Human Tissue Authority

The regulator for human tissue and organs

Research sector review: July 2016

Executive Summary

Last year, the HTA completed the first round of inspections for all the establishments we have licensed in our research sector since the HTA’s inception. This review presents the trends found on those inspections, as highlighted through our reported findings. Through the review, we also aim to share good practice and promote improvements. Through our regulation, we want to encourage and support a culture of responsible custodianship, something we believe is already present in the research sector. In fostering this environment, the drive for improvement and high standards is shared with the people best placed to effect long-lasting changes and deliver continuous improvements at local and national levels. 

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. Our website remains the most up-to-date source of information for all the sectors we regulate and includes not only codes of practice and other documents but also guidance produced in collaboration with other bodies working within the research regulatory environment.

In the period November 2010 to March 2015, we conducted 87 site visit inspections for the remaining uninspected establishments licensed within our research sector. During these inspections, we identified a total of 103 shortfalls against the HTA’s licensing standards and offered 517 items of advice. In more than half of the inspections, no shortfalls were identified. This summary report shows that HTA-licensed research establishments generally met the HTA’s licensing standards. We found that the main areas which required improvement were related to governance and quality systems. This review summarises our key learning points for improving practices in these areas, as well as in other areas where shortfalls were identified.

High levels of compliance and good practices were observed throughout our inspections, which confirm the HTA’s long-held view of the research sector and supports its ‘low risk’ reputation.

A summary of HTA inspection findings, advice and learning