Human Tissue Act 2004
The Human Tissue Act 2004 came into force on 1 September 2006. This legislation regulates the storage and use of human organs and tissues from living individuals and the removal, storage and use of human organs and tissues from the deceased. The Human Tissue Authority is the competent authority overseeing implementation and compliance with the Act.
What is human tissue?
Human tissue is referred to as “relevant material” and includes any material that comes from a human body that consist of, or includes, human cells, with the exception of hair and nails from the living and live gametes and embryos created outside the human body. It includes blood (except for treatment) and other bodily fluids.
What is covered by the Act?
The activities covered by the Act are referred to as “scheduled purposes”. They are divided into two groups:
- Anatomical examination
- Determining the cause of death
- Establishing after a person’s death the efficacy of a drug or treatment
- Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person
- Public display
- Research in connection with disorders or the functioning of the human body
- Clinical audit
- Education or training relating to human health
- Performance assessment
- Public health monitoring
- Quality assurance
Consent is the central focus of the legislation and carrying out any of the activities listed as scheduled purposes without the necessary consent is an offence. As a general rule consent is always required for activities listed in Part 1. Part 2 activities require consent if the material is from a person who is dead at the time the material was removed
Human Tissue Act and Research
The main requirements of the Act in relation to research involving human organs or tissues are:
Consent must be obtained for any storage and use of tissue removed after death for research purposes
Consent is required for the storage and use of tissue from living individuals for research unless the material has been anonymised, such that the person carrying out the research does not know the identity of the donor, and the research project has been approved by a “research ethics authority” or approval is pending.
Storage of human material for research
The main requirements of the Act in relation to the storage of human material, organs or tissue are:
Consent is required for the storage of material from a living individual for any Part 1 activity except where it is anonymised tissue stored for a research project that has research ethics authority approval or approval is pending.
Consent is required for the storage of material from a deceased person for both Part 1 and Part 2 activities.
Storage of material removed from living individuals only requires a licence if it is stored for future research that does not have ethical approval (tissue banks).
The storage of tissue from a deceased individual requires a licence except where it is stored for use in a research project that has received approval from a research ethics authority (see above) or approval is pending.
The Research Institute for Sport and Exercise Sciences (RISES) holds a license from the Human Tissue Authority for the storage of relevant material which has come from a human body for research in connection with disorders or functioning of the human body.The following people are responsible for ensuring that research is conducted in accordance with the conditions of the license:
Name Role Contact Details Prof Tim Cable Designated Individual 0151 904 6282 email@example.com Dr Sue Spiers Person Designated 0151 904 6476 firstname.lastname@example.org Dr Dave Harriss Person Designated 0151 904 6236 email@example.com Dr Jatin Burniston Person Designated 0151 904 6265 firstname.lastname@example.org Monica Barclay Person Designated 0151 904 6211 email@example.com
Further information on the Human Tissue Act and using human tissue in research can be found in the following documents:
Obtaining Informed Consent for Research Participation
Material Transfer Agreements for Human Tissue Samples
Disposal of Human Research Tissue Samples
What is relevant material?
British Medical Association: Guidance on Human Tissue Legislation
The Medical Research Council's Data and Tissue Toolkit can be viewed at http://www.dt-toolkit.ac.uk/home.cfm
The Human Tissue Authority's Codes of Practice can be downloaded at http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice.cfm