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The application of artificial intelligence and machine learning (ML) technologies in healthcare have immense potential to improve the care of patients. While there are some emerging practices surrounding responsible ML as well as regulatory frameworks, the traditional role of research ethics oversight has been relatively unexplored regarding its relevance for clinical ML. In this paper, we provide a comprehensive research ethics framework that can apply to the systematic inquiry of ML research across its development cycle. The pathway consists of three stages: (1) exploratory, hypothesis-generating data access; (2) silent period evaluation; (3) prospective clinical evaluation. We connect each stage to its literature and ethical justification and suggest adaptations to traditional paradigms to suit ML while maintaining ethical rigor and the protection of individuals. This pathway can accommodate a multitude of research designs from observational to controlled trials, and the stages can apply individually to a variety of ML applications. [ABSTRACT FROM AUTHOR]

In this paper, we explore the recent creation of "iBlastoids," which are 3-D structures that resemble early human embryos prior to implantation which formed via self-organization of reprogrammed adult skin cells. We explore some of the ethical, philosophical, social, and regulatory issues related to this research, with focus particularly on what it means to "anticipate" research outcomes when using novel methods or when serendipitous discoveries are made. We defend the need for reflexive, anticipatory, and deliberative ethical and conceptual work by researchers working in emerging and contentious research domains, in collaboration with interdisciplinary scholars, as well as regulators, funders, and publics. [ABSTRACT FROM AUTHOR]

The author comments on the article "Think Pragmatically: Investigators' Obligations to Patient-Subjects When Research Is Embedded in Care" by Stephanie Morain and Emily Largent which argue that investigators and possibly institutions have distinct ethical duties when conducting or participating in pragmatic trials. Topics include their arguments that there are at least six morally significant differences between explanatory and pragmatic trials and their suggestion to avoid a fiduciary framing.

While experience often affords important knowledge and insight that is difficult to garner through observation or testimony alone, it also has the potential to generate conflicts of interest and unrepresentative perspectives. We call this tension the paradox of experience. In this paper, we first outline appeals to experience made in debates about access to unproven medical products and disability bioethics, as examples of how experience claims arise in bioethics and some of the challenges raised by these claims. We then motivate the idea that experience can be an asset by appealing to themes in feminist and moral epistemology, distinguishing between epistemic and justice-based appeals. Next, we explain the concern that experience may be a liability by appealing to empirical work on cognitive biases and theoretical work about the problem of partial representation. We conclude with preliminary recommendations for addressing the paradox and offer several questions for future discussion. [ABSTRACT FROM AUTHOR]

While the accumulation and increased circulation of genomic data have captured much attention over the past decade, privacy risks raised by the diversification and integration of omics have been largely overlooked. In this paper, we propose the outline of a framework for assessing privacy risks in multi-omic research and databases. Following a comparison of privacy risks associated with genomic and epigenomic data, we dissect ten privacy risk-impacting omic data properties that affect either the risk of re-identification of research participants, or the sensitivity of the information potentially conveyed by biological data. We then propose a three-step approach for the assessment of privacy risks in the multi-omic era. Thus, we lay grounds for a data property-based, 'pan-omic' approach that moves away from genetic exceptionalism. We conclude by inviting our peers to refine these theoretical foundations, put them to the test in their respective fields, and translate our approach into practical guidance. [ABSTRACT FROM AUTHOR]

The article presents responses to commentaries on the article on an ethical framework that address limitations of fetal therapy trials in 2022. Topics covered include the article's focus on research, and the need to equally consider the psychosocial and biomedical effects in fetal therapy trials. Also noted is the assumption that fetuses have interests after a pregnant person decides not to abort.

The authors offer a response for those who offer comments with regard to the protection-inclusion dilemma in research oversight. Topics include the quality and form of the protection-inclusion dilemma in areas of research in which they are immersed, informative example of the need to respond to obligations to protect and include on a case-by-case basis, and ethical considerations of institutional review boards (IRBs).

Since the early 1980's, with the clinical advent of in vitro fertilization resulting in so-called "test tube babies," a wide array of ethical considerations and concerns regarding artificial womb technology (AWT) have been described. Recent breakthroughs in the development of extracorporeal neonatal life support by means of AWT have reinitiated ethical interest about this topic with a sense of urgency. Most of the recent ethical literature on the topic, however, pertains not to the more imminent scenario of a physiologically improved method of neonatal care through AWT, but instead to the remote scenario of "complete ectogenesis" that imagines human gestation occurring entirely outside of the womb. This scoping review of the ethical literature on AWT spans from more abstract concerns about complete ectogenesis to more immediate concerns about the soon-to-be-expected clinical life support of what we term the fetal neonate or fetonate. Within an organizing framework of different stages of human gestational development, from conception to the viable premature infant, we discuss both already identified and newly emerging ethical considerations and concerns regarding AWT and the care of the fetonate. [ABSTRACT FROM AUTHOR]

The authors present a response to commentaries made on their article "Do Clinicians Have a duty to Participate in Pragmatic clinical Trials." They talk about their gratefulness for the commentaries that expand and further develop some of the arguments and ideas they offered in the article, concerns raised in the commentaries, and ways in which the authors can exercise moral suasion without compelling compliance.

The article focuses on identifying ethical considerations and concerns regarding artificial womb technology (AWT) and care of the fetonate. Topics discussed include legal and ethical status of the fetonate, the role and status of the mother in first-in-human trials and neonatal physiological transition, including blood pressure/distress and respiration.

This open peer commentary refers to the article "Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases?" by Holly Fernandez Lynch, Arthur Caplan, Patricia Furlong and Alison Bateman-House that was published within the issue. Topics discussed include efficiency of utilitarian thinking, data sharing, and prioritization of most promising research proposals.

The article presents the discussion on commentators taking the time for commenting on the work. Topics include data sovereignty and collaboration in the research process respecting indigeous forms of knowledge and independence; and facilitating the development of research being sensitive to the harms and benefits of AI/ML research.

The history of research in American Indian/Alaska Native (AI/AN) communities has been marked by unethical practices, resulting in mistrust and reluctance to participate in research. Harms are not limited to individual persons—tribal communities experience harmful misrepresentation and generalizations disrespectful of AI/AN groups' heritage, cultures, and beliefs. The Belmont Report's research ethics principles are applied primarily to protect individual research participants. The principles of sovereignty and solidarity are argued to be important concepts in extending Belmont's research protections to tribal communities. Sovereignty, an expression of respect for autonomy at a group level, is the basis for tribal self-determination. The principle of solidarity provides an ethical underpinning for tribes' obligations to protect community interests and culture. Extension of Belmont through these principles should serve to minimize harms to AI/AN groups in research. [ABSTRACT FROM AUTHOR]

The article presents the discussion on machine learning in health care posing new challenges for appropriating evaluation for safe use in clinical care. Topics include introduction of algorithmic biases particularly in relation to race, gender, and class; and identifying a number of potential ethical concerns inherent in medical research employing AI.

The article presents the discussion on role of low and middle-income countries (LMICs ) strengthening through effective global governance. Topics include supporting systematic inquiry in the development of artificial intelligence (AI) and machine learning (ML) technologies in healthcare; and accomplishing healthcare goals and the targets under the Sustainable Development Goals (SDGs).

The author comments on the article "Extending Research Protections to Tribal Communities," published in the issue, which is described as an attempt by B. Saunkeah and colleagues to revise principlism for research in native communities. Topics covered include the argument that Belmont's framework requires further conceptual support from frameworks like community based participatory research and strategy used to support appending principlism with sovereignty and solidarity.