Regulatory and Governance Environment
The UKCRC is working to promote a streamlined
regulatory and governance environment that facilitates high quality
clinical research whilst protecting the rights, dignity and safety
of patients. 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.
The UKCRC is ensuring that there is consistency and standardisation
in process, interpretation and advice. Current activities
include:
-
Streamlining information requirements for permissions and
approvals through the implementation of the Integrated Research
Application System (IRAS)
- Development of a suite
of model agreements for commercial and non-commercial
research
- Streamlining R&D Permissions in
the Health Service
- Development of a coordinated strategy to
enable early warning of, and engagement with, regulatory
developments
- Implementation of a coordinated and
authoritative
advice service for all aspects of health research regulation
and governance
- Work to streamline the approach to issuing
honorary research contracts for multi-centre studies through the
development of a '
Research Passport’
- Creation of a
database holding details of projects associated with a range of
regulatory and governance issues. This enables the coordination of
work and avoids duplication of effort.
PowerPoint slides giving an overview of
the UKCRC's work in the regulatory and governance area are
available for download. Recent progress with these activities
can be found in the latest Update.