If you have any further questions, please read our Frequently Asked Questions below. If that did not answer your question you can reach out to ceto@ou.nl.

Last update: 24 July 2023

I. General

1. What is a research line?

A line of research consists of several studies in which the same type of questions are assessed. For example, it concerns the same type of experiment but among different population (e.g., general adult population with and without particular health problems). It can also concern a series of studies in a larger project (e.g., a PhD project). Also in the context of a Bachelor or Master's thesis, if you plan to perform several comparable studies, you can submit a line of research.

2. Where is my approved research application(s) in the 'old' cETO portal?

Your application is no longer available online. There is a back-up of all applications, which is accessible by the cETO.

3. Where can I find more information on how to prepare my research application?

We highly recommend to use the checklist 'ethical assessment' containing an overview of the content of the online cETO app. On the page ‘Forms and guidelines’ there are also more documents and templates you can use for your research.

II. GDPR

4. What is personal data?

The term 'personal data' is defined in Art. 4 (1) GDPR: 'Personal data are any information which are related to an identified or identifiable natural person [...]'
- Obvious: name, email-address, phone number, video files
- Less obvious: IP-address, education, work employment
- Even less obvious: collection of data in relation to a small sample size, e.g., a boy 12 years old of English origin studying at the primary school XXX in Maastricht.

Collect as little as possible!
In practice, personal data is involved quite quickly, and you need a legal ground to collect them. In the field of research, that legal ground is an active consent.

5. What is special personal data?

Special personal data (Art. 9 GDPR): racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, and genetic data, biometric data, data concerning health or data concerning a natural person’s sex life or sexual orientation.

It is forbidden to collect special personal data unless there is a clear motivation, and you have an explicit active consent of the participant to collect those data.

6. Does the GDPR apply throughout Europe?

Please note that the GDPR is only applies to countries part of the Economic European Area (EEA). An external party located in a country which is not part of the EEA is considered as higher risk.

7. When am I controller of personal data?

The term 'controller' is defined in Art 4(7) GDPR: the natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data. These purposes and means could be e.g. choosing the research topic, the personal data to be collected, the data storage location or the resources employed.

8. When am I processor of personal data?

The term 'processing' is defined in Art. 4(2) GDPR: any operation or set of operations which is performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction.

III. Ethical procedure

9. How do I have access to the cETO app?

You can access the cETO app with your OU Microsoft account. You can find the cETO app here or as tile on MijnOU. Important to know is that all research applications written by students and PhD candidates must be approved by the supervisor.

10. How long does an ethical assessment take?

When a research application is under review (status 'reviewing'), the ethical assessment is about two weeks for fast track applications and amendments, or about four weeks for full track applications. Then you receive either a revision request or a final decision. In case of a revision request, the assessment period will take longer, so it is recommended to plan some extra time in advance.

11. What is the difference between a full track and a fast track procedure?

The fast track procedure is used for research applications [1] of which the research design was already assessed by a funding grant, such as NWO, KWF kankerbestrijding, ZonMW or a comparable research foundation; [2] Master thesis research (except with children under 12 years old) that has been approved by the supervisor (you need to upload the approval document); [3] pilot studies. In any other case you should apply for the full track procedure.

Full track applications are assessed on research design, methods, research execution and GDPR aspects, while the assessment of fast track applications is focused on research execution and GDPR aspects, and not on research design and methods.

12. I have an ethical approval. How long is it valid?

The ethical approval of a research application is valid as long as the research is still running. Please keep in mind that this applies to the research as it was submitted for ethical assessment. For research lines, the approval is valid for five years. If the research period needs to be extended, you can request an extension from the cETO by email. The cETO will check if the research application is still in accordance with the latest rules and regulations. If the extension also entails significant changes, you need to submit an amendment.

13. I have an ethical approval, but I want to change something. Do I need to submit an amendment?

If you make a substantial change to your research application, you need to submit an amendment. Such changes could be related to the target group, research design, procedure or intervention, expected burden for participants and/or research aspects that may have consequences for the safety of the participants. If you are unsure, please contact the cETO for advice: ceto@ou.nl.

14. Is it still possible to submit an amendment in the 'old' cETO portal?

If you want to submit an amendment of an application reviewed in the old portal, can use the 'template amendment'. Filled in templates can be sent to ceto@ou.nl.

15. I am conducting research with children under the age of 12 years. Can I submit my application as a research line?

Children under 12 years old are a sensitive target group and need extra protection. You can submit your research application as a research line under the following conditions:

The study has no troublesome-sensitive procedures, interventions or questionnaires that may lead to (unusual) risks for the participants. Further, you need to provide a clear motivation of the risk assessment. The motivation will be assessed during the ethical assessment.

16. I am a teacher. Can I submit an application (by myself)?

In case you are a teacher at the OU, or you have another non-research-related position within the OU, please contact the cETO for consultation.

17. I am doing a research internship and I will finish my research plan during the internship. When can I submit an application for ethical assessment?

It is not possible to request an ethical assessment if the research plan is not finished, because documents like the information letter, informed consent forms and questionnaires are part of the ethical assessment. Once the research plan is finished and you have prepared the required documents, you can submit an application for ethical assessment.

IV. Participant information

18. Why do I need to inform my participants?

Participation in research requires informed consent. The written information is part of this process. Oral information, exchange of views and asking questions can also be part of this. Participants, or their legal representatives, must be given ample opportunity to understand the nature and anticipated consequences of research participation. They need to be informed in written about the purpose, procedures and means of the study before they provide their written consent. The information must be unambiguous, upright and sufficient to ensure participants can make a proper informed decision about their participation (or not) in the study.

19. What information is required in the information letter?

Please check the document 'Aim and requirements of the participant Information Letter (PIF)' for an overview of the required information. You can also use the available templates.

20. How should I inform participants, if I collect personal information?

If you collect personal data, the GDPR states that participants must also be fully informed about what personal data will be collected, how the data will be stored and what the rights of the participants are.

V. Informed consent

21. Who needs to sign the informed consent?

Who needs to sign the informed consent depends on the age of the participants and whether they are mentally competent.

• Participants who are 16 years and older that are mentally competent must personally sign consent. It may be good practice to inform the parents or guardians of participants that are 16 and 17 years of age. For some type of research, it is even needed to ask the consent of the parent or guardians.
• For adults that are mentally incompetent, consent must be granted by the legal representative or, if unavailable, by the person that has a written mandate from the person concerned, or if unavailable, by the spouse or other life partner of the person concerned.
• In case of minors between the age of 12 and 15 years, consent must be personally granted by those involved and their parent(s) or guardians
• In case of minors younger than 12 years, and minors as of the age of 12 that are (temporarily) mentally incompetent, consent must be granted solely by the parent(s) that exercise authority or the guardian.

22. Can I use a passive consent?

By default consent is active. Passive consent ('opt-out') can be considered under special circumstances, but only if (a) active consent leads to substantial and demonstrable disadvantages with respect to the quality or aim of the research, and/or the interests of the participants (b) there is minimal burden and no risk for participants, (c) special care is taken to inform participants and/or their representatives of the study and the possibility to opt out, (d) the opt-out procedure is straightforward. Any opt-out procedure is to be reviewed by the Ethics Review Board. Important: passive consent is not possible if you collect personal data.

23. When do I need a written consent of an external organization?

For certain studies you need external organizations to recruit your participants. In some of these situations you also need a written consent of the organization:

• Written consent of the organization is needed when: recruiting a specific target group within the external organisation with a hierarchical structure or dependent condition. For example, children at a school, patients in a nursing home or managers and their employees of a specific company. You can find a template for this consent at the Forms and guidelines.
• Consent of the organisation via the participants is needed when: recruiting only a few participants of one or more organizations, or participants who are part of an association. You can ask consent from the organization via the participant, by adding an extra bullet to the informed consent of the participants, for instance 'I declare that my management/board consents with my participation'.
• No consent is needed when: recruiting participants through the contact lists of a network (without a hierarchical structure), such as a patient organisation, sport club members or members of a church community. Distributing your recruitment message already counts as a permission. You do not need a (written) consent of the network.

It is important for you to collect the consent(s) of the organization, because it is a valuable document to show that the organization agreed to carry out the research in case you need this afterwards (for instance, if there are complaints or research visitations). Note: if you collect the consent(s) online, please make sure to use SURFfilesender to safeguard the personal data written on the consent(s). The consent(s) need to be stored in a safe manner on Research drive, T-drive or in a closed closet or room during the research. When the research is finished, you can store the online consent(s) on T-drive and/or the written consent(s) can be archived at Oasis.

VI Recruitment

24. Can I use incentives during the recruitment process?

It is not obligatory to offer a compensation for participation, but it could motivate potential participants to take part in the research. Please make sure that the value of the incentive is in proportion with the research burden, i.e., the incentive should be an extra motivation but should not be the main motivation to participate. And there is no conflict of interest.
Examples:

• Children filling in a survey for 20 minutes, receive an apple.
• Lottery of a gift card of 50 euro is offered to children of second grade for filling in a survey of 30 minutes
• Reimbursement of (travel) expenses
• Students receive course credits for joining research.

Advice to contact an OU accountant for more information about financial reward, because offering financial rewards could require the registration of personal data of the participants.

25. How much consideration time should I offer participants?

Provide sufficient time for participants to consider participation, which is dependent on the nature of the research. General rule: higher impact or burden, means more time.

VII. Research outside the Netherlands

26. Do I need a liability insurance for research outside the Netherlands

The OU has a liability insurance for research outside of the Netherlands. This insurance does not always apply to research in Belgium. In some cases, a No-Fault insurance is required. For more information, please, check the cETO flowchart on the cETO website.