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Access Governance for Biobanks: The Case of the BioSHaRE-EU Cohorts.

https://arctichealth.org/en/permalink/ahliterature279361
Source
Biopreserv Biobank. 2016 Jun;14(3):201-6
Publication Type
Article
Date
Jun-2016
Author
Jane Kaye
Linda Briceño Moraia
Colin Mitchell
Jessica Bell
Jasper Adriaan Bovenberg
Anne-Marie Tassé
Bartha Maria Knoppers
Source
Biopreserv Biobank. 2016 Jun;14(3):201-6
Date
Jun-2016
Language
English
Publication Type
Article
Keywords
Biological Specimen Banks - legislation & jurisprudence - organization & administration
Biomedical Research - legislation & jurisprudence
Cooperative Behavior
Databases, Factual
European Union
Finland
Germany
Humans
Information Dissemination - legislation & jurisprudence
Interprofessional Relations
Netherlands
Norway
United Kingdom
Abstract
Currently, researchers have to apply separately to individual biobanks if they want to carry out studies that use samples and data from multiple biobanks. This article analyzes the access governance arrangements of the original five biobank members of the Biobank Standardisation and Harmonisation for Research Excellence in the European Union (BioSHaRE-EU) project in Finland, Germany, the Netherlands, Norway, and the United Kingdom to identify similarities and differences in policies and procedures, and consider the potential for internal policy "harmonization." Our analysis found differences in the range of researchers and organizations eligible to access biobanks; application processes; requirements for Research Ethics Committee approval; and terms of Material Transfer Agreements relating to ownership and commercialization. However, the main elements of access are the same across biobanks; access will be granted to bona fide researchers conducting research in the public interest, and all biobanks will consider the scientific merit of the proposed use and it's compatibility with the biobank's objectives. These findings suggest potential areas for harmonization across biobanks. This could be achieved through a single centralized application to a number of biobanks or a system of mutual recognition that places a presumption in favor of access to one biobank if already approved by another member of the same consortium. Biobanking and Biomolecular Resources Research Infrastructure-European Research Infrastructure Consortia (BBMRI-ERIC), a European consortium of biobanks and bioresources with its own ethical, legal, and social implications (ELSI) common service, could provide a platform by developing guidelines for harmonized internal processes.
PubMed ID
27183185 View in PubMed
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Biological specimen banks in neonatal screening.

https://arctichealth.org/en/permalink/ahliterature58811
Source
Acta Paediatr Suppl. 1999 Dec;88(432):106-9
Publication Type
Article
Date
Dec-1999
Author
B. Nørgaard-Pedersen
H. Simonsen
Author Affiliation
Department of Clinical Biochemistry, Statens Serum Institut, Copenhagen S, Denmark. bnp@ssi.dk
Source
Acta Paediatr Suppl. 1999 Dec;88(432):106-9
Date
Dec-1999
Language
English
Publication Type
Article
Keywords
Biological Specimen Banks - legislation & jurisprudence - standards
Blood Specimen Collection - standards - trends
Denmark
Ethics, Medical
Female
Humans
Infant, Newborn
Infant, Newborn, Diseases - diagnosis
Male
Neonatal Screening - legislation & jurisprudence - methods
Specimen Handling
Abstract
The Danish neonatal screening program analyses dried blood spot samples (DBSS) from close to 70,000 newborns annually from Denmark, Greenland and the Faroe Islands. Since 1982, all DBSS have been stored in a biological specimen bank at -20 degrees C as a routine procedure after analysis. Before sampling, parents are given written information about the screening tests, the biobank and its use, and can choose to opt out. Since 1993 the biobank has been regulated by specific legislation, and thus assumes a unique position among biological specimen banks. Its purposes are: (i) diagnosis and treatment of diseases screened for, including repeat testing, quality assurance and group statistics; (ii) other diagnostic uses during infancy; and (iii) research projects. The stored samples have been used successfully to diagnose a range of genetic diseases using biochemical and molecular genetic assays, and to diagnose congenital CMV and toxoplasmosis infections using assays for specific IgM antibodies and pathogen nucleic acids. The unbiased nature and comprehensive coverage of the samples in the biobank make them attractive for research purposes. Our studies have focused on the epidemiology of genetic disease alleles and other molecular disease markers and on retrospective screening projects, which have allowed rapid appraisal of the performance of novel screening modalities, saving years of prospective screening trials. Storage of neonatal screening samples is thus beneficial not only to the individual testees, but also to future generations of newborns.
PubMed ID
10626593 View in PubMed
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Consent for Biobanking: The Legal Frameworks of Countries in the BioSHaRE-EU Project.

https://arctichealth.org/en/permalink/ahliterature279368
Source
Biopreserv Biobank. 2016 Jun;14(3):195-200
Publication Type
Article
Date
Jun-2016
Author
Jane Kaye
Linda Briceño Moraia
Liam Curren
Jessica Bell
Colin Mitchell
Sirpa Soini
Nils Hoppe
Morten Øien
Emmanuelle Rial-Sebbag
Source
Biopreserv Biobank. 2016 Jun;14(3):195-200
Date
Jun-2016
Language
English
Publication Type
Article
Keywords
Biological Specimen Banks - legislation & jurisprudence
Biomedical Research - legislation & jurisprudence - organization & administration
Consent Forms - organization & administration
Ethics Committees, Research - legislation & jurisprudence
European Union - organization & administration
Finland
France
Germany
Humans
Netherlands
Norway
United Kingdom
Abstract
Currently, there is no single, Europe-wide regulation of biomedical research using human samples and data. Instead, the law that applies spans a number of areas of law, such as data protection, clinical trials, and tissue regulation. In the absence of harmonized regulation, there is considerable scope for national legal variation. This article analyzes the legislative frameworks that apply to biobanking activities to identify differences in legal requirements between the BioSHaRE-EU project countries: Finland, France, Germany, the Netherlands, Norway, and the United Kingdom. This article highlights the primary role of consent and accompanying governance mechanisms, such as research ethics committee oversight, which enable consent exemptions in the context of research. Our analysis identifies a complicated legal landscape, whereby broadly similar provisions are contained in varied sources of law in each jurisdiction. The challenge for researchers is locating the applicable legal provisions within each national legal framework.
PubMed ID
27145287 View in PubMed
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Genomic Databases and Biobanks in Denmark.

https://arctichealth.org/en/permalink/ahliterature280292
Source
J Law Med Ethics. 2015;43(4):743-53
Publication Type
Article
Date
2015
Author
Mette Hartlev
Source
J Law Med Ethics. 2015;43(4):743-53
Date
2015
Language
English
Publication Type
Article
Keywords
Access to Information - legislation & jurisprudence
Biological Specimen Banks - legislation & jurisprudence
Confidentiality - legislation & jurisprudence
Databases, Genetic - legislation & jurisprudence
Denmark
Genetic Research - legislation & jurisprudence
Humans
Abstract
Biobanking in Denmark is regulated via patients' rights laws, data protection laws, and research ethics reviews. Danish law recognizes tissue samples as personal data for purposes of the data protection laws, meaning research with tissue samples may be subject to research ethics review, data protection laws, and patients' rights requirements depending on the circumstances of collection. However, research on information gained through whole genome sequencing is subject only to data protection laws, despite the similarity in the nature of the information. The regulatory framework treats biobank samples collected from patients differently than samples collected from research participants, particularly with respect to autonomy. Importantly, biobanks established for future unspecified research are not subject to research ethics review. Biobank-based research has gained more prominence on the national level recently, and the potential for a less fragmented and more consistent regulatory approach may emerge from this attention.
PubMed ID
26711414 View in PubMed
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A nation's genes for a cure to cancer: evolving ethical, social and legal issues regarding population genetic databases.

https://arctichealth.org/en/permalink/ahliterature81982
Source
Columbia J Law Soc Probl. 2004;37(3):359-411
Publication Type
Article
Date
2004
Author
Hsieh Alice
Author Affiliation
Columbia Journal of Law and Social Problems, Columbia University, USA.
Source
Columbia J Law Soc Probl. 2004;37(3):359-411
Date
2004
Language
English
Publication Type
Article
Keywords
Access to Information - legislation & jurisprudence
Biological Specimen Banks - legislation & jurisprudence
Confidentiality - legislation & jurisprudence
Databases, Genetic - ethics - legislation & jurisprudence
Disclosure - legislation & jurisprudence
Estonia
Ethics Committees, Research
Family
Genetics, Population
Great Britain
Haplotypes - genetics
Human Genome Project
Humans
Iceland
Informed Consent - legislation & jurisprudence
Internationality
Presumed Consent - legislation & jurisprudence
Refusal to Participate - legislation & jurisprudence
Singapore
Abstract
The advent of the human genome sequence has focused research on understanding underlying genetic links to complex diseases such as cancer, asthma and heart disease. In the past few years, individual countries, such as Iceland, Estonia, Singapore and the United Kingdom, have created national databases of their citizens' DNA for comparative research. Most recently, an international consortium including Nigeria, Japan, China and the United States launched a $100 million project called the International HapMap to map the human genome according to haplotypes, blocks of DNA that contain genetic variation. Such population genetic databases present challenging ethical, social and legal issues, yet regulation of genetic information has developed sporadically, from region to region, without a consistent international standard. Without a clear understanding of the consequences of genetic research in terms of individual and community-wide discrimination and stigmatization, genetic databases raise concerns about the protection of genetic information. This Note provides a survey of the evolving landscape of population genetic databases as a legislative and public policy tool for national and international regulators. It compares different approaches to regulating the collection and use of population genetic databases in order to understand what areas of consensus are formulating a foundation for an international standard. As the first population genetics project that will span multiple countries for the collection of DNA, the International HapMap has the potential to become an influential standard for the protection of population genetic information. This Note highlights issues among the national databases and the HapMap project that raise ethical, social and legal concerns for the future and recommends further protections for both individual donors and community interests.
PubMed ID
16755693 View in PubMed
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The process of moving from a regionally based cervical cytology biobank to a national infrastructure.

https://arctichealth.org/en/permalink/ahliterature269123
Source
Biopreserv Biobank. 2015 Apr;13(2):94-7
Publication Type
Article
Date
Apr-2015
Author
Nasrin Perskvist
Loreana Norlin
Joakim Dillner
Source
Biopreserv Biobank. 2015 Apr;13(2):94-7
Date
Apr-2015
Language
English
Publication Type
Article
Keywords
Biological Specimen Banks - legislation & jurisprudence - organization & administration - standards
Biomedical research
Cervix Uteri - cytology
Female
Humans
Registries
Sweden
Tissue Banks - economics - legislation & jurisprudence - standards
Vaginal Smears
Abstract
This article addresses the important issue of the standardization of the biobank process. It reports on i) the implementation of standard operating procedures for the processing of liquid-based cervical cells, ii) the standardization of storage conditions, and iii) the ultimate establishment of nationwide standardized biorepositories for cervical specimens. Given the differences in the infrastructure and healthcare systems of various county councils in Sweden, these efforts were designed to develop standardized methods of biobanking across the nation. The standardization of cervical sample processing and biobanking is an important and widely acknowledged issue. Efforts to address these concerns will facilitate better patient care and improve research based on retrospective and prospective collections of patient samples and cohorts. The successful nationalization of the Cervical Cytology Biobank in Sweden is based on three vital issues: i) the flexibility of the system to adapt to other regional systems, ii) the development of the system based on national collaboration between the university and the county councils, and iii) stable governmental financing by the provider, the Biobanking and Molecular Resource Infrastructure of Sweden (BBMRI.se). We will share our experiences with biorepository communities to promote understanding of and advances in opportunities to establish a nationalized biobank which covers the healthcare of the entire nation.
PubMed ID
25599404 View in PubMed
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Tensions Between Policy and Practice in Finnish Biobank Legislation.

https://arctichealth.org/en/permalink/ahliterature274836
Source
Biopreserv Biobank. 2015 Oct;13(5):379-81
Publication Type
Article
Date
Oct-2015
Author
Aaro Tupasela
Source
Biopreserv Biobank. 2015 Oct;13(5):379-81
Date
Oct-2015
Language
English
Publication Type
Article
Keywords
Biological Specimen Banks - legislation & jurisprudence - standards
Finland
Humans
Abstract
In 2012 a new biobanking law came into effect in Finland which, according to some, is one of the most comprehensive and broad national biobanking legislations in the world to date. The law covers both clinical and research collections and provides institutions with great flexibility in terms of transferring existing collections into a biobank. The law also includes provisions for individuals whose samples are stored in the biobank to request information regarding the studies in which the sample has been used. However, this provision also compels biobanks to provide an account of the significance of the research findings to their individual health. This legal provision has created tension between policy and practice in that most biobanks will struggle to interpret and apply this provision in practice. The relationship between the rights and needs to conduct research using biobank material and individual rights of access is sometimes unclear and fraught with interpretational challenges. The derivation of national interpretations of European Directives and Conventions gives rise to what I call interpretive regulatory dissonance. This is expected to be a challenge for harmonizing European and global biobanking activities in the future.
PubMed ID
26418975 View in PubMed
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[The law concerning biobanks is a strain on health care work].

https://arctichealth.org/en/permalink/ahliterature185008
Source
Lakartidningen. 2003 May 8;100(19):1730-1
Publication Type
Article
Date
May-8-2003
Author
Anders Lindgren
Author Affiliation
Medicinkliniken, Södra Alvsborgs sjukhus, Borås. anders.lindgren.fiskeback@telia.com
Source
Lakartidningen. 2003 May 8;100(19):1730-1
Date
May-8-2003
Language
Swedish
Publication Type
Article
Keywords
Biological Specimen Banks - legislation & jurisprudence
Documentation
Humans
Informed consent
Patient Education as Topic
Sweden
Workload
PubMed ID
12800300 View in PubMed
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Will forensic use of medical biobanks decrease public trust in healthcare services? Some empirical observations.

https://arctichealth.org/en/permalink/ahliterature83501
Source
Scand J Public Health. 2007;35(4):442-4
Publication Type
Article
Date
2007
Author
Bexelius Christin
Hoeyer Klaus
Lynöe Niels
Author Affiliation
Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden. Christin.Bexelius@ki.se
Source
Scand J Public Health. 2007;35(4):442-4
Date
2007
Language
English
Publication Type
Article
Keywords
Adult
Aged
Biological Specimen Banks - legislation & jurisprudence
Female
Forensic Genetics - legislation & jurisprudence
Humans
Male
Middle Aged
Public Opinion
Questionnaires
Sweden
Trust
Abstract
AIM: The authors tested the prevalent hypothesis that forensic use of medical biobanks has a negative impact on public trust in healthcare services. METHOD: A questionnaire was sent to 1,184 inhabitant in the age group 20-80 years in Stockholm County, Sweden, in November 2005. RESULTS: With a response rate of 68.4%, the results showed that a majority (88.1%) of the respondents thought that it would be acceptable for the police to gain access to genetic samples stored in relation to healthcare; 5.6% said no and 6.3% were uncertain. In the case of police access to medical biobanks, a minority (6.3%) indicated that this would have a negative impact on their trust, a larger proportion (37.8%) that it would influence their trust in the healthcare services positively, and 56% stated that it would not affect their trust at all. CONCLUSION: The hypothesis tested appears to be unfounded. This should cause us to reconsider prevalent assumptions and current policies on the interface of medical and forensic genetics.
PubMed ID
17786809 View in PubMed
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9 records – page 1 of 1.