Research agreements

Getting research agreements in place can be a complex process. We work closely with the Research Contracts and Legal teams in the University of Edinburgh and NHS Lothian to help.

Research agreements: what you need to know

When should agreements be prepared?

Agreements should be initiated as early as possible - well before the project start date, and ideally as soon as the key details of any collaboration are known. Early preparation helps avoid delays and ensures all parties are aligned before the study begins.

The Contracts team in the Edinburgh Research Office typically leads with initiating these agreements.

Who reviews and signs agreements?

  • For the University of Edinburgh, a Contracts Manager from the Edinburgh Research Office Contracts team or a Solicitor from the Legal team will prepare and coordinate the contract review.
  • For NHS Lothian, the Principal R&D Manager and their team will lead the review process.

As the Principal Investigator (PI), you’ll be involved in reviewing the agreement, along with your Sponsor Representative and other relevant teams - such as Edinburgh Innovations, the University Insurance Office, Information Governance, and Finance.

When should an agreement be signed?

Contracts are signed once the relevant reviewers (usually the University Contracts Manager and NHS Lothian Principal R&D Manager) confirm the agreement is finalised.

Agreements must be signed before your study opens to recruitment, unless your Sponsor Representative advises otherwise.

Please note: Only individuals with official delegated authority may sign agreements. For the University of Edinburgh, this is usually a Contracts Manager or Solicitor. For NHS Lothian, this is the Principal R&D Manager or their designee.

Types of agreement you may need

Types of agreements you may need
Funding Agreement Usually provided by the funder to the University of Edinburgh. The Contracts Team will review the terms and confirm them with the Principal Investigator (PI). Provisions from the funding agreement often flow down into other associated agreements.
Collaboration Agreement Required when the project involves other academic institutions, such as co-applicants named in a funding application.
Co-Sponsor Agreement For CTIMPs and CIMDs, and clinical trials to study a novel intervention, a Co-Sponsor Agreement between NHS Lothian and the University of Edinburgh is required. This is arranged by your Sponsor Representative.
Site Agreement Required for each participating site in a multi-centre study. This may be covered in the appendices of the Organisation Information Document (OID) or through the nationally agreed Model Non-Commercial Agreement (mNCA). Your Sponsor Representative will advise on the appropriate format.
Drug Supply Agreement Needed when an investigational drug is supplied by an external organisation. This agreement outlines responsibilities for supply, handling, and quality.
Technical Agreement Covers manufacturing, packaging, or re-labelling processes carried out by a third party (i.e. not the drug supplier).
Research Services Agreement / Subcontract Used when a third party provides research-related services such as Quality Assurance or Monitoring. These can be referred to as either Research Services Agreements or Subcontracts, depending on the context.
Service Level Agreement Used when services are provided by another part of the University - for example, internal laboratories.
Tissue/Material Transfer Agreement (MTA) Required when human tissue or other research materials are transferred between organisations, unless already covered within an OID or Site Agreement.
Data Transfer Agreement (DTA) Covers the sharing of research data with third parties - such as transcription services, data analysts, or external collaborators - particularly when personal or sensitive data is involved.

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