It is essential that all research at KU Leuven and UZ Leuven takes place within a strict ethical and legal framework. National and international ethical guidelines and/or legal regulations exist with regard to all forms of research (biomedical, but also social scientific). This applies in particular to research involving the human person.
For this reason, all master's theses within the Biomedical Sciences group are subjected to an ethical review procedure.
If, depending on the answers to the questions in the decision tree (SCONE-tool), you're advised to submit the project to EC Research, this is the only possible route if you wish to carry out your project. If you perform a master's thesis in collaboration with an external organisation, you may submit your master's thesis directly to EC using the tool below, no submission to CTC is required. If your master's thesis falls under the Experiments Act, you should follow the 'experiment' procedure. In that case, you will need a validation from the CTC before you can submit to EC Research.
The protocol drawn up based on the OBC template is best used as the research protocol for submission to EC.
Please note that the master's thesis may only start following receipt of a final favourable opinion of the EC Research UZ/KU Leuven.
The submission for a master's thesis in collaboration with an external organisation to EC contains:
- cover letter of the investigator
- CV of the promotor (KU Leuven)
- application (protocol)
- internship contract concluded with the external organisation
- if applicable for study, GCP certificate promoter
- if applicable: ICF (preferably in separate document)
- if applicable: filled out agreement KU Leuven with external organisation https://www.kuleuven.be/studentenvoorzieningen/juridischedienst/studiestage/overeenkomst.html