I am Designated Individual (DI) for the University of Warwick’s HTA Research Licence, which covers two sites, one at the University campus and the other in laboratory space that the University rents from a local NHS Trust. We have five departments where human tissue is used in research, with great diversity in the projects, tissue types and characters involved in the research.
At Warwick, the DI is responsible for ensuring that material held under our HTA licence is stored in compliance with HTA regulations. Consequently, I need to know which tissue is under the HTA licence, where and how it is stored, which project it is associated with, which academic is responsible for it, and so on, documenting all the evidence to support the legitimacy of its continued storage. Since human tissue for research can be stored either under HTA licence, or under a recognised Research Ethics Committee’s approval, one of the challenges is knowing when REC approval ‘ends’. Nowadays, the end date is rarely given as say 1 October 2024, and more likely as ‘when the last patient is recruited’ or something similar. Samples where REC approval has expired would default to our HTA licence, so keeping track of end dates is necessary.
Other responsibilities involve, for example, ensuring that all those using human tissue are appropriately trained, and ensuring that all storage facilities are suitable and appropriately monitored. Further tasks are standard within the quality management system (QMS), such as ensuring equipment maintenance, recording any incidents that arise, risk management, audit, document control and so on.
My DI role is notionally 0.2 full time equivalent, undertaken within my joint clinical science academic role, alongside university research, teaching, and patient care in the NHS. My background is in IVF, so before taking up the HTA DI role in 2021, I was more familiar with the Human Fertilisation and Embryology Authority (HFEA) than the HTA. Clearly, keeping track of and caring for human eggs, sperm and embryos in a laboratory setting has much in common with managing human samples stored for research. I have been ‘Person Responsible’ for an HFEA Research Licence for many years. I also used to undertake inspections for the HFEA, back when they used independent external advisors rather than their own inspectorate.
I was already active in IVF research when the HFEA began in 1991, so when the HTA arrived in 2004, I had some idea what to expect. Some of my research involved human ovarian tissue (not under HFEA), so when the University set up its HTA licence, I started to receive periodic requests for updates on tissue holdings and reminders about training, ‘human tissue’ notices on storage tanks and so on. I gained some further insight by being an observer at an HTA inspection in 2009 and having my samples inspected during a University HTA inspection in 2019. So for me, it has been interesting to compare the approaches of HTA and HFEA, sister organisations which share an address in London.
My immediate challenge upon taking up the DI role in 2021 was to understand who was doing what with human tissue across the University. There was a massive amount of detailed information diligently recorded by my predecessor, but reading it wasn’t the way to find out what was happening. I needed to get out and about.
I had been at the University for many years, so knew quite a lot of people, but it has been exciting to discover the range of interesting and relevant research going on. Visiting research labs to check suitability of facilities and to discuss projects has been really enjoyable. One of my first tasks was to identify Persons Designated (PDs) for each location, so that I had well-connected, reliable and helpful people to call upon and to act as a familiar point of contact for local researchers. These people have been a major source of help and support, and I rely upon their expert management of technical aspects such as temperature monitoring and equipment maintenance.
As a researcher myself, I understand the preoccupations of researchers. The very last thing I want to do is delay or stop anyone doing their valuable research. So I facilitate, helping colleagues to negotiate the hurdles of today’s governance and regulation. I make training as straightforward as possible, and I provide checklists and contact points for the necessary paperwork. I turn queries around as quickly as I can. As well as safeguarding tissues and the public, my role is a service to researchers, supporting their research to meet the highest standards.
My most useful actions to date have involved bringing people closer together to share information and streamline communications. We now have a better working relationship with our local tissue bank and a clearer understanding of responsibilities at the interface between Warwick and other organisations. Our PD network shares experiences and skills and I have set up a University-wide steering group, with external representatives too, to ensure that all disciplines and perspectives are properly represented. I have developed closer links with ethical experts at Warwick, to reflect on interesting queries that arise and to develop consensus on policies where necessary. Our excellent administrative team has been improving our record-keeping and QMS, producing Material Transfer Agreements, embedding a risk-based approach to sample management, and minuting meetings as well as rounding up new or incoming researchers for training.
The DI role is strangely rewarding. It is a good feeling to know that things are as they should be, and that our ‘system’ is coping well with the ever-changing and complex environment that is University research.
Geraldine Hartshorne
BSc MA PhD FRCPath PFHEA
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