Human Tissue Act 2004
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 which are available at http://bit.ly/HumanTissue. Any enquiries should be sent to firstname.lastname@example.org 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, 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.
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. See https://bit.ly/HumanTissue_Consent for more information about Consent at LJMU.
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.
For information on governance structure and approved storage facilities see the LJMU Human Tissue Operations Manual (https://bit.ly/HumanTissue_OpsManual)
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
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 https://esrc.ukri.org/funding/guidance-for-applicants/research-ethics/
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
Mental Capacity Act 2005
From 1 October 2007, research covered by the Mental Capacity Act cannot include any person who lacks the capacity to consent to the research unless:
- The research has the approval of a research ethics committee recognised by either the Secretary of State or the Welsh Assembly Government, as appropriate
- The researcher considers the views of carers and other relevant people
- The research treats the person’s interests as more important than those of science and society, and
- The researcher respects any advance decisions or expressed preferences of a person who lacks capacity and any objections the person makes during the research
The following documents provide further information about the implications of the Mental Capacity Act and research:The Mental Capacity Act Code of Practice
Ethical Approval of Invasive Teaching Procedures
Where teaching practices involve invasive (physiological or psychological) procedures on human participants eg blood sampling, videoing, administration of personal questionnaires or use of equipment to measure physiological responses JMU REC will provide an ethical opinion on the teaching procedure and associated consent process. Responsible staff eg the relevant programme or module leader should submit the following documentation to the ethics committee secretary for consideration by the REC:
- An outline of the procedure in question including its purpose, typical use and information regarding storage of any personal data/information collected during the procedure
- A code of practice for staff / students
- A sample participant information sheet
- A sample consent form or, in the case of verbal consent, details of the consent process
- A copy of any risk assessment undertaken
- A list of all staff wishing to be approved to supervise or perform the procedure.
The code of practice should ideally describe the procedure in question and address the need for the procedure in the context of the teaching programme, any associated risks and how they will be mitigated, the consent process and what will happen to any personal data which is generated by the procedure.
Following successful review approval for the Code of Practice for teaching purposes will be issued for a maximum period of 3 years.
During the 3 year approval period the named individual for the procedure will be required to notify the REC of:
- any substantial changes to the procedure
- the addition or removal of named staff to the approved list
- any adverse events which occur in relation to the named procedure