Human Tissue Act

The Human Tissue Act

HT Act became effective from 1st September 2006. The HT Act regulates removal, storage and use of human tissue – defined as material that has come from a human body and consists of, or includes, human cells. This means that it is now unlawful to carry out these activities without an appropriate licence. The Act is upheld and regulated by the Human Tissue Authority which is an independent watchdog with the remit of protecting public confidence by ensuring that human tissue is used safely and ethically, and with proper consent. Organisations that store and use human tissue for the purposes of research must have a licence to do so.

The University of Cambridge holds an HTA Research Licence (12196). See below the structure of Departments working with this Research licence:

University's HTA (Research) Licence (12196) chart by Department 

Departments wishing to join the licence must contact the Safety Office, before bringing in any samples.

If your Department is based on the Addenbrooke's Biomedical Campus and you wish to join an HTA licence, you must contact the Addenbrooke's Research Licence team.  This is the current structure of the Addenbrooke's Biomedical Campus HTA (Research) Licence.

HTA Codes of Practice and Standards

• Code A: Guiding Principles and the fundamental principle of consent
• Code B: Post-mortem examination and Standards
• Code C: Anatomical examination and Standards
• Code D: Public display and Standards
• Code E:Research; Code of Practice and standards
• Code F: Donation of solid organs and tissue for transplantation - Part One: Living organ donation
• Code F: Donation of solid organs and tissue for transplantation - Part Two: Deceased organ and tissue donation
• Code G: Donation of allogenic bone marrow and peripheral blood stem cells for transplantation
• Research licensing standards and guidance
• Guides for the general public on codes of practice

Compliance Audit for HTA (Research) University Licence (12196) against Code E HTA Standards

Please refer to the Frequently Asked Questions for further advice on the Act or to see if you are affected. Further information may be obtained from the Safety Office at hta@admin.cam.ac.uk

HTA Training

The Human Tissue Authority recommends two e-learning modules MRC on-line learning and a HRA course (research using human tissue).  All members of staff involved in working with human tissue should undergo at least one of these training courses.  Training records should be kept and made available to the Departmental Person Designate for auditing purposes.

The HTA has created a self-assessment tool.  Please visit the site and take the quiz to test your general knowledge on the areas encompassed within the HTA regulations.

The MRC Regulatory Support Centre provides virtual face-to-face training courses via Zoom. Dates for the next Academic Year will be provided in due course.

University of Cambridge Documents

• Quality Manual 
• Licence Structure - January 2025
• HTA Contacts
• Centralised Database for HTA Samples - Tissue Tracker
• HTA Audit against all HTA Standards

Other Relevant Guidance Documents

• HTA Human tissue xenografts
• HRA consent and participant information guidance
• MRC information - consent summary
• MRC guidance - for staff asked to volunteer samples
• Donor record document
• MRC Guidance on Import and Export of Human Tissue 
• MRC Guidance to Human Tissue Disposal
• MRC HTA Decision Tree

The University Database Tissue Tracker can be found here: Human Tissue Tracker | IT Help and Support

Serious Adverse Event (SAE) Reporting

Serious Adverse Event (SAE) Reporting - Contact us if you suspect a SAE. The HTA define this as ‘any untoward occurrence which may be associated with the procurement, testing, processing, storage or distribution of tissue or cells intended for human application’.  Please use the Accident/Incident reporting system for reporting SAEs.

The following types of incidents should be reported to the Safety Office:

• Specimen loss

• Missing or incorrect documentation

• Security breach

• Abnormalities in storage temperature records

• Inappropriate disposal