A national biobank

Why is the biobank needed?

Who will have access to the samples?

How will privacy be ensured?

Who will the samples be taken from?

How will the samples be taken and processed?

How will sample donors be informed?

Is it possible to prohibit use of the sample at a later date?



Why is the biobank needed?

Blood and bone marrow samples from patients with hematological disorders are collected for the Finnish Hematology Registry and Clinical Biobank. These samples are needed for studies investigating methods for the prevention, diagnosis, treatment and follow-up of severe hematological disorders, especially leukemia. Samples are needed for basic cancer research as well as for clinical research studies.

At the moment, patients with leukemia are primarily treated with high-dose cytostatic agents and stem cell transplantation. These treatments are hard on the patients and difficult to target for optimal individual effect. There is a great need for treatment development because current therapies are not effective in all patients, and some patients cannot tolerate them.

The aim of clinical research studies is to develop therapies that are safer, more targeted and more effective than current therapies. One objective is to develop treatments that are tailored individually on the basis of genetic or protein abnormalities to target malignant stem cells (personalized medicine).

Who will have access to the samples?

The samples will only be made available for medical research that falls within the biobank’s field of research. In order to be granted access to the samples, researchers must produce a written application and a release request. These must be submitted together with the study protocol and a report on the processing of samples and data as well as the information needed to evaluate whether the requirements for release are satisfied. The professional and scientific competence of the recipient of the samples and data will also be evaluated before release is granted. The samples and data made available for research are always coded, and the privacy of the sample donors is thus protected. Information about research projects utilizing the samples is published on the biobank’s website.

How will privacy be ensured?

As with any other patient data, registry information relating to the samples, including personal information, is handled in compliance with the strictest data protection criteria.

The samples are coded separately for each study. In other words, the code number used by the biobank will not be disclosed, and each sample and the related data will be assigned a new code number for each study. As a result, only the biobank can compile the data accumulated from the sample.

Who will the samples be taken from?

The goal is to be able to obtain and store samples from all patients with hematological disorders for research purposes.

How will the samples be taken and processed?

Blood and bone marrow samples will be taken from patients at different stages of the disease (e.g. at the time of diagnosis, at remission and at relapse). Two small skin biopsy specimens will also be taken when the first samples are collected. Samples needed for diagnostic and therapeutic purposes always take precedence and are collected before samples to be stored in the biobank.

The samples are taken in accordance with the guidelines of the biobank and sent to the Blood Service for processing. The Blood Service uses a quality-controlled sample processing system that also includes validated sample transport from hospitals. The Blood Service processes the samples for storage and sends them to FIMM, where they are stored in ultra-low temperature freezers in gas phase liquid nitrogen.

How will sample donors be informed?

A nurse, a study nurse or a doctor reviews the sample donor’s information sheet and consent form with the patient and answers any questions before the samples are taken.

The sample donor’s information sheet will already have been sent to the patient with the appointment letter. The person who reviews the information sheet with the patient will witness signing of the consent. Data and samples will only be collected from patients who have consented to it.

Is it possible to prohibit use of the sample at a later date?

If the patient wishes to withdraw his/her consent later during the project, he/she is free to do so. In such cases, the patient’s registry data and samples will not be used for any further research. Samples that have already been made available for research projects will not be tracked.