The barriers to sample and data sharing between biobanks in Switzerland

Background The potential benefits of biobanks for biomedical research have received much attention in the last decade. Research using stored biosamples enables material from numerous individuals to be pooled by a research group, without the need for the various donors to be present. Hence, studies may achieve large sample sizes from multinational donor pools. However, the potential of biosample research has reportedly been limited by inefficiencies and difficulties in the sample sharing process. The aim of this thesis is to determine whether there are currently obstacles affecting the sharing and exchange of biological samples, both in general and with particular regard to Switzerland. If reports of such obstacles are made, then the degree to which these issues affect biobank stakeholders will be explored. This data will be compared with the current literature, and will form the basis of recommendations for addressing any difficulties. Methods A literature review was conducted in order to identify explicit references to obstacles in sharing biosamples. Following this, semi-structured interviews were carried out with biobank stakeholders working in Switzerland. Stakeholders included biobank managers, clinicians, pathologists, lawyers and ethicists. Participants responded to questions from an interview guide addressing their experiences with sample sharing, potential obstacles to this process, and specific difficulties at the stages of sample acquisition, storage, and use. Results 15 distinct barriers to sample sharing were identified in 27 articles. The most frequently cited issues were differences in standard operating procedures between biobanks, and legal issues concerning sample use and transfer. 36 individuals participated in the interviews. Standard operating procedures were again one of the most frequently cited explicit difficulties; in contrast with the literature review, the consent process, and networking in Switzerland, were also frequently mentioned. Finally, issues only sparsely mentioned in the literature, such as considerations of fairness, the nomenclature of biobanking, and authorship on publications, were addressed in detail. Conclusions The findings of this study suggest that clarity and transparency must be a priority in all written materials regulating biosample exchange, in order to reduce confusion about storage practices, obtained consent and the existence of legal constraints and requirements. The second key message is that networking amongst biobanks and biosample researchers is still at an early stage; interdisciplinary databases and biobank conferences may help to inform a greater number of researchers about the potential for collaboration and sample exchange

Knowledge and Attitudes of The Emirati General Public Towards Biobanking for Genomic Research: Policy Implications

The successful launch, sustainable operations and broad applicability of population-based biobank research relies primarily on public trust, engagement and widespread voluntary participation. In Abu Dhabi, UAE, there are no existing emirate-wide data on the Emirati general public's views regarding establishing a population-based biobank for future genomic research. There are also, no data on their understanding of the benefits, risks and implications of donating biosamples and health information for biobanking for future genomic research. Study Aims: This study aims to establish the first emirate-wide data regarding the Emirati general public's knowledge and attitudes towards biobanking for genomic research, assess their willingness to participate in a proposed population-based biobank for future genomic research, and explore factors associated with their willingness to participate. Methods: This study was a cross-sectional, Emirate-wide study in which data were collected through telephone interviews, using a structured survey questionnaire. Eligible participants were adult Emirati volunteers drawn at random from a list of individuals who underwent Weqaya screening, as prospective participants of the future biobank project. The sample was equally balanced by gender. The study was conducted over 11 months, from April, 2015 to March, 2016. Quantitative statistical analysis was conducted using Stata Statistical Data Analysis software version 11.2. Basic descriptive summary statistics was performed to address research objectives. Univariate and multivariate analysis were conducted to explore the association between the independent variables and willingness to participate in a population based biobank. Results: The response rate was 71.7%. A total of 603 telephone interviews were conducted, 313 males and 290 females. The vast majority of the survey respondents had a positive attitudes about biomedical research (90.9%), donation of biosamples for research (84.3%), the potentials of the biobank (91.6%), and had trust in the Health Authority-Abu Dhabi, HAAD (82.5%). However, only a few had good knowledge on biomedical research (4.8%) and genomics (16.1%), were familiar with biobanking (16.4%) or ever participated in medical research (6.0%). The overall probability of those definitely willing to participate in the proposed biobank was 76.6%, 80.8% for males and 71.0% for females, (P=0.005). After adjusting for other covariates, the independent factors associated with willingness to participate in the biobank were: being a male (OR=1.52; 95%CI: 0.96 to 2.39, P=0.07), having good knowledge on biomedical research (OR=10.4; 95%CI: 1.11 to 97.8, P=0.04), perceived altruistic benefits such as 'improve health of future generation' (OR=2.17; 95%CI: 1.44 to 3.63, P<0.001) or 'support medical research' (OR=2.11; 95%CI: 1.36 to 3.46, P=0.001), had a positive attitudes towards the biobank (OR= 2.62; 95%CI: 1.27 to 5.39, P=0.009), definitely accepted recontact (OR=3.25; 95%CI: 2.03 to 5.19, P<0.001), definitely desire to receive feedback on individual genetic research results (OR=3.16; 95%CI: 1.84 to 5.54, P<0.001) and family influence on participation (OR=3.19; 95%CI: 1.84 to 5.53, P<0.001). Conclusions and recommendations: The Emirati general public were positive about biomedical research and optimistic about the potential value of the biobank. However, they had limited knowledge on biomedical research, the concept of biobanking for future biomedical research and its related risks, as well as reported few misconceptions about its benefits. These were comparable with findings from other countries, including other Arabs. Outstandingly, the Emirati general public were very enthusiastic about participation in the biobank and had high trust in the government, acceptance for recontact and expectation for returning genomic research results. Overall, there were great variation across populations with regards to factors associated with public's willingness to participate in a population-based biobank. To ensure informed participation and active engagement in the biobank, this study's conclusions support the following recommendation: (i) ensuring ongoing public consultation and empowerment; (ii) developing tailored information and educational resources and (iii) strengthening medical research regulations and establishing a governance framework and structure for biobanks. Future follow-up studies are recommended, to explore the Emirati general public's views on other important areas not addressed in this study, evaluate actual participation after implementation of the biobank project and assess and enhance health and research literacy, to improve trust and overall experience with healthcare system

Principles of data management and sharing at European Research Infrastructures

Under the umbrella of the BioMedBridges project, fourteen research infrastructures in the biological, biomedical and environmental sciences developed commonly agreed principles of data management and sharing. The document makes key recommendations on how data management and sharing via the research infrastructures can be supported and encouraged: The RIs encourage data sharing and reuse and support the notion that public funders should encourage Open Access to data from publicly funded research where possible. Some data may only be shared under certain conditions and with appropriate safekeeping mechanisms in place, such as personally identifiable data, data subject to ethical or legal restrictions, or restrictions for intellectual property protection. To encourage data sharing, systematic reward and recognition mechanisms are necessary. Proposals for publicly funded research at RIs should include a data management plan concerning the deposition of data in long-term archives that addresses specific resources and activities (including standardisation of data production and curation/annotation). Funding for tools and activities connected to data deposition must be available. Systems, services and resources must be in place to facilitate straightforward data deposition by researchers, including support concerning the necessary data use agreements and consent forms for data with data protection or intellectual property requirements. Systems are also needed to capture and track data provenance and use. To ensure necessary trust by data providers or depositors, RIs must guarantee high standards of security and traceability

Baobab LIMS: An open source biobank laboratory information management system for resource-limited settings

Philosophiae Doctor - PhDA laboratory information management system (LIMS) is central to the informatics infrastructure that underlies biobanking activities. To date, a wide range of commercial and open source LIMS are available. The decision to opt for one LIMS over another is often influenced by the needs of the biobank clients and researchers, as well as available financial resources. However, to find a LIMS that incorporates all possible requirements of a biobank may often be a complicated endeavour. The need to implement biobank standard operation procedures as well as stimulate the use of standards for biobank data representation motivated the development of Baobab LIMS, an open source LIMS for Biobanking. Baobab LIMS comprises modules for biospecimen kit assembly, shipping of biospecimen kits, storage management, analysis requests, reporting, and invoicing. Baobab LIMS is based on the Plone web-content management framework, a server-client-based system, whereby the end user is able to access the system securely through the internet on a standard web browser, thereby eliminating the need for standalone installations on all machines. The Baobab LIMS components were tested and evaluated in three human biobanks. The testing of the LIMS modules aided in the mapping of the biobanks requirements to the LIMS functionalities, and furthermore, it helped to reveal new user suggestions, such as the enhancement of the online documentation. The user suggestions are demonstrated to be important for both LIMS strengthen and biobank sustainability. Ultimately, the practical LIMS evaluations showed the ability of Boabab LIMS to be used in the management of human biobanks operations of relatively different biobanking workflows

Biobanks in Europe: Prospects for Harmonisation and Networking

Biobanks (i.e. the organised collections consisting of biological samples and associated data, have gained great significance for research and personalised medicine) are increasingly recognised as a crucial infrastructure for research. However, at the same time the widely varied practices in biobanking regarding for example collection, storage and consent procedures may also pose a barrier to cross-border research and collaboration by limiting access to samples and data. In this context, a recent study indicates that the limited sharing and linkage of samples is a key barrier for research, such as pharmacogenetics. Wide variation is observed in the implementation of relevant existing regulation, which may add further burden to harnessing the public health benefit of these collections. Therefore, it has been suggested that there is a strong need for a harmonised approach on biobanking practices and improved networking of existing and new collections. This Report shows information on the extent of biobanking in Europe, collected through a survey of existing European biobanks regarding both technical aspects (e.g. storage conditions) and aspects of governance and ethics (e.g. sample and data sharing, consent procedures, collaborations etc.). In total, 126 biobanks from 23 countries in Europe were surveyed. Significant lack of harmonisation has been found, especially in the legal aspects (e.g. data protection, consent). This may be partly attributed to the varied interpretation and implementation of EC directives covering aspects of biobanking by national authorities. One of the main complications is that, although the field of data protection is harmonised through the EC directive on data protection, the collection, storage, and sharing of samples is not. Furthermore, in countries that have introduced special biobanks acts it is not always clear where the borderline lies between the scope of these acts and that of the Directive. Indeed, according to the survey, biobanks within the same country reported different practices, suggesting that the problems of harmonization might be higher than expected and claimed. Not only are there different national laws, but apparently within EU member states biobanks do not implement homogenous practices on privacy and data protection issues. Desk research and expert interviews were done to complete the picture presented by the survey. Experts widely recognised the need to improve collaboration and networking among the numerous existing biobanks, as well as new initiatives in Europe (and world-wide). Efficient organisation of these resources through the development, for example, of an infrastructure would potentially facilitate financial sustainability and greatly contribute to the rapid progress of research and development of better diagnostic and therapeutic approaches. The most favoured model involved the development of a virtual biobank that would allow networking of biobanks across different countries and centralisation of data rather than samples. However, several organisational challenges (wide variation in biospecimen collection, storage techniques, data comparability, etc.) may hamper such an effort. The lack of uniform regulatory and ethical requirements and/or practices may pose an additional barrier. The European Commission has already recognised the importance of international biobank projects and many of them have been funded and established in the context of the EU Framework Programmes. To help promote networking of biobanks and thus maximise public health benefits, at least some degree of harmonisation must be achieved. Whether this should be achieved solely at the level of legal/regulatory requirements and practices and/or by technical standardisation requires further investigation. Experts suggested the establishment of an international (rathen than just a European) umbrella (or network) organization, which would establish common operating procedures.JRC.DDG.J.2-The economics of climate change, energy and transpor

Magnetic resonance imaging biomarkers for chronic kidney disease: a position paper from the European Cooperation in Science and Technology Action PARENCHIMA

Functional renal magnetic resonance imaging (MRI) has seen a number of recent advances, and techniques are now available that can generate quantitative imaging biomarkers with the potential to improve the management of kidney disease. Such biomarkers are sensitive to changes in renal blood flow, tissue perfusion, oxygenation and microstructure (including inflammation and fibrosis), processes that are important in a range of renal diseases including chronic kidney disease. However, several challenges remain to move these techniques towards clinical adoption, from technical validation through biological and clinical validation, to demonstration of cost-effectiveness and regulatory qualification. To address these challenges, the European Cooperation in Science and Technology Action PARENCHIMA was initiated in early 2017. PARENCHIMA is a multidisciplinary pan-European network with an overarching aim of eliminating the main barriers to the broader evaluation, commercial exploitation and clinical use of renal MRI biomarkers. This position paper lays out PARENCHIMA’s vision on key clinical questions that MRI must address to become more widely used in patients with kidney disease, first within research settings and ultimately in clinical practice. We then present a series of practical recommendations to accelerate the study and translation of these techniques