Types of research contract (Agreement)
There are several types of contract (often referred to as agreements) associated with research. They vary according to the funder and the nature of the research.
This is a contract to provide funding for a specific research project or set of projects within College. It may be funded by a company, government body, charity or other body, and will contain terms and conditions governing the conduct of the project, as well as obligations incumbent upon the College and the funder.
The purpose of a research contract is to set out the roles and responsibilities of the parties involved in a research project, i.e. the College, the academics, researchers, students and the funding body. The contract will:
- Define the work to be undertaken
- Define the financial contributions/payment terms
- Define the share of technical, commercial and economic risks of each party
- Set out publication rights of results
- Establish who will own the results of the work and who has the right to use them
- Set out agreed liability and indemnities.
This agreement sets out the responsibilities, roles and rights of collaborating parties working in conjunction with the College on a specific research project or set of projects. All parties will be bound by the same terms and conditions, and the agreement will usually set out how the overall project will be managed between the parties. The agreement is often drawn up following a joint award/research funding agreement and the terms of this main award will often be reflected in the collaboration agreement. It may also contain funding terms, for example transfer of funding from the lead partner to the other collaborators, or the transfer of additional funding from a commercial partner.
A collaboration agreement is required for work involving at least one other research partner on a project.
European Commission Consortium Agreement
Consortium Agreements for European Commission projects are mandatory for most Framework Programme 7 (FP7) projects and the Commission requires that the Consortium Agreement is negotiated and signed before it will sign the Grant Agreement (i.e. the contract) for the project. The Consortium Agreement is concluded between all partners in the consortium but the Commission is not a party to it. Consortium Agreements supplement the Grant Agreement by expanding on and clarifying key terms and conditions (e.g. Intellectual Property, confidentiality, liability, publication rights) and provide details of the internal management and working practices of the consortium (e.g. voting rights, internal reporting structure, dispute resolution).
Research sub agreement
This agreement engages a research partner on a specific work package under a research project (or set of research projects) held by College, and normally involves payments to the partner. The agreement is often drawn up following a main grant award or another research funding agreement, and will involve discrete and specific pieces of work to be undertaken by a partner organisation. College will remain responsible for the main award, but will often flow down any relevant terms and conditions to the research partner, and as such, these will be reflected in the sub-agreement.
Clinical Trial Single Site Participating Agreement and Sponsorship Agreement
This type of agreement is used for clinical trials taking place in sites external to Imperial College and, in the absence of a formalised overarching agreement with the relevant NHS authority, is also used for clinical trial activity within College’s associated NHS Trusts (Royal Brompton and Harefield, Chelsea and Westminster, North West London Hospitals, Imperial College Healthcare NHS Trust). Where the College is the Sponsor of a multi-centre trial, it must execute an agreement with each participating site (normally a university or NHS Trust). The agreement ensures the site agrees to comply with relevant laws, regulations and codes of practice applicable to the performance of the trial (Research Governance Framework for Health and Social Care/UK Medicines for Human Use (Clinical Trials) Regulations). It includes provisions such as safety reporting, insurance/liabilities, medical confidentiality, Intellectual Property, publications, funding if applicable, etc. A Sponsorship Agreement is a simplified version of a Clinical Trial Single Site Participating Agreement suitable for less complex non-IMP studies (studies not involving Investigational Medicinal Product). The agreement is signed between the Sponsor and participating site and confirms College’s overall responsibility as legal Sponsor and outlines specific responsibilities of the site in relation to the study (i.e. referral or recruitment of patients to College).
Investigator led clinical trial
Investigator led trials are designed by academics and usually sponsored by their employer. Such trials are funded by grants from charities, Research Councils, government agencies, etc. or with support from pharmaceutical companies. Where a pharmaceutical company is providing funding (and in some cases drugs free of charge) an agreement needs to be executed between the College and the company to ensure that each party agrees to comply with the relevant laws, regulations and codes of practice applicable to the performance of the trial. The agreement includes provisions for the supply of drugs, funding, safety reporting, insurance/liabilities, publications, Intellectual Property etc.
Commercially led clinical trial
Commercially-led clinical trials are designed, legally sponsored and funded by pharmaceutical companies. The company contracts with individual organisations (trial centres) either directly or through a Clinical Research Organisation (CRO) to undertake the trial on its behalf.
Drug Manufacturing Agreement
This type of agreement is executed when the College wishes to contract with a pharmaceutical company to produce a medicinal product in accordance with College specifications and/or with materials supplied by the College. Manufacturing Agreements are required for both the production of experimental drugs and for the repackaging/dose alteration of existing drugs for new indications. These are complex agreements and must be reviewed carefully to include regulatory compliance (GMP facilities/standards, compliance with UK/EU/FDA regulations, Manufacturing Authorisation for Investigational Medicinal Product (MA-IMP) requirements etc), warranties and indemnities. College insurance cover must be considered under this type of agreement as well as subsequent use of the product in clinical trials.
Investigational Medicinal Product (IMP) / Drug Data Transfer Agreement
This type of agreement is used when external parties wish to make "in-kind" contributions for investigator-led studies such as the supply of drugs or medical devices. Where provisions for such contributions are not within a principal funding agreement, a Transfer Agreement should be executed between the supplier and the College to outline each party's responsibilities in relation to the study and ensure compliance with regulatory framework (warranties/liabilities, quantities of supply, safety reporting, confidentiality etc).
Qualified Person (QP) Release Agreement
This type of agreement is used for the release of an Investigational Medicinal Product (IMP) by a Qualified Person (QP) before use. The agreement ensures Sponsor compliance with current EU Clinical Trials Directives (Article 51 of Directive 2001/83/EC, Article 55 of Directive 2001/82/EC) / UK Medicines for Human Use legislation.
Fully funded studentship
A fully funded studentship is an agreement to provide a student with funding for PhD or Masters level research. The student will conduct the majority of the research under academic supervision. The focus of the research will be the PhD study itself and ultimately the award of a degree to the student. The funder will cover tuition fees and bursary/stipend, and any consumable/equipment/travel costs required. Funding often comes from industry and government departments but may also come from other sources.
Research Councils fund studentships through a number of routes, mainly Doctoral Training Account (DTA) awards and specific project grants. These awards are against set terms and conditions, which are available from the relevant Research Council website.
Collaborative Awards in Science and Engineering (CASE)
Collaborative Awards in Science and Engineering are industrially focused studentships allocated by Research Councils to companies either directly or via agents. Time is spent working in the company, and the company provides a financial top-up to the core Research Council award. The Research Council funding is often through a Doctoral Training Account (DTA) award. Occasionally a company may provide sponsorship outside of the normal CASE scheme, providing additional funding, resources and/or input. Whilst not strictly CASE, it is treated as such for the purposes of the contract.
Material Transfer Agreement (MTA)
A Material Transfer Agreement (MTA) is a contract that governs the transfer of tangible research materials between two organizations when the recipient intends to use them for their own research purposes. It defines the rights of the parties in respect to scope of use of material, confidentiality, publication, and ownership of Intellectual Property. Occasionally a transfer may include software. These agreements should not include payment for the material, other than reimbursement of transport costs.
There are two types of MTA:
- An MTA-outcovers the transfer of materials owned or controlled by the College to another university, company or other external body for research purposes. These are dealt with by Faculty Research Services teams.
- An MTA-in covers the transfer of materials to the College from another university, a company or other external body. These are dealt with by the Research Office. For further information see the Material Transfer Agreements (MTAs) page.
Confidentiality or Non-Disclosure Agreement (CDA or NDA)
This is an agreement to regulate the ways by which confidential information, including Intellectual Property, may be disclosed by one party to another. The agreement sets out the terms of disclosure and whether information is returned to the provider or destroyed upon request. Confidential information includes any information, results or know-how that is owned by someone, and which the owner wishes to be kept secret. The disclosure of confidential information requires that a confidentiality agreement is signed before any discussions take place.
Service/Consultancy Purchase Agreement (relating to research)
This type of agreement is used to facilitate the commissioning of specific professional services from a third party by the College. No research or novel work is intended to be carried out under these agreements, rather just sta ndard analysis, processing, manufacture or provision of expertise. All results will be owned by the College, with no right of use assigned to the consultant. These agreements are not appropriate to use for a research sub-agreement or collaboration.
Memorandum of Understanding (MoU)
A Memorandum of Understanding is a document intended to de scribe a bilateral or multilateral agreement between parties. It is often a preliminary document and is generally not intended to crea te a legal commitment between the parties but to set out the working principles of the relationship.