Set up a collection
A HBM collection involves taking HBM from a donor, collecting, processing and storing it. It may be either :
- Residual HBM: the remainder of a sample taken as part of care; requires opting out by the hospital
- Prospective HBM: taken specifically for research purposes; requires written consent from the donor.
3 possibilities
- COLLECTION WITHOUT STUDY
Set up a collection for future research not yet defined - COLLECTION WITH STUDY
Set up a collection for a specific research project - MCH COLLECTION WITH OR WITHOUT STUDY TO BE DELIVERED FRESH
- COLLECTION WITHOUT STUDY
A collection can constitute a pool of HBM from a donor population for future, as yet undefined, research: there is no associated study at the outset, but several studies may be linked to it in the future.
Ex: a plasma sample and a urine sample collected weekly between day 0 and day 100 after kidney transplantation
Ex: a plasma, RNA and tumor sample collected at diagnosis from each breast cancer patient
A collection may be used only for a specific research project (the entire sample will be used for this research): collection and study have the same purpose and title
Ex: a blood sample collected at diagnosis from every Crohn's patient for proteomic study of prognostic markers
Ex: a liver biopsy sample to study the expression of a new protein in patients with alcoholic cirrhosis
If there is a research project linked from the outset to a collection, even if (1) supplier and user of the HBM are part of the CHU (or even the same department) or if (2) the partner requesting the HBM finances its collection, this must be done through the BHUL. Simultaneously:
- Set up a new collection between the HBM supplier (CHU or other hospital) and BHUL (or another notified biobank)
- Set up a new study between the BHUL (or another notified biobank) and the research laboratory (CHU, ULiège, public, private)
A collection can also collect HBM both for a specific research project and for research not yet defined. The collection has a broader scope and the study a narrower one (hence different titles)
E.g.: plasma and DNA samples collected from all hospital staff to (1) assay for anti-SARS-Cov-2 antibodies (primary use) and (2) build up a pool of HBM for future research into COVID-19 or other diseases(secondary use)
3) COLLECTION WITH OR WITHOUT STUDY TO BE DELIVERED FRESH
If the HBM collected is to be delivered fresh directly to the laboratory which needs it for its research, without the HBM samples being physically sent to BHUL for processing and storage, these samples must nevertheless be labelled by the supplier and traced by BHUL, as rigorously as for any other collection or study, generally using a register (Excel file) kept up to date by the supplier's department and sent regularly to BHUL.
Procedure
Step 1
- Complete and send (stephanie.gofflot@chuliege.be)
- The request to set up a HBM collection (link to interactive PDF Collection request) by consulting appendices 1 (Conditions for setting up a new HBM collection) and 2 (information on how to complete the form).
- The collection protocol (link to template Collection protocol) including the data protection agreement if the hospital is different from the CHU de Liège.
- Depending on the type of HBM:
- Residual HBM: proof of an opting-out procedure at the hospital (not necessary for CHU)
- Prospective HBM: information and consent form (link to template Collection ICF) - The research project, if the collection is directly linked to such a project. Attach the approval of this project by a recognized scientific committee, if already available.
- The BHUL Office will examine the request on thebasis of the scientific value of the research, respect for ethics and the feasibility of the request in organizational and technical terms. 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 an opinion from Comité d'éthique hospitalo-facultaire de Liège
- Collection protocol (Collection protocol)
- Information and consent form (Collection ICF) or proof of an opting-out procedure at the hospital
- The research project, if the collection is directly linked to such a project.
- 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 collection"(Collection MTA), to be signed:
- In all cases: by the head of department and the President of the BHUL
- If hospital other than the CHU of Liège: also the CEOs of the hospital and the CHU - Document checklist (Collection document checklist)
- In the case of prospective HBM: the consent register (Collection ICF log form)
- Depending on whether or not the HBM will physically transit through BHUL:
- No transit through BHUL: Collection sample registry
- Transit through BHUL: Sample request form. Each sample taken must be accompanied by this form; if the sample is taken at one of the CHU de Liège sites, it can be replaced by an Omnipro prescription set up by the DMI support unit (helpdmi@chuliege.be).
