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.
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.
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.
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.
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.
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.
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.
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.