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As the adoption of digital health accelerates health research increasingly relies on large quantities of biomedical data. Research institutions scattered across a large number of jurisdictions collaborate in producing and analyzing biomedical big data. National data protection legislation, for its part, grows increasingly complex and localized. To respond to heterogeneous legal requirements arising in numerous jurisdictions, decentralized health consortia must develop scalable organizational and 6 technological arrangements that enable data flows across jurisdictional boundaries. In this article, proposals are made to enable health sector organisations to align established biomedical ethics process and data analysis practices to shifting data protection norms through both public law co-regulation, private law tools, and design-oriented approaches., (© The Author(s) 2022. Published by Oxford University Press on behalf of Duke University School of Law, Harvard Law School, Oxford University Press, and Stanford Law School.)

In this article, we discuss Beauchamp and Childress's treatment of the issue of moral status. In particular, we (1) introduce the five different perspectives on moral status that Beauchamp and Childress consider in Principles of Biomedical Ethics and explain their alternative to those perspectives, (2) raise some critical questions about their approach, and (3) offer a different way to think about one of the five theories of moral status (the theory based on human properties) that is more in line with what we believe some of its leading advocates affirm., (© The Author(s) 2020. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Principlism, the bioethical theory championed by Tom Beauchamp and James Childress, is centered on the four moral principles of beneficence, non-maleficence, respect for autonomy, and justice. Two key processes related to these principles are specification-adding specific content to general principles-and balancing-determining the relative weight of conflicting principles. I argue that both of these processes necessarily involve an appeal to human goods and evils, and therefore require a theory of the good. A significant problem with principlism is that it lacks a theory of the good and consequently does not have an adequate solution to the problems of specification and balancing. My conclusion is that principlism must adopt some account of human well-being in order to be a satisfactory bioethical framework., (© The Author(s) 2020. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objective: The purpose of this study was to understand the ethical, legal, and social issues described by parents of children with known or suspected genetic conditions that cause intellectual and developmental disabilities regarding research use of their child's electronic health record (EHR)., Materials and Methods: We conducted 4 focus groups with parents of children with a known (n = 12) or suspected (n = 11) genetic condition, as well as 2 comparison groups with parents who had a child with no known genetic condition (n = 15). Focus group transcripts were coded and analyzed using directed content analysis., Results: After weighing the risks and benefits, parents of children with known or suspected genetic conditions were willing to share their child's EHR for research studies under certain conditions. Preferences were for studies conducted by universities or nonprofits that might benefit their child or others with the same condition. Parents also valued return of research results., Discussion: Trust, transparency, altruism, and concerns about privacy emerged as factors that affect parents' willingness to allow research use of their child's EHR., Conclusion: Researchers should consider how to build trust with parents by increasing transparency of the research process and explaining specifically how they will ensure the confidentiality of EHR data., (© The Author(s) 2020. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

The International Commission on Radiological Protection (ICRP) has recently reviewed the ethical foundations of its recommendations. The approach taken in its report is similar to principlism, i.e. the system of Beauchamp and Childress proposed in their 'Principles of Biomedical Ethics.' The commission identifies a number of 'core values' which have helped shape the evolution of the ICRP system of radiological protection, namely 'Beneficence and non-maleficence', 'Prudence', 'Justice' and 'Dignity'. In addition, 'procedural values' are cited that are important for the system's applications in practice, 'Accountability', 'Transparency' and 'Inclusiveness (Stakeholder Participation)'. It is emphasized that these values are common to or at least acceptable for people from different cultural backgrounds, which for an endeavour as global in nature as radiological protection seems to be quite important and appropriate. Thus, the ICRP document on 'Ethics of radiological protection' could set a standard for other areas., (© The Author(s) 2018. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Large-scale biorepositories that couple biologic specimens with electronic health records containing documentation of phenotypic expression can accelerate scientific research and discovery. However, differences between those subjects who participate in biorepository-based research and the population from which they are drawn may influence research validity. While an opt-out approach to biorepository-based research enhances inclusiveness, empirical research evaluating voluntariness, risk, and the feasibility of an opt-out approach is sparse, and factors influencing patients' decisions to opt out are understudied. Determining why patients choose to opt out may help to improve voluntariness, however there may be ethical and logistical challenges to studying those who opt out. In this perspective paper, the authors explore what is known about research based on the opt-out model, describe a large-scale biorepository that leverages the opt-out model, and review specific ethical and logistical challenges to bridging the research gaps that remain.