Biobanking for Research Purposes

At present, the regulatory framework for research biobanks in Greece is formed by general provisions, particularly those requiring informed consent for interventions in the human body (including sample collection), and those related to the protection of personal data to be used for research purposes (GDPR, art. 9, 89). Specific regulation exists only for research with reproductive material (l. 3305/2005). However, the recent official establishment of networks for the development of precision medicine applications (in cancer and cardiovascular diseases), with the participation of the main research centers in Greece, opens a discussion on future biobanking specific legislation, since biobanks for studying data that might be useful in potential tailor-made therapies, are to be established in these centers. Until then, the above general regulation will govern the area, needing careful implementation to capture all details following each research objective’s particular characteristics.

Our services: Members of our team have an active contribution to the evaluation of research protocols, in terms of law and ethics, in the EU and in national universities’ and research institutes’ research ethics committees, for more than a decade. They have also participated in scientific and legal conferences, workshops and seminars in relevance, with original papers and interventions (often as key-note speakers), dealing with the implementation of existing provisions or new law-making approaches in research biobanking. Services we are offering are related to:

- Preparation of formal applications for the establishment of research biobanks in Greece, according to the existing legal requirements

- Preparation of legally sound information documents and consent forms, for biological samples or data donors

- Preparation of contract templates to be used in biobanking commercial activities, including samples and data transfer, and collaboration with hospitals, clinics, or academic and research institutions

- Consultation on regulatory issues, particularly regarding professional liability of research experts acting as owners or employees in biobanks

- GDPR compliance and DPO services, including impact assessment