Human Tissue Authority Licences and Inspections

HTA Licences 

Organisations that store relevant material for research in England, Wales and Northern Ireland require a licence from the Human Tissue Authority (unless an exemption applies). Organisations in Scotland are not licensed by the HTA for storage of human material under the Human Tissue Act 2004.

The HTA also licenses storage of material for human application (under the EU Tissues and Cells Directive), their remit for this does include Scotland. Organisations should be aware that a licence for this activity is likely to be required from the HTA.

The HTA web pages on Relevant material help clarify what is meant by the term 'relevant material' as defined in the Human Tissue Act 2004.

The HTA web pages on licensing help to clarify which activities are licensed.

It is worth highlighting that the storage of extracted DNA, where no whole cells remain, is not a licensable activity. For more information on the legislative requirements surrounding DNA analysis, please see the Research Scenario on Research analysis of human DNA and RNA

The MRC Regulatory Support Centre has produced a licensing summary, outlining the requirements of and the exemptions from HTA licences for the storage of human tissue for research.

See HTA Licence for further guidance.

 

HTA Inspections

The HTA may inspect licensed premises. An establishment's performance will be assessed against HTA standards (which fall under one of these four headings: Consent; Governance and Quality; Premises, Facilities and Equipment; and Disposal).  In addition, any conditions imposed on the licence will also be reviewed.

Please also see Audit and inspection and the HTA Inspection web page.