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Filing your study with the Social and Societal Ethics Committee

Which approval do you need?

This page covers the SMEC pathway for behavioral research not involving medical procedures. For fMRI studies, patient studies, or TMS/tDCS research, see EC onderzoek instead. Check the ethics overview for more information.

SMEC evaluates research on human subjects that is not related to health science practices or includes medical or pharmacological procedures. You can find all documents and guidance for your application here.

The SMEC performs an integrated ethics and privacy (GDPR) check on all new applications through the PRET platform (external applicants who do not have access to the platform can download the application form here). For assistance, please make use of the manual on how to use this platform and the SMEC-review checklist for an overview of the aspects that will be assessed during the ethical review.

Previous applications

There are ample examples of previous SMEC applications in this folder located on the lab's Teams channel to get you started (access required). A good reference is for example the Methusalem application (G-2024-8685).

A flowchart visualising the review process at SMEC, along with a general time-frame for each step, can be consulted here.

Privacy review

Your application will be first evaluated on its privacy impact (all aspects related to the GDPR and the processing of personal data). Here you can find clarifications of the privacy-related questions in the PRET application form.

GDPR and privacy in research

The e-learning "GDPR and privacy in research" provides specific examples of the application of the main privacy protection rules in the research context. You can follow it here. As of 2025, it is mandatory to follow for researchers processing personal data in the context of their PhD.

Ethical review

The SMEC puts a lot of emphasis on a well thought out recruitment and informed consent procedure, for which you can consult their guidelines here. In short:

Information provided to participants

Researchers should use an information letter, an informed consent form (ICF; Dutch example template, English example template) and a GDPR appendix (template) to provide potential participants with the necessary information about the study.

Information required in the ICF and information letter

Necessary information in the ICF as well as the information letter includes the following:

  • An invitation to participate in the study
  • Information about the study and the researchers
  • The potential risks and benefits of the study
  • The voluntariness of participation and the possibility of withdrawal at any time without disadvantage
  • Conflicts of interest and plans to commercialize research findings
  • Measures to ensure confidentiality
  • Information on compensation and incentives, as well as plan of action in case of disadvantage
  • If applicable, clarification that the study is not set within the hospital context
  • Contact details of the researchers
  • Ethics committee contact information

Do not forget to include version numbers and dates on all documents, preferably in a footer or header, and update them when making amendments.

Brief consent forms

In some cases, it may be justifiable to use a brief consent form (e.g., a short online questionnaire that is likely to be completed on a small screen). A full consent form might be intimidating in this case or considered a barrier that might limit response rates. A concise consent form should include at least the following elements:

  • Short description of the study and the researchers
  • The voluntariness of participation and the possibility of withdrawal at any time without disadvantage
  • Confidentiality of participants and their data
  • The potential risks of participating in the study
  • Reference and easily accessible link to the information letter with the full info about the study (as listed above)
Recruitment materials

To fully assess the recruitment process, the recruitment materials that will be used (e.g., flyer, poster, call on social media, etc.) should be included in the ethics application. Specific guidelines on recruiting participants through social media can be found here.

Research involving minors

Specific guidelines on research involving minors can be found here.

For any further questions, you can check out the FAQ section of the SMEC.

New SMEC/PRET templates

New method-specific PRET templates are being introduced at KU Leuven (more info here). These templates work more with multiple-choice answers and contain pre-approved standard answers to open questions for common research methods, reducing the amount of information researchers need to enter, and - in the future - enabling a faster review process. You can still deviate from the standard answers, but deviations should be justified.

For multi-method studies, multiple methods can be selected so that the relevant standard answers are loaded automatically. The existing generic PRET template remains available for methods for which no specific template exists.

Outcomes of the reviewing process

After the review, you will be informed of the outcome via an automated email from the PRET platform, with three possible results:

  1. Accepted: The ethical approval will remain valid for up to 4 years from its effective date of issue.
  2. Minor revisions: Small adjustments are required, after which approval can be granted immediately.
  3. Major revisions: Resubmission is required (within 6 months), after which the dossier will be re-reviewed by the SMEC panel.

Filing an amendment

Amendments of approved protocols should be resubmitted for additional review. Amendments can only be submitted for small modifications or extensions, and only for dossiers of which the initial approval is no older than 4 years. To do so:

  1. Access the PRET platform.
  2. Open a previously approved application dossier and make a copy to begin your amendment.
  3. Make any necessary changes to the dossier, giving a clear explanation of changes on the communication page prior to submission.
  4. To amend documents, use track changes and re-upload documents to the dossier.
  5. Save and submit the new dossier.