Skip to content

Filing your study with the Social and Societal Ethics Committee

SMEC evaluates research on human subjects that is not related to health science practices or includes medical or pharmacological procedures.

As of February 2020, the SMEC performs an integrated ethics and privacy (GDPR) check on all new applications through the PRET platform (external applicants 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. Also, there are ample examples of previous SMEC applications in this folder located on the lab's Teams channel to get you started.

Info

Please note that there exists a shortened procedure for master's thesis studies in our faculty through this form.

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:

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

  • 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

  • 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)

  • 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.

  • Specific guidelines on research involving minors can be found here.

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

Privacy review

Alongside the ethical review, the privacy impact of the study will be investigated. Here you can find clarifications of the privacy-related questions in the application form.

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.

A flowchart visualising the ethical review process (and its timing) can be consulted here.