial, answer questions, allow enough decision time and verify that the participant or legal representative understands the information.

The information must allow a real choice. It should explain the trial's nature, objectives, possible benefits, implications, risks, inconveniences, duration, alternatives, rights, compensation system, EU trial number and availability of results. It must be concise, relevant and understandable to a layperson.

Mandatory. Submit all information given before the participation decision, the consent form and the recruitment and informed-consent procedure. Population-specific information for legal representatives, minors and other groups must be included when relevant.

Finland language rules

Mandatory. The Participant Information Sheet, Informed Consent Form, recruitment and consent procedure and recruitment advertising must be in Finnish and/or Swedish. The trial code and a concise, clear trial title in Finnish should identify the document unambiguously.

Tukija states that a Swedish Participant Information Sheet does not need to be submitted to CTIS after the Finnish version has been approved. This does not remove the duty to give each participant information in a language they understand.

Conditional. For a participant who speaks neither Finnish nor Swedish, provide all patient-facing documents in a language the participant understands. If the study team does not speak that language, arrange an interpreter throughout the research, not only for the signature visit. The interpreter should understand clinical trials, the participant's culture and the Finnish operating environment.

Length, readability and design

Tukija recommends a focused Participant Information Sheet of about 5 to 8 pages and normally no more than 10 pages. A complex trial may justify a somewhat longer document. Keep the main decision information in the sheet and move detailed operating instructions to a separate document when appropriate.

Use clear everyday language. Define unavoidable medical or foreign terms at first use. Use consistent units, time periods and forms of address. Adapt translated examples to Finland rather than preserving foreign healthcare processes or measurements.

Avoid commands, inducements and wording that assumes the reader will agree. Explain restrictions that affect the participation decision, such as diet, contraception, prohibited medicines or frequent questionnaires. Do not overload the information sheet with step-by-step product-use instructions.

Recommended. Test the draft with lay readers and research staff. Tukija also advises consulting the patient group concerned. Consider an easy-language version when the target population needs it.

Required participant information

Trial identification and voluntary choice

State clearly that this is a clinical trial on medicinal products. Include the trial name, code and EU trial number. Explain why the person is being invited. Place voluntariness near the start, including the right to refuse or withdraw without giving a reason and without losing treatment rights.

Sponsor, sites and contacts

Identify the sponsor, Finnish trial site, principal investigator and implementing organisation. Identify the controller or joint controllers and explain who answers data-protection questions. Give usable contact details for trial questions, adverse events, withdrawal and privacy matters.

Purpose, design and procedures

Explain the primary and principal secondary objectives in neutral language. Describe the investigational medicinal product, placebo or comparator, randomisation, blinding and treatment groups in terms a layperson can understand. State the trial duration, visits, calls, follow-up, extra procedures and what differs from standard care.

Describe the target group without reproducing the full eligibility list. If combined medicinal-product and medical-device elements apply, say so. Explain any genetic analysis and whether it is limited to the current trial.

Benefits, alternatives, risks and burdens

Do not promise benefit. State whether direct benefit is expected and explain the value of the research separately. Include the most severe and most common adverse reactions in the main sheet, plus risks from comparator treatments and procedures. Explain meaningful everyday burdens, washout periods, emergency medicines and treatment alternatives.

If the trial includes ionising radiation, explain each examination, its purpose, dose and relevant risk in understandable terms. State when exposure is no greater than conventional care. Provide the frequency and total dose when several examinations are used.

Pregnancy and contraception

Describe protocol-specific contraception methods, pregnancy restrictions and what happens if pregnancy occurs. State whether maternal, pregnancy-outcome, foetal or infant information will be collected and for how long.

The main participant document may cover follow-up of a trial participant who becomes pregnant. Collecting information about a pregnant partner requires a separate Participant Information Sheet and Informed Consent Form. The Finland pregnancy follow-up guide explains the distinction.

Biological samples and future use

Explain samples collected under the protocol, their purpose, handling, storage, transfer and any genetic analysis. Future research outside the protocol must not be hidden inside the main consent. Tukija advises a separate optional information and consent package for future use of biological samples and related data. Refusing that optional use must not prevent trial participation. The Finland secondary-use consent guide covers the additional document.

Confidentiality and data protection

Provide the information required by GDPR Articles 12 to 14. Identify the controller, purposes, legal bases, data categories, recipients, retention, rights, complaint route, sources, transfers and safeguards. State where patient-record or registry data will be obtained and whether direct remote access to confidential health records is planned.

Tukija's template identifies Articles 6(1)(c), 6(1)(e) and 9(2)(i) as possible Finnish statutory bases, while leaving the controller responsible for the final selection. Cite the chosen article, paragraph and point. If legitimate interest is used, explain that a balancing test has been performed and briefly describe it.

Use pseudonymisation accurately. Do not call coded data anonymous when a key still exists. Describe transfers outside the EU or EEA and the applicable safeguard. In Finnish participant-facing text, Tukija advises using the equivalent of ethnic background rather than the word race.

Costs, compensation and insurance

State that the investigational medicinal product and protocol-required procedures are normally free. Explain travel reimbursement, loss-of-income compensation and any inconvenience payment. Identify the trial funder, payments to the centre or staff and relevant financial interests in neutral terms.

Retain Tukija's Finland-specific insurance explanation unless the actual cover requires amendment. It distinguishes unexpected adverse reactions covered by Pharmaceutical Injuries Insurance from other healthcare-related injuries addressed through the trial site's patient insurance. Explain an alternative arrangement when the investigational medicine is not covered.

Ending the trial and access to results

Explain follow-up after treatment or withdrawal, what happens to previously collected data, possible sponsor or investigator discontinuation, unblinding after the trial and how results will be available in the EU database. If participants will not receive a category of findings, explain why.

Consent form and signatures

At CTIS submission. Submit an unsigned, version-controlled consent form. Tukija's general dossier instruction says signatures are not required in the application documents.

When consent is obtained. The participant or legal representative signs and dates the form. The person who conducted the consent discussion also signs and dates it. The form should record who gave the explanation, the voluntary decision, withdrawal rights and the permitted processing needed for trial oversight.

The original signed document remains in the investigator's archive. Give a paper or electronic copy to the participant or legal representative.

If the participant can consent but cannot write, use the Finland impartial witness procedure. If a representative gives consent, prepare a separate representative information sheet and consent form rather than simply changing the signature label.

Population-specific variations

The standard adult consent set is not enough for every trial. Prepare and link the correct variation:

• healthy volunteer consent for non-therapeutic participation
• minor consent and assent for children, adolescents and guardians
• limited-capacity and legal representative consent for adults unable to consent independently
• emergency enrollment consent when Article 35 applies
• pregnancy follow-up consent for participant and partner pathways
• secondary-use consent for optional use outside the protocol

Before submission, apply the Finland patient-facing document QC checklist. The Finland CTIS hub links the complete guide series.