Human Tissue Act 2004 (HT Act) in the NDMRB
The Human Tissue Authority (HTA) was set up to regulate 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 - set out in the Human Tissue Act 2004 (HT Act). The HT Act covers England, Wales and Northern Ireland and came into force on 1 September 2006.
Research sample collections within the NDMRB may be registered under the governance of HTA licence 12217 which has a Satellite licence covering the University buildings on the Old Road Campus and the OUHFT Churchill Hospital site. The Designated Individual (DI) for the licence is Dr Brian Shine. For research samples to be stored legally, unless an exemption is in place, they must be registered under the governance of the HTA licence, to ensure that the DI has adequate oversight and can be assured that the requirements of the HTA Act are being met.
The procedure for registering collections is described in the Core SOP for the licence, HTA006 Quarantine, registration and audit.
It is mandatory for anyone working under the governance of the HTA licence to have completed the HT Act, HTA and HTA Codes of Practice training which is provided online on WebLearn.
In addition it is a requirement that anyone working under the governance of the HTA licence must be aware of the University procedures which are outlined in the Core SOPs. These are provided on the Research Services website in addition to being provided in WebLearn. Staff working under the governance of the licence must acknowledge that they have read the SOPs, that they understand them and that they will adhere to the procedures within them. An electronic record of acknowledgement is provided on WebLearn for each SOP and must be completed by each relevant staff member/ student.
The NDMRB management policy is to ensure compliance with the Human Tissue Act and with the standards and guidance set by the Human Tissue Authority. The level of quality required is achieved through the adoption of a system of procedures that reflect the regulatory standards and guidelines and the information contained within this document.
Everyone who works with human tissue is responsible for ensuring that they are working lawfully and in accordance with the HT Act and are involved in achieving compliance with these procedures. Everyone is individually responsible for the quality of their work, which should result in a continually improving working environment for all.
The NDMRB Person Designated (PD) is Professor Jane McKeating. The role of the PD is to assist the DI in ensuring compliance with HTA standards, to assist with developing procedures, and to assist with the reporting of incidents. The DI has a legal duty to ensure that statutory and regulatory requirements are met. The DI has the primary (legal) responsibility under Section 18 of the Human Tissue Act to ensure:
- that suitable practices are used in undertaking the licensed activity;
- that other persons working under the licence are suitable and;
- that the conditions of the licence are complied with.
2.0 Objectives of the HTA
- Provides safeguards and penalties to prevent a recurrence of the distress caused by the retention of tissue and organs without proper consent
- To improve public confidence so that people will be more willing to agree to valuable uses of tissues and organs
- To improve professional confidence so that properly authorised supplies of tissue for research, education and transplantation can be maintained and improved.
2.1 Main provisions relevant to research
- Regulates storage and use of human tissue (“relevant material”) and removal of tissue from the deceased
- Makes CONSENT a fundamental principle underpinning removal, use (“Scheduled purposes”) and storage of tissue.
- Established the Human Tissue Authority to advise on and oversee compliance with the HT Act
- Makes it an offence to analyse DNA without consent
- It is an offence to possess any bodily material with the intent to analyse the DNA unless consent has been given.
- ‘Bodily material’ differs from ‘relevant material’ as it includes hair and nails from the living and gametes.
- Use of the results of DNA analysis for research does not require consent if the bodily material from which it is extracted is from a LIVING person, anonymised and the study is approved by an NHS REC.
- The HRA expects researchers intending to extract DNA from acellular material and use it in research without consent, to submit their proposals for ethical review by an NHS REC.
For more information about DNA analysis and excepted purposes please visit:
3.0 Definitions of “relevant material”
RELEVANT MATERIAL (Must be declared annually and fully auditable records kept):
The HT Act refers to ‘relevant material’, defined as ‘material, other than gametes, which consists of or includes human cells’.
- Cells that have divided or been created outside the human body.
- Cells that have been treated, processed or lysed through a process intended to render them acellular. This would include the freezing or thawing of cells only where that process is intended to render the material acellular.
- Animal derived material (except when part of a xenograft).
- Eggs, sperm and gametes - while outside the definition of relevant material for the purposes of the HT Act, these materials fall under the remit of the Human Fertilisation and Embryology Act 1990, and are regulated by the Human Fertilisation and Embryology Authority (HFEA).
- DNA and RNA - not relevant material; does not contain cells.
- Hair and nails from the living (except when the intention is to extract DNA).
4.0 Exemptions to licensing
Samples collected and used with approval from a recognised REC (e.g. an NHS NRES REC) are exempt from the licensing requirement of the HT Act. This includes samples collected as part of a clinical trial that has been conducted in the UK. The approval has to be current and valid, i.e. the end of study declaration must not have been submitted to the REC more than 12 months ago.
Samples obtained for a specific research project from an ethically approved research tissue bank (RTB), where the samples have been provided under the ethical approval of that biobank (not all RTBs confer ethics, evidence of approval must be obtained in writing).
Samples stored for no more than 7 days pending transport to an HTA licenced site.
Samples stored with the intention of rendering them acellular that are stored for no more than 7 days.
Samples stored for purposes other than ‘Scheduled purposes’.
The HT Act does not apply to bodies or relevant material where the person died before the HT Act came into force on 1 September 2006; and at least 100 years have elapsed since the date of the person’s death.
5.0 HTA Licensing
The activities licenced by the HTA are:
- Removal and storage of relevant material from a deceased person
- Storage of anatomical specimens
- Storage of relevant material from a living person for research (other than for a specific ethically approved project, where the REC is a recognised REC)
- For human application
- Carrying out of an anatomical examination
- Conducting of a postmortem examination
- Public display of a body or material from deceased person
6.0 Declaration of HTA relevant material
Annually, the PD for the NDMRB will put out a call for a declaration of current holdings which are HTA relevant. It is the responsibility of each PI to complete the declaration which must detail all holdings which are being stored under the licence. If a group is holding no relevant material then a “null” declaration must be made.
If a group has the intention of bringing in HTA relevant material after the annual declaration has been made, the PD for the NDMRB must be notified before and when the samples arrive, so that the cohort can be registered and subject to audit against the HTA Standards for Research (see HTA Codes and Standards for Research). The PD will work with the PI / Collection custodian and the Research Services Human Tissue Governance Team (Licence 12217) (HTGT), to complete the registration process as per the Core SOP HTA006.
7.0 Risk Assessment
NDMRB-RA-120 Human Tissue Act (HTA) in the NDMRB
The information on this page will be reviewed and amended if necessary every three years by the NDMRB PD or alternative relevant personnel.
- Reference: Human Tissue Act (use of Human Samples in Research): An introductory Level Workshop, Carol Smee
- https://www.hta.gov.uk/sites/default/files/Code%20E%20-%20Research%20Final_0.pdf[GM1] [GM2] [GM3]
- Link to Core SOPs:
- Further information about the Human Tissue Act and Biobanks can be found here.
The general advice, in regards to HTA relevant material, is to discuss your project and material type with the "Person Designated" who will be able to advise you accordingly. The PD for the NDMRB is Jane McKeating