Aim

Ensuring independence of researchers in studies financed through project-based contract (“derde geldstroom”) and private (“vierde geldstroom”) funding.

Description

Traditionally, scientific research at an academic medical faculty has been financed through funding from the Ministry of Education, Culture and Science, and through independent public institutions (Netherlands Organisation for Scientific Research (NWO), the Royal Netherlands Academy of Arts and Sciences (KNAW) and the Netherlands Organisation for Health Research and Development (ZonMw)). Scientific research (as well as equipment, course or conference visits, and authorships, professorships and advisory appointments) is increasingly being financed from other sources, such as government (partially), charity and industrial organisations (project-based contract and private funds). Inadequate agreements about the design, implementation and reporting of the research may affect the quality of the research and the researcher's independence.

The focal points discussed below in the Details section may be useful in avoiding potential conflicts and could be used when drafting a research contact that needs to be signed in advance of the study by the director of the EMGO+ Institute and the funder. The director is solely authorised to sign agreements with third parties. Always contact the manager, Barry de Wit, in advance of any studies of this kind. He has examples of contracts. You may like to consider whether the draft agreement should be reviewed by one of the VU University Medical Center’s lawyers

The full independence of the researcher needs to be explicitly guaranteed in the research contract for all phases of the research process (including publication of the results). It is preferable for the researcher to create the research protocol. In all instances the researcher should have a deciding role in the ultimate formulation of the research question(s), study design and proposed analysis. The contract should contain clear agreements in respect of the following issues:

1. The exact location and method of data collection and analysis.
2. The conditions under which the study can be prematurely halted. Think about the scientific as well as financial aspects of the study.
3. The property rights associated with the research data. These belong, in a strict sense, to the organisation employing the researcher (in most cases this will therefore be the EMGO+ Institute). However, in consultation these may be officially transferred to the funder as long as privacy legislation is taken into consideration.
4. Publication and presentation strategy. The principle is that the researcher has responsibility for the final manuscript and has the freedom to publish and present the findings at any stage. It is good practice to include in the protocol who is responsible for preparing the manuscript and what the procedure is for reporting to and requesting potential input from the funder. It is common practice for funders to receive drafts of articles, and to be allowed two weeks to respond to the text. Potential modifications can then be included with mutual approval. However, the researcher should always have the final say. Additionally, it also needs to be established in advance whether and under which conditions the funders can be included as potential co-authors, and how the role of funders is to be reported in publications and presentations. Strategic or patent interests should be respected, but should never be allowed to prevent publication.
5. What and when is reported in progress reports.

Prior to implementing the study a clear financial agreement needs to be established, including details about what is to be reimbursed and at what point (for staff, laboratory costs, travel costs, etc.), and how the final payment from the grant is to be managed. There also needs to be a policy in the event the study is terminated to early.

V1.2  1-1-2009: Translated into English
v1.1, September 29, 2006: Minor textual amendments.
February 17, 2004: Role of manager and director added. Various minor clarifications.

• Is the project funding based on contract funding (e.g. charities) or private/commercial (e.g business, private investments)?
• Has a contract been signed with the funder?
• Does the funder (or has the funder had) a role in one or more of the points described below?
• Creating the research protocol
• Data collection
• Data analysis
• Interpretation and reporting of results
• Have other goods or services been offered by the grant provider? If so, which ones? Please describe what was done with them.