Human Tissue Authority

The regulator for human tissue and organs

Research sector compliance updates review - 2015/2016

Introduction

To support our system of continuous licensing, 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 questionnaire. This helps us to maintain oversight of the sectors we regulate, guide our regulatory approach to each sector, and inform the scheduling of site-visit inspections. These ‘compliance updates’ have been collected every two years since the first round in 2011.

In December 2015, we completed the collection of compliance information for the research sector. This ‘snapshot’ report presents selected findings from these compliance updates and provides a brief analysis of the trends and themes. 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 human tissue research.

For the 2015 compliance updates, we received information from the 151 establishments licensed in the research sector. A high level of compliance and good practice was found, which affirms our experiences of regulating the sector and supports our view of the sector as ‘low risk’. 

Data from the submitted compliance updates is analysed and any points requiring clarification are followed up with individual establishments. If necessary, and with our support, improvements are put in place. Compliance data is evaluated and, along with information such as the length of time since the last inspection, is used to prioritise establishments for inspection.

Feedback on the compliance update questions and the process was sought and was very positive about both. The instructions were found to be clear, the accompanying guidance useful and the submission process much improved. However, we are not
complacent, and we will use the comments to further improve future data collections.