Code E: Introduction
This page includes an introduction to the Human Tissue Authority Codes of Practice and the Research Code
Introduction to the Human Tissue Authority Codes of Practice
1. The Human Tissue Authority’s (HTA) regulatory remit is defined in the Human Tissue Act 2004 (HT Act). The HTA regulates the following activities through licensing:
a) post-mortem examination;
b) anatomical examination;
c) public display of tissue from the deceased; and
d) the removal and storage of human tissue for a range of purposes, including research, medical treatment, education and training.
2. The HTA also assesses applications for organ, bone marrow and peripheral blood stem cell (PBSC) donations from living people.
3. Further information about the legislative background and context of the HTA and its Codes of Practice (including geographic coverage) is set out at Annex A.
4. This document is part of a suite of seven Codes of Practice produced by the HTA. The Codes give practical guidance to professionals carrying out activities which lie within the HTA’s remit under the HT Act and Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 (the Regulations). They will also be of interest to members of the public.
5. The HTA Codes of Practice provide guidance on activities within the scope of the HTA’s remit. Whilst the HTA may offer advice on matters outside its remit, it has no power to act in relation to these and will endeavour to provide signposts to other agencies where issues arise that are beyond its regulatory reach.
6. HTA Code A: Guiding principles and the fundamental principle of consent contains information that is applicable to all establishments and professionals operating under the HT Act and the Regulations. It sets out the following four guiding principles, which should inform the actions of anyone undertaking activities falling within the remit of the HTA:
a) consent;
b) dignity;
c) quality; and
d) honesty and openness.
7. With regard to the Research sector, these principles translate into actions which ensure that potential donors are given the information they need to make the best decisions requiring their consent. It is also incumbent on regulated organisations to manage human material in accordance with expressed wishes, removing, storing, using and disposing of material properly and respectfully.
8. In combination, Code A and this Code aim to provide anyone undertaking activities relevant to this sector with a reference source which gives practical advice on the minimum steps necessary to comply with the relevant legislation and HTA policy.
The role of HTA in regulating research under the Human Tissue Act 2004
9. The type of research regulated by the HTA under the HT Act usually takes the form of ‘laboratory bench’ research. HTA ensures that tissue for this type of research is removed and stored in an appropriate and well managed way.
10. The HTA licenses organisations for removal and storage for research in England, Wales and Northern Ireland. Our licensing role in research is limited to licensing premises, such as tissue banks, to store tissue from the living and the deceased. We also license establishments, including establishments in the post mortem sector, for tissue to be removed from the deceased for research.
11. We do not license the ‘use’ of tissue for research or approve individual research projects or clinical trials. Neither do we have a role in the ethical approval of research. We do, however, work in partnership with other organisations with the aim of helping researchers to navigate and understand their regulated activities. We do this by discussing matters of joint relevance, sharing information, working together on answering enquiries and producing joint positions or guidance.
Scope of this code
12. This Code is primarily intended to guide those people whose work we regulate, primarily through licensing and inspections but it may be useful to members of the public, particularly potential donors and their relatives.
13. In addition to providing information on statutory and regulatory requirements, it also makes reference to the HTA licensing Standards that HTA-licensed organisations are expected to meet
14. This Code should be read in conjunction with Code A, Guiding principles and the fundamental principle of consent, which sets out the principles which govern the conduct of activities within the HTA’s remit and informs the content of this and the other Codes.
Offences under the Human Tissue Act
15. The HT Act sets out a number of offences, for which the maximum penalty is three years imprisonment and/or a fine. In relation to the Research sector, the offences are as set out below.
16. Section 5 of the HT Act makes it an offence to remove relevant material from the deceased and to store and use bodies and relevant material for a purpose set out in Schedule 1 of the HT Act (a scheduled purpose), including determining the cause of death, without appropriate consent. Where there is consent to use material for one purpose, it may not be used for another purpose without appropriate consent for that purpose. Section 5 of the HT Act also makes it an offence to falsely represent that there is appropriate consent to do an activity, or that Section 1 of the HT Act does not apply. A person does not commit an offence if they reasonably believed that appropriate consent was in place, or that the activity carried out was not one that required consent.
17. Section 16(1) and (2) of the HT Act prohibit the following activities in the Research sector, except under the authority of a licence:
a) the removal (otherwise than in the course of the carrying-out of an anatomical examination or the making of a post-mortem examination) of relevant material from the body of a deceased person for use for scheduled purposes other than transplantation; and
b) the storage of the body of a deceased person, or relevant material which has come from a human body, for use for scheduled purposes.
18. To undertake an activity listed in section 16(2) without the authority of a licence from the HTA is an offence under section 25(1). A person does not commit an offence if they reasonably believe the activity they are carrying out is not licensable, or that they are acting under the authority of a licence.
19. The offence of non-consensual analysis of DNA and the exceptions to it are set out in section 45 of the HT Act and covered in detail later in this Code.
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