Voluntary submission to EC

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. Please ensure to include a cover letter, CV and a protocol for this purpose.

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.

Last edit: 18 April 2024