Sweden CTIS Part II Patient Information and Consent Requirements

What the Swedish participant information must explain

The information must be written so that a lay person can understand the decision being asked of them. Under the CTR and Läkemedelsverket guidance, it should allow the participant to understand:

• the purpose of the trial
• expected benefits, consequences, risks and inconveniences
• the participant's rights and protections
• the right to refuse participation
• the right to withdraw at any time without negative consequences and without having to give a reason
• how the trial will be conducted and how long participation is expected to last
• available treatment alternatives where relevant
• follow-up if trial participation is stopped
• the right to compensation for trial-related injury
• the EU trial number and how trial results can later be found in the EU database

The information should be exhaustive enough for an informed decision but still concise, clear, relevant and understandable.

Content that is conditional on the protocol

Several topics belong in the participant documents only when they apply to the study.

Conditional. Pregnancy and contraception. Explain pregnancy risks, contraception requirements, pregnancy testing, reporting and what happens after a pregnancy is identified when these are part of the protocol. If pregnancy follow-up of a participant or partner is planned, use the Sweden pregnancy follow-up guide.

Conditional. Biological samples. Explain which samples are collected, why, how long they are retained, where they may be sent, what analyses are planned and what choices the participant has. If the Biobank Act applies, ensure that the participant information matches the Swedish biobank application and the authorised CTIS sample description. Use the Sweden secondary use consent guide for future-use choices.

Mandatory. where applicable. Compensation and insurance. The participant-facing explanation must not conflict with the Part II insurance and financial arrangement documents. State relevant reimbursement, compensation and injury-protection information in a way the participant can understand.

Mandatory. where personal data are processed. Explain the study's handling of participant information consistently with the protocol and data-protection documentation. Do not use a research consent checkbox as a substitute for the sponsor's separate data-protection obligations.

Mandatory. Contacts. Give the participant practical contacts for trial questions, medical issues and rights or complaints where applicable to the approved study documents.

Swedish consent and signature logic

The normal consent pathway is written consent. The consent is dated and signed by the participant, or the legally designated representative where applicable, and by the person who gives the information.

Sweden adds a professional-role rule. Under HSLF-FS 2021:109, the person responsible for obtaining informed consent also conducts the Article 29 interview. The normal rule is that this is a licensed physician or licensed dentist. Läkemedelsverket can permit another healthcare professional when special reasons exist. If the sponsor proposes that arrangement, the reason should be justified in the protocol.

The signed consent and written information are retained at the trial site, and a copy is given to the participant or representative.

Population-specific consent versions

The main adult consent form is not enough when a population has different legal or practical consent logic.

• For healthy volunteers, use the healthy volunteer consent guide.
• For participants under 18, use the minor consent and assent guide. Sweden has a specific rule for participants aged 15 or older who understand the trial.
• For adults without decision-making capacity, use the limited-capacity and legal representative guide.
• For Article 35 emergency enrollment, use the emergency enrollment consent guide.
• When a participant cannot write or sign, use the impartial witness guide.
• For pregnancy-related follow-up, use the pregnancy follow-up guide.
• For optional future use of data or samples, use the secondary use guide.

Submission timing

At initial Part II submission, upload the final proposed Swedish participant documents with controlled version numbers and dates. Do not pre-sign participant consent documents.

Before any trial-specific procedure, obtain consent using the approved process unless the protocol lawfully uses the emergency enrollment exception under Article 35. If the approved participant information or consent logic changes materially, assess whether a substantial modification and participant re-consent are required before implementing the change.

Return to the Sweden CTIS Part II hub or run the patient-facing document QC checklist before upload.