Health Service R&D permissions

Health Service R&D Permissions Presentation notes: To carry out research in the Health Service you need to get NHS R&D permission. However, there was a general feeling from the research community was that there is too much bureaucracy, a lack of consistency and no standardised approach so that obtaining R&D permission, particularly in multi-centre studies, was a onerous part of study start-up In response to concerns raised by the research community to the increasing impact of regulation and legislation, the UK Health Departments have each sought to streamline the administrative processes associated with initiation of research and R&D permission. These streamlined systems for R&D permission are listed here: Northern Ireland - A national system has been in place for some time, based on local review with standard systems using the same IT software. The current reorganisation of Health and Social Care Trusts will impact on research management arrangements and has precipitated the review of research support systems, including the case for centralisation. Scotland - A central review system for multi-centre non-commercial research (MRAD) has been piloted, and a similar approach for commercial research is being developed. The system separates out criteria reviewed once centrally from criteria reviewed locally at each site. This approach is now being reviewed prior to finalising the procedures. England - A NIHR Coordinated System for NHS Permissions (NIHR CSP) for NIHR portfolio studies is being developed which will collate evidence of the approvals, agreements and resources for a study. This will integrate with the activities of Comprehensive Local Research Networks which will support and facilitate the local permission process. Wales - A project to streamline the review and approval process for Wales has been initiated. Plans are underway to establish a central R&D office for primary care. For secondary care, a baseline assessment and stakeholder consultation has been completed and options are being assessed, with decisions due to be made later in 2007. Activities to streamline the regulatory and governance environment are being brought together and coordinated under the UKCRC umbrella, and the UKCRC also provides a forum in which solutions can be negotiated. There is broad agreement that compatibility across the UK does not need the systems to work in exactly the same way in all the nations, and that different systems may be necessary for the different statutory provisions, organisational structures and scales of each nation. Mutual acceptance of procedures conducted and centralised elsewhere will be achieved through UK-wide agreement of operational arrangements that allow for acceptance of each other's systems so that activities are not duplicated. This approach will also highlight procedures that remain to be conducted. Work to facilitate this UK-wide agreement is already underway and further information on the details of the systems will be published as it becomes available on the UKCRC website. Under the auspices of the UKCRC, a range of other activities are taking place simultaneously that support the concept of streamlining bureaucracy. These include the development of an integrated application system for regulatory and governance approvals, the transfer of Site-Specific Assessment to NHS/HSC R&D offices, the Research Passport system, and streamlined research management systems. These initiatives are already linked in development and implementation to ensure that the emerging regulatory and governance environment for research removes unnecessary bureaucratic burden. Further information: Please see the UKCRC regulatory and governance web pages: http://www.ukcrc.org/activities/regulationandgovernance.aspx Or contact the UKCRC secretariat at info@ukcrc.org, phone +44 (0)20 7670 5452.