Set up a study
Step 1
- Complete and send (stephanie.gofflot@chuliege.be)
- MCH study request (link to template Study request) by consulting appendices 1 (Conditions for the use of HBM aliquots) and 2 (information on how to complete the form).
- The research project (summary of a few pages maximum) specifying the objectives of the research, the nature and quantity of HBM aliquots required, the associated clinical data desired and the experiments planned.
- Attach approval of the project by a recognized scientific committee, if already available.
- The BHUL Office will examine the request on the basis of the scientific value of the research, the respect of ethics and the availability of HBM. The financial terms of the project will also have to be considered.
Step 2: 2 simultaneous steps
- Request the opinion of the Comité d'Ethique Hospitalo-Facultaire de Liège, with :
- The form for requesting the opinion of the Comité d'éthique hospitalo-facultaire de Liège (MCH résiduel)
- The research project.
NB: in some cases, especially if required by the funding organization, the research project will already have been approved by the CE. If the project was not explicit about the nature and quantity of the desired HBM aliquots or the associated clinical data, an amendment must be submitted to the EC.
- Prepare other documents with BHUL: BHUL (stephanie.gofflot@chuliege.be) will prepare these documents and send them to you for completion and approval:
- The " Material Transfer Agreement for a study"(Study MTA), which will be signed :
- In all cases: Head of Department and President of BHUL
- If institution other than CHU de Liège or ULiège: also the CEOs of the institution and CHU.
-Study document checklist.
-Study aliquot registry for tracking aliquots delivered to the lab.
- Aliquot requestform, enabling the lab to request aliquots as and when required. :
When the applicant wishes to make the HBM aliquots planned for the study available, he or she completes an Aliquot requestform and sends it to BHUL (stephanie.gofflot@chuliege.be). The HBM and the Study aliquot registry are then prepared. Transport of the HBM is the responsibility of the researcher; a "Fiche de transfert de MCH à l'utilisateur" (Aliquot transfer form) is enclosed with the shipment, must be completed by the carrier and the recipient of the shipment, and returned to BHUL.
The researcher must comply with the obligations described in the MTA and Appendix 1 of the Study request (Conditions for the use of HBM aliquots), in particular:
(1) restrictions on the use of HBM aliquots;
(2) transmission of discovered information with implications for the donor or his family;
(3) citation of BHUL in any publication;
(4) maintaining the aliquot register and providing the annual activity report.
