Human Tissue Act 2004

Human Tissue Act 2004 at Liverpool John Moores University

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 o as "relevant material" and includes any material that comes from a human body that consists 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 fro 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.

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:

(i) Consent must be obtained for any storage and use of tissue removed after death for research purposes.
(ii)  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. National 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:

(i) 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.

(ii) 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.


 

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 license within specifically designated facilities on the Byrom Street site.  Anyone wishing to work with relevant materials should firstly refer to the University processes which are available at http://www.ljmu.ac.uk/RGSO/93204.htm and then, depending on the type of research, should liaise with the appropriate member of Faculty staff before bringing any relevant materials under the Act onto the premises:


• Sports and Exercise Science based research in the Tom Reilly Building: Monica Barclay (0151 904 6211 m.barclay@ljmu.ac.uk)
• Cell and Tissue Research on the 1st Floor Life Sciences Building:  (0151 231 2163)
• Bones and teeth: Denise Philip (0151 231 2367 d.m.phillip@ljmu.ac.uk)

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 and students will be informed of the procedures and given access to the facilities once training is completed.


 

1. Governance Structure


The following people are responsible for ensuring that research is conducted in accordance with the conditions of the license:

 Name Role
  Details
 Prof Robin Leatherbarrow Institutional License Holder  0151 231 3503  r.j.leatherbarrow@ljmu.ac.uk
 Prof Peter Wheeler Designated Individual  0151 231 2042 p.e.wheeler@ljmu.ac.uk
 Prof Andrew Young Person Designated  0151 904 6475 a.j.young@ljmu.ac.uk
 Aly Leigh Person Designated (Faculty Head of Operations)   0151 231 2242 a.j.leigh@ljmu.ac.uk
 Monica Barclay   Person Designated (Senior Technician & HTA Training Co-ordinator)   0151 904 6211 m.barclay@ljmu.ac.uk
 To be confirmed by February 2015
 Person Designated (Senior Research Officer & HTA Tissue Co-ordinator)  0151 231 2163
 Dr Denise Phillip  Person Designated (Senior Research Officer - Anthropology)  0151 231 2367 d.m.phillip@ljmu.ac.uk
 Dr Cathy Montgomery  Person Designated (Psychology)   0151 904 6295 c.a.montgomery@ljmu.ac.uk
 Dr Isabelle De Groote  Person Designated (Anthropology)  0151 231 2812 i.degroote@ljmu.ac.uk
 Dr Gordon Lowe  Person Designated (Pharmacy & Biomolecular Sciences)  0151 231 2142 g.m.lowe@ljmu.ac.uk
 Dr Dave Harriss  Person Designated (Sports & Exercise Sciences)  0151 904 6236 d.harriss@ljmu.ac.uk

    
LJMU Policy and Guidance Documentation relating to the HT Act is endorsed by the University’s Research Ethics Committee and approved by the Designated Individual.  All matters concerning the Human Tissue Act (2004) are reported to the Faculty’s Research, Knowledge Transfer and Scholarship Committee and the Faculty Management Team (FMT).  Professor Peter Wheeler (DI) is a member of both committees and Chair of the FMT.  Points related to procedure or institutional policy and/or guidance are referred to the University Research Ethics Committee as a matter of routine.
The Faculty is also required to provide an annual report at the end of each academic year that reflects activity, developments, compliance, audits, etc. as appropriate. This feeds into the University’s Research Ethics Committee’s annual report, which goes to the University Research Strategy Committee and Academic Board.

2. Approved Human Tissue Storage Facilities:

Access to designated areas can be granted to authorised staff and students via the appropriate technical and research staff:

• Sports and Exercise Science based research in the Tom Reilly Building: Monica Barclay (0151 904 6211 m.barclay@ljmu.ac.uk)
• Cell and Tissue Research on the 1st Floor Life Sciences Building:  (0151 231 2163)
• Bones and teeth: Denise Philip (0151 231 2367) d.m.phillip@ljmu.ac.uk)
• DNA facilities: Jerry Bird (0151 231 2187) j.bird@ljmu.ac.uk
Life Science Building (Byrom Street)

• 1st Floor: room 1.25 (3 freezers): HTA freezer 1, HTA freezer 2, SPS Muscle  
     Metabolism
• 1st Floor: room 1.23 (-20 freezer)
• *2nd Floor: room 2.16b (within the DNA laboratory)

James Parsons Building (Byrom Street)

• 2nd floor: room 247 (locked cabinet): Human Cremated Remains

• 4th Floor: room 446 (locked cabinet): Human Remains

*Presently not being used.

No HTA relevant materials are to be stored anywhere else in LJMU, other than in these locations.

3. Documentation

The documentation for HTA is available via the Faculty of Science Share-point and this is available to staff and students after training.   Only those trained and deemed competent are authorised to work with human tissue under the license.  A list of authorised personnel and students is kept up to date and is available to view on the Procuro Database.
All documentation is reviewed annually, usually in December/January.  All documentation has the version date specified and users can easily tell that they are using the most recent version by the version date specified for instance a document with a version date that is more than 18 months old will not the most up to date version. 

Related LJMU Policy and Guidance documentation:

1. HTA (2004) at LJMU 
2. Guidance on Research and the Human Tissue Act 2004
3. What is relevant material?
4. HTA relating to DNA work
5. Obtaining Informed Consent for Research Participation
6. Material Transfer Agreements for Human Tissue Samples
7. Tissue Tracking Policy and Procedures
8. Disposal of Human Research Tissue Samples
9. Adverse Events Relating to HTA
10. LJMU Human Remains Policy 
11. Audit Procedures

Training Documentation

12. HTA at LJMU Training Manual and Guidance 
12a. HTA at LJMU Accreditation Training Presentation

LJMU Related Policy and Forms:

13. Risk Assessment for Working with Human Tissue
14. Consent Form (refer to document 4)
15. Material Transfer Agreement Form (refer to document 5)
16. Verbal Consent form
17. Participant Complaint Form
18.  Adverse Event Form (refer to document 7)
19. Training Record Form (refer to document 11).

Process Flow Diagrams

20. Summary of Procedures
21. Tissue Co-ordinator’s Responsibilities
22. Training Co-ordinator’s Responsibilities
23. Consent Procedures Flow Diagram
24. Adverse Event Procedures Flow Diagram

 

4. 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.
a) University Research Ethics Committee  http://www.ljmu.ac.uk/RGSO/93042.htm


b) The Human Tissue Act 2004 (http://www.legislation.gov.uk/ukpga/2004/30/contents)

c) The Human Tissue Authority's Codes of Practice can be downloaded at http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice.cfm

d) British Medical Association: Guidance on Human Tissue Legislation: http://bma.org.uk/search?query=Human%20tissue%20legislation

e) The Medical Research Council's Data and Tissue Toolkit can be viewed at
http://www.dt-toolkit.ac.uk/home.cfm

f) National Research Ethics Committee (NRES) (http://www.nres.nhs.uk/)

g) University Health & Safety Unit http://www.ljmu.ac.uk/HSU/index.htm


h) Practical guidance on the consent requirements for DNA analysis can be found in the HTA's Code of practice on Consent


 



Page last modified 29 January 2015.

Send feedback
 
LJMU Logo banner imageLJMU Logo banner image (print)