Secondary use of human biological materials for scientific research

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1 This presentation is the intellectual property of the author/presenter. Contact for permission to reprint and/or distribute. Secondary use of human biological materials for scientific research Marjanka K Schmidt In absence presentation was given by Susanne Rebers 29 juni 2012 Overgebleven Lichaamsmateriaal -afgenomen in het kader van diagnostiek of behandeling- Voorbeelden - Bloed/serum, bv over na screening voor prostaatkanker (PSA) - Weefsel, bv borstweefsel na een operatie (FFPE of vries)

2 Waarom wordt weefsel opgeslagen na een operatie? 1) Diagnostiek i.v.m. behandeling (direct na operatie) 2) Bewaren voor eventuele aanvullende diagnostiek (bv bij terugkeer van de ziekte) 3) Wetenschappelijk onderzoek 4) Onderwijs 5) Controlemateriaal voor laboratoriumbepalingen Paraffine blokje Coupes van paraffine blokjes op glaasjes Gebruik weefsel in wetenschappelijk onderzoek - Bijna altijd alleen nuttig in combinatie met medische gegevens! - Uit weefsel kunnen weer nieuwe (medische) gegevens gehaald worden.

3 Gebruik weefsel in wetenschappelijk onderzoek Voorbeeld 1 Tumor markers (eiwit) kleuring van coupes van paraffine blokjes bv HER2 bepaling heeft geleid tot nieuwe behandeling borstkanker met trastuzumab (Herceptin) HER2 kleuring van borstweefsel Gebruik weefsel in wetenschappelijk onderzoek Voorbeeld 2 RNA of DNA uit paraffineblokje of vriesweefsel - Onderzoek naar erfelijke mutaties - Onderzoek naar tumor markers/expressie-profielen voor prognose voorspelling

4 Wet en regelgeving Wet Geneeskundige behandelingsovereenkomst Anonieme gegevens en lichaamsmateriaal mogen gebruikt worden in wetenschappelijk onderzoek als de patiënt geen bezwaar heeft gemaakt Zelfregulerende codes ook gecodeerde gegevens - NB: EU Council Recommendation on research on biological materials of human origin laat hier ook ruimte voor Onderzoek met overgebleven lichaamsmateriaal moet beoordeeld worden door een commissie Consent for secondary use

5 Informed consent procedures Opt out Opt in Explicit (written) informed consent One time general Repeated What is the opinion of donors? Secondary use of tissue research I NKI AVL Breast cancer Diagnosed II VUmc Breast colorectal Recently diagnosed III NKI AVL Breast colorectalprostate Recently diagnosed Among responders: 73% did NOT know that tissue was stored consent for use in research: 96% 97% Vermeulen, Schmidt et al JCP 2008, EJC 2009, BJC 2009

6 Information for patients NKI AVL Information for patients NKI AVL

7 Tissue Issue ongoing research Determine which consent procedure is in the best interest of patients, scientific researchers ánd medical staff Development of a uniform, specific information leaflet and consent procedure 1800 patients (all ages; academic and non academic hospitals) Opt out Opt out plus Informed consent 400 cancer patients 200 non cancer patients 400 cancer patients 200 non cancer patients 400 cancer patients 200 non cancer patients S Rebers & MK Schmidt FE van Leeuwen NA Aaronson Secondary use procedures NKI AVL

8 Biobanks in NKI AVL Department of Pathology ( Opt Out ) Formalin fixed paraffin embedded tissue Glass slides (FFPE) Frozen tissue Department of Clinical Chemistry (de novo Biobank; one time general consent for blood draw, storage, use in research; optout/withdraw possible at any time) Serum collection (also spijtserum collected in the past) Blood collection (eg for DNA isolation) Registration of opt out Opt out registration In medical (paper) files (until 3 years ago only option) In tumor registry In (new) tissue tracking system of Department of Pathology In (new) blood/serum tracking system of Department of Clinical Chemistry How to opt out? Inform treating physician Write letter (know of one patient who did) No standard form for opt out, except for recently (2010) established blood biobank (governance document and standard form to withdraw consent); similar initiative for Pathology biobank ongoing.

9 How do researchers apply? Application for the secondary use of human tissue in research: Through Core Facility Molecular Pathology and Biobanking (CFMPB) (since 2011) Steps: Inventory request to CFMPB whether material is available Submission of standardized proposal to Translational Research Board** (by researcher; CFMPB coordinates) CFMPB collects material from Pathology and/or Clinical Chemistry, where applicable CFMPB takes care of standardized/protocol use of material (eg DNA isolation) Coded material is handed to researcher NB this procedure has been approved by METC and Board NKI AVL How do researchers apply? ** TRB approval: critical evaluation of use of material Each proposal has to be approved by: 1. A pathologist or clinical chemist 2. Tumor working group or relevant clinician 3. A researcher On aspects of: Relevance, feasibility, translation Expertise and knowledge of investigators on the proposal Possible clinical relevance and consequences Need for involvement of additional experts Note: material can only be used if enough is left for later diagnostic purposes

10 How do researchers apply? Application for the secondary use of human tissue in research: Through Core Facility Molecular Pathology and Biobanking (CFMPB) (since 2011) (coordinator: A Broeks) Steps: Inventory request to CFMPB whether material is available Submission of standardized proposal to Translational Research Board** (by researcher; CFMPB coordinates) CFMPB collects material from Pathology and/or Clinical Chemistry, where applicable CFMPB takes care of standardized/protocol use of material (eg DNA isolation) Coded material is handed to researcher NB this procedure has been approved by METC and Board NKI AVL