Research Contracts Navdeep Bains Research Development Manager (Medicine) 16 th April 2014

WHY? Good governance (protection/traceability) –sets out responsibilities/obligations –compliance with law and regulations –Sets out liabilities (contractual/legal liability) Minimises risk Prevent or avoid lengthy disputes

“A contract is an agreement entered into voluntarily by two or more parties with the intention of creating legal obligations which are enforced or recognised by the law. The factor which distinguishes contractual from other legal obligations is that they are based on the agreement of the contracting parties” DEFINITION

BASIC STRUCTURE OF CONTRACT Parties Recitals Definitions Main body Executing and dating the contract Schedules (scope of work, payment terms etc)

TYPES OF CONTRACTS Confidentiality Agreement Material Transfer Agreement Sponsorship Agreement Site Agreement

Non- Disclosure Agreement Exchange of confidential information only 1 way, 2 way, multiple Pre-existing IP, results, data etc Should include a purpose which is: Broad to cover discussion Not encapsulate wider subject matters Duration of obligations CONFIDENTIALITY AGREEMENTS

Covers the transfer of material Material supplied (chemicals, plasmid, tissue) Incoming/ Outgoing Academic/ Research use Licence for use with restrictions –Custodianship –Consents –Approvals Return/disposal on termination MATERIAL TRANSFER AGREEMENTS

SPONSORSHIP AGREEMENTS More than one organisation Responsibilities (Research Governance Framework, Medicines for Human Use (Clinical Trials) Regulations) –Design –Management –Finances –Pharmacovigilance Co-sponsorship never joint sponsorship Sets out –Responsibilities –Liabilities Responsible for your actions only

SITE AGREEMENTS mNCA Participating Sites Required for R&D approvals Standardisation Ensure compliance with: –Law –Protocol –Approvals/ gain necessary consents Manage Risk –Standard clinical care/ surgical risks versus Study risks.

WARWICK PROCESS (FP14) All Research contracts Review and drafted by RSS Head of department approval (FP14b) Signed by authorised signatory –Director or Deputy Directors of RSS –Registrar –Finance Director Academics or Researchers cannot sign Involve RSS as early as possible.

Questions?