Svetlana Gramatiuk
Ukraine Associated of Biobank, Ukraine
Keynote: J Stem Cell Res Ther
Quality biological samples stored in Biobanks are essential for the provision of appropriate health services and also act
as a reservoir for the development of precision medicine and biotechnological innovation. The Ukrainian Association
of Biobanks (UAB) coordinates the network procedures, based on ESBB, ISBER, BBMRI and NCI guidelines, which are
standardized across the entire network. Policies and documents including Patient Consent Policy, Patient Information Sheet,
Biobank Informed Consent Form, and Sample Application Form after extensive and constructive discussion in UAB have been
agreed for use in each hospital and medical institute. An optimum sequence for document preparation and submission for review
have been outlined. At the outset, UAB employed ESBB standard operating procedures (SOPs) for tissue collection, storage,
and processing. Harmonization of policies and SOPs is an ongoing activity and standardization is achieved via workshops and
training in data protection, database management, data sharing, tissue collection and storage, ethical considerations, sample
access, and quality control. It was important at the initiation of UAB to develop a sequence for policy development, review,
and approval. It was essential that policies were compliant with both national and European guidelines and directives. UAB
introduced a standardized Patient and Volunteers Information Letter, Informed Consent Form of Biobank and Sample Access
Policy in Ukraine for the first time. It was difficult, in the beginning, to distinguish the order in which to develop, to agree and
finally to submit documents of UAB for review. The Ireland pathway was identified as the most effective for Ukrainian local
circumstances and it was decided to adopt a similar sequence of document development and submission. Fist, the consensus
was reached with each hospital within the network. Second, a review of documents by the Risks and Legal Department in UAB
was performed. Parallelly a formal legal statement was obtained from an independent lawyer specialized in medical research.
Conclusion: The UAB short- to medium-term objectives include expanding the current network and to include each of the
major medical research centers in Ukraine. Enlargement of the network could be undertaken with modest capital investment
and UAB medium size will facilitate a swift and dynamic approach to network expansion. Ideally, the Ukrainian biobank
network should be integrated into working groups within larger European networks in the future as it is affiliated with the
Science and Innovation Working Group for international biobanking ESBB. By now, the UAB is reaching its goal: to develop
infrastructure and facilitate the biomedical research nationally and internationally.
Svetlana Gramatiuk (MD, PhD) serves as President of Ukraine Associated of Biobank that she co-founded in 2017. She was also the Medical Director Research Biobank ASK-Health (2015-2016) and the Ukraine Editor of the journal Advanced Research Biobank and Pathophysiology from 2017. Previously, she also established and/or managed several biobanks in Ukraine. In addition to his unique expertise in Biobanking, she also did Master of Science Biobanking in Medical University Graz and has an in-depth knowledge of oncology biomarker research in the position holding a from Head Department Medical and Research Laboratory in the Grigoriev Radiology and Oncology Institute and having completed a Post-Doctoral Fellowship at the Kharkiv National Medical University (Department Pathophysiology from Kharkiv, Ukraine).
E-mail: gramatyuk@ukr.net