Research collaboration agreements

Amsterdam UMC researchers collaborate with a wide range of parties, including academic institutions, companies, local and national governmental agencies, charities, and the European Commission. These collaborations impose a responsibility to carefully weigh the obligations of Amsterdam UMC against the interests of the collaborating partners. The independence of the researchers and the research from the collaborating or funding party must be protected. In all collaborations with third parties, conflicts of interest should be avoided, and the general principles of research integrity, transparency and independence must be respected.

The Dutch Code of Conduct for Research Integrity provides the following guideline for good research practice with respect to collaborations:

"Enter into joint research with a partner not affiliated with an institution which has adopted this or a comparable Code only if there is sufficient confidence that your own part of the research can be conducted in compliance with this Code and the joint research results meet generally accepted principles of integrity in research". Dutch Code of Conduct for Research Integrity

For cross-boundary collaborative research, which can present extra challenges for the responsible conduct of research because of differences in legal systems, organization and culture, the Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations provides guidance. Particular attention should be paid to research collaborations with parties in low- and middle-income countries, to guard against ‘ethics dumping’—the practice of exporting unethical research practices to lower-income settings. The Global Code of Conduct for Research in Resource-Poor Settings aims to combat ‘ethics dumping’ and to achieve fair research partnerships in such settings.

Research collaboration agreements entered into by Amsterdam UMC include clear definitions of rights and responsibilities towards third parties, which can help us to uphold our commitment to the highest standards of research integrity.

Responsibilities

For liability reasons, it is not the researchers themselves who enter into research collaboration agreements with third parties; all agreements have to be signed by the Amsterdam UMC executive board, or a delegate. The principal investigators (PIs) are responsible for the proper conduct of the research project. When considering collaborative research with third parties, researchers must ask themselves whether the proposed research can potentially help to advance medical knowledge. They must also verify with their supervisor and/or a legal expert of the Legal Research Support department that the project does not conflict with other legal commitments of Amsterdam UMC.

Ruling principles

When research agreements with third parties are being prepared, the following principles should be adhered to:

  1. The work plan is the most important part of the agreement. It is attached to the agreement as an appendix. The plan should contain a description of the scientific objectives of the project and the methods to be used, state what each partner will contribute, both separately and in collaboration, and describe when (parts of) the project should be completed.
  2. Since the course of research is by its nature unpredictable and research results are inherently uncertain, Amsterdam UMC research is generally conducted on a reasonable efforts basis, performed at a standard that is consistent with research at UMCs
  3. Amsterdam UMC will not enter into research agreements that involve commitments and obligations that are in conflict with those accepted under other research agreements, and does not accept provisions that preclude the PI or the institution from performing research for or with other parties in related areas
  4. It is essential to Amsterdam UMC that publication of scientific results is guaranteed, even if these results are negative or disprove the hypothesis. Therefore, publications may never be subject to final approval by the collaborating party. However, they may be subject to review by the collaborating party with respect to protection of that party’s confidential information and intellectual property. Therefore, it is necessary to include in the collaboration agreement how a proposed publication may be amended and how long it may be delayed in order to accommodate the interests of the relevant parties. Delay should be for a reasonable period and in general not longer than 90 days from first submission to the reviewing party.
  5. It is important to establish whether contracting partners require access to Amsterdam UMC’s know-how, materials and/or IP rights, and, if so, under what conditions. Also, researchers must ensure that no IP right licensed to Amsterdam UMC by a third party—including materials obtained under a Material transfer agreement (MTA)—will be used outside the scope of its license or MTA without the third party’s prior consent. Generally, Amsterdam UMC retains ownership of all inventions and discoveries arising from the conducted research, whether or not these are patentable. Amsterdam UMC may grant the other party a first right to negotiate a commercial license to use the results arising from the research under terms that are at arm’s length and market-conform. See also Chapter 'Valorization'.
  6. Amsterdam UMC encourages open discussion and exchange of ideas. At times, however, it may be necessary to maintain the confidentiality of information. This will then be arranged in a confidentiality agreement (see under 'Types of research collaboration agreements' for more information).
  7. Amsterdam UMC cannot accept penalty clauses or contractual/payment obligations that establish rigid deadlines or rigid deliverables. Research agreements will have appropriate provisions to limit Amsterdam UMC’s liability.
  8. Arrangements on early termination of research projects have to reflect the parties’ investments and efforts in the project, and assure payment for work already performed and uncancellable costs reasonably made.
  9. If research collaborations involve third parties obtaining access to personal data, the rights and privacy of the respective subjects must be guaranteed. Data protection agreements are required, and they must specify how to protect the rights of data subjects, the allocation of data protection responsibilities, and the legal ground for processing the personal data (see section below).

    Types of research collaboration agreements

    11 types of research collaboration agreements

    Support

    For all aspects discussed in this chapter, the Legal Research Support department of Amsterdam UMC or Innovation Exchange Amsterdam (IXA)—the joint knowledge transfer office of HvA, UvA, VU and Amsterdam UMC (ixa-st@amsterdamumc.nl)—provide expert advice and support.