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Regulation under the Human Tissue Authority (HTA)

The Human Tissue Authority (HTA) is an independent regulator, established by the Human Tissue Act 2004 (the HT Act) to protect public confidence by ensuring human tissue is used safely and ethically, and with proper consent. The HTA licenses and inspects organisations that store and use human tissue for the following activities (Scheduled Purposes under the HT Act, for which consent from the donor is required):

  • teaching about or studying the human body;
  • carrying out post-mortem examination;
  • using human tissue to treat patients;
  • carrying out research on human tissue;
  • displaying human bodies or tissue in public (e.g. in a museum).

The HTA aims to:

  • make sure that these laws are followed by setting clear and reasonable standards;
  • provide codes of practice and other advice, guidance and support (including the provision of workshops and e-learning packages);
  • give the public confidence that their wishes when donating tissue will be respected, that their donated tissue will be put to the best possible use, and in turn increase the willingness of the public to donate;
  • give the professionals confidence that they are working within a clear and effective regulatory framework for the removal, retention, use and disposal of that donated tissue.

For further information see:

HTA Licensing and inspection

An HTA licence is granted to an organisation if it shows it will comply with certain essential standards set by the HTA. When an organisation applies for a licence it assesses itself against the HTA standards. The HTA then evaluates the information provided and where necessary asks for more information before it issues a licence (Phase 1 Inspection). The HTA also inspects organisations to check that they maintain good standards and follow appropriate procedures (Phase 2 Site Inspection).

Each licensed organisation has to nominate a person who will supervise the activities being carried out - the Designated Individual (DI). DIs undergo training provided by the HTA via the Medical Research Council Learning Management System to undertake this role and have statutory duties as set out in the HT Act (Section 18). Further training is also provided by the Health Research Authority .

A licence is granted for a principle activity or ‘scheduled purpose’, such as research, and specifies the premises where the activity is to be carried out (where there may be multiple places where the activity is undertaken, but within the same organisation, the licence will specify a hub site and other satellite sites, where these different premises have separate postcodes).

The HTA grants licences in five key areas of activity (sectors):

  • Human Application;
  • Post Mortem;
  • Anatomy;
  • Research;
  • Public Display.

A licence is granted under certain conditions:

  • Statutory (e.g. licensed activities must only take place on the premises specified in the licence; licensed organisations must ensure activities carried out under the licence are supervised; information required by the HTA is recorded and access to it is given to HTA inspectors as required; licence fees are paid to the HTA);
  • Standard;
  • Additional (require compliance where a standard is not being met; to support the improvement of standards).

The HTA can revoke, vary or suspend a licence where, for example:

  • information in the licence application is found to be false or misleading;
  • DI has failed to discharge their duties;
  • premises are no longer suitable.

A licence is required to store relevant material for use in research. There is an exception where tissue is being stored for use in a specified NHS REC-approved project and is not retained after that project for unspecified future use. The licence will allow storage for the specified activity (in this case research) to take place at the specified premises under the supervision of the DI named on the licence. The licence requires particular records to be kept and to be made available to the HTA during inspection.

The DI carries out the main responsibilities under the licence. The DI needs to ensure that suitable people carry out the activity using suitable procedures (and Standard Operating Procedures need to be available for these) and that any conditions attached to the licence are met.

For further information about the University’s HTA Inspection, see: HTA Inspection, July 2010

HTA Codes of Practice

The HTA's current Codes of Practice and Standards came into force in April 2017.

These Codes of Practice provide guidance and lay down expected standards for each of the sectors regulated by the HTA. The Codes are designed to support professionals by giving advice and guidance based on real-life experience. The two key Codes for staff and students undertaking research are as follows:

The HTA’s Codes of Practice should be read in conjunction with the University’s Standard Operating Procedures (SOPs).

HTA Standards

In order to obtain an HTA licence, an organisation must demonstrate that it meets a number of core standards. These relate to consent provision of the HT Act and the regulatory requirements for governance and quality systems, suitable premises and appropriate arrangements for disposal. The four core standards can be summarised as follows:

  • Consent – must be obtained as set out in the HTA Code of Practice 1: Consent
  • Governance and Quality systems – must have systems in place to ensure the provision of safe tissue of reliable quality
  • Premises, Facilities and Equipment – must be suitable for the licensed activity undertaken
  • Disposal – establishments should develop a clear and sensitive disposal policy

The standards are generic, give goals to be achieved and provide a basis for the assessment of compliance with the Human Tissue Act, 2004and the HTA’s Codes of Practice.

The HTA expects compliance with all its standards, even if human tissue is to be held only for a short period of time or if only a few samples are held under the authority of a licence. The University’s Quality Management System for research involving the use of human samples has been established to provide a robust and practical framework for compliance with these standards and the licensing obligations of Human Tissue Act, 2004.