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, 2.42MB) - summary of HT Act 2004 requirements for DNA analysis, applicable to whole of UK. Updated in 2015.
- Consent summary (PDF, 2.45MB) - summary of consent requirements of HT Act 2004, applicable for England, Wales and Northern Ireland. Updated in 2015.
- Licensing summary (PDF, 2.46MB) - summary of licensing requirements of HT Act 2004, applicable for England, Wales and Northern Ireland. Updated in 2015.
- Disposal summary (PDF, 108KB) - summary of disposal requirements of HT Act 2004, applicable for England, Wales and Northern Ireland.
- Import/export summary (PDF, 128KB) - summary of Import/Export requirements of HT Act 2004, applicable for England, Wales and Northern Ireland.
- NEW Scotland summary - summary of Human Tissue (Scotland) Act 2006 and DNA analysis section of HT Act 2004, applicable for Scotland.
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) - Updated in 2014 to reflect the MRC and cross-funder commitment to ensuring that research resources, such as human samples and data, are supported with multiple use in mind, encouraging a high level of transparency in the collection, storage and use of such samples. This guidance focuses on ethical principles and provides more detailed information to achieve these principles in practice. For the legislative framework please see the Summaries above.
- Standards for transfer of human tissues (PDF, 22KB) - MRC guidance for the transfer of human tissue samples, e.g. frozen tissues or samples containing whole cells (excluding cell lines), histology blocks and slides.
- Human Tissue e-learning
- Data and Tissues Tool Kit
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. 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 forum for Designated Individuals, Persons Designated, equivalents within Scottish university units, and managers of other MRC-funded tissue collections to share information and post comments.