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: 22 December 2022

I. Transition portal

1. When will the new cETO app go live?

The new cETO app will go live on 9th of January 2023. You can still submit your application(s) in the old portal till then. All new applications that have not yet been submitted (meaning that the workflow status is not set on SUPERVISOR APPROVED), need to be re-written in the new cETO app. Advice is to wait for the new cETO app to go live and then submit the research application.

2. What are the differences between the cETO portal and the new cETO app?
The new cETO app has some improvements compared to the ‘old’ cETO portal:;

• You can access the new app with your OU Microsoft account;
• Questions became more specific that should help researchers provide more specific information and speed up the assessment process;
• Pop-up windows with extra information are available throughout the application form;
• Researchers can submit their research application with one click (there is no two-step approval anymore). Except for PhD candidates and Master student, who still need approval of their supervisor.
• There are two additional sections about Data management, that will be checked by the Data steward;
• Amendment entails making changes in the original application.

3. How can I submit an application if I do not have an OU Microsoft account?

All OU employees have an OU Microsoft account. The licences for students will be arranged in January 2023. In case you do not have an OU Microsoft account, you can request a temporary guest-account. This link is now closed and will be active in January 2023.

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

Once the new cETO app is live, it is no longer possible to submit a new full or fast track application in the old portal. New applications can only be submitted in the new cETO app.
Submitting an amendment in the old portal will be possible till 6th of February. From then on, amendments can be submitted by e-mail via ceto@ou.nl. Explain in the e-mail what the changes entail and - if applicable- attach the necessary documents.

5. What will happen to my application in the 'old' cETO portal holding the status 'Reviewing'?

Application that are under review, will be assessed and finished in the old portal. The cETO keeps notice that all applications are finished before the ‘old’ portal goes offline.

6. What will happen to my finished research application(s) in the 'old' cETO portal?

You can access your finished applications in the old portal till March 2023. There will be a back-up of all applications, however this back-up is only accessible for the cETO. If you want to store your own application as back-up, it is advised to download the PdF version of the application and store it on your own OU-server. Deadline: 1st of March.
Note: PdF versions contain links to online attachments, however these attachments are no longer accessible once the old portal is offline. So, please make sure to download every attachment.

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

We highly recommend to check the renewed website of the cETO. Here you can find a checklist explaining what information need to be provided and what documents are required.

II. General

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.'

18. 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, such as 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. 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 the written consent(s) can be archived at Oasis.

III. Ethical procedure

19. 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.

20. 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.

21. 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.

22. 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.

23. 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.

IV. Participant information

V. Informed consent

24. 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, such as 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. 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. Research outside the Netherlands

25. 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.

Recruitment

26. 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.