Human Tissue Authority

The regulator for human tissue and organs

Research sector compliance update report 2019

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 2019, we completed a collection of compliance updates for the Research sector. Research sector establishments are organisations that store relevant material for research studies ‘in connection with disorders, or the functioning of the human body’.

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 research.

In summary, the data we collected in the 2019 round of compliance updates shows:

  • Information from all 171 establishments licensed in this sector, including 17 new establishments licensed during the 2018/19 period; and
     
  • That HTA-licensed Research establishments are largely compliant with our licensing standards. This affirms 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 2019, the feedback we received from the Research sector was positive. 99% of establishments found the instructions and communications from the HTA prior to submission clear. 98% found the accompanying guidance within the questions useful. 98% of establishments found the submission process to be improved or similar to that of previous years. We will continue to monitor this feedback as part of our commitment and focus on continuous improvement for future compliance updates.

Description: 
Key findings from the 2019 round of compliance updates from the Research sector
Last updated on: 7 Jul 2020