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Biobanks' activity is based not only on securing the technology of collecting and storing human biospecimen, but also on preparing formal documentation that will enable its safe use for scientific research. In that context, the issue of informed consent, the reporting of incidental findings and the use of Transfer Agreements remain a vast challenge. This paper aims to offer first-hand tangible solutions on those issues in the context of collaborative and transnational biobanking research. It presents a four-step checklist aiming to facilitate researchers on their compliance with applicable legal and ethical guidelines, when designing their studies, when recruiting participants, when handling samples and data, and when communicating research results and incidental findings. Although the paper reflects the outcomes of the H2020 B3Africa project and examines the transfers from and to the EU as a case study, it presents a global checklist that can be used beyond the EU., (© 2023 The Authors. Developing World Bioethics published by John Wiley & Sons Ltd.)

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 biobank's 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., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Akyüz, Goisauf, Martin, Mayrhofer, Antoniou, Charalambidou, Deltas, Malatras, Papagregoriou, Stefanou and Voutounou.)

Big data and artificial intelligence are key elements in the medical field as they are expected to improve accuracy and efficiency in diagnosis and treatment, particularly in identifying biomedically relevant patterns, facilitating progress towards individually tailored preventative and therapeutic interventions. These applications belong to current research practice that is data-intensive. While the combination of imaging, pathological, genomic, and clinical data is needed to train algorithms to realize the full potential of these technologies, biobanks often serve as crucial infrastructures for data-sharing and data flows. In this paper, we argue that the 'data turn' in the life sciences has increasingly re-structured major infrastructures, which often were created for biological samples and associated data, as predominantly data infrastructures. These have evolved and diversified over time in terms of tackling relevant issues such as harmonization and standardization, but also consent practices and risk assessment. In line with the datafication, an increased use of AI-based technologies marks the current developments at the forefront of the big data research in life science and medicine that engender new issues and concerns along with opportunities. At a time when secure health data environments, such as European Health Data Space, are in the making, we argue that such meta-infrastructures can benefit both from the experience and evolution of biobanking, but also the current state of affairs in AI in medicine, regarding good governance, the social aspects and practices, as well as critical thinking about data practices, which can contribute to trustworthiness of such meta-infrastructures., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Akyüz, Cano Abadía, Goisauf and Mayrhofer.)

The coming-into-force of the EU General Data Protection Regulation (GDPR) is a watershed moment in the legal recognition of enforceable rights to informational self-determination. The rapid evolution of legal requirements applicable to data use, however, has the potential to outstrip the capabilities of networks of biomedical data users to respond to the shifting norms. It can also delegitimate established institutional bodies that are responsible for assessing and authorising the downstream use of data, including research ethics committees and institutional data custodians. These burdens are especially pronounced for clinical and research networks that are of transnational scale, because the legal compliance burden for outbound international data transfers from the EEA is especially high. Legislatures, courts, and regulators in the EU should therefore implement the following three legal changes. First, the responsibilities of particular actors in a data sharing network should be delimited through the contractual allocation of responsibilities between collaborators. Second, the use of data through secure data processing environments should not trigger the international transfer provisions of the GDPR. Third, the use of federated data analysis methodologies that do not provide analysis nodes or downstream users access to identifiable personal data as part of the outputs of those analyses should not be considered circumstances of joint controllership, nor lead to the users of non-identifiable data to be considered controllers or processors. These small clarifications of, or modifications to, the GDPR would facilitate the exchange of biomedical data amongst clinicians and researchers., (© 2023. The Author(s).)

Data practices in biomedical research often rely on standards that build on normative assumptions regarding privacy and involve 'ethics work.' In an increasingly datafied research environment, identifiability gains a new temporal and spatial dimension, especially in regard to genomic data. In this paper, we analyze how genomic identifiability is considered as a specific data issue in a recent controversial case: publication of the genome sequence of the HeLa cell line. Considering developments in the sociotechnological and data environment, such as big data, biomedical, recreational, and research uses of genomics, our analysis highlights what it means to be (re-)identifiable in the postgenomic era. By showing how the risk of genomic identifiability is not a specificity of the HeLa controversy, but rather a systematic data issue, we argue that a new conceptualization is needed. With the notion of post-identifiability as a sociotechnological situation, we show how past assumptions and ideas about future possibilities come together in the case of genomic identifiability. We conclude by discussing how kinship, temporality, and openness are subject to renewed negotiations along with the changing understandings and expectations of identifiability and status of genomic data., Competing Interests: Conflict of interestOn behalf of all authors, the corresponding author states that there is no conflict of interest. Authors also note that they have no competing interests—intellectual or financial—in the research detailed in the manuscript., (© The Author(s) 2023.)

Artificial intelligence (AI) is being applied in medicine to improve healthcare and advance health equity. The application of AI-based technologies in radiology is expected to improve diagnostic performance by increasing accuracy and simplifying personalized decision-making. While this technology has the potential to improve health services, many ethical and societal implications need to be carefully considered to avoid harmful consequences for individuals and groups, especially for the most vulnerable populations. Therefore, several questions are raised, including (1) what types of ethical issues are raised by the use of AI in medicine and biomedical research, and (2) how are these issues being tackled in radiology, especially in the case of breast cancer? To answer these questions, a systematic review of the academic literature was conducted. Searches were performed in five electronic databases to identify peer-reviewed articles published since 2017 on the topic of the ethics of AI in radiology. The review results show that the discourse has mainly addressed expectations and challenges associated with medical AI, and in particular bias and black box issues, and that various guiding principles have been suggested to ensure ethical AI. We found that several ethical and societal implications of AI use remain underexplored, and more attention needs to be paid to addressing potential discriminatory effects and injustices. We conclude with a critical reflection on these issues and the identified gaps in the discourse from a philosophical and STS perspective, underlining the need to integrate a social science perspective in AI developments in radiology in the future., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Goisauf and Cano Abadía.)

Biobanks act as the custodians for the access to and  responsible use of human biological samples and related data that have been generously donated by individuals to serve the public interest and scientific advances in the health research realm. Risk assessment has become a daily practice for biobanks and has been discussed from different perspectives. This paper aims to provide a literature review on risk assessment in order to put together a comprehensive typology of diverse risks biobanks could potentially face. Methodologically set as a typology, the conceptual approach used in this paper is based on the interdisciplinary analysis of scientific literature, the relevant ethical and legal instruments and practices in biobanking to identify how risks are assessed, considered and mitigated. Through an interdisciplinary mapping exercise, we have produced a typology of potential risks in biobanking, taking into consideration the perspectives of different stakeholders, such as institutional actors and publics, including participants and representative organizations. With this approach, we have identified the following risk types: economic, infrastructural, institutional, research community risks and participant's risks. The paper concludes by highlighting the necessity of an adaptive risk governance as an integral part of good governance in biobanking. In this regard, it contributes to sustainability in biobanking by assisting in the design of relevant risk management practices, where they are not already in place or require an update. The typology is intended to be useful from the early stages of establishing such a complex and multileveled biomedical infrastructure as well as to provide a catalogue of risks for improving the risk management practices already in place., (© 2021. The Author(s).)

This article examines managerial control practices in a public bureaucracy at the moment of introducing remote work as part with a new ways of working (NWW) project. The qualitative study builds on 38 interviews with supervisors and subordinates conducted before the advent of COVID-19. By interpreting interviewees' conversations about current and anticipated future work practices in the changing work setting, we reveal tacit and hidden practices of managerial control that are currently prevalent in many organizations introducing remote working. Three constitutive moments of the organization's transformation to NWW are analytically distinguished: (i) how implicit becomes explicit, (ii) how collective becomes self, and (iii) how personal becomes impersonal. Our findings emphasize that the transition to NWW must take into account prevailing institutional logics and must reconnect to a fundamental and often neglected question: What does doing work mean within the particular organization? Negotiating this fundamental question might help to overcome supervisors' uncertainties about managerial control and provide clarity to subordinates about what is expected from them while working remotely. Finally, we discuss how the transition to NWW may serve as both an opportunity and a potential threat to established organizational practices while highlighting the challenge supervisors face when the institutional logics conflict with remote working., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Hartner-Tiefenthaler, Goisauf, Gerdenitsch and Koeszegi.)

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., Competing Interests: The authors have declared that no competing interests exist.

While there is consensus on the essential importance of public engagement in further developments of biobanking, the related investigation of public views predominantly focused on the concerns expressed by the publics, and the concrete formats of public engagement, without delving into the ways these concerns are constituted. In this article, we summarize recent research on public engagement in order to describe the constitution of respective concerns as "engagement of knowledges." By shifting the focus of analysis from "publics" to "knowledges," we draw attention to the interaction dynamic through which citizens embed the new knowledge they receive during expert interactions into the stock of knowledge they already possess. Analyzing our recent investigation of public views on biobanking in the form of citizen-expert panels in the Austrian infrastructure of biobanks (BBMRI.at), we trace this dynamic through citizens' recurrent concerns that the research and consent practices related to biobanking should be "appropriate."