igniting our potential Research Governance Issues in Higher Education Brunswick Sub Group: 2 March 2006 Standardised Agreements

Igniting our potential 2 March Drivers for Change

Igniting our potential 2 March 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

Igniting our potential 2 March 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 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 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 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 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 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 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 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 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 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 igniting our potential