Compile the file
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
- GDPR questionnaire
If relevant for your study, the following components are also submitted:
- Method of recruitment - Recruitment material
- Information and consent form, patient documents
- Suitability of the facilities/agreement involved supporting services
- Contracts/ financial agreements.
E.g. Clinical Trial Agreement, Material/Data Transfer agreement, Confidentiality agreement, contract access KWS, etc.
Prepare the file
Only one file per component can be uploaded.
Do you have several files per component? Group them in a compressed folder (zip-file).
Submit the study
When you start your application, you need to complete the whole process.
Do you have all the components?
Artificialized or extracted human body material
For artificialised and extracted material, when they are not used for genetic research it suffices to submit the research project and its purpose to EC Research. The researcher is responsible for complying with all conditions (i.a. not being used for genetic research…) and confirms this in a (short) declaration we provide (cf. highlighted below). If EC Research does not express any concern within 28 (calendar) days after receipt of the research project and the completed declaration, the research project can start and registration in a biobank is not needed anymore. It also implies that artificialised and extracted material, when they are not used for genetic research, can be imported and exported without the need to involve a biobank, can be used without consent of the donor, are not subject to traceability requirements (towards the donor) and are exempt from obligations to report incidental findings.
Declaration for research with artificialised and extracted material when they are not used for genetic research
Protocol for transfer artificialized or extracted human body material
EC, in collaboration with Leuven Research & Development (LRD) and the Biobank, has developed a new protocol template. This protocol is specifically designed for the transfer of artificialized and extracted material from a researcher at KU Leuven to a third party.
This protocol requires close collaboration between both parties: the 'provider-scientist' (the researcher from KU Leuven) and the 'recipient-scientist' (the receiving researcher). Certain essential data must be provided by the 'provider-scientist', while other information needs to be submitted and supplemented by the 'recipient-scientist'.
Please submit the protocol via email@example.com. The EC will then assign a unique S-number to the project.