A biobank is a place where biological samples and associated information are kept to be used for medical research. Samples can be either blood, saliva or urine, taken from both patients and healthy individuals from the general population. The information includes general characteristics (age, gender, race, education, occupation) of the individual and their medical data, all collected with consent of the individual. Biobanks preserve samples for a number of years and thus they make most medical research possible as they allow for long-term research projects. The aim is to discover ways of improving prevention and diagnosis, and making breakthroughs of novel treatments and/or cures to a range of diseases.

Our biobank is called DwarnaBio.

Participation in biobanking and medical research is voluntary. Whether you decide to participate or not, any medical treatment you may receive will not be affected. Your participation will involve giving your consent to donate biological samples (generally blood, urine and/or swab samples) together with information about you, including both general data (age, gender, race, education, occupation) and medical data, which will be treated with the utmost care and strictest confidentiality.
You will be able to ask questions at any stage if you need any clarifications.
You will also have the right to withdraw participation at any time, without giving any reason and without suffering any harm.

All the information collected or discovered is strictly confidential and private.
After donating your sample to DwarnaBio, your identity is kept private by replacing your name with a code. This process is referred to as pseudonymisation. The code will label the sample and all the associated data. The sample collection is under the responsibility of the designated curator, the Biobank Manager.

The processing and storage of this data is managed through secure computerised systems at the University of Malta. All paper documents (for example, the signed consent forms) will be stored securely in an office at DwarnaBio and will be in the care of the Biobank Manager and the Data Controller.

The samples and their associated data can only be linked to your personal contact details through the pseudonymisation code, which is stored separately from other data and is available only to the Biobank Manager and the Data Controller. Any data obtained from research studies and any work published from the studies will not and cannot be traced back to you.

Pseudonymisation is the process of keeping the identity of an individual private and confidential by using a code instead of their name or personal identifiers.

In technical terms, the General Data Protection Regulation (GDPR) defines pseudonymisation as “the processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the personal data are not attributed to an identified or identifiable natural person.”

Yes. You will always have the right to stop participating in DwarnaBio at any time. This means that you will be able to decide to withdraw your samples and all associated personal data from DwarnaBio. Once you withdraw consent, your sample will be destroyed, and all associated personal data will be deleted.

Moreover, the code that links your sample to your personal data will also be destroyed. However, if your sample has already been used in research (as always in a way that does not identify you), and has led to data and results that have been processed, these cannot be removed or destroyed.

If you are already a participant and would like to withdraw your sample and consent from DwarnaBio, you should contact the biobank manager on telephone number 2340 3866 or email contact@dwarna.mt.

Yes. This is possible by using the Dynamic Consent facility on dwarna.mt. You can decide to withdraw consent for a research study at any time without giving a reason and with no negative consequences to you. Your sample will be retained in DwarnaBio for future use in research studies about which you will be contacted and invited to participate.

This is possible by using DWARNA portal. Here you will find details about research studies in progress. If you would like to update your consent to give permission to use your sample in a new study, go to Manage my Consent and follow the step by step instructions there. If you need help with this, or require more information , please get in touch with us at contact@dwarna.mt or phone 2340 3866.

The GDPR is a European legal instrument that protects personal data by regulating the processing of personal data. The aim is to ensure that data subjects are protected from any form of harm, by ensuring that personal data is kept private. So, the GDPR applies to biobanks and biomedical research since biobanks collect, store and/or process human biological material, in combination with personal data, such as contact information, genetic information and health data.

The GDPR ensures transparency and accountability in scientific research, amongst other areas. The GDPR grants research participants the right to access, rectify or erase their personal data. The GDPR has made the appointment of a Data Protection Officer (DPO) mandatory and for DwarnaBio, this is the University DPO, Dr Luisa Spiteri-Baluci.

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Biobank information leaflet. [document on the internet] 2010, Apr (accessed 30th September, 2010) Available from:
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https://www.um.edu.mt/biobank/faqs