Human Tissue Act
This site is for staff members in the Schools of Biochemistry, Cellular & Molecular Medicine, Physiology & Pharmacology and at the Vet School, Langford (staff in CCCA in Southwell Street should contact the Designated Individual (DI) Steve Gaze, email Steve.Gaze@bristol.ac.uk) who wish to acquire Human Tissue for a research project. Background material regarding the Human Tissue Act and links to the Human Tissue Authority are available at Arrangements for Complying with The Human Tissue Act 2004 . This includes a detailed policy, documentation and instructions on how to dispose of human tissue waste by the appropriate routes.
The two key points
- The key point for people to understand is that all human material stored in the Medical Sciences Building, and in the Vet School, Langford, must have current Ethics Approval (NRES).
- All PIs will be required to submit a regular audit of the human tissue stored in their labs, upon request.
Detailed summary
- As a research and teaching organisation using human tissue, we are required by law to comply with the regulations laid down under the Human Tissue Act (2004), and to be licensed by them. This Act is enforced through the Human Tissue Authority (HTA) and covers the storage of human tissue. This is why we are required to keep storage record cards and complete regular internal audits.
- For definition, human tissue is any material that contains human cells in an unmodified or untransformed state. Immortalised human cell lines are therefore not included in this definition, whereas saliva samples would be included. Samples where the structure of the cell have been broken down, for example in lysates or homogenates, or for example in DNA samples, are therefore also not included in the tissue definition and are not covered by the Act.
- The Medical Sciences Building and its satellite site the Vet School, Langford, already have a licence granted by the HTA. This licence covers ‘Research in connection with disorders, or functioning of the human body’ and ‘Education or training relating to human health’, and allows us to store human material in the building for use in these regards.
- There is a requirement for a ‘Designated Individual’ (DI) who has responsibility for ensuring that the activities within the premises comply with the Human Tissue Act. The DI for the Medical Sciences Building and Vet School, Langford is Professor Alastair Poole, School of Physiology & Pharmacology.
- For research purposes it is expected now that all human material introduced into the premises must have been sought under Ethics Approval (NRES). This material we define as category A material. Very exceptionally it may be requested that material be brought into the premises without Ethics Approval, and permission needs to be sought prior to storage in the premises through application (see below) to the DI, Professor Alastair Poole (a.poole@bris.ac.uk).
- An audit of stored material will be conducted regularly, and normally every 6 months. All PIs in the premises will be required to submit their audit of human tissue material when requested to do so. The request will be sent out to all PIs by email, normally giving 2 weeks notice for submission of the audit.
1) Audit
All staff using Human Tissue will be required to complete the Human Tissue Audit Form [Word, 47 KB] every six months.
In order to ensure that we remain compliant with the Human Tissue Act a regular audit of ALL Human Tissue stored within SMS will be conducted.
2) Acquisition of Human Tissue in Exceptional Circumstances
Approval to obtain and/or store Human Tissue under exceptional circumstances (detailed below) has to be approved by the Designated Individual, Professor Alastair Poole. The process, for new projects, will also include an application to the FMVS Ethics Committee, for approval of the project.
Exceptional circumstances are defined as:
- Acquisition of new material for a pilot study for which ethics approval (NRES) has not yet been granted or applied for.
- Lapse of ethics approval for old material of defined origin, i.e. transfer from category A to category B.
- Old material (prior to Sept 2006) obtained without ethics approval.
- Material obtained from an outside source, e.g. from a collaborator.
Once approval of the project has been obtained then complete this form Category B: Acquisition of Human Tissue in Exceptional Circumstances [Word, 25 KB] to ensure compliance with the Human Tissue Act.
