www.le.ac.uk

Working with the Joint Office on Grants and Contracts –the University perspective

Dr Lisa StocksEnterprise Business DevelopmentBrian BerryResearch Support OfficeUniversity of Leicester

Agenda

• Purpose of today – provide awareness of University support services for clinical researchers in securing external research funding whilst complying with University and legislative governance requirements

• Focus on Clinical trial research (but the content would equally apply to health research)

• University perspective (but collaborative with UHL)

• One of key aims to ensure there is proper capture, allocation and distribution of research income

What we do• Fully support and advise the Academic community in seeking

funding from various sources (both public and business funding streams)

• Support applications and negotiations for Research Grants, Contracts and Tenders, maximising income and protecting IP.

• Developing new and existing partnerships with business

– Working with business to seek funding

• Contract negotiation and sign off - central point for Institution authorisation

• Work collaboratively with key staff within the University e.g. Dept admin re costings.

In a nutshell

• RSO – Public Sector Funders

– Research Councils, Charities, Government bodies, NHS, NIHR, EU…..

• EBD – Business and industry

– Pharma, life sciences, CROs…..

– UK and overseas

Contract Responsibilities

Public funders only

including RC’s,

Charities, Govt Offices

Private sector

(commercial)

funders &

regional funding

Public and private

sector partners

Confidentiality

Agreements

RSO EBD EBD

Clinical Trials RSO EBD EBD

Research Grant

Contracts and

Collaboration

Agreements

RSO EBD EBD

Consultancy EBD EBD EBD

Analytical Services EBD EBD EBD

Material Transfer

Agreements

EBD EBD EBD

EU funding contracts RSO RSO RSO

Joint Working with R&D UHL• Memorandum of understanding in place for University to

work collaboratively with UHL

• Non-commercial trials: University to secure funding and contract with funders (charitable, or business).

• Using model agreement, University will contract with UHL on arrangements for use of facilities and patients.

• Commercial trials: Overarching agreement to regulate financial arrangements.

• Using national model agreements, UHL to contract with Pharma and using standard sub-contract with University

Costing proposals for Clinical Trials

• There are various models of funding clinical trials.

• Most common:

– Pharma funded and sponsored CT

– Pharma funded but Trust sponsored CT

– Pharma funded but University led and Sponsored CT

– University led and Sponsored CT funded by Public sector (e.g charities)

Costings :

• Commercial Clinical Trial (Pharma-sponsored)

• Commercial funded but UHL sponsored Trial

• Use CRN Template (Not fEC)

• Refer to Protocol

• Discussion between PI/University/Trust/Company

Costings :

• University Sponsored and academic led (funded by Pharma)

• Non-commercial template and/or fEC

• Discussion between PI/University/Trust/Company

Costings - Industry funding

• Where fEC costing is appropriate, project to be fully costed under fEC regardless of what the funder pays (use costing tool – Lucre)

• Even if it is only outline bid - need the full costs of the project

• Need to fully justify costs

• EBD team to support costings and negotiations with industry for MBSP (working with College to agree any negotiated costs, and UHL to ensure all costs are met)

Internal sign-offs – Industry funding

• Involve EBD early in discussions with business– No formal application procedure, therefore early

involvement ensures opportunity to address key matters early!

• All potential industry funded applications notified to College

• Head of Department sign-off approval form to confirm figures

• Terms of contracts vary hugely. EBD negotiates contracts in conjunction with academic/college to ensure contract terms are appropriate (eg IP ownership, publication etc.)

Costings : Public Sector funders

• NIHR/MRC

• Charitable funders (eg CRUK)

• Need to use fEC model (to cost project)

• NIHR schemes generally fund HEI at 80% fEC

• Charities : generally only 100% Directly Incurred

• EU generally pay 75% of eligible actual costs (+ overheads)

Costings - Public sector funding

• All projects have to be costed under fEC regardless of what the funder pays (use costing tool – Lucre)

• Even if it is only outline bid - need to record the full costs of the project

• Need to fully justify costs

• Dedicated RSO team to support costings and submissions for MBSP (with specialists in EU funding)

Internal sign-offs – Public sector funding

• Peer review for School of Medicine- All research grant applications worth more than £50k (award not Fec) must be peer reviewed by College

• Head of Department sign-off approval form to confirm figures and application

• HOC requirement to approve all funding grant applications worth more than £100k to Leicester

• On receipt of approvals, RSO submits application electronically.

General tips before bidding for funding

• Read all guidelines, terms and conditions

• Check application form requirements, e.g.

referee reports, signatures, length of proposal

• Allow plenty of time: check deadlines/method of

submission.

• Get the finances right – check with RSO/EBD

• Justify costs in application

• Remember institutional sign off and College

requirements

Handling Awards and Contracts• Contracts with funder need to be formalised. RSO and

EBD to review terms

• In some cases, confidentiality agreements are necessary before contracts are set up.

• Where University applications has to go via the UHL, contracts to be set between UHL and University

• The University and UHL Trust are setting up standard templates

• Overall requirement to ensure compliance with GCP and legislation

Challenges with contracts

• Using DOH approved model agreements but,

• Need to ensure terms of the agreement are not inconsistent with terms of protocol

• Specific issues to consider: Conditions of payments; Indemnity/insurance issues; University IP position/ storage of data; material transfer

• Recognise some delays may occur to resolve specific issues (e.g. HR, insurance, legal). Sooner our offices get involved, the better

Contractual governance arrangements

• For each trial, we work with Research Governance Manager to identify the Sponsor roles and ensure there is appropriate delegation of responsibilities (site agreements)

• Work in progress to set up appropriate SLA with regards to drugs and UHL Pharmacy services provision

• If involvement of Clinical Trials Unit – ensure delegation of responsibilities

Post award issues

• RSO will manage and track all payments and invoices (industry and public sector funders)

• NIHR contract may require ethical approval in place before release of funding

• Charitable funders (such as BHF) need to approve CVs of unnamed staff before appointment of staff

Final messages

• Talk to us as early as possible – CT require joined up thinking from application stage onwards

• Every protocol and every funder is different - Never negotiate your own prices

• Never sign a contract

• Under Joint Office remit we work very closely with UHL. It’s early days and problems might occur but working hard to align our contracting processes.

Key Contacts

• EBD: Dr Lisa Stocks

• lisa.stocks@le.ac.uk or 252 5120

• RSO: Brian Berry

• brian.berry@le.ac.uk or 223 1814

• R&D UHL: Dr David Hetmanski

• David.Hetmanski@uhl-tr.nhs.uk or 258 4199