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

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)


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



NHS Infrastructure(Networks and

Experimental Medicine)

Research Workforce

Regulatory and Governance Environment

Incentives in the NHS

Coordinating Research Funding

UKCRC Activities


NHS Infrastructure(Networks and

Experimental Medicine)

Research Workforce

Regulatory and Governance environment

Incentives in the NHS

Coordinating Research Funding

UKCRC Activities


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)


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



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)



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!


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


• Material Transfer Agreements


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


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)


• Material Transfer Agreements



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

www.ukcrc.org

Documents

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