Human Research Tissue Bank System Integration

Cambridge University NHS Foundation Trust (CUH) is seeking a development partner to scope, design and deliver an integrated solution for the collection, storage, use and release of human tissue for research. The state-of-the-art solution must be fully compliant with the legal framework of the Human Tissue Act 2004 and ensure that there is transparent and real-time auditable, tracking and ethical use of all human tissue samples, irrespective of their source, across the Cambridge Biomedical Campus. The solution will also support ISO accreditation (ISO 20387 for biobanking and ISO 15189 for diagnostic laboratories)

Central to the new system for tissue originating on the Campus, will be the use of the Epic electronic patient record at CUH. Streamlined and efficient interoperability between Epic and existing data systems – for example the Achiever Database used by research teams across the campus and the Edge Research Management system is essential. Human tissue sent from external organisations must also be tracked once it arrives on the Campus.

User-centric interfaces and back-end services driven by secure AI-based processes will be central to the delivery of rich functionality which would include new case identification, timely specimen collection, real time data updates on specimens and linked data and continuous audit to detect potential statutory breaches.

The collection, storage and release of tissue samples is the responsibility of the Human Research Tissue Bank (HRTB) in the Histopathology Department at 1000 Discovery Drive. Duplicate between-system data entry must be avoided. Full integration with the working processes in the Histopathology Department is required, including the Inpeco automated tissue management system and the Phillips Image Management System. The Histopathology Department uses the Epic Beaker Laboratory Information Management System (LIMS) linked to the Epic electronic patient record. At its core the new system must be designed to support the day-to day work of all the HRTB staff and the statutory responsibilities of the Designated Individual for the Human Tissue Authority.

The solution must support current and future consent models, including structured capture of research tissue consent status, consent versioning, selective permissions where approved, withdrawal/revocation, and auditable linkage of consent status to tissue requests and release decisions. The system must be designed so that future broad front-door research consent, wider data linkage and patient-facing transparency can be supported, and provide consenting participants with access (potentially through the NHS app or the Epic MyChart app) to a secure timely audit of how their tissue and data has been used.

The tissue and linked data collected through this proposed system will be made available to approved academic and commercial researchers in the UK and abroad. All such access must ensure patient anonymity and confidentiality. The developed system must provide a detailed and easy to use search facility through which potential samples can be identified and requested. The system should allow users to request specific samples be collected and selected tissue cohorts to be supplemented.

In line with Trust policy, human tissue will never be sold for profit. For the system to be sustainable, however, a full cost-recovery for tissue samples and data services will be applied where appropriate. The development partner in collaboration with commercial teams at CUH will review and evaluate existing and potential cost models which, once agreed, will require implementation.