Sheffield Biorepository - Human Tissue Storage


    The Human Tissue Act establishes the Human Tissue Authority as the regulatory body for all matters concerning the removal, storage, use and disposal of human tissue (excluding gametes and embryos) for Scheduled Purposes. The HTA has issued good practice guidance in its Codes of Practice and answers to Frequently Asked Questions are available on their website. The HTA licences a number of activities under the HT Act, one of which is the storage of tissue for research.

    The University of Sheffield Medical School holds a licence for the storage of human tissue for the purposes of research. Before 2019 the university and Sheffield Teaching Hospitals Trust held a joint licence creating the Biorepository to satisfy all requirements under the regulations. Professor of Clinical Cardiology and Honorary Consultant Cardiologist, Professor Chris Newman, holds the licence as the designated individual responsible for the Sheffield Biorepository; copies of this licence can be viewed in room EU17 of the Medical School.

    The Human Tissue Act 2004 was fully implemented on 1st September 2006 and covers the use of tissue for a number of 'Scheduled Purposes', which include research, clinical diagnosis and teaching. The HT Act makes consent the fundamental principle underpinning the lawful storage and use of body parts, organs and tissue from the living or the deceased for specified health-related purposes and public display. This includes 'residual' tissue remaining following clinical and diagnostic procedures. It also covers the removal of such material from the deceased.


    Our service

    We provide a fully compliant, safe and secure, storage facility for all human tissues, including:

    • Blood (buffy coat, serum, plasma)
    • Saliva, cerebrospinal and other fluids
    • Urine
    • Breast milk
    • Semen, cervical swabs

    Standard Operating Procedures (SOPs)

    For any general queries please contact us at biorepository@sheffield.ac.uk or call us on +44 114 215 9620.

    Sheffield Teaching Hospital enquires relating to HTA or NRES should be directed to Jemima Clarke.


    Our service and facilities

    Our Biorepository offers a secure centralised storage location, with fully alarmed freezer units and facilities that are closely monitored by staff within the Medical School of Sheffield University. We have a partnership with Sheffield Teaching Hospitals that guarantees compliance and best practice with HTA regulations.

    For your individual requirements we can provide a range of safe storage systems via proven cryogenic facilities, along with provision for collections of samples suitably prepared for room temperature storage. We also have a range of conventional freezer and refrigeration based storage options.


    Facilities

    We have a range of facilities to meet all your storage requirements:

    • -80c freezer banks
    • Liquid Nitrogen Storage Tanks
    • A range of cold storage from 4c to -20c
    • FFPE Storage Areas
    • Boxes for Slide Cataloging
    • Whole Tissue Storage Location

    Service

    Our service features all the following:

    • Fully certified power backup system provided by Sheffield Teaching Hospitals
    • Internet based, secure remote monitoring service with telephone contact list for staff who are on call 24 hours a day
    • Secure storage with access limited to Biorepository staff and accompanied visitors
    • Via online Tissue Auditor software we provide full access to sample information

    CloudLIMS BioTracer Database

    CloudLIMS Lite is a Laboratory Information Management System (LIMS), offered as SaaS, enabling the Biorepository to automate our workflows and securely store all sample data with full audit trails.

    Tutela Alarm System

    Tutela monitoring system is reinforced with a 24/7 fully manned human Alarm Response Team based in the UK. We are notified of any alarms by the trained operators following a pre-arranged contact list of Biorepository staff, ensuring absolute viability of your samples stored at our facility.


    HTA Regulations and Guidance

    Within the Human Tissue Act, human tissue is referred to as ‘relevant material’ and this is defined as ‘material that has come from a human body and consists of, or includes, human cells’. Under the Act, "relevant material" means material, other than gametes, which consists of or includes human cells.

    References to relevant material in the Act do not include:

    (a) embryos outside the human body, or

    (b) hair and nail from the body of a living person.

    The Human Tissue Authority has furthered defined ‘relevant material’ and has divided tissues into three categories as follows:

    Specifically identified relevant material

    This includes material like bodily organs and tissues, consisting largely or entirely of cells, and clearly identifiable and regarded as such. This category of relevant material includes human bodies, internal organs and tissues, skin and bone; and specifically the following:

    • stem cells created inside the human body
    • embryonic stem cells
    • non blood derived stem cells
    • umbilical cord blood stem cell
    • bone marrow
    • primary human cell cultures

    BUT NOT
    • cultured cells which have divided outside the human body
    • artificially created embryonic stem cells
    • cell lines
    • extracted DNA
    • plasma extracted DNA

    Processed material

    Where a processed material is generally agreed – as a result of the process – to leave it always either cellular or acellular, then the presumption should be that all examples should be regarded as such. The HTA would rely on the stakeholders’s assurance that the process in question had been carried out. Under this category plastinated tissue and plastinated body parts (where the cellular structure is retained by the plastination process) are to be regarded generically as relevant material; while plasma or serum, for example, will be regarded as not. The two latter processed materials, widely produced from blood taken for treatment, are however examples of where ‘normal expectations’ may well need to be exercised.

    Bodily waste products (including excretions and secretions)

    Bodily waste is a less well characterised group of material. Nevertheless the Authority considers it important to provide a framework of guidance. The Authority considers bodily waste should normally be regarded as relevant material: the Act cannot be denied on this point. The Act’s wording is clear and reflects the possibility that even a single cell can be subject to research. While acknowledging the views of stakeholders who have argued for greater individual discretion, it would be inappropriate to encourage people to grant themselves an exemption on the basis of their own interpretation of the Act. However the Authority may be able to offer nuanced advice in specific instances. There will be cases where a stakeholder believes that material, intended for a scheduled purpose, is actually acellular. In such cases the stakeholder would need to consult the Authority, and we would then refer the case for advice to a members’ panel if necessary.

    Guidance for Staff 

    Guidance below is for staff at the University of Sheffield to help with HTA compliance.

    The HTA & Primary cell lines

    All material which consists of or includes human cells is covered by the Human tissue Act (HT Act) and includes the initial isolation of cells for primary culture. Once the cells have divided outside the body they are no longer considered to be covered by the act.

    The following provides guidance on the Schools procedures for the use of Primary cell lines obtained from tissue direct or via a commercial source.

    Isolated primary Cells

    If isolating primary human cells from tissue you must have obtained ethical approval for the project, this will ensure you have considered all the implications relating to consent, storage, use and disposal.

    Commercially obtained Primary Cells

    Although it could be assumed that primary cell lines obtained from commercial sources will have been culture outside the human body for at least one passage and so not covered by the HT Act, the school has decided to put in place the following procedure:

    • The supplier will be contacted before purchasing Primary cell lines to request information regarding the HT Act and ethical sourced material.
    • Upon receipt of the cell line the Primary cell line form should be completed.
    • If the Cell line is to be sub cultured immediately, then once passaged the form should be signed off and returned to Room EU17.
    • If the cell line is to be stored before use then it must be placed in a licensed bank until required. Again once the cell line is defrosted then a form should be completed and returned to Room EU17.

    At the end of a project the all remaining cells must be destroyed in an approved manner (see SOPs).


    Liquid Nitrogen Storage

    Departmental Sample Storage

    The storage of biological samples within liquid nitrogen tanks ensures protection for these vital research materials.

    The Biorepository provides secure sample storage for the departments of Infection, Immunity and Cardiovascular Disease (IICD) and Department Of Oncology and Metabolism (O&M).

    Collections of samples are housed for researchers inside Taylor Wharton 80K storage tanks. Tanks utilise the vapour phase of liquid nitrogen at -196°C to avoid any possibility of cross-contamination. The system has a fully automated refilling mechanism and several weeks of built in nitrogen supply redundancy, therefore eliminating limitations normally associated with manual fill vessels. Temperature gradients and abnormal changes in nitrogen levels cannot occur during normal operation of the system.

    The designated technicians for this service are: Jess Willis (IICD), Jon Kilby (IICD), Svetlana Solovieva (O&M), Eva Wild (O&M), Jess Medcalf (O&M) and Ben Durham (IICD).

    The service aims to deliver best practice cryogenic storage for a twenty-first century research environment. We hope to achieve these standards while providing a reliable service meeting key objectives:

    • Quality: Custody of the "cold chain" to safeguard samples
    • Environmental: Reducing consumption of Liquid Nitrogen and other materials
    • Safety: Minimising transport of Liquid Nitrogen inside buildings
    • Cost: Promoting efficiency savings and a fair pricing strategy

    Below is a quick step-by-step guide to the storage and access procedures:

    Storage

    1. Email to request sample storage
    2. Receive confirmation via email
    3. Deposit your samples for storage in a CryoPod carrier (E146)
    4. Samples are taken by a designated technician for storage in the 80K tanks
    5. Samples transferred into the Biorepository
    6. Receive confirmation of storage and Biorepository ID

    Access

    1. Email request for access to samples
    2. Receive confirmation via email
    3. Accessed samples are retrieved from the 80K tanks by designated technicians
    4. Samples transferred out of the Biorepository
    5. Receive confirmation your samples are ready to collect (E146)
    6. Collect your samples from the CryoPod carrier

    Whether you wish to store samples or have any other queries please contact: biosampleservice@sheffield.ac.uk.


    FAQs

    What is a biorepository?

    A biorepository is a facility that stores, secures and distributes biological specimens. Our biorepository stores human tissue, mainly under cryogenic conditions, and fully complies with the requirements set out under the Human Tissue Act 2004.

    What is HTA regulation?

    The Human Tissue Act 2004 covers England, Wales and Northern Ireland. It established the HTA to regulate activities concerning the removal, storage, use and disposal of human tissue. Consent is the fundamental principle of the legislation and underpins the lawful removal, storage and use of body parts, organs and tissue. Different consent requirements apply when dealing with tissue from the deceased and the living. The Human Tissue Act 2004 lists the purposes for which consent is required (these are called Scheduled Purposes).

    Who are the staff members within the Sheffield Biorepository?

    The Sheffield Biorepository has the following key members of university staff working within, and responsible for it's activities, on a daily basis:

    Francesco S di Giovine - Biorepository Director

    Steve Haynes - Biorepository Manager

    Helen Murden - Core Facilities Technician

    When do my study samples need to be transferred to the biorepository?

    Samples collected in compliance with HTA consent that are to be used in future research projects, or samples needing to be stored in the biorepository after a REC approved research project has ended, must be stored in an HTA licenced facility.

    Below is a more detailed explanation of these HTA requirements:

    An HTA licence is for the storage for use in research, not the use itself. Specific research projects undertaken with approval from recognised Research Ethics Committee (REC) committees (or for which approval by such a committee is pending), do not require an HTA storage licence.

    The HTA and National Research Ethics Service (NRES) have agreed a position whereby NHS Research Ethics Committees (RECs) can give generic ethical approval for a research tissue bank's arrangements for collection, storage and release of tissue, providing the tissue in the bank is stored on HTA-licensed premises. This approval can extend to specific projects receiving non-identifiable tissue from the bank. The tissue does not then need to be stored on HTA-licensed premises; nor does it need project specific ethical approval.

    What storage systems are available?

    We have a range of facilities to meet all your storage requirements:

     -80c freezer banks

     Liquid Nitrogen Storage Tanks

     A range of cold storage from 4c to -20c

     FFPE Storage Areas

     Boxes for Slide Cataloging

     Whole Tissue Storage Location

    How are storage systems monitored?

    The Tutela monitoring system is installed connecting all freezers to a centralised monitoring centre. The contact centre is provides a 24/7 fully manned human Alarm Response Team – based in the UK.

    All freezer units will alarm if the temperature rises above -70C, or if contact is lost with a unit for more than 30 minutes.We are notified of any alarms by the trained operators following a pre-arranged contact list of Biorepository staff, ensuring absolute viability of your samples stored at our facility. Furthermore continuous temperature monitoring data is always available for our staff via an online access portal.

    What security is in place for my samples?

    The biorepository storage facilities are all within locked rooms at the Royal Hallamshire site. Security staff are available 24/7 and will immediately respond to any alarms. The freezer banks and liquid nitrogen facilities outside the mai nhospital buildings have burglar alarms fitted and are behind locked gates. All cryo-storage areas can only be accessed by biorepository staff with access to multilock keys.

    I have samples and would like to find out about storage

    Please see the services section (above) for the types of storage we can offer you.

    Contact us by email with any questions about your sample types and the duration of storage available in the biorepository.

    What are the costs of storing my samples in the biorepository?

    Please contact us with details of your samples for our internal and external pricing.

    Contact us

    The Biorepository is located within Sheffield University Medical School, which is attached to the Royal Hallamshire Hospital. Customers are welcome to come along to the facility either to drop off samples or discuss their research with the team. The facility is busy so visitors are advised to telephone, or email, the facility in advance to ensure that a member of the team is available. Alternatively, you can get in touch with us via email, telephone or by mail using the details below.

    The Sheffield Biorepository
    Room EU17
    The Medical School
    University of Sheffield
    Beech Hill Road
    Sheffield S10 2RX

    Email: biorepository@sheffield.ac.uk

    Main Contact Number: +44 114 21 59620

    Name Role Email Phone
    Ms Lynne Baxter Brain Bank Technical Lead l.baxter@sheffield.ac.uk +44 114 222 2272
    Mrs Jemima Clarke STH HTA Lead jemima.clarke@sth.nhs.uk +44 114 226 5943
    Dr Francesco Di Giovine Biorepository Director biorepository@sheffield.ac.uk +44 114 271 1605
    Mr Steven Haynes Biorepository Manager s.haynes@sheffield.ac.uk +44 114 271 3450

    A world top-100 university

    We're a world top-100 university renowned for the excellence, impact and distinctiveness of our research-led learning and teaching.