The purpose of hVIVO’s research biobank is to provide a resource of Human Biological Samples (HBS) that can support research and development and address unmet needs within the expanding market for HBS. The research biobank will enable new knowledge generation to improve disease management and , improve laboratory testing processes and to aid innovation in the research and discovery of new medicines, using healthy control samples and infected samples in the fields of viral and respiratory medicine. hVIVO has an in depth understanding of UK regulatory and global industry requirements. hVIVO operates the research biobank in compliance with these regulations, including applicable legal and ethical principles. Our regulatory team remains committed to ensuring all hVIVO operations are compliant with current regulations and stays abreast of regulatory changes to ensure continued compliance. Although hVIVO’s research biobank is newly approved in 2024, hVIVO’s core business operations in human challenge trials have demonstrated consistent and reliable delivery since 1989.
Principles:
• hVIVO can provide supporting regulatory documents (such as UK’s Human Tissue Authority approval, Research Ethics Committee approval and donor consent information) to demonstrate research biobank compliance with applicable regulations.
• Connections with potential donors are established through UK’s Health Research Authority approved recruitment processes. All HBS are collected with the informed consent of the donor. Donors are advised of the potential commercial and non-commercial use of their samples and data, including the fact that any new discoveries, tests or medicines will not result in any monetary benefit to the donor.
• hVIVO adheres to industry standards and all applicable regulations for HBS collection, processing, analysis, storage, and transport procedures. This maintains integrity of the HBS from the point of collection to the point of delivery to the requestor.
• All HBS are handled in accordance with strict chain of custody processes ensuring traceability of the samples from collection to final distribution. Research biobank specific labelling, tracking records and quality control procedures are in place, managed within the wider context of hVIVO’s Quality Management System and applicable certifications.
• Any personal data included in the research biobank are subject to the considerations and protections of the UK Data Protection Act 2018, including pseudonymization of all samples and donor minimizing the risk of any breach of confidentiality. hVIVO complies with all applicable laws and regulations for the use of donor information, including, where necessary, data breach reporting and notification processes.
• Custom collections for prospective samples can be collected under the terms of hVIVO’s Research Biobank Research Ethics Committee approval or the Research Ethics Committee (or equivalent approval) obtained by the requesting research party.
• Requirements for custom collections are discussed, explored and captured in detail to ensure the procurement of HBS to that meet the requesting party’s exact specification.
• All applicable research requests are reviewed and approved by hVIVO’s Access and Governance Committee.
• Researchers are charged a fee to receive HBS, determined on a cost-recovery basis. The fee may vary depending upon the type of sample, number of samples requested and/or data requested.
• Defined processes are overseen by the Access and Governance Committee thereby ensuring the appropriate use and provision of samples.
