The cETO is a university-wide advisory committee, appointed by the Executive Board of the Open University of the Netherlands (OU). It operates under the deans of the Faculties.
On request, the cETO:
- Assesses whether or not studies involving human participants performed by researchers, (external) PhDs and students of the OU fall within the scope of WMO (Medical Research Involving Human Participants Act (Wet medisch-wetenschappelijk onderzoek met mensen, WMO).
- Assesses studies not covered by WMO rules performed by researchers, (external) PhDs and students for ethical acceptability.
Ethical assessment is obligatory for all studies involving human participants for employees of the Psychology and Educational Science Faculty (PenOW) (this does not apply for secondary data-analysis). This obligation comes into effect for all students performing a study in the faculty in November 2017. The cETO provides binding written advice.
- Study proposals must be submitted to the cETO before the study is carried out, i.e. before recruitment of the participants.
- The cETO is not an accredited MREC (METC in Dutch) and is not authorized to give approval for studies following WMO rules. If the cETO concludes that a study requires WMO compliance, then the study proposal should be submitted to a MREC for approval (if the researcher decides to continue the initiated procedure).
- Some funding bodies and institutions demand that the study should be submitted to a MREC for approval, even when the study would not otherwise require compliance with WMO-guidelines. In such cases, approval of the cETO could be insufficient. It is the responsibility of the researcher to find out what the appropriate procedure is.
- When publishing results of a study that does not require compliance with WMO guidelines, it is recommended to submit the study proposal to the cETO for ethical assessment (obligatory for PenOW). Many journals demand evidence indicating that the study was approved by a research ethics committee.
- Informing students (including (external) PhDs) is the responsibility of the supervisor (PhD supervisor in case of a PhD study; principal investigator in case of a non-PhD study).
- The research proposal must be submitted using the online application procedure. There are three different application procedures for cETO assessment: full track assessment, fast track assessment and amendment assessment (for more detail, see below).
- The Dean of the Faculty of the applicant has the final responsibility and receives the advice of the cETO for inspection. The Dean has the opportunity to object to the advice and/or the study proposal within two weeks.
- In the case of studies that require WMO compliance, the researcher is responsible for submitting the proposal for assessment by the MREC and for the (potential) additional costs without the involvement of the cETO.
- The researchers, including (external) PhDs and students, are required to act according to the law and regulations.
The application procedures are:
- Full track: full assessment of the ethical aspects of the study (advice on WMO obligation can be obtained)
- Fast track: brief assessment of ethical aspects of the study (focus on participant information, informed consent, Personal Data Protection Act) (only possible under certain conditions. See the fast track checklist)
- Amendment: in case of substantial changes to applications previously approved by the cETO (only possible under certain conditions. See the amendment checklist).
In case of internship or master’s thesis studies, students prepare the application, but only the OU researcher bearing primary responsibility (University lecturer (UD), associate professor (UHD) or professor) is authorized to submit a final study proposal (follow the instructions in the online form). Students can only submit a study proposal for full or fast track assessment, not as an amendment.
Assessment of studies using secondary data
The ethical assessment by the cETO basically concerns studies involving human participants in which data of participants (or through intermediates who provide data of the participants) still need to be collected. Studies concerning secondary data are therefore not assessed. When a study using secondary data re-uses personal records or data is combined in such a manner that data are re-traceable, than the cETO has to assess the study according to the Personal Data Protection Act.
Preparing the application
Before submitting an application, researchers need to have a cETO online account. All PenOW members already have an account (username = email address). If you do not have an account, then complete the account application form at https://ceto.ou.nl. You will receive an email with personal login details. Before you submit a study proposal, you need to prepare the application. There are several checklists for each application procedure (including references to important information and forms) that you can use.
Checklist Full Track
Checklist Fast Track
To submit a final study proposal, go to https://ceto.ou.nl.
Manual for routing in the online cETO system
See image: Flowchart of the online application procedure
- You must read the data storage procedure and conform to it (see attachment 16 'Important information'). For more information about collecting personal data, see the guidelines of the Personal Data Protection Act (see attachment 1 'Important information').
cETO Procedures, information and members