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Biobanks are collections of biological samples (e.g. tissue samples and body fluids) and their associated data intended for various approaches in medical research. The field of biobanking evolves rapidly as an interdisciplinary branch of research and requires educational efforts to provide skilled experts in Europe and beyond. New ways in research and research education play a pivotal role in the future of biobanking.

The increasing of requests and potential uses of biospecimens from biobanks necessitates an international and national intensified transfer of forward looking knowledge and know-how. In Austria, this could be realized by special trainings as well as a postgraduate education. Furthermore, the forward looking research and further development of infrastructure will play a pivotal role in biobanks in the future.

Few opportunities are available for specific education on biobanking in Europe. This could be remedied by the creation networks of ISO-certified biobanks and co-operation with interested parties.

The current research focuses on the situation of information transfer in the field of biobanking in Europe. A wider investigation in better harmonization and standardization of methods in other parts of the world would be beneficial.

The value of biomolecular resources such as biobanks has previously been discussed in detail, e.g. by the Time magazine. The paper focuses on demonstrating the importance for education in the future of biobanking in general.

Medical research requires biological material and data collected through biobanks in reliable processes with quality assurance. Medical studies based on data with unknown or questionable quality are useless or even dangerous, as evidenced by recent examples of withdrawn studies. Medical data sets consist of highly sensitive personal data, which has to be protected carefully and is available for research only after the approval of ethics committees. The purpose of this research is to propose an architecture to support researchers to efficiently and effectively identify relevant collections of material and data with documented quality for their research projects while observing strict privacy rules.

Following a design science approach, this paper develops a conceptual model for capturing and relating metadata of medical data in biobanks to support medical research.

This study describes the landscape of biobanks as federated medical data lakes such as the collections of samples and their annotations in the European federation of biobanks (Biobanking and Biomolecular Resources Research Infrastructure – European Research Infrastructure Consortium, BBMRI-ERIC) and develops a conceptual model capturing schema information with quality annotation. This paper discusses the quality dimensions for data sets for medical research in-depth and proposes representations of both the metadata and data quality documentation with the aim to support researchers to effectively and efficiently identify suitable data sets for medical studies.

This novel conceptual model for metadata for medical data lakes has a unique focus on the high privacy requirements of the data sets contained in medical data lakes and also stands out in the detailed representation of data quality and metadata quality of medical data sets.

Big Data analysis is one of the key challenges to the provision of health care to emerge in the last few years. This challenge has been spearheaded by the huge interest in the “4Ps” of health care (predictive, preventive, personalized, and participatory). Big Data offers striking development opportunities in health care and life sciences. Healthcare research is already using Big Data to analyze the spatial distribution of diseases such as diabetes mellitus at detailed geographic levels. Big Data is also being used to assess location-specific risk factors based on data of health insurance claims. Other studies in systems medicine utilize bioinformatics approaches to human biology which necessitate Big Data statistical analysis and medical informatics tools. Big Data is also being used to develop electronic algorithms to forecast clinical events in real time, with the intent to improve patient outcomes and thus reduce costs.

Yet, this Big Data era also poses critically difficult ethical challenges, since it is breaking down the traditional divisions between what belongs to public and private domains in health care and health research. Big Data in health care raises complex ethical concerns due to use of huge datasets obtained from different sources for varying reasons. The clinical translation of this Big Data is thus resulting in key ethical and epistemological challenges for those who use these data to generate new knowledge and the clinicians who eventually apply it to improve patient care.

Underlying this challenge is the fact that patient consent often cannot be collected for the use of individuals’ personal data which then forms part of this Big Data. There is also the added dichotomy of healthcare providers which use such Big Data in attempts to reduce healthcare costs, and the negative impact this may have on the individual with respect to privacy issues and potential discrimination.

Big Data thus challenges societal norms of privacy and consent. Many questions are being raised on how these huge masses of data can be managed into valuable information and meaningful knowledge, while still maintaining ethical norms. Maintaining ethical integrity may lack behind in such a fast-changing sphere of knowledge. There is also an urgent need for international cooperation and standards when considering the ethical implications of the use of Big Data-intensive information.

This chapter will consider some of the main ethical aspects of this fast-developing field in the provision of health care, health research, and public health. It will use examples to concretize the discussion, such as the ethical aspects of the applications of Big Data obtained from clinical trials, and the use of Big Data obtained from the increasing popularity of health mobile apps and social media sites.

Patients having ventricular arrhythmias and atrial fibrillation, that are early markers of stroke and sudden cardiac death, as well as benign subjects are all studied using the electrocardiogram (ECG). In order to identify cardiac anomalies, ECG signals analyse the heart's electrical activity and show output in the form of waveforms. Patients with these disorders must be identified as soon as possible. ECG signals can be difficult, time-consuming and subject to inter-observer variability when inspected manually.

There are various forms of arrhythmias that are difficult to distinguish in complicated non-linear ECG data. It may be beneficial to use computer-aided decision support systems (CAD). It is possible to classify arrhythmias in a rapid, accurate, repeatable and objective manner using the CAD, which use machine learning algorithms to identify the tiny changes in cardiac rhythms. Cardiac infractions can be classified and detected using this method. The authors want to categorize the arrhythmia with better accurate findings in even less computational time as the primary objective. Using signal and axis characteristics and their association n-grams as features, this paper makes a significant addition to the field. Using a benchmark dataset as input to multi-label multi-fold cross-validation, an experimental investigation was conducted.

This dataset was used as input for cross-validation on contemporary models and the resulting cross-validation metrics have been weighed against the performance metrics of other contemporary models. There have been few false alarms with the suggested model's high sensitivity and specificity.

The results of cross validation are significant. In terms of specificity, sensitivity, and decision accuracy, the proposed model outperforms other contemporary models.

Purpose: This chapter sets out to lay out and analyse the effectiveness of the General Data Protection Regulation (GDPR), a recently established European Union (EU) regulation, in the local insurance industry.

Methodology: This was done through a systematic literature review to determine what has already been done and then a survey as a primary research tool to gather information. The survey was aimed at clients and employees of insurance entities.

Findings: The general results are that effectiveness can be segmented into different factors and vary regarding the respondents’ confidence. Other findings include that the GDPR has increased costs, and its expectations are unclear. These findings suggest that although the GDPR was influential in the insurance market, some issues about this regulation still exist.

Conclusions: GDPR fulfils its purposes; however, the implementation process of this regulation can be facilitated if better guidelines are issued for entities to follow to understand its expectations better and follow the law and fulfil its purposes most efficiently.

Practical implications: These conclusions imply that the GDPR can be improved in the future. Overall, as a regulation, it is suitable for the different member states of the EU, including small states like Malta.

The teaching of cooking is an important aspect of school-based efforts to promote healthy diets among children, and is frequently done by external agencies. Within a limited evidence base relating to cooking interventions in schools, there are important questions about how interventions are integrated within school settings. The purpose of this paper is to examine how a mobile classroom (Cooking Bus) sought to strengthen connections between schools and cooking, and drawing on the concept of the sociotechnical network, theorise the interactions between the Bus and school contexts.

Methods comprised a postal questionnaire to 76 schools which had received a Bus visit, and case studies of the Bus’ work in five schools, including a range of school sizes and urban/rural locations. Case studies comprised observation of Cooking Bus sessions, and interviews with school staff.

The Cooking Bus forged connections with schools through aligning intervention and schools’ goals, focussing on pupils’ cooking skills, training teachers and contributing to schools’ existing cooking-related activities. The Bus expanded its sociotechnical network through post-visit integration of cooking activities within schools, particularly teachers’ use of intervention cooking kits.

The paper highlights the need for research on the long-term impacts of school cooking interventions, and better understanding of the interaction between interventions and school contexts.

This paper adds to the limited evidence base on school-based cooking interventions by theorising how cooking interventions relate to school settings, and how they may achieve integration.

The purpose of the Ethics Support Office, funded by the Clinical and Translational Science Award (CTSA) and administered by the Institute for Translational Sciences (ITS) at the University of Texas Medical Branch (UTMB), is to provide research ethics support to faculty, fellows, and students. This chapter reports on an ongoing qualitative study to understand scientists' views on ethical issues in team science and their suggestions for advancing ethical policy and activities in order to improve ethics training. We originally conducted face-to-face, semistructured, qualitative interviews with a convenience sample of 20 key ITS researchers, representing the majority of researchers. The scientists' most general approach to ethics – in perceiving them, understanding them, and applying them – is to appreciate ethics in terms of their relevance to particular research situations and problems. They prefer to deal with ethics as a common feature and value incorporated into their work. Respondents suggested that those teaching ethics in multidisciplinary translational research must develop strategies that help scientists see and understand the relevance of ethics education to their work. Strategies include improving communication skills, providing shared opportunities for learning, sensitizing researchers to the demands on others on the team who are expected to contribute data and knowledge to the success of the project, and imbedding ethicists on research teams. In tune with the key finding of the study, ethics instructors and coaches need to become well acquainted with the nuances of their scientists' work. This approach will respond to the scientists' desire to conduct ethical research, but in practical terms of the specialized nature of their work.

The purpose of this paper is to contribute to develop a standard providing requirements for managing the quality and competence of the biological resource centres (BRC).

The methodology for the standard setting was based on the principles of credibility, transparency, alignment and consistency. A justification study was performed to establish its objectives and scope, avoid overlap and prevent the risks in implementation. International documents providing rules for standard development were taken into consideration. Requirements were assembled from several standards and participation of interested parties was promoted.

No relevant international document exists covering fundamental issues for BRC operation. It is possible to develop a consistent and aligned standard, under a credible and transparent process that fits BRC purposes.

This standard will strengthen the BRC technical competence increasing its capability to provide authenticated high-quality biological materials – a crucial factor for biotechnological developments in the fields of health, agriculture and environment. It will serve as a basis for the BRC compliance assessment and the launch pad for establishing the global BRC network.

Original paper.

Governance of healthcare organisations and health systems requires many different competencies, with a great emphasis on evidence and information governance, which are traditional fields of librarians’ expertise. However, stakeholders are unaware of how health and hospital libraries are contributing with specific activities and what are the trends in library support for health/clinical governance in Europe, mainly because traditional methods of measuring impact are restricted to specific library activities or are not showing direct impact long term. The paper aims to discuss these issues.

A model combining components of clinical and health governance (C/HG), related library activity types, and the possible impact was developed based on a literature review and tested by a European expert panel. A web-based survey was offered to the members of the European Association for Health Information and Libraries (EAHIL) to offer further insight into activities and examples of contribution to C/HG.

Librarians from 25 European countries participated in the survey. The model proves that librarians in Europe are involved in supporting most identified components of C/HG, with examples of clinical effectiveness and research, education and training, patient and public involvement, partnership engagement, formulating strategic direction, etc.

The authors were unable to cover the roles of libraries in all European countries in this paper, but dialogue and research will continue within the EAHIL group.

No such comparative research has been undertaken before, looking at what activities and tasks libraries undertake to support C/HG. This research has highlighted valuable services and tools that can be replicated in libraries across health care organisations and at the same time promote libraries and librarians as significant actors in organisational governance.