Filing your study with the Ethical Committee UZ/KU Leuven

Which approval do you need?

This page covers the EC onderzoek (Medical Ethics Committee) pathway, required for fMRI studies, patient studies, UZ Leuven studies, and TMS/tDCS research. For behavioral studies not involving medical procedures, see SMEC instead. Check the ethics overview for more information.

The EC Research UZ/KU Leuven evaluates research that falls within the scope of the Belgian law of 7 May 2004 on Experiments on Human Beings (the ‘Human Experiments Act’).

Step 1: Register your study at the CTC

1. Submit your study details

Fill in this online form in order to register your study in the central clinical research database of the Clinical Trial Center (CTC) of UZ Leuven. You can find a user guide on how to do this here.

At the minimum, you will need to:

• indicate the study type
• fill in the names/roles of all involved researchers
• upload your protocol

It is easiest to fill in your own name as the applicant/contact person to ensure you receive most administrative correspondence sent out by the CTC. Make sure the PI and the study assistants (e.g., Klara or Silke) are also correctly listed, as key CTC communications are distributed across these roles as well. It might happen that some emails are sent directly to the PI and/or study assistants (without CCing the applicant), so keep good communication with them throughout the process.

Policy of UZ Leuven: WUG and VMS requirements

The principal investigator (PI) for studies involving medical imaging has to have a WUG recognition, meaning that the researcher is legally recognised to practise a healthcare profession under the Belgian law (e.g., doctor, nurse, clinical (educational) psychologist, speech therapist).

In addition, for studies that take place at UZ Leuven, the UZ Leuven policy requires a member of the permanent medical staff of UZ Leuven (VMS) as co-investigator if the PI is not part of the VMS. This also applies to studies involving healthy volunteers.

Our current (and approved) approach for studies involving medical imaging at UZ Leuven is to involve Stefan Sunaert as the VMS co-investigator, given his VMS status and main responsible for the research infrastructure.

2. Obtain your S-number

After submission of the registration form to the CTC, you should receive:

1. a confirmation e-mail with an overview of your responses
2. an e-mail that your submission (not your application) is accepted ("CTC submission accepted")
3. another e-mail ("CTC S-number appointed") in which you are assigned a study number (the famous S-number)

You will need this number for your application to the EC.

3. Contact supporting UZ Leuven departments

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.

You will receive:

• a confirmation e-mail with an overview of your responses
• another e-mail when your request was approved (by CTC and by Trialbureau Radiologie)

The latter might end up in the mailbox of your PI or study assistant(s).

In addition, the UZ Leuven GDPR questionnaire or KU Leuven PRET questionnaire should be completed.

Important

Both the form for supporting departments and the GDPR questionnaire are requirements for admissibility to submit your study to the EC.

4. Obtain CTC approval

In case the CTC needs extra (safety, financial or legal) information about your study, the study assistants will be contacted.

After the internal UZ Leuven stakeholders have reviewed all the documentation and no further questions arise, you will obtain approval from the CTC via an automated validation email to your PI ("CTC study validated").

🎉 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 CTC 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.

Different study type?

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.

Language of documentation

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

Have a look at previous lab applications

Have a look at the most recently filed applications from the lab as a guidance for your new application. You can find all past applications here (Teams access needed).

A good reference is for example the Methusalem application (S70813).

Required documents

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

Accompanying letter signed by the PI

You can find more specific guidelines here.

Research protocol, including a summary of the protocol in Dutch

You can find more specific guidelines here.

They generally recommend to follow the CTC template, which already includes the correct info on e.g., safety procedures.

Participant recruitment

Please consult these guidelines.

Note that all recruitment materials (posters, brochures, flyers, etc.) have to be submitted under this section; and that there are specific guidelines regarding advertising your study, especially via social media.

Informed consent forms (ICFs), in English and in Dutch

The EC prefers the use of 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), the correct wordings, etc. You can find them here.

Here you can also find specific guidelines for drawing up your ICF.

Generally, it consists of three parts:

• essential information to make the decision to participate
• the consent form
• any additional information (appendices)

Resume of the Principal Investigator (dated and signed)

You can find more specific guidelines here.

Note that the PI (and preferably every researcher to be involved in data collection) should also have a valid Good Clinical Practice (GCP) certificate.

The training can be followed online via Transcelerate.

GDPR / PRET questionnaire

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

Read the guidelines here.

Proof of no-fault insurance

Proof of "no fault" insurance, which you can find here if UZ/KU Leuven is the sponsor of the study.

Suitability/agreement of the relevant supporting UZ Leuven departments

See this page.

Submit the application

Once you have written all the necessary documents, you can file your application here by uploading all necessary information.

Warning

Please note that only 1 (zip)file per component is allowed.

Filing an amendment

An amendment can only be approved if the EC has provided a prior opinion on the initial protocol. For UZ/KU Leuven there are three types of amendments:

Substantial amendments

Requirements for submission (for detailed information, see this page):

• Cover letter of the PI
• Amended documents with changes marked using track changes and updated version numbers and dates
• If changes to the ICF are needed, an ICF addendum for ongoing participants is recommended (the addendum includes only the changes or new information, making it clearer for participants than a revised ICF with marked changes)
• Contact details of the contact person within UZ Leuven/KU Leuven (other than the investigator) who will follow up the file

Amendments for participation of additional centres in a previously approved study

Requirements for submission (for detailed information, see this page):

• Cover letter of the PI
• Written confirmation from the sponsor that the file was simultaneously submitted at all new centres
• Contact details of the added local ethics committees
• Name of the local principal investigator(s) for whom the local ethics committee issues an opinion
• Contracts of all added centres, with specification of the compensations (if the contracts are identical for all centres, one model contract is sufficient, together with a written declaration from the sponsor that all contracts are identical)
• Concise CV(s) of the investigator(s) of the added centres
• Contact details of the contact person within UZ Leuven/KU Leuven (other than the investigator) who will follow up the file

Notifications

Amendments that do not involve substantial changes in content must be submitted as a notification. Requirements for submission (for detailed information, see this page):

• Any amendments to the documents must be made using track changes
• Amended documents must have a new version number and new version date
• Contact details of the contact person within UZ Leuven/KU Leuven (other than the investigator) who will follow up the file

Detailed information on which option to choose can be found here.

How to submit an amendment

In all cases, the submission is made electronically via Liquidfiles or by email (ecstaf@uzleuven.be).