Sweden CTIS Part II Healthy Volunteer Consent Requirements

When a healthy-volunteer version is needed

Conditional. Use a healthy-volunteer participant information and consent version when the trial recruits people without the disease or condition being studied and the standard patient document would give a misleading explanation of benefit, alternatives, procedures or compensation.

The document must still be in Swedish and meet the ordinary Article 29 information and consent requirements.

Main differences from a patient SIS and ICF

Where no direct therapeutic benefit is expected, say so clearly. Do not use patient-treatment language that suggests the investigational product is being offered as therapy.

Explain:

• the scientific purpose of exposing healthy volunteers
• dosing and escalation where relevant
• confinement or residential requirements
• washout, fasting or activity restrictions
• blood volume and other repeated sampling
• foreseeable adverse effects and uncertainty
• stopping rules that affect the volunteer
• contraception and pregnancy restrictions where relevant
• follow-up after dosing
• reimbursement and compensation
• injury protection and insurance

The compensation wording must match the Part II financial arrangements. Payment should not be presented as a benefit that changes the voluntary nature of the decision.

Swedish consent process

The normal Swedish rule remains that the participant and the person providing the information sign and date the consent. The person responsible for obtaining consent normally must be a licensed physician or licensed dentist. Another healthcare professional requires special reasons and a Läkemedelsverket exception.

The blank Swedish form is submitted in CTIS. The volunteer signs only when consent is obtained.

Protected populations

Do not treat a person as an ordinary healthy volunteer merely because the study is non-therapeutic. Swedish law prohibits a clinical trial not connected with treatment of disease from being performed on a person receiving care under the Swedish compulsory psychiatric care legislation or forensic psychiatric care legislation.

If the protocol includes minors or adults without decision-making capacity, use the separate Swedish population pathway rather than the healthy-volunteer form alone.

Templates and submission set

No dedicated Swedish authority healthy-volunteer consent template was identified in the sources reviewed. Use the normal Swedish participant information requirements and create a population-specific version that accurately reflects the protocol.

Make sure the compensation document, insurance evidence, recruitment material and consent procedure all describe the same volunteer pathway.

Return to the Sweden CTIS Part II hub or use the Sweden patient-facing QC checklist before submission.