Types of research collaboration agreements
To give an overview of the various types of research agreements and associated considerations, the list below describes the most common types of agreements.
Concerns funding for a specific research project or a certain research area. Research grants typically come from governments or charities, but industry can also provide research grant.
Covers collaborative fundamental, experimental or applied research of mutual interest to Amsterdam UMC and the collaborator, which is usually performed by both parties. Each party may provide the other party access to its proprietary IP rights, materials, software or other valuable background IP for the performance of the project. Collaborative research projects may not always be conducted on the basis of (full or partial) cost recovery by the collaborator. Therefore, the IP is always subject to negotiation (see also Chapter 'Valorization'). If more than two parties are involved in the collaboration, the agreement may also be called a consortium agreement; this can be a supplementary agreement in relation to a research grant agreements.
Covers well-defined research of specific interest to the sponsor that is performed solely by Amsterdam UMC, usually at the sponsor’s request. The sponsor usually drafts the project plan or protocol, and provides a financial contribution and/or access to the sponsor’s proprietary IP rights, materials, software or other valuable background IP. Sponsored research projects are generally conducted on the basis of (at least) full cost recovery, including payment of indirect costs, at Amsterdam UMC’s established rate and IP fees. Prepayment or early payment may be necessary, as Amsterdam UMC does not utilize its working capital to finance large expenditures incurred in the course of sponsored research.
This agreement facilitates the performance of specialized services by Amsterdam UMC, using the institution’s existing expertise and equipment. No further intellectual research efforts are required for the provision of these services. Research services are provided for a market-conform reimbursement value, as all results will be owned by the other party. If the service encompasses advisory activities only, this may be a consultancy agreement (see below).
In accordance with the ICH Good Clinical Practice guideline (ICH-GCP), a CTA specifies arrangements made between the sponsor/sponsors of a clinical trial and the investigators’ institution or institutions regarding the allocation of tasks and obligations, and any financial matters. CTAs are important to allocate risks and responsibilities, and to protect academic, legal and intellectual property and integrity. CTAs must be submitted to the MREC for approval on the topics of publication and early termination. Various templates for CTAs, compliant with all laws and regulations and approved by the relevant organizations, are provided by the CCMO. For the general rules and regulations on clinical research, see also Chapter 'Dealing with human subjects involved in research'.
This is a contract under which advisory activities are provided by Amsterdam UMC employees to third parties (e.g. participation in an advisory board). Importantly, researchers providing consultancy to companies must not share novel ideas and inventions relating to their own research; they should only contribute their expert knowledge of their research field (current state of the art). See also Chapter 'Conflicts of interest' and the regulations in article 9.3 of the Collective Labor Agreement for University Medical Centers (CAO UMC, 2022-2023) regarding external employment or outside activities.
This type of agreement defines the basis upon which parties transfer or obtain access to biological or chemical compounds or research tools. MTAs regulate the terms relating to material transfers, in particular terms regarding the purpose, ownership, liability, publications, and inventions. Body material from human subjects involved in research may be transferred to other parties under MTAs, provided that it is used in accordance with applicable laws and regulations. Transfer of body material to companies is generally not appropriate under an MTA; in most cases this requires a collaborative research agreement.
Describes the basis upon which parties transfer or obtain access to personal data. These agreements regulate the terms relating to the purpose, data protection responsibilities, ownership, publications, and inventions.
This agreement is required when the research institution in its role as ‘data controller’ engages a third party (such as a hosting or database building service provider) to process personal data. At Amsterdam UMC, use of the Template Data Processing Agreement of the BoZ (Brancheorganisaties Zorg) is encouraged.
A CDA is typically put in place in order to allow conversations exploring the possibility of entering into a research collaboration. This agreement obligates the parties to treat as confidential all information that should only be shared between them, such as information regarding project proposals, budgets and IP matters. Inventions can only be patented if they are novel, i.e. not previously disclosed to any third party. Nevertheless, it may be necessary to share a not-yet patented invention with a third party during discussions about a potential collaboration. A CDA allows the invention to be shared without harming its novelty.
A visiting scientist agreement is intended to safeguard the IP rights and confidentiality with regard to information provided to temporary scientific staff and scientific trainees.