Use of human samples in medical research

Human tissue legislation came into force on 1st September 2006.  The Human Tissue Act 2004 applies in its entirety in England, Wales and Northern Ireland; with one section (on DNA analysis) applying UK wide.  In Scotland, the Human Tissue (Scotland) Act 2006 also applies.  The resources below will help you understand how the law applies across the UK.

Human tissue legislation summaries

Our summaries offer a quick and easy explanation of the UK legislation:

• Flowchart Summary (PDF, 68KB) – summarises when the consent and licensing requirements of the Human Tissue Act 2004 (HT Act 2004) apply for research.
• 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.
• DNA analysis summary (PDF, 892KB) - summary of HT Act 2004 requirements for DNA analysis, applicable to whole of UK.  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

There are legal and good practice requirements when using samples from colleagues (just as there are for any research participant). Research Ethics Committee (REC) review should be sought and take into consideration how fully informed, freely given consent will be obtained; any feedback of clinically significant findings; and how colleagues’ confidentiality will be protected.  For more see our guidance for staff asked to volunteer blood and/or other samples (PDF, 35KB).

Human Tissue Forum

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

Still have a question?

If you have a specific question about the use of human tissue in research which we haven’t answered here, you can ask us at: rsc@mrc.ukri.org.