What is the the Human Tissue Act and what does it mean?
The Human Tissue Act 2004 (Statutory Instrument 2005 No. 919)
The law on the retention and use of organs and tissue was reviewed following public inquiries into post-mortem organ retention scandals, namely, at Bristol Royal Infirmary and the Royal Liverpool Children's Hospital - Alder Hey and following the Isaacs Report (2003), which revealed the widespread practice of storing and using human tissue and organs without proper consent.
The Human Tissue Act (2004), (HT Act) replaces the Human Tissue Act (1961), Anatomy Act (1984) and the Human Organ Transplants Act (1989), and came into force on 7 April 2006. The storage of human tissue and cells for human application has been regulated since April 2006. The regulation of the use and storage of human organs and tissue from the living, and the removal, storage and use of tissue and organs from the deceased for a Scheduled Purpose, such as research, anatomical examination commenced on 1 September 2006, when the HT Act came fully into force.
The HT Act has far-reaching implications and affects the public; academic, clinical and private establishments involved in activities such as research, organ donation and transplantation, and the public display of human organs. The implications for UCL are vast given the complexity of our orgainsation, the intenstiy of our research and teaching activities. Establishing appropriate systems and governance arrangements to adhere to the Codes of Practice underpinning the HT Act is key.
The HT Act refers to term "relevant material"; which basically means material that has come from a human body and consists of, or includes human cells i.e. whole cells/cells (intact membranes).
“ The purpose of the Act is to provide a consistent legislative framework for issues relating to whole body donation and the taking, storage and use of human organs and tissue. It will make consent the fundamental principle underpinning the lawful storage and use of human bodies, body parts, organs and tissue and the removal of material from the bodies of deceased persons. It will set up an over-arching authority which is intended to rationalise existing regulation of activities like transplantation and anatomical examination, and will introduce regulation of other activities like post mortem examinations, and the storage of human material for education, training and research. It is intended to achieve a balance between the rights and expectations of individuals and families, and broader considerations, such as the importance of research, education, training, pathology and public health surveillance to the population as a whole.”
Source: The Human Tissue Act 2004
Who regulates activities that fall under the Human Tissue Act?
The Human Tissue Authority (HTA).
Who at UCL is responsible for HTA regulated activities?
Several UCL staff are responsible for activities that are regulated by the HTA. Designated Individuals are central to the HTA's licensing framework and have specific responsibilities that are set out in the HT Act (Section 18). They are supported by key personnel referred to as Person(s) Designated. Currently, UCL has 7 Designated Individuals.
How can I found out more about licenses and when/if I will need one?
To find out under what circumstances an HTA licence is required please refer to the Human Tissue Act Toolkit, devised by Dr Mark Lowdell (UCL HTA Governance Committee Vice-Chair & Designated Individual). Several activities fall outside of HTA regulation and a summary of these activities can be found via: Activities Excluded from the HT Act and HTA licensing and consent exemptions.