Use of human samples in medical research

Human tissue legislation summaries

Our summaries offer a quick and easy explanation of the UK legislation for those carrying out research using human tissue or biological samples:

• Overall research requirements of the HT Act 2004 (PDF, 68KB) - Flowchart summary of the Human Tissue Act 2004 (HT Act 2004).
• DNA analysis summary (PDF, 892KB) - summary of HT Act 2004 requirements for DNA analysis, applicable to whole of UK.  Updated in 2019.
• Consent summary (PDF, 784KB) - summary of consent requirements of HT Act 2004, applicable for England, Wales and Northern Ireland.  Updated in 2019.
• Licensing summary (PDF, 395KB) - summary of licensing requirements of HT Act 2004, applicable for England, Wales and Northern Ireland.  Updated in 2019.
• Disposal summary (PDF, 812KB) - summary of disposal requirements of HT Act 2004, applicable for England, Wales and Northern Ireland. Updated in 2019.
• Import/export summary (PDF, 509KB) - summary of Import/Export requirements of HT Act 2004, applicable for England, Wales and Northern Ireland. Updated in 2019.
• Scotland summary (PDF, 1.85MB) - summary of Human Tissue (Scotland) Act 2006 and DNA analysis section of HT Act 2004, applicable for Scotland. Updated in 2016.

Additional MRC resources

Further information on MRC Policy and the legislation can be found in:

• MRC Ethics Series Human Tissue and Biological Samples for use in Research (PDF, 731KB)
• MRC/Wellcome Trust Framework on the feedback of health-related findings in research (PDF, 421KB)
• Standards for transfer of human tissues (PDF, 22KB)
• Human Tissue e-learning

Using samples from colleagues

The same legal and good practice requirements apply when using samples from colleagues as would be the case for any research participant. Research Ethics Committee (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.

Our working with biological agents guidance document (PDF, 564KB) and guidance for staff asked to volunteer blood and/or other samples (PDF, 35KB) for research provide further guidance in this area.

MRC DIs and Tissue Bank Managers Portal

Our fora site provides a platform for Designated Individuals, Persons Designated, equivalents within Scottish MRC units, and managers of other MRC-funded tissue collections to access and share information.