The Human Tissue Authority (HTA) requires that licensed organisations have a quality management system to ensure robust compliance with HTA standards.

Swansea University's quality manual and standard operating procedures must be read and understood by all individuals who intend to store human tissue considered 'relevant material' under the Human Tissue Act (HT Act).

The QMS aims to ensure appropriate levels of:

  • Compliance with the HT Act, HTA standards and HTA Codes of practice
  • Risk mitigation for donated tissues and researchers
  • Quality assurance to maintain and enhance organisational reputation
  • Confidence in donors in providing samples for research

The QMS includes several Standard Operating Procedures (SOPs), Templates and Forms developed in line with the HTA Codes of Practice. Templates may be adapted by researchers and renamed as local documents for specific studies.


Quality Manual for Human Tissue Research

This quality manual should be read by all staff and students considering research projects involving human tissue samples before commencing their projects.

Open book with a book shelf in the background full of other books

HTA Core Standard Operating Procedures

Swansea Univeristy's Core Standard Operating Procedures (SOPs) for Research Involving Human Tissue.