The CFMPB follows a standard procedure for all requests of human biospecimens for translational research and uses an in house developed web application and database system “ Application and Request Tool” (ART) for study registration, Institutional Review Board (IRB) review, lab logistics, track and trace of biospecimens and cost recovery.
In 2011 a new version of the Code of Conduct for dealing responsibly with human material in the context of health research was drawn up by the Federation of Dutch Medical Scientific Societies (FEDERA). The document prescribes precision review processes for studies that involve human material and derived data. The NKI-AVL, adheres to this Code of Conduct (Human Tissue and Medical Research: Code of conduct for responsible use). ‘The use of archival material and data for research purposes at the Netherlands Cancer Institute have been executed pursuant to Dutch legislation and international standards. Prior to 25 May 2018, national legislation on data protection applied, as well as the International Guideline on Good Clinical Practice. From 25 May 2019 we also adhere to the GDPR. Within this framework, patients are informed and have always had the opportunity to object or actively consent to the (continued) use of their personal data & biospecimens in research. Hence, the procedures comply both with (inter-) national legislative and ethical standards.’
It is obligatory that each research study involving human (material) and/or derived data according to the ‘ Law on Medical Research Involving Human Subjects (WMO) will be reviewed regarding medical and ethical aspects by an accredited medical ethical committee (MEC) (CCMO). Research that does not meet the WMO criteria (e.g. secondary use, biobank studies) does not have to be reviewed by an accredited METC however is eligible for review by the InstitutionalReview Board (IRB). The IRB approval procedure for ‘secondary use’ of human material, data or biobank initiation is approved by the NKI-AVL Board of Directors.
Following IRB approval the CFMPB coordinator will make a plan of action with the applicant and all relevant contributors (co-workers, PI, involved pathologist, technicians, etc.) for estimation of the costs, logistics, duration, lab assistance, etc..
For the performing of a translational study with human material an applicant can:
I. Request materials using the online material request forms in ART from:
- Pathology: HE/IHC slides, FFPE tissue, frozen tissue & fresh tissue.
- Clinical chemistry: serum, blood, ctDNA, etc.
- CFMPB/Molecular diagnostics: DNA, RNA.
II. Place work order requests in ART for:
- Immunohistochemistry (list of 340 available antibody staining can be found in ART, new antibody staining protocols can be requested;
-BenchMark Ultra (Ventana, Roche) , Discovery Ultra (Ventana, Roche)
-Brightfield & IF
- Tissue microarray (TMA) construction (GrandMaster, Sysmex)
- Digital Pathology, image analysis
-Scanning, Slidescore, Vectra, image analysis (HALO)
- DNA/RNA isolation (FF, FFPE, Blood etc) plus QC
- Molecular analysis: Sequenom, PCR, (digital)MLPA, Archer, HPV, NGS, Nanostring etc.
Each new request will be screened using the ART search tool (mini Datawarehouse, web serves built on the existing hospital database systems) for consent, previous use of the materials and to prevent unnecessary duplication.
The staff members of the CFMPB can advise you with their specific expertise about proper biomarkers, techniques to be used and selection of patient groups.