UKCRC Regulatory and Governance Advice Service

UKCRC R&G Advice Service Presentation notes: The Regulatory and Governance environment for research in the UK is highly complex and changing. Until recently regulatory and governance advice in the UK was fragmented; there were no clear procedures in place for answering queries; many advisers are asked about issues they did not feel confident about answering. Therefore needed to improve quality of, and access to advice. Also Best Research For Best Health (BRfBH) (DH England Strategy) and corresponding Implementation Plan 4.1 announced proposals for developing a national advice service with front-line advisers in the Comprehensive Local Research Networks, linked to national experts on regulatory processes, approvals and permissions. The Regulatory and Governance Advice Service was therefore developed under the auspices of UKCRC to provide a UK-wide service that supports local advice providers, such as those in R&D offices, RDSUs, clinical trials units. The service provides regulatory and governance advice on all types of health research, particularly providing a route for handling more complex queries and those involving more than one regulatory issue. In addition to responding to individual queries it is also developing authoritative, web-based resources, such as tool kits and a new online Q&A resource, as a means of sharing good practice, promoting consistency and providing support to local R&D. The Advice Service has been developed and is delivered by the UKCRN Coordinating Centre and the MRC Regulatory Support Centre and together they staff the coordinating team, which runs the service and liaises with the network members. The Advice Service is supported by a network of regulatory and governance bodies including the Medicines and Healthcare products Regulatory Agency (MHRA), Human Tissue Authority (HTA), National Research Ethics Service (NRES), Patient Information Advisory Group (PIAG), all 4 UK Health Departments. The Advice Service is funded by the National Institute of Health Research (NIHR) through UKCRN Background: The Advice Service was piloted across the UK between September 06 and March 07 – a report of the pilot is available through the UKCRC website The Service was launched through a series of roadshows from April 2007. Linkage to other activities: Links with other activities aimed at improving the regulatory and governance environment, including initiative to coordinate regulatory and governance training and the initiatives involved with streamlining permissions and approvals. Further information: UKCRC Website on the Advice Service: http://www.ukcrc.org/activities/regulation_and_governance/r__g_advice_service.aspx The dedicated UKCRC R&G Advice Service Website (with access to query submission, Q&A, toolkits and other resources): www.ukcrc-rgadvice.org Or contact the UKCRC secretariat at info@ukcrc.org, phone +44 (0)20 7670 5452.

UKCRC R&G Advice Service website www.ukcrc-rgadvice.org The dedicated UKCRC Regulatory and Governance Advice Service website provides route to submit queries to the advice service as well as access online resources including toolkits, Q&A’s, Best Practice Documents and Regulatory and Governance news and events. Further information: UKCRC Website on the Advice Service: http://www.ukcrc.org/activities/regulation_and_governance/r__g_advice_service.aspx The dedicated UKCRC R&G Advice Service Website (with access to query submission, Q&A, toolkits and other resources): www.ukcrc-rgadvice.org Or contact the UKCRC secretariat at info@ukcrc.org, phone +44 (0)20 7670 5452.