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

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

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

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

  2. 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

  3. DEFINITION “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”

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

  5. TYPES OF CONTRACTS • Confidentiality Agreement • Material Transfer Agreement • Sponsorship Agreement • Site Agreement

  6. CONFIDENTIALITY AGREEMENTS • 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

  7. MATERIAL TRANSFER 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

  8. 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

  9. 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.

  10. 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.

  11. Questions?

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