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Use of Human Tissue at Warwick

Ethical Approval

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, the University’s Biomedical Research Ethics Sub-Committee (BSREC) or an overseas ethics committee. Please note, research using established human cell lines and adult stem cells are exempt from ethical review, as long the topic of research does not raise any sensitive issues. N.B., this does not include embryonic stem cells, which may require ethical review.

All samples must be collected with appropriate consentLink opens in a new window and, when held on the University, must be fully traceable from their acquisition through to their disposal, with appropriate records kept.

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. Registration is a requirement irrespective of an individual’s experience of working with human samples either at the University or elsewhere. It is an important means by which the DI can identify all those working with human samples and communicate effectively with them, to provide effective training, advice and guidance. Registration will be renewed every four years. Failure to register or attend the appropriate training and briefings may result in a research project being delayed, or a researcher being unable to undertake research using human samples.

To Register, you must:
a) Complete the MRC e-learning module ‘Research and human tissue legislation’ which can be accessed hereLink opens in a new window and provide the certificate.
b) Attend a training session with the DI (knowing your responsibilities) - contact for course information
c) Be familiar with the HTA Codes of Practice A and E - HTA Codes of PracticeLink opens in a new window
d) Complete a Declaration of Registration - Form

Working with Human Tissue

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. Any import or export of human samples must be formalised through a Material Transfer Agreement (MTA) which must be authorised by Research & Impact Services.

QMS and SOPs

You must follow All relevant policies and procedures as documented in the Quality Manual and SOPs.