The Biobank Register

When a principal has decided to set up a biobank, a notification must be submitted to the Health and Social Care Inspectorate (IVO).

Notification of  a biobank

The beneficial owner of the biobank is required to submit the notification. The notification must include details of:

• where the biobank will be kept;
• who will be responsible for the biobank;
• the scope of the biobank.

The notification must be submitted within 1 month of the decision to establish the biobank. If any of the information in a previous notification changes, the beneficial owner must notify the IVO within 1 month of the change. The beneficial owner need not be the party responsible for the biobank. If the beneficial owner wishes to make their tissue samples available to someone else, this must be notified within 1 month of the decision.

Permission from IVO is required for a beneficial owner to transfer a biobank to another beneficial owner. The application must state the reasons for the transfer, who is to take over the biobank, and where it is to be kept.

Consent from IVO is required to close a biobank and destroy tissue samples. The notification must state why the biological material is no longer relevant for the purpose(s) for which the biobank was established and why there is no public interest in preserving the samples.

In addition to supervision , the register is used to produce statistics. However, it does not contain personal information of individuals.

Please note that the notification requirement does not imply any authorisation procedure.

Forms

Notification of a biobank or Notification of the release of tissue samples from a biobank.

The biobank notification form must be sent to:

Inspektionen för vård och omsorg
Box 45184
104 30 Stockholm

Information Requests

It is easy to place a request with us, and in most cases the process  time is short. Beneficial owners recorded in the Biobank Register can also request a register excerpt to see what is registered after which a notification of changes can be made.

Examples of requests to the Biobank Register are queries regarding how many registered biobanks there are, who is responsible, and contact details.

You can send requests by email or post:

Inspektionen för vård och omsorg
Box 45184
104 30 Stockholm

Email: registerfragor@ivo.se

Questions about registers

If you have any questions about registers, please write to registerfragor@ivo.se.

The information in our registers is accessible in accordance with the usual disclosure rules under the Public Access to Information and Secrecy Act (offentlighets- och sekretesslagen).