Human Tissue Authority

The regulator for human tissue and organs

Amount of samples

The number of samples of ‘relevant material’ varies greatly between establishments. The establishment with the largest collection holds over six million samples, while several establishments hold fewer than 100 samples.

Three-quarters of establishments holding material under their HTA licence also hold material under ethical approval from recognised research ethics committees (RECs). RECs exist to safeguard the rights, safety, dignity and well-being of research participants.

The majority of establishments adopt a harmonised approach to sample management, with overarching governance for both material held under the HTA licence and material held for projects with qualifying REC approval. This is recommended by the HTA as inspection data has shown us that there are risks associated with varying practices where samples being stored for REC-approved projects are managed differently to samples subject to HTA licensing standards.

Last updated on: 28 Mar 2019