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Introduction: While Learning Healthcare Systems (LHSs) have received increasing attention in health care and research, the amount of operational LHSs remains limited. Given the investment of resources in these projects, a moral responsibility to pursue the transition toward an LHS falls on projects and their participating stakeholders. This paper provides an ethics framework for projects that have taken steps toward building an LHS and are in the position to transition to an operational LHS. Method: To articulate relevant ethical requirements, we analyze established ethics frameworks in the fields of LHSs, data‐intensive health research, and transitioning or innovating health systems. The overlapping content and shared values are used to articulate overarching ethical requirements. To provide necessary context, we apply the insights from the analysis to the Innovative Medicines Initiative ConcePTION project. This project is specifically designed to generate knowledge on the safety of medications used during pregnancy and lactation through the establishment of an LHS. Results: Upon analyzing the consulted frameworks, we identified four overlapping ethical requirements that are also of significant relevance within the scope of our ethics framework. These requirements are: (1) public benefit and favorable harm–benefit ratio; (2) equity and justice; (3) stakeholder engagement; and (4) sustainability. Additionally, we apply these ethical requirements to the context of an LHS for pregnant and lactating people. Conclusion: Although tailored to the context of pregnancy and lactation, our ethics framework can provide guidance for the transition to an operational LHS across diverse healthcare domains. [ABSTRACT FROM AUTHOR]

Pervasive technologies such as Artificial Intelligence, Virtual Reality and the Internet of Things, despite their great potential for improved workability and well-being of older workers, entail wide ethical concerns. Aligned with these considerations we emphasize the need to present from the viewpoint of ethics the risks of personalized ICT solutions that aim to remedy health and support the well-being of the ageing population at workplaces. The ethical boundaries of digital technologies are opaque. The main motivation is to cope with the uncertainties of workplaces' digitization and develop an ethics framework, termed SmartFrameWorK, for personalized health support through ICT tools at workplace environments. SmartFrameWorK is built upon a five-dimensional approach of ethics norms: autonomy, privacy, transparency, trustworthiness and accountability to incite trust in digital workplace technologies. A typology underpins these principles and guides the ethical decision-making process with regard to older worker particular needs, context, data type-related risks and digital tools' use throughout their lifecycle. Risk analysis of pervasive technology use and multimodal data collection, highlighted the imperative for ethically aware practices for older workers' activity and behaviour monitoring. The SmartFrameWorK methodology has been applied in a case study to provide evidence that personalized digital services could elicit trust in users through a well-defined framework. Ethics compliance is a dynamic process from participants' engagement to data management. Defining ethical determinants is pivotal towards building trust and reinforcing better workability and well-being in older workers. [ABSTRACT FROM AUTHOR]

Abstract Background Citizen science and models for public participation in health research share normative ideals of participation, inclusion, and public and patient engagement. Academic researchers collaborate in research with members of the public involved in an issue, maximizing all involved assets, competencies, and knowledge. In citizen science new ethical issues arise, such as who decides, who participates, who is excluded, what it means to share power equally, or whose knowledge counts. This article aims to present an ethics framework that offers a lens of understanding and heuristic guidelines to deal with ethical issues in citizen science. Methods We conducted seven case studies between 2015 and 2021 to attune and validate the ethics framework for the context of citizen science. The cases related to studies with older adults, people with a psychiatric vulnerability, people dependent on community care, people who are unemployed or living in poverty or both, and young adults with respiratory disease. Results Ethics in citizen science reaches beyond the ethical issues in traditional biomedical and health research. It entails more than following procedures about informed consent and privacy and submitting a proposal to a Medical Research Ethics Committee. Ethics in citizen science relates to everyday ethical issues during the study, including relational and moral complexities concerning collaboration, sharing power, and democratic decision-making. Dealing with these issues requires ethics work of researchers. This entails seeing ethically salient issues and reflecting on everyday ethical issues. Ethics work consists of seven features: framing work, role work, emotion work, identity work, reason work, relationship work, and performance work. All are relevant for researchers in citizen science. Conclusions Ethical issues in citizen science often relate to power differentials, partnership, and collaboration between academics and non-academics. The ethics framework prepares researchers for the work needed in citizen science to act responsibly and offers a heuristic guide to reflect on ethics. Reflection on ethics is a pathway towards ethical citizen science, especially if researchers collaboratively reflect in partnership with non-academics who are subject to the moral issue.

Background: Citizen science and models for public participation in health research share normative ideals of participation, inclusion, and public and patient engagement. Academic researchers collaborate in research with members of the public involved in an issue, maximizing all involved assets, competencies, and knowledge. In citizen science new ethical issues arise, such as who decides, who participates, who is excluded, what it means to share power equally, or whose knowledge counts. This article aims to present an ethics framework that offers a lens of understanding and heuristic guidelines to deal with ethical issues in citizen science.Methods: We conducted seven case studies between 2015 and 2021 to attune and validate the ethics framework for the context of citizen science. The cases related to studies with older adults, people with a psychiatric vulnerability, people dependent on community care, people who are unemployed or living in poverty or both, and young adults with respiratory disease.Results: Ethics in citizen science reaches beyond the ethical issues in traditional biomedical and health research. It entails more than following procedures about informed consent and privacy and submitting a proposal to a Medical Research Ethics Committee. Ethics in citizen science relates to everyday ethical issues during the study, including relational and moral complexities concerning collaboration, sharing power, and democratic decision-making. Dealing with these issues requires ethics work of researchers. This entails seeing ethically salient issues and reflecting on everyday ethical issues. Ethics work consists of seven features: framing work, role work, emotion work, identity work, reason work, relationship work, and performance work. All are relevant for researchers in citizen science.Conclusions: Ethical issues in citizen science often relate to power differentials, partnership, and collaboration between academics and non-academics. The ethics framework prepares researchers for the work needed in citizen science to act responsibly and offers a heuristic guide to reflect on ethics. Reflection on ethics is a pathway towards ethical citizen science, especially if researchers collaboratively reflect in partnership with non-academics who are subject to the moral issue. [ABSTRACT FROM AUTHOR]

This commentary responds to the article "Compulsory Research in Learning Health Care: Against a Minimal Risk Limit," by Robert Steel. Steel acknowledges that our ethics framework for a learning health care system, published in the 2013 special report Ethical Oversight of Learning Health Care Systems , includes an obligation on the part of patients to participate in learning activities, but he argues that this obligation does not go far enough. Steel, who provides an interesting justification for compulsory research participation in learning health care, claims that our obligation is limited to only minimal risk research. We take exception to that characterization insofar as it detracts from what we believe is most relevant for assessing learning activities, which is how much additional risk and burden a learning activity poses compared to clinical care alone. We also clarify that the level of additional risk is not the only morally relevant consideration in determining if a learning activity should be compulsory. Also important is whether the learning activity includes interventions or choices that engage values of importance to patients. [ABSTRACT FROM AUTHOR]

On March, 24, 2020, 818 cases of COVID-19 had been reported in New South Wales, Australia, and new cases were increasing at an exponential rate. In anticipation of resource constraints arising in clinical settings as a result of the COVID-19 pandemic, a working party of ten ethicists (seven clinicians and three full-time academics) was convened at the University of Sydney to draft an ethics framework to support resource allocation decisions. The framework guides decision-makers using a question-and-answer format, in language that avoids philosophical and medical technicality. The working party met five times over the following week and then submitted a draft Framework for consideration by two groups of intensivists and one group of academic ethicists. It was also presented to a panel on a national current affairs programme. The Framework was then revised on the basis of feedback from these sources and made publicly available online on April 3, ten days after the initial meeting. The framework is published here in full to stimulate ongoing discussion about rapid development of user-friendly clinical ethics resources in ongoing and future pandemics. [ABSTRACT FROM AUTHOR]

Ethical decision-making frameworks assist in identifying the issues at stake in a particular setting and thinking through, in a methodical manner, the ethical issues that require consideration as well as the values that need to be considered and promoted. Decisions made about the use, sharing, and re-use of big data are complex and laden with values. This paper sets out an Ethics Framework for Big Data in Health and Research developed by a working group convened by the Science, Health and Policy-relevant Ethics in Singapore (SHAPES) Initiative. It presents the aim and rationale for this framework supported by the underlying ethical concerns that relate to all health and research contexts. It also describes a set of substantive and procedural values that can be weighed up in addressing these concerns, and a step-by-step process for identifying, considering, and resolving the ethical issues arising from big data uses in health and research. This Framework is subsequently applied in the papers published in this Special Issue. These papers each address one of six domains where big data is currently employed: openness in big data and data repositories, precision medicine and big data, real-world data to generate evidence about healthcare interventions, AI-assisted decision-making in healthcare, public-private partnerships in healthcare and research, and cross-sectoral big data. [ABSTRACT FROM AUTHOR]

Ethics guidelines and commentary suggest that a central function of research ethics committees is to assess the scientific merit of the protocols they review. However, some commentators object to this role, and evidence suggests that the assessment of scientific merit is a significant source of confusion and animosity between ethics committees and clinical investigators. In this essay, we argue that ethics committees should assess the scientific value and validity of research protocols and that new decision‐making tools are needed to help them do so in a systematic, transparent, and reliable way. We present a novel ethical framework that can assist in this task. [ABSTRACT FROM AUTHOR]

The Living Organ Donor as Patient: Theory and Practice, by Lainie Friedman Ross and J. Richard Thistlethwaite, Jr. (Oxford University Press, 2021), offers a stimulating opportunity to consider the ethics of living solid organ donation in more depth. Ross and Thistlethwaite detail a framework of five principles—respect for persons, beneficence, justice, vulnerability, and responsibility—that positions prospective living donors as patients. The authors engage readers by applying these principles across a series of examples, issues, and possibilities, the "practice." Readers may wish to reflect further on the framework's implications, including those related to vulnerability, power, and social justice (to name a few), particularly as these relate to the "theory" of this book. The book is well worth the read for clinicians, ethicists, and others involved in organ donation and transplantation. [ABSTRACT FROM AUTHOR]

The influential public health ethics framework proposed by Childress et al. includes five "justificatory conditions," two of which are "necessity" and "least infringement." While the framework points to important moral values, we argue it is redundant for it to list both necessity and least infringement because they are logically equivalent. However, it is ambiguous whether Childress et al. would endorse this view, or hold the two conditions distinct. This ambiguity has resulted in confusion in public health ethics discussions citing the Childress et al. framework, as demonstrated by debate between Resnik and Wilson and Dawson. We analyse this debate to resolve these ambiguities. Finally, we argue that the necessity/least infringement principle of the Childress et al. framework applies only in cases in which only one intervention is to be implemented to achieve one specific goal. In other cases, it is not essential to require that only the least infringing intervention be implemented. [ABSTRACT FROM AUTHOR]

This special issue of ETR&D is devoted to ethics in the broad domain of educational technology. Many ethical issues arise involving the study and use of educational technologies. A well-known issue involves the digital divide and the degree to which the introduction of new technologies is increasing the digital divide and disadvantaging some students while benefitting others. The potential of educational technologies to improve learning and instruction is generally well known. Many of the problems associated with the successful implementation of educational technologies are also generally well known. However the ethical issues involved with educational technology implementation, use and research are not well explored nor widely known. This paper provides a preliminary framework for ethical decision making with regard to educational technologies. [ABSTRACT FROM AUTHOR]

Personal values guide ethical decision-making behaviors. Business professors have traditionally addressed undergraduate ethics-based learning through a learn ethics approach using case studies, simulations, presentations, and other activities. Few offer a live ethics orientation requiring completion of a personal values self-assessment and creation of a personal values and mission statement through a reflective paper. Utilizing content analysis, the authors’ findings suggest that undergraduates’ narratives can serve as a cognitive developmental tool to actively engage ethical reasoning awareness and encourage moral formation and development within the learning environment. [ABSTRACT FROM PUBLISHER]

The authors led the development of a framework for ethical decision-making for an Academic Health Sciences Centre. They understood the existing mission, vision, and values statement (MVVs) of the centre as a foundational assertion that embodies an ethical commitment of the institution. Reflecting the Patient and Family Centred Model of Care the institution is living, the MVVs is a suitable base on which to construct an ethics framework. The resultant framework consists of a set of questions for each of the MVVs. Users of the framework are expected to identify two or more possible decisions to address the issue at hand and then, by applying the provided sequence of questions to each, examine these options and determine the overall ethically preferable decision. The construction of such a framework requires the creative involvement of the institution's staff. Thus the development of the framework can represent a training process in ethical decision-making as well as advance the ethical atmosphere of the institution. This novel approach has the advantage of placing the MVVs on active duty, at the centre of ethical decision-making, and lifts it from its otherwise relative obscurity in most institutions. [ABSTRACT FROM AUTHOR]

Recommendations advising against mothers and their infants sharing a bed during sleep (bedsharing) have sparked heated debate in recent years, the effects of which are that bedsharing is now most often only considered in the polarised contexts of being either 'the norm' or 'inherently unsafe'. This has resulted in significant tensions between supporters of bedsharing and public health bodies who seek to eliminate the risks associated with SIDS. This paper considers the issues surrounding this debate by examining the evidence associated with bedsharing, SIDS and breastfeeding. This is undertaken using Baum's six-step framework for analysing potential ethical tensions in public health policy, which includes the principles of utility, evidence base and effectiveness of action, fairness, accountability, costs and burdens, and community acceptance. This framework has allowed us to examine the competing principles involved in the bedsharing and breastfeeding debate, and arrive at a position constructed using ethical considerations. [ABSTRACT FROM AUTHOR]

Background: Data have become an essential factor in driving health research and are key to the development of personalized and precision medicine. Primary and secondary use of personal data holds significant potential for research; however, it also introduces a new set of challenges around consent processes, privacy, and data sharing. Research institutions have issued ethical guidelines to address challenges and ensure responsible data processing and data sharing. However, ethical guidelines directed at researchers and medical professionals are often complex; require readers who are familiar with specific terminology; and can be hard to understand for people without sufficient background knowledge in legislation, research, and data processing practices.Objective: This study aimed to visually represent an ethics framework to make its content more accessible to its stakeholders. More generally, we wanted to explore the potential of visualizing policy documents to combat and prevent research misconduct by improving the capacity of actors in health research to handle data responsibly.Methods: We used a mixed methods approach based on knowledge visualization with 3 sequential steps: qualitative content analysis (open and axial coding, among others); visualizing the knowledge structure, which resulted from the previous step; and adding interactive functionality to access information using rapid prototyping.Results: Through our iterative methodology, we developed a tool that allows users to explore an ethics framework for data sharing through an interactive visualization. Our results represent an approach that can make policy documents easier to understand and, therefore, more applicable in practice.Conclusions: Meaningful communication and understanding each other remain a challenge in various areas of health care and medicine. We contribute to advancing communication practices through the introduction of knowledge visualization to bioethics to offer a novel way to tackle this relevant issue. [ABSTRACT FROM AUTHOR]