The Human Tissue Act (2004), (HT Act), provides a legal framework for regulating the storage and use of human tissue from the living, and the removal, storage and use of tissue from the deceased.
Working with Human Tissue at the University
As the University does not have a human tissue licence, we remain compliant by ensuring any relevant human tissue is held in our premises under a relevant research project that has received ethical approval from an NHS Research Ethics Committee (REC).
Alternatively, researchers can collaborate with a licensed facility, using a Research Tissue Bank (RTB) with a favourable REC opinion, or by outsourcing the storage of tissue to a HTA-licensed establishment. The important aspect is that the project-specific ethical approval covers the exemption for storing the tissue in a given location.
For more information please watch the recording or the presentation slides of our Research Ethics Open House on this topic.
Training
Anyone working with human samples, whether relevant or non-relevant material, in research must undertake training on the Human Tissue Act and its related codes of practice.
For more information about this training and how to access please read our dedicated guide.
Risk Assessment
The Human Tissue Authority (HTA) is responsible for independently regulating organisations that remove, store and use human tissue for research, medical treatment, post-mortem examination, education and training, and display in public. Under their Governance and Quality Standard 6 on the Code of Practice for Research, there is a requirement to perform risk assessments for all practices and processes requiring compliance with the HT Act and the HTA’s Codes of Practice.
All research projects using Relevant Materials as defined by the HT Act must submit a risk assessment considering potential areas in which the project could possibly fail to comply with the HTA codes of practice.
These are in addition to risk assessments related to health and safety issues.
Completion of this template risk assessment form is a mandatory requirement for Sponsorship to be considered.