Relationship with external funder

Aim

Ensuring that researchers are doing their research independently from the financers of the study.

 

Requirements

  • Written contract ensuring the independent position of the researchers (for details, see How To)
  • Contract must be checked by an organisational lawyer (for details, see How To)

 

Documentation

  • Copy of the contract
  • Copy of all other terms or conditions that apply to the granted study, but are not listed in the contract (standard conditions, site letters and appendices ect). This information should preferably be kept digitally or on paper and not as an URL (since conditions may chance over time).

 

Responsibilities

Executing researcher: Knowledge of the content of the contract;
Project leaders: Negotiate a contract fulfilling the requirements and check with the head of the department who is responsible for approval (and signing) of the contract (depends on the amount of money that is involved).
Research assistant: N.a.

 

How To

Contract
The full independence of the researchers needs to be explicitly guaranteed in the research contract for all phases of the research process, including defining the research design, data collection, data analyses and publication of the results.How much the independence of the researcher is under pressure depends on the arrangements (effort versus result obligation) in the contract and the type of financer  (for-profit organization or non-for-profit organization) To ensure the independent position of the researcher the written contract should contain:
  1. That there is no publication veto (freedom to publish results independently). Yet an embargo period of reasonable length (up to a maximum of three months) could be agreed upon.
  2. That the trial or study can only be stopped in case of serious unexpected circumstances, e.g. serious adverse events (based on planned interim analysis) or problematic participation rates (as documented upfront). Marketing reasons or unwanted short-term results cannot be a reason to stop the study. A clear description on the policies in case the study is prematurely terminated should be provided (e.g. financial consequences).
  3. Agreement about data sharing and data ownership. Ownership of the data preferably lies with the research institute.
  4. Financial agreements including details about what is to be reimbursed and when (for staff, laboratory costs, travel costs, etc.).
  5. Any other financial agreements apart from the payment of the study, such as performance bonuses for individuals or organisations should be listed. This is needed for transparency in financial conflicts of interests.
Contracts must be checked by an organisational lawyer to be reached at the Technology Transfer Office (TTO), which is part of IXA. Always seek legal assistance in an early stage of the contract negotiations. Contract may only be signed by authorised people. Most researchers are not authorized by the hospital or University to sign contracts. Ask the head of your department who is authorized to sign your contract.

 

Agreements
In addition, the following issues need to be agreed upon and documented:
  1. The exact location and method of data collection and analysis, and the person(s) doing this. Most often the researcher is responsible for data collection and analyses, which is guaranteeing independency. In exceptional cases, employees of the funder can also be involved in this process. In that case, special agreements need to be made to warrant independency, transparency and controllability of the process.
  2. The exact conditions under which the study can be prematurely halted and at what time points these are determined (e.g. serious adverse events, participation rates).
  3. The property rights associated with the research data. These belong, in a strict sense, to the organisation employing the researcher, but anonymous data should always be shared with other parties if a reasonable and substantiated request is submitted. The researcher and the organisation employing the researcher are responsible for following the (privacy) legislations that are applicable, including the statutory retention period for keeping personal data. In exceptional cases, and only when thoroughly motivated, ownership of the data may be officially transferred to the funder, as long as (privacy) legislations are followed.
  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. However, only if the agreements are in line with requirements for good authorship practice [links naar QH richtlijn] and requirements considering transparency about financers and financial conflicts of interest of the organisations involved and journals. Strategic or patent interests should be respected, but should never be allowed to prevent publication.
  5. What to report in scheduled progress reports.

 

Appendices/references/links

  • See also “Independence in scientific research” in the VUmc AMC research code, and more specifically the chapters 7 “Research data management”, 8 “Research collaborations with third parties” and 9 “Ownership and valorization of research results”.

 

Audit Questions

  1. Is the project funding based on contract funding (e.g. charities) or private/commercial (e.g business, private investments)?
  2. Has a contract been signed with the funder?
  3. 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
  4. Have other goods or services been offered by the grant provider? If so, which ones? Please describe what was done with them.

 

V2.1: Sept 6, 2018: minor textual amendments
V2.0: July 1 2015: Revision format
V1.3: Oct 31 2013: Reference to VUmc-AMC research code added
V1.2: Jan 1 2009: Translated into English
V1.1: Sept 29, 2006: Minor textual amendments
V1.0: Feb 17, 2004: Role of manager and director added. Various minor clarifications