Conducting research may pose risks to the people involved. People who are involved in - for instance - interviews, surveys, collection of log data or interventions are defined as human participants. The cETO assesses scientific research involving human participants, with the aim to protect and safeguard the rights and interest of these participants. Research involving human participants, that is initiated for educational purposes and could lead to a publication, can also be submitted for ethical assessment. This also applies for all master thesis research. No ethical assessment is required for research that is performed to evaluate and improve education, because there are no scientific and/or publication purposes. Whether or not ethical assessment is obligatory or recommended, the General Data Protection Regulations (GDPR) and the Code of ethics for the research in social and behavioural sciences involving human participants applies to all types of research.

When can you apply for ethical assessment?

For each research there are individual circumstances whether ethical assessment is obligatory or recommended:

• Researchers can request a WMO check (go to WMO-obligation) if they are unsure whether the research is in the scope of WMO.
• Ethical assessment is obligatory for all research performed at the Faculty of Psychology and the Faculty of Educational Sciences, involving human participants, including master thesis research and research initiated for educational purposes possibly leading to scientific publication.
• For all other faculties, it is recommended to apply for ethical assessment if the scientific research involves human participants.
• If a journal or publisher requires an ethical approval of the research to be published.

Please note, the cETO does not assess research application in the following circumstances:

• Research that is performed to evaluate and improve the quality of the education at the Open Universiteit.
• Research that is in the scope of WMO obligation (see WMO-obligation).
• Research containing strictly anonymous secondary data (in case data is not strictly anonymous, you can find more information here).
• Research which is ethically approved by another ethics committee
• Research in which the recruitment procedure and/or the data collection already has started. In this case, please, contact us as soon as possible.

In case of questions or uncertainties, you can reach out us via ceto@ou.nl.

How to prepare a cETO application for ethical assessment?

A good preparation of your research application will prevent delays and will help you during the review procedure.
New checklist for cETO applications

Here are some other useful tips:

• Be informed about ethical and legal rules;
• Check for relevant documents in our section Forms and guidelines;
• Use templates if available (in section Forms and guidelines);
• Prepare your time schedule properly and plan some extra time for revisions;
• If you have questions, please check our section FAQ.;
• In case there are still questions, please contact us via ceto@ou.nl.

How is the ethical review procedure organised?

There are three different types of ethical assessment:

Full track
A full track procedure includes an assessment of ethical aspects based on the ethical guidelines as well as the requirements established by the General Data Protection Regulation (GDPR) for the processing of personal data. You can also apply a full track application when you need advice on WMO obligation. The assessment procedure also contains a section data management, which will be assessed by the data steward.

The full track procedure is applicable under the following conditions:
[1] individual research (unless the research complies with one of the conditions of the fast track);
[2] a research line;
[3] research involving children aged < 12 years or participants who are mentally incapable. This research should be submitted as individual research. Applying a research line is only possible in case of no or low risk, supported by a clear motivation of the risk assessment. The motivation will be assessed during the ethical assessment;
[4] research that includes sensitive procedures, data, interventions or questionnaires that may lead to risk situations, harm or damage for the participants;
[5] a PhD thesis (unless the research complies with one of the conditions of the fast track);
[6] if it is unsure whether your research falls within the scope of WMO.

You will receive a response within four weeks.

Fast track
A fast track is a shorter and faster assessment of the research application on ethical aspects and GDPR requirements. The assessment focusses primarily on the execution of the research, which entails the recruitment procedure, selection of participants and data collection. There will be no assessment of research questions and research methods. The fast track also contains a data management checklist by the data steward.

This procedure is only possible under certain conditions:
[1] research granted by NWO, KWF kankerbestrijding, ZonMW or a comparable research foundation. It is obligatory to upload the grant letter in the research application;
[2] master thesis research/educational purposes only (e.g., master thesis’ graduation). Master students need approval of their research application from their supervisor and upload the approval document in the research application;
[3] a pilot study: a pre-study with the aim to get insight in type of answers to expect in the main research. It is also a possible way to test the soundness of a questionnaire and/or other research methods.

You will receive a response within two weeks.

Amendment
Researchers can apply for amendment in case substantial changes are needed to applications previously approved by the cETO. Substantial changes could be a change in a 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 whether a change is substantial, you can contact the cETO for advice.

You will receive a response within two weeks.

Response by cETO
When the assessment period is finished (two or four weeks depending on the type of ethical assessment), the researcher will receive a response by the cETO, which is either a revision or a final decision:

[1] a revision. The researcher will be asked to respond and/or adjust the research application. The submitted response will be reviewed within two weeks.

[2] a final decision. The researcher will receive a written and binding decision of the ethical assessment by email. The decision is also sent to the Dean of the faculty (and to the supervisor, if applicable).

How to submit your research proposal?

All research application can be submitted using the cETO app, available here or as tile on MijnOU. With your OU Microsoft account you have access to the cETO app. Important to know is that all research applications written by students and PhD candidates must be approved by the supervisor. In case you are a teacher at the OU, or you have another non-research-related position within the OU, and you want to do research, please contact the cETO first for consultation.

Note: researchers who want to submit an amendment of an application reviewed in the old online portal, can use the ‘template amendment’. Filled in templates can be sent to cETO.

Questions?

If you have any questions, please check the page FAQ or contact the cETO.