Human Tissue Governance

The HTA (2004) at LJMU

The Faculty of Science 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.

Staff and students can only work with relevant materials under the licence within specifically designated facilities on the Byrom Street site. Anyone wishing to work with relevant materials should firstly refer to the University processes. Any enquiries should be sent to human.tissue@ljmu.ac.uk and these will be dealt with by the Human Tissue Team.

There are strict rules in operation in terms of training and the recording and storing of relevant materials under the HTA Act (2004). The Faculty has specially designated rooms and facilities on the Byrom Street site for storing such materials and these are the only places within the University where relevant materials are permitted to be stored. Staff will be allocated a storage location following completion of training (see the 'training' page of the Human Tissue Site).

HTA licence number – 12528

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 consists of, or includes, human cells, except 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.

The activities covered by the Act are referred to as “scheduled purposes”. They are divided into two groups:

Part 1

  • 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
  • Transplantation

Part 2

  • Clinical audit
  • Education or training relating to human health
  • Performance assessment
  • Public health monitoring
  • Quality assurance

Consent

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.

For further information:

UREC Research Ethics Training includes training on consent.

Human Tissue Act and Research

The HTA regulates research which is commonly thought of as ‘laboratory bench’ research. The Act ensures that tissue is removed and stored in an appropriate and well managed way.

The main requirements of the Act in relation to research involving human organs or tissues are:

  1. Consent must be obtained for any storage and use of tissue removed after death for research purposes.
  2. 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 the relevant “research ethics authority” e.g. NHS Research Ethics Committee.

Storage of human material for research

The main requirements of the Act in relation to the storage of human material, organs or tissue are:

  1. 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 National Research Ethics Authority approval.
  2. 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 from a national research ethics body.

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 the relevant research ethics authority e.g. National Research Ethics Bodies.

For information on governance structure and approved storage facilities see the LJMU Human Tissue Operations Manual.

Other Resources and Useful Related Information

There are other useful resources for researchers, but LJMU policy and guidance must be followed for all work undertaken under the LJMU license.