Research and knowledge exchange

Human Tissue Act (2004)

The Human Tissue Act 2004 (HT Act) governs the storage and use of relevant material from the living and the removal, storage and use of relevant material from the deceased, for a scheduled purpose.

University of Sussex HTA Governance Framework

 

The Human Tissue Act (2004) (HT Act) is the legislative framework which governs the storage and use of relevant material from the living and the removal, storage and use of relevant material from the deceased, for a scheduled purpose. 

The Act focuses on both consent and licensing, making consent fundamental to the removal, storage and use of human tissue for certain scheduled purposes.

Relevant material, as defined by the HT Act, is material derived from a human body, other than gametes,* which consists of or includes cells (including bodily waste products).

The following are excluded from the Act:

  • Hair and nail from the body of a living person
  • Embryos outside the human body*
  • Cell lines and other material created outside the human body 
  • Any sample that has been processed to render it acellular (e.g. serum and plasma)

*Regulated by Human Fertilisation and Embryology Act 1990

A supplementary list of relevant material is available from the Human Tissue Authority.  This list is neither exhaustive nor exclusive. Potential users of human tissue are asked to seek guidance from Human Tissue Authority where classification of human tissue is unclear.

 

The Human Tissue Authority (HTA)

 

HTA logo

 

 

 

 

 

 

 

 

 

 

The Human Tissue Authority regulates activities related to the HT Act and issues codes of practice and practical guidance for the storage and use of human tissue.  It acts as the licensing authority and carries out inspections to ensure that licence conditions are met.

The University has four licences with the Human Tissue Authority with oversight provided by an internal governance framework:

 

  • HTA Research Licence (12561) : Brighton and Sussex Medical School
    Designated Individual: Prof Chris Pepper
  • HTA Anatomy Licence (12098) : Brighton and Sussex Medical School
    Designated Individual: Dr Claire Smith
  • HTA Public Display Licence (12687)
  • Designated Individual: Dr Claire Smith

Any planned activity involving the University's Human Tissue Authority licences must be notified in advance to the relevant licensed tissue centres. Note: Tissue held for a specific project currently approved by an NHS Research Ethics Committee does not need to be stored under premises licensed by the Human Tissue Authority.

 

Any planned activity by University researchers involving the transfer or storage of human tissue outside of the University's HTA licensed centres must be notified in advance to the relevant School HTA Person Designate.

 

Guides for the Public

The Human Tissue Authority has published eight Public Guides to the HTA Codes of Practice that  set out basic rights when dealing with an establishment regulated by the HTA. The guides also explain how the use of human tissue is regulated in England, Northern Ireland and Wales. This includes who can give consent for different activities, the information individuals should receive and options for using and disposing of tissue.

 

Licensing and consent requirements for human tissue for research

University researchers must take all appropriate steps to ascertain whether any human tissue samples they plan to obtain, use or store need to be held under a HTA licence. Code A (Guiding Principles and the fundamental principle of consent) should be read by all researchers at the onset of planning to work with human tissue. All HTA codes were updated in April 2017.

 

The Medical Research Council (MRC) have a useful site that summarises the HTA legislation with easy to follow guidance. They also have a very useful e-learning module which is free and takes around 40 minutes to complete. It is recommended that anybody doing research with human samples would benefit from taking the time to go through this.

 

Quality Management System

 

The University has developed a Quality Management System which includes Standard Operating Procedures and guidance documents to ensure compliance with the HT Act.

 

These SOPs must be followed by all staff and students working on research projects involving human tissue. 

The most up-to-date versions of the SOPs and other guidance documents can be found below:

 

Contacts and Notifications

 

Planned activity involving the University's Human Tissue Authority licences must be notified in advance to the relevant contacts below:

 

Brighton and Sussex Medical School (BSMS):

 

Dr Natalie Harriman (Person Designate Research) - n.harriman@bsms.ac.uk

Dr Clare Smith (Designated Individual Anatomy) - Prof Clare Smith

 

School of Life Sciences, School of Psychology :

Dr Rob Fowler (Person Designate - Life Sciences) - r.e.fowler@sussex.ac.uk

Dr Daniel Campbell-Meiklejohn - (Person Designate - Psychology) - daniel.cm@sussex.ac.uk

 

Failure to engage with the relevant individual at an early stage of your research may impact on timely commencement of activity.