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.
For more information, see: Legislation and Regulation
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. Project documentation will be held by the Human Samples Office.
All relevant policies and procedures are documented in the Quality Manual and SOPs.
For more information, see: Quality Management System and Standard Operating Procedures (SOPs).
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, undergo training and maintain a training portfolio.
Registration is a 3-stage process:
- attendance at the training session with the DI – Knowing Your Responsibilities;
- completion of the MRC e-learning module – Research and human tissue legislation;
- completion of a Declaration of Registration.
PLEASE CONTACT THE DI TO ENSURE YOU CAN BE REGISTERED
failure to register may result in access to human samples being denied and delays to your research.
Other staff, for example, technical and administrative staff, supporting research involving human samples are also welcome to attend the in-house training session and may find it valuable to complete the MRC e-learning module. They may not need to be fully registered if they are not handling human samples. Please contact the DI for further information and advice.
For more information, see: Registration and Training.
Advice and guidance
For further advice and guidance regarding the use of human samples, please contact:
Professor John Davey - Designated Individual
J.Davey@Warwick.ac.uk or 02476 968693
HTA Administrative Support
The DI will seek further advice and guidance directly from the HTA, where appropriate.
For more information, see: Advice and Guidance