If you're planning a project that does not fall under the categories of experiment, clinical trial, clinical research, performance study, or retrospective study, and does not involve the use of body material (primary or secondary), in principle, you do not require approval from EC Research. Examples of such projects include quality improvement initiatives, internal organizational research, non-healthcare-related studies, expert focus groups,...
In other words, the research has no objective of expanding knowledge of the healthcare professions. However, if desired, you still have the option to submit the project for EC Research approval using the provided tool. The following are mandatory for a valid application:
- Cover letter of the investigator
- Protocol (+ summary)
- Suitability/competence of the principal investigator/promoter by means of CV
If an ICF or questionnaires are used for the study, this should also be submitted.
Projects with foreign sites where UZ/KU Leuven serves as the principal investigator should also be submitted under this category. These studies fall under the scope of local legislation and must be submitted to us to avoid Ethics dumping.
Pay the study
Provide the following data to EC Research on submission of a commercial study:
- Invoicing address (preferably an address in Belgium)
- Name of contact
- PO number (Purchase Order), if applicable
- VAT number
You will receive an invoice from the Financial department of UZ Leuven (with payment reference).
Payment is only possible upon receipt of an invoice of the Financial department.