Human Tissue Authority

The regulator for human tissue and organs

Research sector compliance updates report: 2017/18

Introduction

All establishments licensed in our Anatomy, Post-Mortem, Public Display and Research sectors are required to provide us with periodic updates of licensing information and to complete a compliance questionnaire. The data from this collection helps us to maintain oversight of the sectors we regulate, guide our regulatory approach for each sector, and inform the scheduling of site-visit inspections. We call these ‘compliance updates’ and we collect them every two years.

In October 2017, we completed a collection of compliance updates for the Research sector. Research sector establishments are organisations that store (and occasionally remove) human tissue for research in England, Wales and Northern Ireland, such as tissue and brain banks.

This report presents a snapshot of the key findings from the collection, identifying trends and themes we found from Research sector submissions. We hope that this report will be useful to people working in the sector, as well as to members of the public who have an interest in medical research.

The data we collected in the 2017 round of compliance updates shows information from 165 establishments licensed in this sector. This includes two establishments newly licensed during the 2016/2017 period.

Research sector establishments reported high levels of compliance and good practice. This is consistent with our experiences of regulating the sector and supports our view of the sector as ‘low risk’.
 

How we gather compliance data

We carefully analyse the data we receive from compliance updates. If we require further clarification on any aspects of the data, we follow these up with individual establishments. Compliance data is evaluated along with information such as the length of time since the last inspection. We use this information to prioritise establishments for future HTA inspections.
 

Compliance updates are submitted electronically, through the HTA Portal. As part of the submission, we ask establishments for feedback on the process. In 2017, all establishments found the instructions and communications from the HTA prior to submission clear. Furthermore, this year, the HTA chose to add accompanying guidance within the questions and all establishments found this to be useful. 97% of establishments found the submission process to be improved or similar to that of previous years.

Last updated on: 29 Mar 2019