Secondary use
A study involving secondary use of human body material is a scientific study using residual body material (residue from standard care that would otherwise be discarded) or body material that is already available (e.g. from other studies).
Compile the file
Mandatory
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
Optional
If relevant for your study, the following components are also submitted:
- GDPR questionnaire
- 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
If your study has been validated by CTC and/or Biobank, you can submit it to EC Research via the link below.
When you start your application, you need to complete the whole process.
Do you have all the components?
Supplement/modify the study
Artificialized or extracted human body material
For more information and context, please read this internal guideline. It was prepared by the EC, CTC, and Biobank, and was coordinated with the LRD.
Artificialised body material is body material created or cultured outside the human body. Extracted body material is material extracted from human body material, but which no longer contains cells: e.g. proteins, organelles,...
For artificialised and extracted material, when they are not used for genetic research it suffices to submit the research project to EC Research. The researcher is responsible for complying with all conditions (i.a. not being used for genetic research…) and confirms this in the registration form. If EC Research does not express any concern within 28 (calendar) days after receipt of the research project, 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.
If artificialised or extracted material is used in the project for genetic research, the category "Human body material (HBM) – Artificialised/Extracted without application in man" must also be selected in the registration form. In this case, registration with the biobank is still required.
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 register using the form below.