| From | Research Ethics & Governance Office |
| Approval date | 18 June 2025 |
| Related policies | |
| Related procedures | |
| Approving authority | Senate |
| Contact point | Head of Research Ethics and Governance |
| Review | 3 years |
| Version | 1.0 |
| Consultation | UREC, RIGC, UEB |
| EDI assessment (if required) | N/A |
This policy sets out how human tissue samples are to be collected, stored and used for research within the ÃÛÌÒTV. This will be achieved though the following objectives which ensure the University complies with Human Tissue Act 2004 and International Conference on Harmonisation Good Clinical Practice Guideline (ICH GCP).
This policy is relevant to any activity in the University involving human tissue that will be used for research. This policy applies to all members of staff involved in research using human tissue including: students, locums, bank and agency staff and staff employed on honorary contracts.
5.2.1.1 The Act is concerned with regulating activity involving Relevant Material which is defined as “…any material, other than gametes, which consists of, or contains human cells."
Blood, plasma, serum and urine may contain human cells and are considered Relevant Material until fully processed to an acellular state and any residual cellular material has been discarded.
5.2.1.2 A cultured human cell line is Relevant Material for as long as it is likely to contain original cells from the person who donated the material. Once the cell line has been established and is unlikely to contain original cells then it is no longer considered Relevant Material (for ÃÛÌÒTV 3 passages will be considered sufficient to remove original material).
5.2.1.3 The Act also covers activity that involves extraction of DNA from Bodily Material (which includes all Relevant Material plus embryos, hair and nails). The Act applies differently depending on whether tissue samples are collected and used for a specific study or for generic research.
5.2.1.4 DNA/RNA analysis can only be conducted on samples collected under another research project with qualifying consent. The original consent must be for use of samples for future research which includes the use of DNA.
See further details in section 5.2.4
NOTE: Any data arising from DNA/RNA analysis may be identifiable as personal data and its use will fall under the Data Protection Act 2018.
5.2.2.1 Subject to the exceptions below, there must be explicit consent to collect human tissue for research.
5.2.2.2 Tissue may be collected for storage and use in research without consent if:
5.2.2.3 Material imported from outside the UK is not subject to the consent provisions of the Act, but is regarded as good practice and expected that there are mechanisms in place to provide assurance that the tissue has been obtained with valid consent.
5.2.2.4 Notwithstanding point 5.2.1.1 and 5.2.2.2 above, a key principle of the Act is that, wherever possible, there should be consent in place to collect samples to use in research.
5.2.2.5 Consent to collect samples for a specific research study should be obtained using a study specific information sheet and consent form that has been approved by an appropriate research ethics committee as part of the overall review of the research study.
5.2.2.6 If it is likely that some relevant material may remain at the end of the study AND it is intended that these samples could be used for further research, then the initial consent form must include an option to use these samples for future ethically approved, unspecified research. Otherwise- re-consent will be required to use the samples and this must be in place before the original REC approval expires.
5.2.3.1 Samples specifically collected for research cannot be stored after ethical approval has ended in any University labs, offices, general storage facilities (such as liquid nitrogen tanks, freezers, fridges) as these areas are not covered by an HTA licence unless the samples were collected with consent to be stored for future use (see 5.2.2.6 above).
5.2.3.2 Any research teams who have material stored that is no longer under ethical approval must make immediate arrangements to dispose of the material in line with HTA expectation or transfer to an HTA licensed tissue bank (providing appropriate consent is in place for future use).
5.2.3.3 Any researcher who is leaving the University must ensure the responsibility for all human tissues samples collected for existing are either transferred to a new researcher (team) or disposed of before departure. The researcher must also inform the REGO team of these plans.
5.2.4.1 It is a criminal offence to hold tissue samples with the intention of performing DNA analysis without consent unless:
5.2.5.1 Unless exempt (as previously outlined in 5.2.2.2) Relevant Material collected for research purposes must be stored in premises that have been licensed by the Human Tissue Authority
5.2.5.2 Relevant material collected for a specific research study with REC approval may be stored in any appropriate facility for the duration of the study.
5.2.5.3 There are no specific storage requirements for samples that are not considered as Relevant Material, although material which requires processing to be rendered acellular for non-specific research can only be stored for a maximum of 5 days outside of a licensed facility.
5.2.5.4 Licensed facilities (such as the Faculty of Medicine Tissue Bank) are subject to inspection by the Human Tissue Authority and must comply with quality standards issued by the HTA.
5.2.5.5 It is expected that unlicensed facilities holding samples for specific studies with REC approval will follow some basic quality standards including:
5.2.5.6 Samples containing cellular material that are intended to be processed to render acellular or are to be sent to another organisation may be held for a short period of time (no longer than one week) in an unlicensed premise.
5.2.5.7 Samples that are intended to be transferred to a licensed tissue bank may only be stored for up to one week before transfer.
5.2.6.1 Material held by the Tissue Bank is available to anyone wishing to use it for high quality ethically approved research which is managed through a formal application process managed by the Tissue Bank.
5.2.6.3 Applications are reviewed and approved by committee.
5.3.7.1 All research studies which include the collection and use of human tissue must be logged and approved on the ethics and governance online platform (ERGO II).
5.3.7.2 Research studies must then be submitted to an appropriate ethics committee for review and approval. No work, including consenting and tissue collection, can begin until ethical approval has been received.
5.3.7.3 The ethics review process will check the arrangements for consent storage and use. Any change in the way samples will be collected, stored or used during the study must be notified to the REC as an amendment (approval must be granted before work can progress).
5.3.7.4 Tissue samples collected for use for a specific study may not be used for a different study unless the alternate study has received a favourable opinion from a REC and there is explicit consent from the donor for use of the samples in other research studies.
5.2.8.1 Human tissues that have been purchased from reputable suppliers, have been supplied with information stating they have been screened, and are clear for the presence of blood-borne viruses are not subject to any additional requirements.
5.2.8.2 All work with unscreened human tissue must be undertaken in containment level 2 laboratories that comply with the University Biological Containment Laboratories Policy.
5.2.8.3 All Principal Investigators and Chief investigators must ensure that work is conducted in accordance with the University Health and Safety Policy – Health and Safety requirements for the use of human tissue.
5.2.9.1 Where possible, ethical approval should be obtained from a Research Ethics Committee (REC) or equivalent in the source country. You should comply with the legal and ethical framework applicable in the source/recipient country, bearing in mind this may differ from the UK.
5.2.9.2 Justification for the need to import material must documented within the ERGO application.
5.2.9.3 Imported and exported tissue should be procured, used, handled, stored, transported and disposed of in accordance with the consent given.
5.2.9.4 Systems should be in place to cover the use of imported tissue e.g. quality management, SOPs, coding and records to ensure audit trails, risk assessment and traceability.
5.2.9.5 Material transfer agreements should document governance arrangements relating to consent, confidentiality, sharing with third parties and disposal / return of any remaining tissue.
5.2.9.6 Researchers must consult with the Biological Safety Officer before importing any human tissue onto ÃÛÌÒTV premises (see 5.2.8.3).
5.2.10.1 End of ÃÛÌÒTV Procedures for dealing with residual human tissue should be place.
5.2.10.2 If any sample material remains at the end of the study then the sample must:
NOTE: Samples cannot be held pending a future REC application.
5.2.11.1 Review of tissue handling arrangements is included as part of the standard REGO Governance Office process for reviewing applications.
5.2.11.2 Researchers will be required to complete and return closeout reports at the end of study to include either destruction logs or transfer logs.