Human Tissue Act 2004
The Human Tissue Act 2004 covers England, Wales and Northern Ireland. It established the HTA to regulate activities concerning the removal, storage, use and disposal of human tissue. Consent is the fundamental principle of the legislation and underpins the lawful removal, storage and use of body parts, organs and tissue. Different consent requirements apply when dealing with tissue from the deceased and the living. The Human Tissue Act 2004 lists the purposes for which consent is required. For more information visit the Human Tissue Authority website.
It is the responsibility of individual researchers to comply with the requirements of the Human Tissue Act concerning storage and use of relevant human material. The University has HTA licences, research tissue banks, and research ethics support in place to support compliance with the law.
Researchers must ensure that cellular human tissue stored for the purpose of research is registered under a Human Tissue Authority licence or is covered by ethics approval from an NHS Research Ethics Committee (REC). If relevant material will continue to be held when a research project's ethics approval comes to an end, it must comply with HTA standards, and be registered as a collection on a licence or transferred to a research tissue bank.
Here is the link to the University's online Human Tissue Act (HT Act) and Human Tissue Authority (HTA) training. Training is mandatory for anyone working with human samples. This means people who are involved with study design, set up, applying for approvals, recruiting participants, seeking consent, collecting, transporting, processing, storing, managing, releasing, using, transferring or disposing of human samples. For the purposes of defining who should carry out the training, human samples means all samples from people regardless of what type of samples they are, cellular or not. It also includes people who are working on studies that are being conducted under a REC approval that are not currently in the remit of the HTA. The reason for this is that REC approval is not enduring, and staff must know what to do when a study comes to an end.
NDM's Designated Individual is Professor Chris O'Callaghan, with local academics responsible for HTA matters in each NDM sub-unit: