Biobanks store and manage human tissues (also called biological  samples) on behalf of hospitals, clinics, scientific societies or industrial manufacturers, for the use of research. For this process they act as Processors.

Human tissues can designate samples of blood, marrow, bones, flesh, skin, organs and any other element from the human body of human subjects.

Biobanks can also perform analysis on the samples; for example they can isolate the DNA so that it is ready to use by other researchers in other research studies.

These biological sample warehouses store not only the biological tissues, but also the data associated with it: code of the patient, indication for which it was collected, if relevant name of the research study for which the sample has been obtained and analysed, name of the hospital where it was  collected from the patients, and of course all biological parameters derived from the sample. 

Biobanks release elements of the samples to researchers who request them for their own research; in that case, biobanks act as Controllers. In some cases, researchers can be based outside EU, which then generates what is called a transfer of personal data to a third country. This needs of course to be strongly controlled, with Data Privacy by design.

Because all these data are stored, and because the human sample itself is a personal data, biobanks store and manage very sensitive personal data: even if patient data are encoded (= pseudonymised), because usually samples are collected for specific diseases, the identity of the patient could be found again with limited effort.

Since the scandal of contaminated blood happened in several countries in the 80s and 90s, biobanks are subject to very rigorous regulations from the EU and from local health autorities: they need to comply with strick guidelines, and are audited regularly by local healthcare authorities.

Recommended storage duration varies from country to country, from one year to until the 'end of life' of the sample. So, you can understand that personal data protection at biobanks is a very sensitive job. 

In addition, you need to take into account the  wishes expressed by each patient  for the processing of his/her samples after death.

At PharMarketing, we work for biobanks and thus understand the way they operate, and are aware of the regulations they need to comply with. Most importantly, we know the key points to check for personal data protection. Also, we have a simple approach which is tailored to the limited resources of biobanks.

Ask us for more information and for a quote!