Sweden Secondary Use Consent CTIS

Data-related secondary use

A separate optional research-consent checkbox is not automatically required for every possible later use of trial data. Decide first whether the proposed use is part of the authorised trial, a defined optional substudy or a future project outside the present trial.

If an optional use is genuinely separate from main-study participation, make that choice clear. Refusal of the optional use should not be drafted as refusal of the main trial unless the protocol actually makes the activity necessary for participation.

Keep the participant information consistent with the sponsor's data-protection documentation. Research consent and the legal basis for personal-data processing are related but not interchangeable concepts.

Biological samples within the authorised clinical trial

Mandatory. when samples are part of the trial. The CTIS application should describe collection, storage and use of biological samples. Sweden provides a national biological-sample compliance template, and a parallel biobank process may apply.

Under the Swedish Biobank Act, samples used for a clinical medicinal product trial can be used in accordance with the authorised CTR application when that application contains information on the collection, storage and use of the samples.

This makes early consistency essential. A broad sentence in the ICF cannot repair an application that does not describe the intended sample use.

New purpose after the original consent

The Biobank Act states that a stored sample may be used for a purpose outside the earlier information and consent only when the person who gave consent has been informed about and consented to the new purpose, subject to the Act's specific rules.

For a new purpose that is ordinary research outside the clinical-trial rule, Etikprövningsmyndigheten or the appeals board decides, when approving the new purpose, what information and consent requirements apply.

For a new purpose that itself is a clinical medicinal product trial, the Biobank Act links permitted use to the authorised CTR application, provided the application contains the required sample information.

Do not promise that a one-time broad future-use checkbox removes the need for later ethical or biobank review.

Withdrawal and restriction of sample consent

Under the Biobank Act, consent to retain or use a sample can be withdrawn. The donor can also restrict one or more permitted purposes.

When withdrawal covers retention or all use, the Act sets consequences for destruction or, where destruction is not possible without destroying other samples, de-identification.

The participant-facing document should explain the applicable withdrawal effect accurately and avoid promises that conflict with the law or the physical realities of samples already used in completed analyses.

Sharing and transfer

If samples will be sent to another legal entity, laboratory or country, explain this consistently with the protocol and biobank documentation.

Swedish biobank rules include conditions for making samples available and for sending samples for a specific action. The biobank process should be arranged before trial start where it applies.

Parallel biobank process

When the Biobank Act applies, Biobank Sweden recommends contacting the Regional Biobank Centre early. For regional biobanks, an unsigned biobank application can be sent in parallel when the clinical trial application is registered in CTIS.

The final biobank agreement takes effect only after the required sponsor and biobank approvals and signatures. This process is separate from uploading the Swedish biological-sample compliance document in CTIS.

Required document set

Depending on the study, prepare:

Swedish main participant information describing current trial sample use
optional Swedish future-use consent if the protocol offers a separate future-use choice
Swedish CTIS biological-sample compliance document
the applicable biobank application and forms
any later new-purpose information and consent required by the approved future project

No universal Swedish form can substitute for defining the actual future purpose.

Return to the Sweden CTIS Part II hub and use the patient-facing QC checklist to reconcile the protocol, ICF, CTIS sample document and biobank application.