Human Tissue
Please also visit the Data and Tissues Tool Kit
and Use of Human Tissue
policy page.
Guidance for those working with human tissue
Useful guidance documents are provided below including our Research and Human Tissue Legislation Summaries which offer a quick and easy explanation of the UK legislation for those carrying out research using human tissue samples:
- Overall research requirements of the HT Act 2004 (Flowchart summary)
- Consent summary - summary of Consent requirements of HT Act 2004, applicable for England, Wales and Northern Ireland.
- HTA Licensing summary - summary of Licensing requirements of HT Act 2004, applicable for England, Wales and Northern Ireland.
- Disposal summary - summary of Disposal requirements of HT Act 2004, applicable for England, Wales and Northern Ireland.
- Import/Export summary - summary of Import/Export requirements of HT Act 2004, applicable for England, Wales and Northern Ireland.
- Scotland summary - summary of Human Tissue (Scotland) Act 2006 requirements and DNA analysis section of HT Act 2004, applicable for Scotland.
- DNA Analysis summary - summary of HT Act 2004 requirements for DNA analysis, applicable to whole of UK.
- Standards for transfer of human tissues - guidance for the transfer of primary human tissue samples only, i.e. frozen tissues or samples containing whole cells (excluding cell lines), histology blocks and slides.
Human Tissue – are you compliant with the law?
We offer a consultancy service which provides practical advice on compliance with the human tissue legislation. Further details are available on our Advice & Consultancy page.
Using samples from colleagues
The same legal and good practice requirements apply to samples from colleagues as they would to any other participant in research. REC review should be sought and take into consideration the process of obtaining consent (fully informed, freely given); arrangements for feedback of any clinically significant findings; and the standards in place to protect colleagues’ confidentiality. The MRC’s Working with biological agents guidance document and Guidance for staff asked to volunteer blood and/or other samples for research provide further guidance in this area.
MRC DIs and Tissue Bank Managers Portal
The MRC portal provides a forum for Designated Individuals; Persons Designated; equivalents within Scottish units; and managers of other MRC-funded UK tissue collections to share information and post comments.
Human Tissue Authority Licences
The RSC has produced guidance for MRC units applying for an HTA Licence.
