A biobank is a place where biological samples used for medical research are kept. Samples can be either blood, saliva or urine, taken from both patients and healthy individuals from the general population. 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.

DwarnaBio currently has projects researching cancer, heart disease, diabetes, arthritis and a range of rare diseases such as Thalassemia and ALS.

Through medical research it is possible to learn why some individuals are susceptible to certain disease whereas others are not. Such information then allows for the discovery of novel drug targets for therapy.

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 access to your medical data, which will be treated with the utmost care and strictest confidentiality. You will be able to ask questions at any stage should you have any problems. You will also have the right to withdraw participation at any time.

As a donor, you retain the right to withdraw your consent at any time. You will also be able to decide to withdraw your samples from the biobank, should this be possible. This is only not possible when samples are fully anonymised, since the Biobank Manager would be unable to determine which samples are yours. Once you withdraw consent your data will no longer be processed.

If you are already a participant and would like to withdraw your consent to one or more of the studies you are participating in, you should contact the biobank manager. You can also withdraw consent through the Dynamic Consent page.

When you withdraw consent from a research study, the biospecimen cannot be used any longer in that research study. If you have consented to participate in any other research studies, the biospecimen may still be used in those studies until you withdraw from them as well.

When you ask for your data to be entirely removed, you automatically withdraw consent to continue participating in all research studies. All of your data is also erased from the Dwarna web portal and instructions will be forwarded to DwarnaBio to destroy your biospecimen. Erasing your data is irrevocable. To start participating in research again, you would need to start the process from scratch by registering as a new research partner/participant.

All the information collected or discovered is considered strictly confidential and private. After donating your sample to DwarnaBio, any medical information will be stored securely in an office in the University of Malta and will be in the care of the Data Custodian. The clinical data is kept separately with a secure method to link clinical information to biological specimens. Any data obtained and any work published from the studies will not and cannot be traced back to you.

The GDPR ensures transparency and accountability in scientific research, amongst other areas. The GDPR enhances the rights of research participants such by enforcing mandatory procedures for managing data breaches. The aim is to ensure that data subjects are protected from any form of harm, by ensuring that personal data is kept private. The GDPR has made the appointment of a Data Protection Officer mandatory. Entities which do not comply to GDPR are faced with remedies, sanctions and fines.

The GDPR also applies to biobanks and biomedical research since biobanks collect, store and/or process human biological material, in combination with other sensitive data, such as genetic and health data.

The 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.”

There is no direct and immediate gain to yourself when donating your biological sample. Your participation however will greatly benefit clinicians and researchers to advance knowledge on diseases with genetic links, and find new ways of treating them.

Should our laboratory scientists identify genetic variation that can cause disease, we can let you know. It is entirely your choice whether you wish to be informed. We will only contact you about these actionable findings if you give us your permission in the consent form. The Dwarna biobank is not a DNA profiling service at an individual level, so if you have any concerns about heritable conditions, please contact your family doctor so they will refer you to a genetic counsellor.

BBMRI Common Service ELSI. The EU general data protection regulation answers to frequently asked questions 1.0. 2016: http://www.bbmri-eric.eu/wp-
content/uploads/2016/08/BBMRI-ERIC_FAQs_on_the_GDPR_V1.0_for_print.pdf

UK Biobank information leaflet. [document on the internet] 2010, Apr (accessed 30th September, 2010) Available from:
http://www.ukbiobank.ac.uk/docs/BIOINFOBK14920410.pdf.

Macleod AK, Liewald DC, McGilchrist MM, Morris AD, Kerr SM, Porteous DJ. Some principles and practices of genetic biobanking studies. Eur Respir J. 2009;33(2):419-25. https://pubmed.ncbi.nlm.nih.gov/19181915/

http://www.bbmri.eu/index.php/about-bbmri/background (accessed 30th September, 2010).

https://www.um.edu.mt/biobank/faqs