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Support staff

Support staff crucial to successful clinical genetic studies

Increasing recruitment into clinical studies is a key objective of the NHS and its research arm, the National Institute for Health Research (NIHR). However, such recruitment is time-consuming and labourintensive, so specific funding and trained staff are required. Twenty-five Comprehensive Local Research Networks (CLRNs) provide funding for research nurses, administrators and co-ordinators to help cut through the red tape of research and development (R&D) approval, and consent patients into studies.

"Not only are they key to the recruitment into research studies, having someone in place to do the R&D paperwork is brilliant.  It wouldn't happen without them," notes Gill Borthwick, National Research Coordinator for the NIHR Genetics Specialty Group (GSG), who was speaking at a recent conference, the GenRes study day, for genetic research nurses, counsellors and co-ordinators.  This study day offered participants the chance to meet people from other centres, share ideas and discuss any problems. 

For instance, while no one feels undervalued, some question whether everyone appreciates the full extent of their work. Not only does each research nurse or administrator have a large number of trials to support, they have a range of responsibilities that extends far beyond recruitment. Julie Phipps, a genetics research nurse in Clinical Genetics Oxford, was initially appointed to assist on a few genetic studies. She now works with over 12 studies."It was a mountain of paperwork at first and even now there doesn't seem to be enough hours in the day!" she says. "At the moment I do everything from gaining NHS Trust approval and raising the profile of
the department, to recruitment and setting up study sites in other centres."

Similarly, Isobel Giblin, based at Great Ormond Street Hospital, London, is both a co-ordinator for the Central East London GSG and a research
administrator for a clinical trial investigating non-invasive prenatal
diagnosis, called RAPID. For that she is responsible for setting up new recruitment sites for the trial in the UK.  "If you're a lead site, you are responsible for setting up recruitment centres in other areas in the UK," explains Lucy Harrison, a research nurse at the Wessex Clinical Genetics Service. "You have to send the other centre a file with all the ethical
agreements, the funding information and any other paperwork that needs
localising. Then during the study recruitment, you have to assist and
support the other centres."

But, as Gill notes, each NIHR Portfolio study needs to recruit their target number of participants before the funding ends - those that haven't will be considered a failed study by the NIHR. As such, another support staff role is to monitor recruitment, and be ready to apply for an extension on the funding if necessary. "It's all activity-based funding, so I'm constantly thinking about research from a financial point of view," says Isobel. "If we have the R&D approval then we need to recruit people into the study. You have to
think about how to promote it, and get the support of clinical geneticists."

Julie has succeeded in increasing recruitment through mentoring other
centres, having regular meetings with them, and involving the consultants in the process. "Consultants enjoy discussing their research, so by getting them to speak to geneticists in different centres you get an influx of potential candidates" she explains. "This approach raises awareness of research projects with clinicians who then ask if certain patients are suitable - it's
really effective."

"The role is very much one that you can develop and make your own," says Lucy. There are opportunities to bring in your own ideas, or request funding for training courses. However, an aspect that is thought to put some nurses off is the fact contracts are on a rolling, yearly basis. "The funding doesn't come with a project, it comes from the CLRN each year - we don't even know
if we've got a job in 2013" says Julie.  "CLRN funding is based on successful
recruitment to studies; we're really motivated to improve recruitment to our
research studies so we can justify our role to the CLRN" During the GenRes study day, another problem discussed was the excessive amount of paperwork associated with R&D approval, a particular issue for trials
involving rare genetic diseases. "We want to have an agreement in place by the end of the year that if you have a study that's noninterventional, low risk, and no money is changing hands, then if the lead site approves it, it's automatically approved in all other centres," explains Gill. Hopefully this
will ease pressure on individual centres - for example, if a study involves a disease with only five known cases in the country, one centre may spend months gaining R&D approval to recruit only one, crucial, patient.

Improvements to the recruitment process are welcomed by the research nurses, who feel their time is often taken up with paperwork when it could be filled with consenting patients into trials. While such measures will not only benefit staff, they will also benefit the patients and families involved. For them, quick and efficient inclusion in clinical trials could speed up access to treatment and reduces emotional stress.