Igniting our potential Research Governance Issues in Higher Education Brunswick Sub Group: 2 March...
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Transcript of Igniting our potential Research Governance Issues in Higher Education Brunswick Sub Group: 2 March...
igniting our potential
Research Governance Issues in Higher Education
Brunswick Sub Group: 2 March 2006
Standardised Agreements
Igniting our potential 2 March 2006 • 2
Drivers for Change
RESEARCH FOR PATIENT BENEFIT WORKING PARTY
FINAL REPORT
“For us, science and research constitute a front-line service, as they too, reduce distress
and pain and save lives”.
(Dr John Reid, Secretary of State for Health, 22 March 2004)
Igniting our potential 2 March 2006 • 3
What is the UKCRC?
• The UKCRC is a partnership of organisations working with
key stakeholders to effect change
Shared vision:
• To establish the position of the UK as a world leader in clinical
research by harnessing the power of the NHS
• To benefit the public and patients by improving national health
and increasing national wealth.
• The UKCRC is also a new way of working
• Core Team of 10.5 staff - working with staff in Partner
organisations
Igniting our potential 2 March 2006 • 4
Igniting our potential 2 March 2006 • 5
NHS Infrastructure(Networks and
Experimental Medicine)
Research Workforce
Regulatory and Governance Environment
Incentives in the NHS
Coordinating Research Funding
UKCRC Activities
Igniting our potential 2 March 2006 • 6
NHS Infrastructure(Networks and
Experimental Medicine)
Research Workforce
Regulatory and Governance environment
Incentives in the NHS
Coordinating Research Funding
UKCRC Activities
Igniting our potential 2 March 2006 • 7
Standardised agreements – objective
To develop a suite of model agreements that are appropriate to
main clinical research relationships
Why?
• Reduce time and expense
• Facilitate initiation of research
• Clarify roles and responsibilities
• Requirement (Research Governance Framework, Clinical Trials
Regulations)
Igniting our potential 2 March 2006 • 8
Standardised agreements – range
Model Clinical Trials Agreement for contract pharmaceutical research
• Developed under auspices Pharmaceutical Industries Competitiveness Task
Force (PICTF) - launched 2003
• Used but with amendments
• Currently in review and revision
Model Agreement for non-commercial research in NHS
• Developed by UKCRC, Council of Heads of Medical Schools (CHMS) and the
Association of UK University Hospitals (AUKUH)
• Draws heavily on the work by:
• The R&D Forum
• A number of other institutions
Model Agreement for medical device research in NHS
• In development
• Work being led by ABHI, DH and ICR
Igniting our potential 2 March 2006 • 9
Model Agreement for non-commercial research in NHS
Aim: To develop an agreement that can be used in a range of
non-commercial research
• Fulfil necessary contractual arrangements between sponsor(s) of non-
commercial research, such as a university, NHS body or research
council, and the NHS body that will be carrying out the study
• Main body of agreement widely applicable – useable without
modification
• Schedules, including protocol, allow tailoring of agreement to particular
research situation (as necessary)
• Simplicity (as far as possible)
Igniting our potential 2 March 2006 • 10
Model Agreement for non-commercial research in NHS
Development plan
• Consultation 1 (October 05 – November 06)
• Concept
• Structure
• General composition
• Consultation 2 (December 05 – January 06)
• Comment on detail of agreement
• Next steps (Work in progress)
• Revision in light of consultation 2
• Independent legal review
• Develop accompanying guidance
• LAUNCH!
Igniting our potential 2 March 2006 • 11
Model Agreement for non-commercial research in NHS – Consultation 2 (consultation document structure)
Main part of agreement: • Agreement to comply with relevant laws
• Definitions
• Obligations of Parties
• Liabilities and indemnity
• Confidentiality
• Publicity
• Publication
• Intellectual Property
• Financial Arrangements
• Term (of Agreement)
• Termination
• Variation
• Force Majeure
• Notice
• Assignment and Subletting
• Dispute Resolution
• Law and Jurisdiction (England & Wales)
• Sign off
Schedules: • Protocol
• Division of Responsibilities
• Financial Arrangements
• Material Transfer Agreements
Igniting our potential 2 March 2006 • 12
Model Agreement for non-commercial research in NHS – Consultation 2 Outcome
• Approximately 20 responses (individuals, organisations & groups)
• Supportive of concept/structure and pleased with direction of
development
• Common themes came through in comments
• Need for clarity in:
• Purpose of agreement & accompanying guidance
• Precedence protocol/agreement
• Record retention responsibilities
• Many cross-referenced comments with PICTF agreement
Igniting our potential 2 March 2006 • 13
Model Agreement for non-commercial research in NHS – Consultation 2 (main comments)
Main part of agreement: • Agreement to comply with relevant laws (regulation listing
moved to guidance)
• Definitions
• Obligations of Parties (wording issues: amendments, CTA)
• Liabilities and indemnity (further review & rewording)
• Confidentiality (more detail needed)
• Publicity
• Publication
• Intellectual Property (standard clauses & option to define in new schedule)
• Financial Arrangements (VAT issues)
• Term of Agreement
• Termination
• Variation
• Force Majeure
• Notice
• Assignment and Subletting
• Dispute Resolution
• Law and Jurisdiction (England & Wales)
• Sign off
Schedules: • Protocol
• Precedence vs agreement
• Remit of protocol (objectives, design, methodology etc)
• IP arrangements
• Recruitment targets > main part (site specific)
• Addition of summary
• Division of Responsibilities
• Wording
• Additional items
• Order and grouping
• IP arrangements (new)
• Financial Arrangements
• Material Transfer Agreements
Igniting our potential 2 March 2006 • 14
Model Agreement for non-commercial research in NHS
Next steps
• Complete revision
• Independent legal review
• Develop accompanying guidance
• LAUNCH!
• Develop additional agreements (e.g. NI, Scotland)
• Collect information on “agreement in use”
• Review
Igniting our potential 2 March 2006 • 15
igniting our potential
www.ukcrc.org