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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)
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.
Gebruik weefsel in wetenschappelijk onderzoek Voorbeeld 1 Tumor markers (eiwit) – kleuring van coupes van paraffine blokjes bv HER2 bepaling Æ 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
Wet en regelgeving
Wet Geneeskundige behandelingsovereenkomst Æ Anonieme gegevens en lichaamsmateriaal mogen gebruikt worden in wetenschappelijk onderzoek als de patiënt geen bezwaar heeft gemaakt Zelfregulerende codes www.federa.org Æ ook gecodeerde gegevens - NB: EU Council ‘Recommendation on research on biological materials of human origin’ laat hier ook ruimte voor Æ Onderzoek met overgebleven lichaamsmateriaal moet beoordeeld worden door een commissie
Consent for secondary use
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 1995‐1997
II VUmc Breast – colorectal 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
III NKI‐AVL Breast‐colorectal‐ prostate Recently diagnosed
Information for patients NKI‐AVL
Information for patients NKI‐AVL
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 400 cancer patients 200 non‐cancer patients
Opt‐out plus 400 cancer patients 200 non‐cancer patients
Informed consent 400 cancer patients 200 non‐cancer patients
S Rebers & MK Schmidt FE van Leeuwen NA Aaronson
Secondary use procedures NKI‐AVL
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; opt‐ out/withdraw possible at any time) ‐ Serum collection (also ‘spijtserum’ collected in the past) ‐ Blood collection (eg for DNA isolation)
Opt‐out registration Registration of opt‐out • • • •
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.
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
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
