The use of human tissue in research is highly regulated to protect tissue donors, their families and researchers. All staff and students who work with human tissue are required to comply with relevant regulatory and legislative requirements. Human tissue which is specifically governed by the Human Tissue Act 2004 (The Act) is termed ‘relevant material’. A joint quality management system (QMS) is in place across Swansea University and Abertawe Bro Morgannwg University Health Board to govern the use of human tissue in research.
Relevant material as defined by the Act is material derived from a human body which consists of or includes cells (including bodily waste products). Human tissue that falls under the legislation is referred to as ‘Relevant Material’ and covers any human sample that may contain even a single cell including blood, urine, skin, sputum, fixed tissue, tears and waste fluids. Researchers should refer to the published Human Tissue Authority (HTA) list of relevant material for a comprehensive guide to the types of human material covered by the Human Tissue Act.
The following are excluded from the act:
- Hair and nails from the body of a living person
- Embryos created outside the human body
- Cell lines
- Extracted cellular components
- Acellular material
The Act, covering England, Wales and Northern Ireland came into full effect on September 1st 2006 to act as a legal framework for the regulation of the removal, storage, use and disposal of human bodies, organs and tissues. The Act was created and implemented in response to public inquiries into events at the Bristol Royal Infirmary and Alder Hey Children’s Hospital which revealed that researchers had removed and stored patient tissue and organs without consent. The Act now enshrines consent for the removal, use and storage of tissue and organs in law.
The HTA, an executive agency of the Department of Health, was established by the Act in 2005 to regulate the removal, storage, use and disposal of human bodies, organs and tissues from the living or deceased for certain purposes including research, transplantation and public display.
Relevant Material can only be legally stored for research either under the governance of NHS Research Ethics Committee (REC) study approval or a HTA Research Sector licence.
University ethics committee approval is not sufficient to comply with legislation for the storage of relevant material for research.
Researchers using human samples are encouraged to seek advice from the Human Tissue Act Compliance Officer on the REC approval and HTA licensing requirements at the outset of the study.
All specific research projects which involve the prospective collection, use and storage of tissue samples from NHS patients or healthy volunteers must gain the appropriate NHS (REC) approval and NHS R&D permission (where appropriate).
Relevant Material which is stored for future use (e.g. retained at the end of a specific study or in a bio-bank) must be stored under a HTA licence. Access to Relevant Material stored under a licence must be restricted and storage overseen by the Designated Individual. This also applies to any other associated clinical data, which must be stored in accordance with GDPR with full consideration of donor confidentiality.