Human Tissue Act
The aim of this site is to provide an overview of the Human Tissue Act (2004), its far reaching implications, the implementation of the Act’s requirements at UCL and the steps taken by UCL to ensure compliance with the Act.
UCL individuals whose activities ("Scheduled Purposes") are encompassed by the Act must ensure that they meet the applicable requirements set out in the Act, the HTA's licensing arrangements and Codes of Practice.
The Human Tissue Act 2004 (Statutory Instrument 2005 No. 919)
The law on the retention and use of organs and tissue was reviewed following public inquiries into post-mortem organ retention scandals, namely, at Bristol Royal Infirmary and the Royal Liverpool Children's Hospital - Alder Hey and following the Isaacs Report (2003), which revealed the widespread practice of storing and using human tissue and organs without proper consent.
The Human Tissue Act (2004), (HT Act) replaces the Human Tissue Act (1961), Anatomy Act (1984) and the Human Organ Transplants Act (1989), and came into force on 7 April 2006. The storage of human tissue and cells for human application has been regulated since April 2006. The regulation of the use and storage of human organs and tissue from the living, and the removal, storage and use of tissue and organs from the deceased for a Scheduled Purpose, such as research, anatomical examination commenced on 1 September 2006, when the HT Act came fully into force.
The HT Act has far-reaching implications and affects the public; academic, clinical and private establishments involved in activities such as research, organ donation and transplantation, and the public display of human organs. The implications for UCL are vast given the complexity of our organisation, the intensity of our research and teaching activities. Establishing appropriate systems and governance arrangements to adhere to the Codes of Practice underpinning the HT Act is key.
The HT Act refers to term "relevant material"; which basically means material that has come from a human body and consists of, or includes human cells i.e. whole cells/cells (intact membranes).
“ The purpose of the Act is to provide a consistent legislative
framework for issues relating to whole body donation and the taking,
storage and use of human organs and tissue. It will make consent the
fundamental principle underpinning the lawful storage and use of human
bodies, body parts, organs and tissue and the removal of material from
the bodies of deceased persons. It will set up an over-arching authority
which is intended to rationalise existing regulation of activities like
transplantation and anatomical examination, and will introduce
regulation of other activities like post mortem examinations, and the
storage of human material for education, training and research. It is
intended to achieve a balance between the rights and expectations of
individuals and families, and broader considerations, such as the
importance of research, education, training, pathology and public health
surveillance to the population as a whole.”
Source: The Human Tissue Act 2004
Who regulates activities that fall under the Human Tissue Act?
The Human Tissue Authority (HTA). The HTA was established under the HT Act on 1 April 2005 to regulate various activities involving the removal, storage, use and disposal of human bodies, organs and tissue for a number of Scheduled Purposes – such as research, transplantation, and education and training. The HTA operates in a similar way to other Regulatory Authorities e.g. the MHRA and and will inspect HTA licensed establishments for check for clear governance procedures and systems to ensure that the establishment is fulfilling the requirements of the HT Act and any conditions attached to a license. See HTA inspections.
Who at UCL is responsible for HTA regulated activities?
Several UCL staff are responsible to activities that are regulated by the HTA. Designated Individuals are central to the HTA's licensing framework and have specific responsibilities that are set out in the HT Act (Section 18).
Currently, UCL has 10 Designated Individuals. UCL holds a (Corporate) License and the named holder is Dr Mark Lowdell and Chair of the UCL HTA Governance Committee. Any member of staff who works under the direction of a Designated Individual must ensure that their activities are conducted in accordance with the HT Act's and HTA's requirements; the granted license with UCL HTA governance arrangements.
How can I found out more about licenses and when/if I will need one?
To find out under what circumstances an HTA licence will be required please refer to the Human Tissue Act Toolkit, devised by Dr Mark Lowdell (UCL HTA Governance Committee Vice-Chair & Designated Individual). This toolkit has been reviewed by the HTA. Several activities fall outside HTA regulation and a summary of these activities can be found here: Activities Excluded from the HT Act and HTA licensing and consent exemptions.
The Human Tissue Authority license, regulate and carry out inspections (See HT Act Schedule 5) at various licensed establishments including universities, NHS Trusts, charities, commercial and private companies to ensure compliance with the HT Act.
The following activities are regulated by the HTA:
- Anatomical examinations
- Making of an post-mortem examination
- Removal of relevant material from a deceased person
- Storage of relevant material from a deceased person (other than for a specific ethically approved project)
- Storage of anatomical specimens
- Storage of relevant material from a living person for research (other than for a specific ethically approved project) or for human application
- Public display of a body or material from a deceased person
Activities that fall outside the Human Tissue Authority’s regulatory remit include:
- Ethically approved research projects or research with ethical approval pending; proposing to use relevant material for research in connection with disorders, or the functioning of the human body
- Use of live gametes, hair and nails from the living, urine, serum or supernatant fluids and substances extracted from tissues where no whole cells remain e.g. DNA
- Activities conducted for the purpose of diagnosis or treatment (material taken from the living only)
- Storage of relevant material, which has come from the body of a living person where the person storing it is intending to use the relevant material, for example, for clinical audit.
For further information on the HT Act exemptions please refer to the HTA’s licensing and consent exemptions webpage.
If you have any concerns about whether tissue or cells you wish to store or use are exempt from HTA licensing you can contact the Joint UCLH/UCL Biomedical Research Unit. Alternatively, advice can be sought directly from the HTA on Tel: 020 7211 3400 Email: firstname.lastname@example.org
Failure to comply with the HT Act is a criminal offence. Enforceable penalties range from a fine to up to three years imprisonment or both.
What are the offences?
- Removal, storage or use of human tissue for Scheduled Purposes without appropriate consent
- Storage or use of human tissue donated for a Scheduled Purpose but used for another purpose
- Trafficking of human tissue for transplantation purposes
- Carrying out licensable activities without holding a licence from the HTA
- “DNA theft” i.e. having human tissue, including hair, nail and gametes with the intention of its DNA being analysed without the consent of the person from whom the tissue came from, or of those close to them if they have died. The exemptions to this include medical diagnosis and treatment, criminal investigations.
Enforceable penalties range from a fine to up to three years’, imprisonment or both. Offences by bodies corporate: HT Act 49 Offences by bodies corporate
UCL - HTA licenses
After consultation with the Human Tissue Authority (HTA), it was advised that UCL act as a (Corporate) Licence Holder and have in place applicable Designated Individuals to supervise activities at premises where HTA licensable activities will be conducted.
Currently, UCL Designated Individuals hold licenses that cover Anatomy (2), Research (7) and for activities involving the storage and use of human cells and tissue for human application (1). Satellite site licences are also in place that cover specific UCL premises. If you would like to know which sites are covered by a satellite site license please contact the Joint UCLH/UCL Biomedical Research (R&D) Unit or your local Joint UCL/NHS R&D Office.
The HT Act Toolkit developed by Dr Mark Lowdell and approved by the HTA will help determine whether an HTA licence is needed for a proposed activity involving the storage/use of human tissue or cells from the living and/or the deceased.
If any your activities are regulated by the HTA, it is important that you understand fully your responsibilities, and the requirements and standards that must be met under the HTA’s regulatory framework and to UCL. If you are involved in any of the activities listed under Activities governed by the HT Act on UCL, NHS Trust premises, or at third party sites, you must ensure that an applicable HTA license is in place.
What is a Designated Individual?
A Designated Individual is the person who is responsible and ultimately accountable for supervising activities under an HTA license and, for ensuring compliance with the Conditions attached to a licence.
Failure of a Designated Individual to comply with the HT Act (see Enforceable offences and penalties under the Human Tissue Act) / license conditions could ultimately lead to a special directions being attached to a licence, or a license being revoked by the HTA; or a fine, or imprisonment, or both! A Designated Individual can delegate duties to persons under their supervision but is is ultimately accountable for activities conducted under their license not establishments.
Who are the UCL Designated Individuals?
Currently, there are 10 UCL Designated Individuals based at the Bloomsbury and Hampstead Campuses. Please contact the Joint R&D Unit if you would like a list and the contact details of UCL-affiliated NHS Trust Designated Individuals and the type of HTA license held.
For further information on the role of a Designated Individual please refer to the HTA Guide to licensing for Designated Individuals and Licence Holders.
What is relevant material?
“Relevant material” as defined in the Human Tissue Act (2004) Part 3 Point 53 means: “…material, other than gametes, which consists of, or includes human cells. In the Act, references to relevant material from a human body do not include (a) embryos outside the human body, or (b) hair and nail from the body of a living person.”
The Human Tissue Authority has now published revised guidance on the definition of relevant material and has published a document listing material classifided as relevant material.
In essence, relevant material is material from a human body e.g. blood, tissue slices bone, skin, sputum, foetal tissue which consists of, or includes human cells with intact / undisrupted cell membranes.
If you have any concerns about whether the tissue or cells you wish to store or use are classed as relevant material advice can be sought directly from the HTA on Tel: 020 7211 3400 Email: email@example.com
UCL HTA Governance Committee
The UCL HTA Governance Committee is Chaired by Professor RJS Frackowiak and supported by the Vice-Chair, Dr Mark Lowdell. UCL and UCL-affiliated NHS Trust Designated Individuals, R&D representatives and Persons Designated form the UCL HTA Research Governance Committee.
UCL Designated Individuals are required to attend the Committee meetings. Since January 2007, the Committee met approx 3 times a year; and from 14 May 2008 the Committee will convene bi-annually.
UCL’s HTA Governance structure and key responsibilities.
Two UCL HTA working parties were been established to assist with the implementation of HT Act requirements at UCL. Both work under the direction of the UCL HTA Governance Committee Chair.
UCL HTA mailing list
UCL and UCL-affiliated NHS Trust Designated Individuals, Persons Designated and R&D representatives are included in the UCL_HTA email distribution list, which enables up-to-date information, guidance and queries to be shared from both internal and external sources.
Investigators who need any information or advice concerning UCL/H HTA/R&D arrangements can contact Dr Oke Avwenagha (o.avwenagha@.ucl.ac.uk); 0207 380 9928 or Dr Susan Kerrison (firstname.lastname@example.org) 0207 380 9927.
Investigators at the Institute of Child Health or Institute of Ophthalmology should contact Subhir Bedi, Senior Research Governance Manager (email@example.com) 020 7905 2249 and Nima Sharma, Research Governance Coordinator (firstname.lastname@example.org) or Dr Helen Jones (email@example.com .uk) for their Institute's’HTA / R&D arrangements.
HTA essentials - Quick links
Human Tissue Authourity. eLearning course for Designated Individuals.
following policies and standard operating procedures (SOPs) were
developed by the UCL policy and SOP working parties. The policies and
SOPs focus on research activities and may need to be tailored for local
activities. Anatomy and Pathology policies and SOPs should be obtained
via the relevant Designated Individual.
- Staff training
- Quality management
- Record management
- Transfer of tissue
- UCL HTA Adverse events/incident reporting / UCL HTA AE/incident report form
Central UCL policies & guidances
- Data Protection
- Whistle-blowing (public interest disclosure)
- Safety policy
- Accident/incident reporting
Templates are to be used as a guide. Please adapt to meet local requirements
- SOP template
- Staff training
- Consent Updated 21.10.08
- Tissue transfer Updated 21.10.08
- Booking tissue Updated 21.10.08
- Recall of tissue Updated 21.10.08
- Complaints Updated 21.10.08
- Disposal Updated 21.10.08
- Managing new SOPs
- UCL HTA AE/incident report form
- SOP template
- Consent template for research
- Filenote template
- UCLB's HTA compliant MTA New version (2.0, 01.05.08)
- Inter-departmental letter agreement
- DI-PD delegation of duties log
- Training log sheet (see staff training SOP)
- Training certificate (see staff training SOP)
In England, Wales and Northern Ireland the storage of tissue for use in research requires a licence from the Human Tissue Authority (HTA), unless the tissue is held for the purpose of a specific project with approval or for which approval is pending from a REC recognised by the United Kingdom Ethics Committee Authority (UKECA) or the Secretary of State e.g. an NHS REC. See HTA FAQ: Research
The majority of UCL-led research projects involving the storage and/or use of relevant material are undertaken with ethics approval. Please note that the UCL REC is not registered with the UKECA therefore if you propose to conduct a research project that will use relevant material from a healthy volunteer you will need to obtain ethical approval from an NHS REC but please note the HTA Code of Practice exemptions relating to University Research Ethics Committees.
What should I be aware of if I want to store the tissue I collected as part of an ethics approved research project?
If you plan to store tissue /cells beyond the life of an NHS REC approved specific project for use in further projects you should consider the following points, as well as what the participant consented to regarding the use / storage of the donated sample:
- Transfer the samples to a HTA licensed research tissue bank (RTB) for further storage or into the holdings of an appropriate Designated Individual who is willing to accept the material under their license or discuss the possibility becoming satellite site with the Designated Individual. See HTA FAQ: Research.
- Make a further research project-based application to the NHS REC. The application must be submitted no later than the date on which the first project ends. The HTA advise "...an application for ethical approval for the new research project should be made in good time to coincide with the end of the current research project." "The samples will need to be transferred to an existing licensed store until either a licence is granted or ethical approval has been obtained." See HTA FAQ: Research.
- Set-up a new RTB and apply for a licence from the HTA to store the material. The HTA advise that an "...application for a licence should be made in good time: we recommend at least three months before the current research project ends." Please note that if you propose to apply for a license on UCL premises please inform the Chair of the UCL HTA Governance Committee, Dr Mark Lowdell. Researchers based at the Institute of Child Health or the Institute of Ophthalamology should contact their Joint R&D Offices for advice.
If none of the above steps are taken, arrangements for disposal of the material at the end of the project must be made in accordance with the HTA's Code of Practice: Code of Practice on the Removal, Storage and Disposal of Human Organs and Tissue.
*A project-specific application to the NHS REC cannot be used to seek open-ended approval for use of stored tissue in future research programmes (although the terms of the consent itself may be broad, allowing for future approved research using the same samples). Furthermore, submissions of substantial amendments for approved projects, in order to use tissue for another project with a different set of research questions is not allowed.
What about research using relevant material e.g. blood from healthy volunteers?
As mentioned above, the UCL REC is not registered with the UKECA therefore if you propose to conduct a research project that will take blood from healthy volunteers you should seek ethical approval from an NHS REC - however, the HTA Codes of Practice for Consent and Research (9) notes when ethics approval can be obtained from a University Research Ethics Commitee.
- EU Tissues and Cells Directive 2004/23/EC
- Human Tissue Act (2004)
- Human Tissue Act (2004) Explanatory Notes
- Directions given under the Human Tissue Act 2004: 001/2006
- HTA Codes of Practice
- HTA Licensing Guidance
- HTA FAQs (including licensing and research)
- Guide to licensing for Designated Individuals and Licence Holders
- Application guide
- Inspections HTA summary inspection reports (2006-2008)
- Satellite sites
- Fees and payment
- Late license applications
- Licensed establishments
- NHS R&D Forum
- Department of Health: Summary of the Human Tissue Act