Introduction to Human Tissue Act (2004) - Keele University
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Introduction to the Human Tissue Act (2004)

History and Keele University Guidelines

The Human Tissue Authority (HTA) is the government appointed body established to oversee establishments that store and use human tissue (and its derivatives) for research, patient treatment, post-mortem examination, teaching and public exhibition.

In order to perform the activities listed above any individual institution must have a Human Tissue Licence (HTL). The HTL is available through application from the HTA.   Keele University holds two separate licences with the HTA; a licence for research and a licence for teaching.  A requirement of the HTL is that the HTA can and will perform inspections of licensed establishments to ensure continuous compliance with the licence conditions.

 

RESEARCH

What does this mean to me?

As a new staff member, and if appropriate to your research, you are required to familiarize yourself with the procedures associated with the HTA at the Institute of Science and Technology in Medicine (ISTM). These can be found on the ISTM intranet within the Health and Safety section (http://www.keele.ac.uk/research/istm/). The ISTM is the single holder of a HTL allowing research with relevant human tissues at Keele University (see below).

 

Key Personnel

Corporate Licence Holder Contact – Professor Mark Ormerod

Designated Individual – Prof Alicia El Haj

Human Tissue Officer – Dr Nicholas R Forsyth

Person Designate – Prof Paul Eggleston (Institute Deputy Director)

Person Designate – Mark Smith (Research Manager)

 

How will this affect my research?

ISTM holds a HTL which permits both research and storage activities. Responsibility for current National Research Ethics Service approval, informed consent, or approval from other authorities lies with the PI of the study. However for best practice you may wish to enquire about the existence of these approvals if you are in any doubt.

The HTL requires us to maintain a certain standard of research practice so you should familiarize yourself with the Standard Operating Procedure templates (found at http://www.keele.ac.uk/research/istm/safety.html) and use them for recording all protocols and procedures associated with human tissue (and their derivatives). This will help your record keeping, experimental control, and potentially enhance your research capabilities.

 

What do I do now?

1) Familiarize yourself with the online HTL related material found at http://www.keele.ac.uk/research/istm/safety.html

2) Contact Dr Nicholas R Forsyth (n.r.forsyth@keele.ac.uk) with any queries about the Human Tissue Act (2004) and its implications for you.

 

TEACHING

Where?

Teaching utilising human material takes place mainly in the HTA licensed Anatomy Facility in the School of Medicine on Keele University campus. The license allows anatomical examination, storage, research and training using whole human cadavers and specimens. Staff who may become involved in teaching in this area need to be approved anatomy teachers and will require to go through a short induction process to familiarize themselves with the facility, staff roles, HTA regulations, Health and Safety, and matters associated with confidentiality, respect and tissue preservation.

 

Key Personnel

Corporate Licence Holder Contact – Professor Mark Ormerod

Designated Individual – Mr Mike Mahon

Persons Designate – Hayley Derricott (Prosector), Paul Clews (Anatomy Manager), Gemma Bailey (Anatomy Technician), Fliss Dunn (Bequeathals Secretary)

 

Further Information

Contact Mike Mahon or any of the above named staff or peruse our website http://www.keele.ac.uk/medicine/anatomy. This site also has links to our Body Donor Programme and the Human Tissue Authority (Anatomy Sector).