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Biobanks are specialized repositories that collect and store biological samples and information from various sources (animals, plants, microorganisms, humans, etc.). The focus of this module is on human biobanks, which collect and store biological samples from human donors (e.g., saliva, urine, blood) and health-related data (e.g., health records, family history, lifestyle, genetic, occupational, residential information, etc.) for research purposes and the development of new diagnostic procedures,  preventive measures, and treatments. Some biobanks collect health-related data from donors throughout their life, and researchers may continue to access and make use of this data after donors’ demise.

These repositories play a crucial role in advancing biomedical research, by providing scientists with access to a diverse array of high-quality biological materials and continuously updated health-related data. Biobanks ensure the preservation of sample integrity,  allowing for researchers to conduct longitudinal studies and other investigations into various health conditions at multiple scales.

For instance, by analyzing samples and data, researchers can search for biological markers, investigate the relationship between biological markers and the sensitivity of diseases to treatment, the aggressiveness of diseases, progression, risk of death, as well as study the genetic and environmental factors that influence the development of certain diseases.

Legal instruments and guidance govern biobank operations to protect the autonomy and dignity of donors, along with their fundamental rights (e.g., private life and data protection) while also advancing the societal benefit of conducting research to address the key public health challenges.

Overall, biobanks contribute significantly to the progress of medical science and personalized medicine.

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Alison, a 42-year-old woman in robust health, was invited to contribute to scientific advancement by donating biological material along with health-related information (data) to a biobank. Alison explained to her friends and family that she wanted to contribute to medical research ‘to give something back’ after seeing her father’s successful treatment for cancer.

The biobank provided Alison with detailed information about the purpose of the biobank,  the types of samples and data needed, risks and potential benefits related to the donation to biobanking and the right to withdraw consent.

Alison then gave her consent to the donation process, acknowledging her understanding and agreement to participate.

Before donating the samples, Alison underwent a thorough screening process which included a review of her medical history and a physical examination.

The samples were carefully labelled, processed, and stored in secure, controlled environments. Storage conditions also comply with stringent ethical and privacy protocols, ensuring the preservation of Alison’s privacy and confidentiality.

Alison was told that her personal information would be de-identified or pseudonymized to protect her identity. As part of the consent process, Alison also gave permission for the biobank to contact her in the future to follow up on her health as she ages and potentially invite her to participate in further studies beyond the scope of her original donation. Maintaining contact with donors is crucial for biobanks when samples are used for longitudinal studies or when follow-up health information is needed.

Alison's donation is now part of a valuable resource for researchers studying various health conditions,  including genetic predispositions and disease markers. Her contribution will allow scientists to conduct longitudinal studies, advancing the understanding of health and potential breakthroughs in personalized medicine. Alison's decision exemplifies the vital role individuals can play in shaping the future of medical research through biobank donations.

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Researchers access biobanks’ collections of samples to conduct a wide range of studies, including genetic research, biomarker discovery, disease modelling, and the development of personalized medicine approaches. The diversity of biological samples allows for comprehensive investigations into the complexities of human health and diseases.

In addition to collecting biospecimens from donors, biobanks also collect a wide variety of health-related data. The types of data collected and stored may be categorized into 4 main categories.

Drag and drop the types of health-related data that may be collected by biobanks into the relevant column. It's important to note that the specific data collected can vary depending on the focus and objectives of the biobank. The contextual information provided by clinical, demographic, and lifestyle data enhances the scientific utility of biospecimens. Researchers can correlate genetic details with health histories, enabling insights into disease mechanisms, personalized treatments, and biomarker discovery. Longitudinal data aids in tracking disease progression, contributing to better prognostics. Collecting comprehensive data alongside biospecimens ensures the quality, relevance, and ethical use of stored samples, fostering advancements in precision medicine and therapeutic development.

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By adhering to these procedures, biobanks ensure that biological samples remain well-preserved, maintaining their scientific utility for years or even decades.

This meticulous approach is crucial for supporting diverse research initiatives and contributing to advancements in medicine and healthcare.

Biological samples in biobanks are stored with meticulous care to ensure their preservation, integrity, and long-term stability. The storage process involves several key steps:

1. '''Sample Processing:''' After collection, biological samples undergo processing to prepare them for storage. This may include centrifugation, separation, and aliquoting to obtain specific components like DNA, RNA, or serum.

2. '''Barcoding And Labelling:''' Each sample is assigned a unique barcode or identifier, linking it to relevant donor and sample information. This labelling system ensures accurate tracking and minimizes the risk of errors during storage and retrieval.

3. '''Temperature Control:''' Samples are stored at controlled temperatures to prevent degradation. Common storage conditions include ultra-low temperatures (-80°C or -196°C in liquid nitrogen) for DNA, RNA, and tissues, or -20°C for certain proteins and blood components.

4. '''Cryopreservation:''' For long-term storage, particularly for cells and tissues, cryopreservation is employed. This involves freezing the samples rapidly to extremely low temperatures, often in liquid nitrogen, to halt biological activity and prevent cellular damage.

5. '''Automated Storage Systems:''' Many modern biobanks utilize automated storage systems with robotic retrieval mechanisms. These systems enhance efficiency, accuracy, and minimize the need for human intervention, reducing the risk of contamination or mishandling.

6. '''Quality Control Checks:''' Regular quality control checks are conducted to ensure sample integrity. This includes monitoring temperature stability, confirming sample identity through barcodes, and assessing sample condition over time.

7. '''Security Measures:''' Biobanks implement stringent security measures to safeguard samples. Access to storage facilities is restricted, and environmental monitoring systems detect any deviations from optimal storage conditions.

8. '''Backup Systems:''' Biobanks often have backup systems in place,  such as back-up freezers and power sources,  to mitigate the risk of sample loss in case of equipment failure or unforeseen events.

9. '''Data Management:''' Accurate and secure data management systems track the entire lifecycle of each sample,  including collection, processing, storage, and retrieval. This comprehensive documentation ensures traceability and transparency.

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International cooperation among biobanks is essential for advancing scientific research, promoting data sharing,  and accelerating global progress in healthcare. Biobanks employ several methods to facilitate this collaboration such as adhering to standardized protocols for sample collection, processing, and storage. Common practices ensure compatibility and comparability of data across different institutions and countries. Efforts to ensure data harmonization ensure that information collected follows standardized formats. This harmonization allows seamless integration and analysis of datasets from diverse sources.

Biobanks often participate in collaborative networks or consortia that span multiple countries. These networks foster communication,  resource sharing, and joint research initiatives. Examples include the [https://dcc.icgc.org/ International Cancer Genome Consortium (ICGC)] and the [https://www.ga4gh.org/ Global Alliance for Genomics and Health (GA4GH)]. Data sharing platforms that comply with established standards for security,  privacy and interoperability* may be used to facilitate the exchange of data while addressing ethical and legal considerations. Additionally, institutions engaging in international collaboration may establish formal agreements through memorandums of understanding. These agreements outline the terms of collaboration, data sharing, and the responsible use of biological samples.

Collaborative research projects involving multiple biobanks encourage the exchange of data and samples for specific research objectives. These projects leverage the collective expertise and resources of participating institutions.

International collaborations may also involve capacity-building initiatives to enhance the capabilities of biobanks in developing countries as exemplified by the establishment of a biobank in [https://www.sciencedirect.com/science/article/pii/S2211883723000989 Western Visayas in the Philippines]. Such inclusivity fosters a more equitable and globally impactful approach to research.

Biobanks navigate complex ethical and legal considerations when sharing data internationally. They establish clear frameworks for obtaining informed consent, protecting donor privacy, and complying with diverse national and international regulations. To regulate access to shared data,  international biobanks often establish data access committees that evaluate research proposals and ensure adherence to ethical, legal, and privacy standards.

<nowiki>*</nowiki> The term ''interoperability'' refers to the ability of different systems, devices, or software to seamlessly exchange and interpret information, allowing them to work together effectively and efficiently without hindrance. It ensures that diverse components can communicate, share data, and collaborate in a cohesive manner, fostering compatibility and synergy across various platforms or technologies.

By employing effective strategies for the sharing of biological samples, biobanks contribute to a global network of knowledge sharing, accelerating scientific discovery, and promoting advancements in personalized medicine and public health on an international scale.

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Thank you for taking this irecs module!

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This link will take you to a new page; [https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fforms.office.com%2Fe%2FcimWP1L4tx&data=05%7C02%7CKChatfield%40uclan.ac.uk%7Cde983f54bcc64d66a02908dcd0b50ccd%7Cebf69982036b4cc4b2027aeb194c5065%7C0%7C0%7C638614723283135084%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=mx6LNK14iRC744b7LLnUg8jxZ%2FKLXd%2Blo6I8kmwz%2Bwg%3D&reserved=0 https://forms.office.com/e/cimWP1L4tx]

Thank you!

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From biological samples to precision medicine for patients. Virchows Arch. 2021 Aug;479(2):23Annaratone L, De Palma G, Bonizzi G, Sapino A, Botti G, Berrino E, Mannelli C, Arcella P, Di Martino S, Steffan A, Daidone MG, Canzonieri V, Parodi B, Paradiso AV, Barberis M, Marchiò C; Alleanza Contro il Cancro (ACC) Pathology and Biobanking Working Group (2021) Basic principles of biobanking:3-246. doi: 10.1007/s00428-021-03151-0. Epub 2021 Jul 13. PMID: 34255145; PMCID: PMC8275637.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8275637/

BBMRI-ERIC Common Service ELSI

https://www.bbmri-eric.eu/services/common-service-elsi/

European Commission (2018) Data protection in the EU

https://commission.europa.eu/law/law-topic/data-protection/data-protection-eu_en

Council of Europe (2016) Recommendation CM/Rec(2016)6 of the Committee of Ministers to member States on research on biological materials of human origin https://search.coe.int/cm/Pages/result_details.aspx?ObjectId=090000168064e8ff

Harati, M.D., Williams, R.R., Movassaghi, M., Hojat, A., Lucey, G.M., Yong, W.H. (2019). An Introduction to Starting a Biobank. In: Yong, W. (eds) Biobanking. Methods in Molecular Biology, vol 1897. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-8935-5_2

Healthtalk.org What is biobanking and why is it important? https://healthtalk.org/experiences/biobanking/what-is-biobanking-and-why-is-it-important/

ISBER (International Society for Biological and Environmental Repositories) (2024) Best practices for repositories  https://www.isber.org/page/BPR

NIH (2024) Genomic Data Sharing (GDS) Policy https://sharing.nih.gov/genomic-data-sharing-policy

OECD  Guidelines for Human Biobanks and Genetic Research Databases (HBGRDs)

https://www.oecd.org/health/biotech/guidelines-for-human-biobanks-and-genetic-research-databases.htm

World Medical Association (2016) Declaration of Tapei on ethical considerations regarding health databases and biobanks

https://www.wma.net/policies-post/wma-declaration-of-taipei-on-ethical-considerations-regarding-health-databases-and-biobanks/

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