TuBaFrost 3: Regulatory and ethical issues on the exchange of residual tissue for research across Europe

Veen, Evert-Ben van; Riegman, Peter; Dinjens, Winand N.M.; Lam, King H.; Oomen, M.H.A.; Spatz, Alan; Mager, R.; Ratcliffe, Chris; Knox, Kirstine A.; Kerr, David; Damme, B Van; Vijver, Marc J. van de; Boven, Hester van; Morente, Manuel; Alonso, Soledad; Kerjaschki, Dontscho; Pammer, Johannes; Löpez‐Guerrero, José Antonio; Bosch, Antonio Llombart; Carbone, Antonino; Gloghini, Annunziata; Teodorović, Ivana; Isabelle, Maripier; Passioukov, A.; Lejeune, S.; Therasse, Patrick; Oosterhuis, J. Wolter

doi:10.1016/j.ejca.2006.04.028

Cited by 62 publications

(40 citation statements)

References 18 publications

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“…Since then, amongst many others, the Council of Europe published recommendations for research on biological materials of human origin (52) and recently the OECD developed guidelines for human biobanks and genetic research databases (53). However, these documents are not legally binding and sometimes tend to become a rhetorical "race to the top" (54,55). Meanwhile, national regulations, adopted after a democratic procedure, have come to a more balanced approach with less restrictive consent procedures, like in the UK, Denmark, Sweden and recently Belgium.…”

Section: Legal and Ethical Issuesmentioning

confidence: 99%

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Cervical Cytology Biobanking in Europe

Arbyn

Veen²,

Andersson

et al. 2010

Int J Biol Markers

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Int J Biol Markers ( 2010; 3 ): 117-125 25 - 117Original article offers a unique tool for etiological studies, studies on the natural history and molecular pathways of carcinogenesis, evaluation of screening and vaccination effectiveness, and the evaluation of early biomarkers (viral DNA, RNA or proteins, or immunological, genetic or other biological host factors) usable in cancer screening or triage of screen positives. Even when, in the future, detection of nucleic acids of human papillomaviruses would become the standard screening methodology, collection of cellular material will be needed to perform HPV tests. Removal of coverslips from archived conventional Pap smears, extraction of DNA from scraped cells or from microdissected dyskaryotic cells, DNA amplification of human or viral genomic sequences and HPV genotyping have been demonstrated to be feasible in previous studies (2-6). Liquid-based cytology (LBC) is a newer method of preparing cervical cytology samples. Collected cells are transferred in a fluid fixative and evenly dispersed across slides (7). Importantly, the leftover sample contains large amounts of fixed cells with well-preserved morphology, INTRODUCTIONEvery year, tens of millions of cervical cell samples are obtained within the European Union. In countries with well organized cervical cancer screening, the 10-year cumulative attendance rate is well above 90% of all women belonging to the target age range. The average number of smears planned over a lifetime varies among member states: from 7 in Finland and the Netherlands to more than 50 in Germany, Austria and Luxembourg (1). Cervical cell samples are usually stored for 5 to 10 years for medicolegal or quality-control reasons. Certain European laboratories have archived series of Pap smears over several decades. This makes archival cervical samples a valuable resource for research where genetic susceptibility, exposure to external etiological factors as well as outcome (cervical and other malignancies) can be documented through the link with cancer registries.A cervical cytology biobank (CCB) linked to a screening registry, a cancer registry and a HPV vaccination registry

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Section: Legal and Ethical Issuesmentioning

confidence: 99%

“…Presumed consent could be the rule, used for cross-national studies when in the country of the sample donor such research would be allowed (55). Individual feedback of study results to sample providers should not be considered a requirement since it would involve breaching of coding and it could have adverse effects (60,66).…”

Section: Legal and Ethical Issuesmentioning

confidence: 99%

Cervical Cytology Biobanking in Europe

Arbyn

Veen²,

Andersson

et al. 2010

Int J Biol Markers

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“…In such scenarios it shall not be neglected, that the combination of experimental (especially genetic) data with detailed patient data poses even further requirements for data protection. Even in the absence of personal data, patient re-identification through the combination of large datasets cannot be excluded [24,32,33]. Therefore, particularly when comprehensive patient-related data will be shared with the scientific community outside the hospital environment in which the patient has been treated, the implementation of more far reaching anonymization tools (e.g.…”

Section: In This Context Separation Of Informational Powers Impliesmentioning

confidence: 99%

IT Infrastructure Components for Biobanking

Prokosch

Beck²,

Ganslandt³

et al. 2010

Appl Clin Inform

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KeywordsRequirement specification, biobanking, translational research information technology infrastructure SummaryObjective: Within translational research projects in the recent years large biobanks have been established, mostly supported by homegrown, proprietary software solutions. No general requirements for biobanking IT infrastructures have been published yet. This paper presents an exemplary biobanking IT architecture, a requirements specification for a biorepository management tool and exemplary illustrations of three major types of requirements. Methods: We have pursued a comprehensive literature review for biobanking IT solutions and established an interdisciplinary expert panel for creating the requirements specification. The exemplary illustrations were derived from a requirements analysis within two university hospitals. Results: The requirements specification comprises a catalog with more than 130 detailed requirements grouped into 3 major categories and 20 subcategories. Special attention is given to multitenancy capabilities in order to support the project-specific definition of varying research and biobanking contexts, the definition of workflows to track sample processing, sample transportation and sample storage and the automated integration of preanalytic handling and storage robots. Conclusion: IT support for biobanking projects can be based on a federated architectural framework comprising primary data sources for clinical annotations, a pseudonymization service, a clinical data warehouse with a flexible and user-friendly query interface and a biorepository management system. Flexibility and scalability of all such components are vital since large medical facilities such as university hospitals will have to support biobanking for varying monocentric and multicentric research scenarios and multiple medical clients.

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“…83 Research rules for residual tissues also vary across Europe. 84,85 While some countries have an opt-out system for their use (eg, Denmark), others allow the waiver of IC, provided that the materials are anonymous and/or an REC has approved (eg, UK, Spain, and Cyprus).…”

Section: Commonalities and Differences In European Countries' Ethicalmentioning

confidence: 99%

Biobanking strategies and regulative approaches in the EU: recent perspectives

Beier¹,

Lenk²

2015

BSAM

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Biobanks, ie, systematic collections of human biological materials and associated clinical and lifestyle data, provide an indispensable infrastructure for modern research. Although biobank research takes place on a global scale, there is no internationally binding framework for its ethical and legal regulation yet. A better understanding of existing regulative approaches is an important prerequisite for its ethical and legal harmonization and, thus, for improving the interoperability of biobank-based research in the future. This review focuses on biobanking strategies, regulative approaches, and recent developments in Europe. Specifically, we discuss selected ethical and legal issues in research biobanking in the European context by looking at population biobanks, new participation models, the cross-border sharing of samples, the participation of minors, the handling of incidental health findings, whole genome sequencing, and commercialization. We also provide an overview of regulations on biobank research in the EU and member states and highlight commonalities and differences. Although several common trends can be identified across Europe, we acknowledge the importance of national research traditions that cannot easily be set aside. Thus, harmonization, rather than a complete unification, of approach seems to be the most realistic vision for future biobank research in Europe.

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TuBaFrost 3: Regulatory and ethical issues on the exchange of residual tissue for research across Europe

Cited by 62 publications

References 18 publications

Cervical Cytology Biobanking in Europe

Cervical Cytology Biobanking in Europe

IT Infrastructure Components for Biobanking

Biobanking strategies and regulative approaches in the EU: recent perspectives

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