R&D Permissions – UK Health Departments
Wednesday, 19 September 2007
In response to concerns raised by the research community about the increasing impact of regulation and legislation, the UK Health Departments have each sought to streamline the administrative processes associated with research. Each nation has taken forward activities, as have those responsible for managing research at a local level. There is now an opportunity to review and address any barriers to the compatibility of processes and systems to streamline NHS/HSC R&D permissions across the UK, given the stage of development of the various activities.
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.
Other activities are taking place simultaneously that support the concept of minimising bureaucracy. These include:
- The development of an Integrated Research Application System for regulatory and governance approvals
- The transfer of Site-Specific Assessment to NHS/HSC R&D offices or NIHR Comprehensive Local Research Networks
- The Research Passport system
- 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, and facilitates high quality clinical research, whilst protecting the rights, dignity and safety of patients.