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e-Pathway: Project Setup
Human Tissue & Data
Working with human tissue
Working with human tissue
If your research involves the use of human tissue it may be governed by the Human Tissue Act. See the Human Tissue Authority for guidance on Relevant Material under the Human Tissue Act 2004.
To ensure you are setting up processes for tissue sample collection, handling, storage and destruction in line with the Human Tissue Act and UoB policies and procedures please see the Laboratory Set-Up and Management SOP (UOB-CRL-SOP-001) [Word, 360 KB], Laboratory Facilities SOP (UOB-CRL-SOP-002) [Word, 357 KB] and Sample Management SOP (UOB-CRL-SOP-003) [Word, 359 KB].
If you are accessing human tissue come from a Research Tissue Bank or repository see the Research tissue banks and research databases page of the HRA website for further guidance.
The University of Birmingham has two licensed Research Tissue Banks, the Human Biomaterial Resource Centre (HBRC) and the Dental Research Tissue Bank (DRTB) which can support your research and can be contacted directly. Please see the Human Biomaterial Resource Centre (HBRC) web page or contact the School of Dentistry for further information.
If human tissue will be imported to the UK for your research, please see the HTA Code of Practice for Research for further information and contact the HBRC for support.
If you will be using tissue for human application, where cells are returned to the body, please visit the Human Application page of the HTA website for further information and contact the Clinical Research Compliance Team for support.
If your research involves human sperm, eggs or gametes please see the Human Fertilisation & Embryology Authority (HFEA) website for further information.
GCP in the Laboratory (analysing samples from CTIMPs)
GCP in the Laboratory (analysing samples from CTIMPs)
Laboratories that process, evaluate or analyse participants’ samples for clinical research projects need to be set up and managed appropriately to ensure patient safety and data integrity are not compromised. This includes ensuring that the laboratories are working to the appropriate standard, i.e., GCP in the laboratory standard for CTIMPs and human tissue standard for clinical studies and non-CTIMPs (see also ‘Working with Human Tissue’ section above).
Attention must be paid to the whole sample pathway, ensuring that procedures are in place to maintain the laboratory facilities, manage samples appropriately whilst on their way to and once they arrive in the laboratory, and through out any storage, processing and/or analysis that takes place. Procedures also need to be in place for if things go wrong, such as equipment breakdown or loss of samples.
Further information on all the processes described above can be found in the following SOPs:
- Laboratory Set-Up and Management SOP (UoB-CRL-SOP-001) [Word, 360 KB]
- Laboratory Facilities SOP (UoB-CRL-SOP-002) [Word, 357 KB]
- Sample Management SOP (UoB-CRL-SOP-003) [Word, 359 KB]
- Laboratory Analysis SOP (UoB-CRL-SOP-004) [Word, 305 KB]
- Reportable Issues SOP (UoB-CRL-SOP-005) [Word, 302 KB]
If a UoB sponsored CTIMP requires the use of a laboratory that is external to UoB, due diligence needs to be performed to ensure that this laboratory also has the processes in place to be working to the required GCP in the laboratory standard. Information on the procedure that needs to be followed and documentation that needs to be produced to evidence this can be found in the External Laboratory Set-up and Oversight SOP (UoB-CRL-SOP-006) [Word, 364 KB].
Data only studies
Data only studies
See HRA guidance for using patient data that clarifies existing rules on use of confidential patient information and on anonymization. It also explains new regulations that enable the use of health data in the context of COVID-19 research.
Further details on data only studies to follow.
Quick links
Your Feedback
e-pathway index
e-pathway index
The clinical research e-Pathway provides a roadmap to guide researchers during the lifetime of their research projects. Click on the links to take yourself to the stage that is of interest. You can also use the roadmap image on each page for navigation.
From Idea to Proposal
Applying for Funding
Project Setup
Green Light - Ready to Go?
Project Management
Project End
Need help with your project? See who can help.
For an overview of the e-Pathway, return to the homepage