Legislation and regulation
Legislation under the Human Tissue Act 2004 provides a framework for the collection, storage use and disposal of human samples (which may be body parts, organs, tissue, bodily waste products, including blood, serum, plasma, etc.). The University is licensed and subject to inspection by the Human Tissue Authority (HTA) to store and use human samples for research, in accordance with the legislation.
Regulation by the HTA requires the University to have a Quality Management System (QMS) and Standard Operating Procedures (SOPs) in place for the effective management of research involving human samples. Responsibility for supervising the activities under the licence and the implementation of the QMS and the SOPs is with the University’s Designated Individual (DI), supported by the Human Samples Steering Group.
Policies and procedures
It is important that all human samples are treated with dignity and respect at all times, and in accordance with the original consent of the donor, where appropriate, and that the quality of the samples is maintained.
All research involving the use of human samples must have appropriate ethical approval before the research can begin. This should be current and specific for the research to be undertaken. Ethical approval may be obtained through:
- an NHS Research Ethics Committee – for example, where NHS patients, data, staff and/or facilities are used;
- an overseas ethics committee – for example, where the research is being conducted, or samples are being collected, overseas;
- the University’s Biomedical Research Ethics Sub-Committee (BSREC) – for example, where samples are taken from healthy volunteers and there is no NHS involvement. Overseas studies may also require review by BSREC but this should be by an expedited process.
All samples must be collected with appropriate consent and, when held on the University, must be fully traceable from their acquisition through to their disposal, with appropriate records kept.
The import or acquisition of human samples should be formalised in a Material Transfer Agreement (MTA) which must be authorised by the University through Research & Impact Services.
All research involving the use of human samples must be defined and recorded as a project, with a clear project proposal, including projects funded externally or internally, own-funded or student projects.
Registration and training
All staff and students undertaking research involving the use of human samples must be able to demonstrate their competency and be registered to do so. They must be familiar with relevant documentation and SOPs and undergo training.
Registration is a 4-stage process:
- completion of the MRC e-learning module – Research and human tissue legislation
- attendance at a training session with the DI – Knowing Your Responsibilities
- knowledge of the HTA Codes of Practice A and E (https://www.hta.gov.uk/guidance-professionals/codes-practice)
- completion of a Declaration of Registration
Other staff, for example, technical and administrative staff, supporting research involving human samples, may find it valuable to complete the training.
For more information, see: Registration and Training.
Advice and guidance
For further advice and guidance regarding the use of human samples, please contact:
Professor Geraldine Hartshorne - Designated Individual
Geraldine.Hartshorne@warwick.ac.uk or 07973 802528
HTA Administrative Support
The DI will seek further advice and guidance directly from the HTA, where appropriate.
For more information, see: Advice and Guidance