A Briefing Note for BTS Members
Background
The National Health Service appointed its first director of R&D for the NHS in 1991. Subsequently NHS research was supported by the Culyer funds but in 2005 the ‘best research for best health’ proposals suggested a new way of creating a world class research collaboration between NHS Trusts, universities, major funders and industry (further information is available here).
This led to the establishment of the National Institute for Health Research (www.nihr.ac.uk). Subsequent initiatives have included the establishment of biomedical research centres and biomedical research units. Most of the original Culyer funding is now being channelled into research networks.
Research Networks
The first research networks were topic specific and the first concerned cancer and mental health. In the second phase topic specific networks were set up for diabetes, stroke, dementias and neurodegenerative diseases and medicines for children. Finally in 2007 primary care research networks were established and the Comprehensive Clinical Research Networks. This briefing concerns the latter which are likely to be of most relevance to BTS members.
Comprehensive Local Research Networks
In the England these networks have been established in twenty six geographical configurations and each network has a clinical director or directors working with a senior manager and RM & G Manager. (More information is available here). This core team will be supplemented by a data manager, an administrator and a commercial studies liaison manager. This core team are charged with establishing and supervising the comprehensive local research network aided by an executive group and reporting to a network board and subsequently to UKCRN. Further information is available here.
The aims of the Comprehensive Local Research Networks
The CLRNs are charged with providing the NHS infrastructure to support clinical research across all areas of disease and clinical need and also importantly to stream line the research management function for UKCRN portfolio studies.
It is thus important to recognise what is meant by a portfolio study and essentially these are multi centre or single centre studies which have been funded by major established funders such as the MRC or Wellcome or a member of the medical research charities collaboration. Some commercial studies may get onto the portfolio but only if they were obtained in open competition and the PI retains full responsibility.
What does having a portfolio study lead to?
Studies which are accepted onto the national portfolio will be eligible for some funds to support the NHS service costs associated with that research. This is likely to be related to the number of patients entered into such a study with eventually some weighting for the complexity of the study. These costs might help contribute towards some PAs for investigators, recognising for example the extra time an outpatient clinic might take if one is also recruiting patients during that clinic. Equally some funds might be payable to support the extra cost of the pharmacist assisting with the study. The networks do not pay for the cost of the research; they pay for the extra costs incurred by the NHS to facilitate that research. More information on the portfolio database is available here.
Is there more to it than just money?
It is important to recognise that in addition to supporting the NHS costs of research the networks are responsible for implementing new systems designed to facilitate research and to ensure adequate standards. These new systems will involve for example the implementation of research passports which allow investigators to move across university and NHS organisations without requiring HR checks at every site. More information on research passports available here.
The networks will also be responsible for rolling out in their area the new coordinated system for NHS permission for studies and this is designed to speed up study start times and reduce duplication of processes (more information available here). An Integrated Research Application System (IRAS) will integrate all the forms from ethics to MHRA to R&D Permissions etc. More information on IRAS available here.
Speciality Groups
Each CLRN will have identified in their area somebody active in research in twenty six different speciality areas and a recommendation will have been made to UKCRN for such a person to sit on a national speciality committee. A chairman for those speciality groups will then be appointed and the national speciality groups will advise CRN on which potential studies should be accepted onto the national portfolio and give advice about feasibility and do-ability of studies, whether commercial or non commercial. At the present time speciality groups are not envisaged to have a remit for portfolio development.
These notes have been put together on the basis of publicly available documents from the UK Clinical Research Network to aid BTS members but if there are specific respiratory relevant queries, please use the Contact Us form available at the top right hand corner of the website.
25 June 2008