The University of Wolverhampton does not currently hold a Human Tissue Licence. Therefore, no researcher can store human tissue unless one of the following exemptions apply (1):
- a research project using relevant material that has been approved by a recognised research ethics committee (e.g. IRAS) and the researcher cannot identify the individual from whom the material has come. The relevant material may be stored without a license for the duration of the project and the end of the project, the relevant material must either be destroyed or returned to the licensed premises. A university ethics committee is not considered to be a recognised research ethics committee for this purpose.
- a research project using tissue provided by a REC-approved bank which has generic ethical approval. The recipients
- do not need to store relevant material under an HTA licence during the period of the research project. On completion of the project, the researcher must return tissue to the bank or to an alternative HTA-licensed establishment, apply for project-specific approval by a REC or destroy it.
- where relevant material is being held with the intention of processing to render the material acellular (eg extracted DNA or protein lysates) prior to research. Tissue may be stored without a licence providing that the processing takes a matter of hours or days and certainly no longer than a week. Please refer to University Policy for a list of relevant material.
Principal Investigators acquiring relevant material for use in research must ensure that all aspects of the process for use of Human Tissue in Research are adhered to, in addition the requirements for storage as outlined in this Code.
For the Faculty, the HTA Compliance Officer will oversee operational matters involving storage of human tissue.
Register of human tissue held in the Faculty of Science and Engineering at University of Wolverhampton
For each sample acquired and stored, an entry must be made on the University register by way of completion of the appropriate information capture form. This is to be done by the Principal Investigator of the research project. This form is available as an associated document to this code on SEEN. The information captured by the form will allow the HTA Compliance Officer to make an appropriate entry to the register of human tissue held within the Faculty.
The register will include details of the project title, Faculty REC approval number, IRAS no (if applicable), Principal Researcher, Start date, finish date, sample receipt dates, specific storage location, scope of consent, transfer of material, dates of audit, dates and means of disposal. The samples will not be accepted for storage unless all details are provided.
In addition, any entry must be updated if the sample has been used/processed in any way.
An audit of the material held by the University will be carried out on a 6 monthly cycle. The Principal Investigator must ensure that the information on the register of material held is kept up to date.
Samples will be stored in a separate, secure, designated facility. The HTA Compliance Officer will allocate storage space to the Principal Investigator. The following will be available: room temperature, cold (2-8oC), freezer (-20oC and -80oC) and cryostorage (liquid N2 cooled vessels at -196oC).
(1) University of Wolverhampton Policy for Use of Human Tissue for Research http://www.wlv.ac.uk/research/about-our-research/policies-and-ethics/ethics-guidance/use-of-human-tissue-for-research/uow-policy-for-use-of-human-tissue-for-research/
(2) Code of Practice :Working with human blood products and other tissue specimens in the faculty of science and engineering (FSE)