Procedure Ethics Review

Why an ethics review?

Human-related scientific research requires attention to scientific quality and value, privacy, data protection and control, and protection of the integrity of participants. Participants in scientific research should be able to assume that research will be conducted in a responsible manner. The objective of the Ethics Review Board is to protect human test subjects against the risks and objections of scientific research, without hindering the progress of science.

When do you need to submit an ethics application?

All studies with data on living human subjects conducted within TSB (School, PhD researchers, and students) require ethical approval. There is one exception to this:

• Research projects by students conducted exclusively for educational purposes (e.g., as a thesis) that are not going to be published. Note that this exemption does not apply for higher risk projects. Examples of higher risk projects include:
  • When particularly sensitive data are collected
  • When participants are part of a vulnerable group
  • When participants can experience physical pain or mental distress

The supervisors should judge whether a student project falls into a “high risk” category or not, and when in doubt consult the department’s ERB committee member.

When a student project is exempted from an ERB application, the supervisors should still make sure that students adhere to the standards of responsible research. 

Because the ethics review comprises not only a section on ethics but also on data management and the GDPR (processing register), the ERB application is also necessary for projects that have already received ethical approval elsewhere (for example, approval from the METC).

Types of applications

There are two types of ethics review: fast-track and full review.
Please note: as of 1 January 2024, we will stop the fast-track review procedure. Fast-track applications can be submitted until the Christmas break (22 December - 7 January).
To qualify for a fast-track review, the project must fall under one of the following categories:

Category 1: Secondary data analysis
The researcher is using existing anonymous or pseudonymized data. In case of pseudonymized data, the researcher does not have access to the key file. Secondary data usually refer to the data collected by third parties (e.g., World Values Survey), without the researcher’s involvement.

Category 2: New data collection in minimal risk projects
Projects that collect new data can qualify for a fast-track review if they meet the following criteria:

• Participants from the general population without complaints. Projects that specifically target participants from vulnerable groups are not eligible for a fast-track review. Examples of vulnerable groups are:
  • Children
  • Prisoners
  • Individuals currently hospitalized
  • Individuals currently dealing with mental health issues
  • Pregnant women
  • Mentally disabled persons
  • Economically and educationally disadvantaged persons
• The burden on participants is minimal in terms of time, procedures, and content of the assessment. Responsibility to evaluate this lies with the researcher, possibly in consultation with the Department’s Ethics Review Board committee member or the ERB Chair.
  Protocols that expose participants to substantial physical or mental pain are not eligible for a fast-track review.
  Projects that specifically target sensitive topics are not eligible for a fast-track review. Examples of sensitive topics are:
  • sexuality
  • trade union membership
  • genetic data
  • biometric data
  • suicidal ideation or behavior
  • current involvement in criminal behavior, violence or aggression 

Projects that do not satisfy these criteria should be submitted for full review. 

Fast-track review is not possible for projects that include multiple studies using different methods or data collection over several years. 

How to apply?

To determine whether your project is eligible for a fast-track review vs. needs to go through full review, fill in this form.

For fast-track review, fill in this form  and send to erb@tilburguniversity.edu.

For full review, you can apply via G.E.D. Started!, the online platform within Tilburg University for the ethics review. Via this tool, you go through the different components of the ethics review: ethics, data management, and GDPR.

Apply through G.E.D. Started!

How does the process work?

The process always begins at the start of a new research project. As soon as you, as a researcher, want to start a new project, you have to apply for ethical approval at the start phase of the project. Without ethical approval, you cannot start the project and ethical approval is not possible after the start of the research (e.g., after the start of data collection). So make sure you submit your application on time.

Once you have submitted your proposal via G.E.D. Started, it will be sent to the ERB. The proposal is usually assessed by 3 people: 2 reviewers and the data representative of the School (note that the fast-track review involves one reviewer). After submitting the research proposal, you will receive a response from the Board within 11 working days. In the case of a revision, you will be asked to answer the Board’s questions or amend parts of the research proposal. In case of approval, you will receive an approval letter.

What will be assessed?

Ethics

The ethical aspect is mainly assessed on whether the participants are sufficiently protected and no ethically irresponsible actions are taken. The reviewers make use of a checklist, see below

• Review form  Ethics

Data management and GDPR

For the data management plan, it is reviewed whether the researcher adheres the TSB. The storage locations and accessibility are assessed. The possibility of making the data public is also examined. For the GDPR part, it is examined whether the processing register has been filled out correctly. Are the correct personal data ticked and what is the legal basis of the research? In addition, an assessment is made as to whether (processor) agreements are required and whether a DPIA is necessary.

Some of the questions in the Data management and GDPR forms might be hard to answer without the knowledge of the relevant legal regulations. As a guideline, we provide a template with TSB default responses here. 

Bulk proposals

Twice a year, each department has the opportunity to upload a so-called bulk proposal to the Ethics Review Board. This bulk proposal contains multiple research proposals of the department. The proposals give a short explanation of the research project and are collected by the ERB member of your department. To include your project in this bulk proposal, your project should meet certain conditions.

Conditions

To apply via the bulk proposal, your research project should have the following characteristics:

• Participants from the general population without complaints
• The burden on participants is minimal in terms of time, procedures, and content of the assessment. Responsibility to evaluate this lies with the PI, possibly in consultation with the Department’s Ethics Review Board committee member or the ERB Chair
• During the project you collect new data or use anonymous secondary data (e.g., World Values Survey)

See attached document for more information about bulk proposals.