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Filing your study with the Ethical Committee UZ/KU Leuven

Step 1: Register your study at the UZ Leuven Clinical Trial Center (CTC)

  1. Fill in this online form in order to register your study in the UZ/KU Leuven central clinical research database. You can find a user guide on how to do this here. At the minimum, you will need to indicate the study type and upload your research protocol.

  2. After submission of the registration form to the CTC, your study will be assigned a study number (the famous S-number), which will be sent to the PI, the identified study contact person at UZ/KU Leuven and the applicant (you) via e-mail. You will need this number for your application to the EC.

  3. As soon as an S-number is assigned, supporting UZ Leuven departments (e.g., radiology) from which study-specific support will be required should be contacted, using the relevant forms. You can find more info on how to do this on this flowchart. In addition, the UZ Leuven GDPR questionnaire or KU Leuven PRET questionnaire should be completed. Both the form and the questionnaire are requirements for admissibility to submit your study to the EC.

  4. After the internal UZ Leuven stakeholders have reviewed all the documentation and no questions arise during the review process, you will obtain approval from the CTC via an automated validation email. Hooray, you are now ready to submit your study for EC review!

For more info about the CTC, navigate here. If you have questions, you can contact them via email or phone (+32 16 34 19 98).

Step 2: Apply for EC approval

Most likely, you are seeking to get ethical approval for a prospective monocentric (academic) study, for which you can find the application guidelines here. (If you are planning to conducting a different type of study, please start here and navigate to the correct study type to find the corresponding info on the application process.)

For a valid application, you are required to upload the following components:

Language of documentation

All the documentation needs to be written in Dutch, except for the research protocol and the translated versions of the ICFs.

  1. Accompanying letter signed by the PI

    • Ask for approval (specify the study type) and add a short description of the (goals of the) project
    • Specify where (national/international) and by whom the study will be conducted (your affiliation)
    • Describe the participant group, the recruitment and reimbursement procedure
    • Specify that the informed consent forms will be signed prior to participation
    • Describe the discomfort for the participant and the procedure in case of accidental findings
    • State (in name of the PI) that:
      • there are no scientific or ethical concerns noted and the study can be executed as described in the protocol
      • no research costs will be charged to the patient, the health insurance or the hospital
    • Refer to the attached documents

  2. Research protocol including a summary of the protocol in Dutch

    • Study title, location, rationale and design (incl. study background and objectives)
    • Description of the end points (= primary and secondary outcomes which the study aims to measure)
    • Research method (e.g., behavioral/psychophysical tests and/or neuroimaging)
    • Participant group(s) (incl. inclusion and exclusion criteria)
    • Statistical analysis (incl. software that will be used and sample size calculations)
    • Include an explanation for the sample size, referring to a power analysis
    • In general for typical fMRI studies, a reference to the paper of Friston (2012) is sufficient
    • Any no-fault insurance
    • Quality assurance
    • Direct access to source data
    • Ethical (and any regulatory) approval
    • Method of data processing
    • Publication policy
    • References

  3. Participant recruitment

    • Describe the procedure that will be used to contact and recruit the study population described in the protocol: where, how, by whom.
    • Make sure to include a justification for the potential recruitment of participants who are unable to give their consent. This info should be provided in a separate document.
    • If recruitment materials (posters, brochures, advertisements, website, etc.) are used, they also have to be submitted under this section. You can read the guidelines on advertising/recruting here.

  4. Informed consent forms (ICFs) (in English and in Dutch)

    • The EC provides some ICF templates which already include information regarding the legal basis for data processing chosen by UZ/KU Leuven (i.e., "public interest", cf. Article 6 of the GDPR), include the necessary contact details of the insurance company, etc. You can find them here (navigate to "niet-EudraCT studies").

    • The ICF should be written in clear and understandable language and consist of the following subsections (in a single document):

      1. Essential information to make the decision to participate, such as a clear description of the study project (context, objectives, methodology and procedure), a brief but clear explanation of the participant's rights (voluntary participation, confidentiality, safety precautions, insurance, etc.) and a description of the risks and benefits. Make sure to also include contact details of the PI such that the candidate has a contact point for further questions.
      2. The consent form
      3. Additional information (appendices) that does not immediately play a role in the decision-making process, such as more detailed information on the study visits (i.e., the number, frequency and content) or on the participant's rights.

    • Each page in the ICF should be numbered ("page X") and mention the full study title and version number and date of the ICF.

    • If the application is covering both behavioral as well as neuroimaging experiments, provide two separate ICFs.

  5. Resume of the Principal Investigator (dated and signed)

    • The CV should include sufficient information to allow the EC to assess the competence of the PI (i.e., education, current position, professional experience, relevant experience in clinical studies, etc.). This template can be used.
    • The CV should also mention a Good Clinical Practice (GCP) certificate, including the date of certification (no more than 3 years old) and the organization that issued the certificate. GCP training is mandatory for all PIs.

  6. A pdf-version of the completed UZ Leuven GDPR questionnaire or the accepted KU Leuven PRET questionnaire

  7. Proof of "no fault" insurance, which you can request by sending an email to liability@kuleuven.be

  8. Suitability/agreement of the relevant supporting UZ Leuven departments

Once you have written all the necessary documents, you can file your application here by uploading all necessary information. Please not that only 1 (zip)file per component is allowed.

TODO: Check whether this still applies → "If the medical ethical committee has an issue with the principal investigator not being connected with UZ Leuven (e.g. in case the PI is a professor at the Faculty of Psychology and Educational Sciences); report this to Prof. Dr. Pol Ghesquière."