UKCRC Regulatory and Governance Workstream Update

1
UKCRC Regulatory and Governance Workstream Update

• Maxine Stead PhD, Acting Director of Operations,
  UKCRN
• UKTMN Annual Meeting, 6 June 2006

2
Aims of Workstream

• Working to promote a streamlined regulatory and
  governance environment that facilitates high
  quality clinical research whilst protecting the
  rights, dignity and safety of patients
• Major focus on the development of streamlined and
  consistent processes, interpretation and advice
  with the aim of improving efficiency and speed
• Members include UKCRN, MRC, Department of Health,
  MHRA, COREC, HTA

3
National Advice Network

• UKCRC working with Health Departments, regulators
  and advice providers to establish a national
  advice network
• Aim is to give consistent authoritative advice on
  regulatory issues and reduce the variation in
  interpretation
• A project to map current training and advice
  provision in regulatory and governance issues is
  nearly complete and will inform the development
  of the advice service
• UKCRN and MRC involved in development of advice
  network
• Pilot to start June, launch of full service early
  2007

4
Honorary Contracts

• Work ongoing to streamline the approach to
  issuing honorary research contracts for
  multi-centre studies
• Greater Manchester and Cumbria and Lancashire
  Strategic Health Authorities have launched their
  trial of a Research Passport recognised by NHS
  Trusts across the area
• A working group has been established to develop a
  plan for national roll out
• Several regions will pilot the scheme during 2006
• The aim is to have the system ready to use from
  April 2007

5
Streamlining information requirements for
permissions, approvals and reporting

• UKCRC working group chaired by Sir John Lilleyman
  
• Working to
• rationalise the information requirements of
  statutory and non-statutory bodies for approvals
  and permissions to initiate clinical research,
  and
• for reports required for ongoing and completed
  research

6
Research agreements

• UKCRC Partners developing a suite of model
  research agreements which are designed to be used
  without modification, thus minimising the delays
  and costs of study start-up
• Re-launch of the revised model Clinical Trial
  Agreement (mCTA) for contract research on
  pharmaceutical and biotech products trials in NHS
  hospital trusts
• Model agreement for non-commercial research in
  the NHS, due to be released in summer

7
Use of Personal Data

• UKCRC Coordination Group on the use of personal
  data
• Share information on existing/planned activities
• Facilitate coordination of activities
• Take forward recommendations of recent reports,
  e.g. AMS report Personal Data for Public Good
• Care Record Development Board working group
  chaired by Sir Robert Boyd to develop a single
  set of guidance on the secondary uses of personal
  information for medical research
• UKCRC RD Advisory Group to Connecting for Health
  to provide RD input to the programme, promote
  collaboration and develop a joint agenda of work

8
Euro intelligence

• UKCRC and the Bioscience Futures Forum are
  working together to develop a coordinated
  approach to gathering and acting on information
  about European regulatory developments
• Aim is to enable early warning of, and engagement
  with, regulatory developments