36 research outputs found
BBMRI-ERIC's contributions to research and knowledge exchange on COVID-19
During the COVID-19 pandemic, the European biobanking infrastructure is in a unique position to preserve valuable biological material complemented with detailed data for future research purposes. Biobanks can be either integrated into healthcare, where preservation of the biological material is a fork in clinical routine diagnostics and medical treatment processes or they can also host prospective cohorts or material related to clinical trials. The paper discussed objectives of BBMRI-ERIC, the European research infrastructure established to facilitate access to quality-defined biological materials and data for research purposes, with respect to the COVID-19 crisis: (a) to collect information on available European as well as non-European COVID-19-relevant biobanking resources in BBMRI-ERIC Directory and to facilitate access to these via BBMRI-ERIC Negotiator platform; (b) to help harmonizing guidelines on how data and biological material is to be collected to maximize utility for future research, including large-scale data processing in artificial intelligence, by participating in activities such as COVID-19 Host Genetics Initiative; (c) to minimize risks for all involved parties dealing with (potentially) infectious material by developing recommendations and guidelines; (d) to provide a European-wide platform of exchange in relation to ethical, legal, and societal issues (ELSI) specific to the collection of biological material and data during the COVID-19 pandemic
Biomarker Research and Development for Coronavirus Disease 2019 (COVID-19): European Medical Research Infrastructures Call for Global Coordination
An effective response to the coronavirus disease 2019 (COVID-19) pandemic requires a better understanding of the biology of the infection and the identification of validated biomarker profiles that would increase the availability, accuracy, and speed of COVID-19 testing. Here, we describe the strategic objectives and action lines of the European Alliance of Medical Research Infrastructures (AMRI), established to improve the research process and tackle challenges related to diagnostic tests and biomarker development. Recommendations include: the creation of a European taskforce for validation of novel diagnostic products, the definition and promotion of criteria for COVID-19 samples biobanking, the identification and validation of biomarkers as clinical endpoints for clinical trials, and the definition of immune biomarker signatures at different stages of the disease. An effective management of the COVID-19 pandemic is possible only if there is a high level of knowledge and coordination between the public and private sectors within a robust quality framework.Peer reviewe
Enhancing reuse of data and biological material in medical research : from FAIR to FAIR-Health
The known challenge of underutilization of data and biological material from biorepositories as potential resources
formedical research has been the focus of discussion for over a decade. Recently developed guidelines for improved
data availability and reusabilityâentitled FAIR Principles (Findability, Accessibility, Interoperability, and
Reusability)âare likely to address only parts of the problem. In this article,we argue that biologicalmaterial and data
should be viewed as a unified resource. This approach would facilitate access to complete provenance information,
which is a prerequisite for reproducibility and meaningful integration of the data. A unified view also allows for
optimization of long-term storage strategies, as demonstrated in the case of biobanks.Wepropose an extension of the
FAIR Principles to include the following additional components: (1) quality aspects related to research reproducibility
and meaningful reuse of the data, (2) incentives to stimulate effective enrichment of data sets and biological
material collections and its reuse on all levels, and (3) privacy-respecting approaches for working with the human
material and data. These FAIR-Health principles should then be applied to both the biological material and data. We
also propose the development of common guidelines for cloud architectures, due to the unprecedented growth of
volume and breadth of medical data generation, as well as the associated need to process the data efficiently.peer-reviewe
Data in question: A survey of European biobank professionals on ethical, legal and societal challenges of biobank research
Source at https://doi.org/10.1371/journal.pone.0221496. Biobanks have evolved, and their governance procedures have undergone important transformations. Our paper examines this issue by focusing on the perspective of the professionals working in management or scientific roles in research-based biobanks, who have an important impact on shaping these transformations. In particular, it highlights that recent advances in molecular medicine and genomic research have raised a range of ethical, legal and societal implications (ELSI) related to biobank-based research, impacting directly on regulations and local practices of informed consent (IC), private-public partnerships (PPPs), and engagement of participants. In our study, we investigate the ways that these concerns influence biobanking practices and assess the level of satisfaction of the cross-national biobanking research communities with the ELSI related procedures that are currently in place. We conducted an online survey among biobankers and researchers to investigate secondary use of data, informing and/or re-contacting participants, sharing of data with third parties from industry, participant engagement, and collaboration with industrial partners. Findings highlight the need for a more inclusive and transparent biobanking practice where biobanks are seen in a more active role in providing information and communicating with participants; the need to improve the current IC procedures and the role of biobanks in sharing of samples and data with industry partners and different countries, and the need for practical, tangible and hands-on ethical and legal guidance
Risk mapping for better governance in biobanking : the case of biobank.cy
Introduction: Risk governance is central for the successful and ethical operation
of biobanks and the continued social license for being custodians of samples and
data. Risks in biobanking are often framed as risks for participants, whereas the
biobankâs risks are often considered as technical ones. Risk governance relies on
identifying, assessing, mitigating and communicating all risks based on technical
and standardized procedures. However, within such processes, biobank staff are
often involved tangentially. In this study, the aim has been to conduct a risk
mapping exercise bringing biobank staff as key actors into the process, making
better sense of emerging structure of biobanks.
Methods: Based on the qualitative research method of situational analysis as well
as the card-based discussion and stakeholder engagement processes, risk
mapping was conducted at the biobank setting as an interactive engagement
exercise. The analyzed material comprises mainly of moderated group
discussions.
Results: The findings from the risk mapping activity are framed through an
organismic metaphor: the biobank as a growing, living organism in a changing
environment, where trust and sustainability are cross-cutting elements in making
sense of the risks. Focusing on the situatedness of the dynamics within
biobanking activity highlights the importance of prioritizing relations at the
core of risk governance and promoting ethicality in the biobanking process by
expanding the repertoire of considered risks. Conclusion: With the organismic metaphor, the research brings the diverse group
of biobank staff to the central stage for risk governance, highlighting how
accounting for such diversity and interdependencies at the biobank setting is a
prerequisite for an adaptive risk governance.peer-reviewe
A practical checklist for return of results from genomic research in the European context
An increasing number of European research projects return, or plan to return, individual genomic research results (IRR) to participants. While data access is a data subjectâs right under the General Data Protection Regulation (GDPR), and many legal and ethical guidelines allow or require participants to receive personal data generated in research, the practice of returning results is not straightforward and raises several practical and ethical issues. Existing guidelines focusing on return of IRR are mostly project-specific, only discuss which results to return, or were developed outside Europe. To address this gap, we analysed existing normative documents identified online using inductive content analysis. We used this analysis to develop a checklist of steps to assist European researchers considering whether to return IRR to participants. We then sought feedback on the checklist from an interdisciplinary panel of European experts (clinicians, clinical researchers, population-based researchers, biobank managers, ethicists, lawyers and policy makers) to refine the checklist. The checklist outlines seven major components researchers should consider when determining whether, and how, to return results to adult research participants: 1) Decide which results to return; 2) Develop a plan for return of results; 3) Obtain participant informed consent; 4) Collect and analyse data; 5) Confirm results; 6) Disclose research results; 7) Follow-up and monitor. Our checklist provides a clear outline of the steps European researchers can follow to develop ethical and sustainable result return pathways within their own research projects. Further legal analysis is required to ensure this checklist complies with relevant domestic laws
You Canât Have AI Both Ways: Balancing Health Data Privacy and Access Fairly
Artificial intelligence (AI) in healthcare promises to make healthcare safer, more accurate, and more cost-effective. Public and private actors have been investing significant amounts of resources into the field. However, to benefit from data-intensive medicine, particularly from AI technologies, one must first and foremost have access to data. It has been previously argued that the conventionally used âconsent or anonymize approachâ undermines data-intensive medicine, and worse, may ultimately harm patients. Yet, this is still a dominant approach in European countries and framed as an either-or choice. In this paper, we contrast the different data governance approaches in the EU and their advantages and disadvantages in the context of healthcare AI. We detail the ethical trade-offs inherent to data-intensive medicine, particularly the balancing of data privacy and data access, and the subsequent prioritization between AI and other effective health interventions. If countries wish to allocate resources to AI, they also need to make corresponding efforts to improve (secure) data access. We conclude that it is unethical to invest significant amounts of public funds into AI development whilst at the same time limiting data access through strict privacy measures, as this constitutes a waste of public resources. The âAI revolutionâ in healthcare can only realise its full potential if a fair, inclusive engagement process spells out the values underlying (trans) national data governance policies and their impact on AI development, and priorities are set accordingly
CORBEL Report on ELSI support needs for BMS RIs and towards a joint Ethical Governance Framework
The aim of the deliverable is to ultimately provide CORBEL partners with an Ethical Governance Framework (Annex 2) and Ethics Check procedure (Annex 3) building on the work of the Common Service ELSI of BBMRI-ERIC and the BioMedBridges project. It shall enable the partners to operate within agreed terms with respect to participant consent, ethics committee approvals and national regulations ensuring researchers supply and access data and/or samples whilst working under a common ethical framework. It aims to build a joint policy to address ELSI considerations of biological resource providers as well as to enhance related procedures for the user community of BMS RIs. Ethics requirements 2 (informed consent), 3 (incidental finding policy), 9 (procedures on data collection, etc) and 10 (relevant authorisations) are addressed in the general provisions of the CORBEL Ethical Governance Framework. CORBEL has to monitor the compliance of the Ethical Governance Framework (e.g. statement of adherence). The responsibility to meet these ethics requirements and legal compliance ultimately lies with the individual sample and/or data provider and not with the respective research infrastructures.
Prior to implementation, the Ethical Governance Framework (including its templates) require validation of its processes and finally the approval of the Executive Board.
The ultimate aim of this Work Package is to establish a single and sustainable support mechanism (Common Service) for all BMS RIs dealing with samples and/or data with ethical, legal and societal implications (ELSI). The submission of this report (D7.1) is an important achievement for reaching this goal