Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles — the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA — effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.

The individual right of access to one’s own data is a crucial privacy protection long recognized in U.S. federal privacy laws. Mobile health devices and research software used in citizen science often fall outside the HIPAA Privacy Rule, leaving participants without HIPAA’s right of access to one’s own data. Absent state laws requiring access, the law of contract, as reflected in end-user agreements and terms of service, governs individuals’ ability to find out how much data is being stored and how (...) it might be shared with third parties. Efforts to address this problem by establishing norms of individual access to data from mobile health research unfortunately can run afoul of the FDA’s investigational device exemption requirements. (shrink)

Regulatory policy for genomic testing may be subject to biases that favor reliance on existing regulatory frameworks even when those frameworks carry unintended legal consequences or may be poorly tailored to the challenges genomic testing presents. This article explores three examples drawn from genetic privacy regulation, oversight of clinical uses of genomic information, and regulation of genomic software. Overreliance on expedient regulatory approaches has a potential to undercut complete and durable solutions.

U.S. regulations do not afford consistent protections to human research subjects. One complaint is that they focus on federally sponsored research, with private research covered only if it falls under the jurisdiction of the Food and Drug Administration. This paper examines a deeper problem: Even when the regulations do apply, they still do not afford consistent standards of protection. The U.S. Common Rule and related FDA regulations lack a workable regulatory control mechanism.

Andrea Wiggins and John Wilbanks offer a rich and nuanced description of citizen science, which they define as “a range of participatory models for involving non-professionals as collaborators in s...

Psychiatry is rapidly adopting digital phenotyping and artificial intelligence/machine learning tools to study mental illness based on tracking participants’ locations, online activity, phone and text message usage, heart rate, sleep, physical activity, and more. Existing ethical frameworks for return of individual research results (IRRs) are inadequate to guide researchers for when, if, and how to return this unprecedented number of potentially sensitive results about each participant’s real-world behavior. To address this gap, we convened an interdisciplinary expert working group, supported by (...) a National Institute of Mental Health grant. Building on established guidelines and the emerging norm of returning results in participant-centered research, we present a novel framework specific to the ethical, legal, and social implications of returning IRRs in digital phenotyping research. Our framework offers researchers, clinicians, and Institutional Review Boards (IRBs) urgently needed guidance, and the principles developed here in the context of psychiatry will be readily adaptable to other therapeutic areas. (shrink)

The genetic testing industry is in a period of potentially major structural change driven by several factors. These include weaker patent protections after Association for Molecular Pathology v. Myriad Genetics and Mayo Collaborative Services v. Prometheus Laboratories, Inc.; a continuing shift from single-gene tests to genome-scale sequencing; and a set of February 2014 amendments to the Clinical Laboratory Improvement Amendments of 1988 regulations and the Health Insurance Portability and Accountability Act Privacy Rule. This article explores the nature of these changes (...) and why they strain existing regulatory frameworks for protecting patients, research subjects, and other consumers who receive genetic testing.Oversight of genetic testing has, at least to date, had two major thrusts: privacy and ethical protections and traditional consumer health and safety regulations. Examples of the first are the Genetic Information Nondiscrimination Act and the HIPAA Privacy Rule, which after 2013 amendments expressly protects genetic privacy as well as other medical privacy. (shrink)

Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of (...) research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance. (shrink)

Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons. We identify participant-centricity and trustworthiness as the most important features of an MIC and discuss the implications for those seeking to create a sustainable, useful, and widely available collection of linked resources for research and other purposes.

In this paper, we explore the perspectives of expert stakeholders about who owns data in a medical information commons and what rights and interests ought to be recognized when developing a governance structure for an MIC. We then examine the legitimacy of these claims based on legal and ethical analysis and explore an alternative framework for thinking about participants' rights and interests in an MIC.

The informed consent process for genetic testing does not commonly address preferences regarding disclosure of results in the event of the patient's death. Adults being tested for familial colorectal cancer were asked whether they want their exome sequencing results disclosed to another person in the event of their death prior to receiving the results. Of 78 participants, 92% designated an individual and 8% declined to. Further research will help refine practices for informed consent.

Ethics rounds in clinical ethics have already taken hold in multiple venues. There are “sit-down rounds,” which usually consist of a bioethicist setting a specific, prescheduled time aside for residents and/or others to bring a case or two for discussion with the bioethicist. Another kind of rounds that occurs on an ad hoc or infrequent basis is to have either a staff or outside bioethicist give hospital-wide and/or departmental “grand rounds.” Grand rounds is a traditional educational format in medicine and (...) adding bioethics to the topics covered in grand rounds is an important means of elevating ethical awareness within a department or throughout a healthcare organization. Newer is the rounding practice of adding a bioethicist to other established rounding processes, such as case management and utilization review rounds. All of these kinds of ethics rounds are important opportunities to elevate the level of moral discourse within a healthcare setting and are becoming part and parcel of any full-service hospital bioethics program. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Mary J. Reichling (March 29, 1941–July 4, 2023)Barbara KennisonIn the early morning hour on July 4, 2023, Mary died from cancer at the age of 82. On July 8, 2023, her family, professional colleagues, former students, and friends gathered in Holy Family Chapel, Nazareth, Michigan to celebrate her life and legacy. In this sacred space, several in attendance offered expressions regarding Mary’s impact on their life professionally and (...) personally. Reflecting on the words in the music served to provide comfort and solace as did the choir and instrumental interludes. Monsignor Michael Hazard celebrated the mass of Christian Burial.Mary was born on March 28, 1941, in Detroit, Michigan, the oldest child of Clarence and Evangeline Reichling. As a young child, she aspired to becoming a physician and was quickly discouraged by others as this was viewed as a profession for men, not women. Her father, recognizing her talent and interest in music, continued to support her as she pursued her music studies, giving her a high level of confidence and skill in piano performance while still in high school.Her teaching career was launched after completing her undergraduate degree from Nazareth College, Kalamazoo, Michigan, August 5, 1966, her Masters in Music Education from Indiana University in 1969, and a Doctor of Music Education from Indiana University in 1991. [End Page 89]Her initial teaching began at Nazareth College, addressing the academic needs of students holding an interest in music and music education. Mary also provided private lessons to young children, teens, and adults. On several occasions I had the opportunity to observe her work with children and young people and was fascinated by her depth of understanding in addressing not only the musical learning needs of her private students as well as the social and psychological issues that had an impact on their musical abilities.An event stands out in my mind. Two adults, well known to the Kalamazoo community, Father John Grathwohl, Pastor, St Thomas Moore Student Parish, Western Michigan University and Evan LeDuc, Kalamazoo’s City Manager, decided to take violin lessons with Mary as their instructor. They appeared at her studio door, dressed like Dan Aykroyd and John Belushi in the film, The Blues Brothers, as they were wearing long oversized trench coats, black overshoes, black felt crumpled hats, and dark sunglasses, carrying their violin cases, and looking unshaven and disheveled. Mary, seeing them, lost her composure and began to laugh uncontrollably as the two stood there in stoic silence. Regaining her composure, she directed them to their respective chairs in front of music stands, had them take out their violins, and the lesson began. Not only was she respected by these two men but also by all the children and young people in her academic care.Having completed her undergraduate and graduate studies, Mary maintained an intense interest in learning, especially in philosophy and neuroscience with a focus on concepts such as thought, imagination, emotion, movement, space, and time. She was fascinated by the relationship between the performer and the audience, with respect to emotion, images, and imagination. Research for her doctoral dissertation, which she titled, “Images of Imagination: A Philosophical Study of Imagination in Music with Application to Music Education,” is reflective of her interest and research in the neuroscience field. Mary was awarded the Dean’s Dissertation Prize, Indiana University and awarded first place in 1991 Outstanding Dissertation in Music Education, national competition sponsored by the Council for Research in Music Education.In 1991, Mary accepted a position in the Department of Music, University of Louisiana, Lafayette where she taught undergraduate and graduate students. She served as advisor to graduate students in the music education concentration as well as serving on students’ dissertation committees. Her commitment to students was exemplified by her availability, in spite of other commitments to the University and music community beyond the university. The fruits of her professorial activity were evident in graduating students obtaining teaching positions in Lafayette, Vermillion, and Iberia parishes.In an effort to promote the music program and recruit students, she maintained a strong connection with area music teachers. This relationship served to [End Page 90] foster and facilitate high school students... (shrink)

This monograph consists of five parts: (1) introductory material including a conference overview; (2) papers presented at an international symposium on the topic of ethical issues in disability and rehabilitation as a section of the Annual Conference of the Society for Disability Studies; (3) responses to the symposium, prepared by four of the participants; (4) selected additional papers which offer views from perspectives or cultures not represented at the Denver conference; and (5) an annotated international bibliography. Representatives from 10 countries (...) discussed ethical issues and decision making in disability and rehabilitation. Conference papers include: "Genetic Engineering--The New Eugenics? Evolving Medical Attitudes towards the Quality of Life" (Hugh Gallagher);"Description of the Decision-Making Project" (Daryl Evans); "Treatment and Nontreatment Decisions with Respect to Extremely Premature, Very Low Birthweight Infants (500-750g)" (Ernle Young); "Allocation of Resources and Distributive Justice" (John Mather); "Quality Assurance as an Aid to Ethical Decision Making in Disability Management: Lessons from Recent Ethical Issues Involving Disadvantaged Groups in New Zealand" (Peter Gow); "Disability and Ethical Issues: A Point of View from the Netherlands" (Yolan Koster-Dreese); "Who Shall Live or How Shall They Live? Consumer and Professional Perspectives on Treatment/Non-Treatment Decisions" (Joseph Kaufert and Patricia Kaufert); and "Debates across Social Movements on Reproductive Technologies, Genetic Engineering, and Eugenics" (Theresia Degener). Conference commentaries include: "The Meeting of Disability and Bioethics: A Beginning Rapprochement" (Adrienne Asch); "A Plea for More Dialogue: Commentary on Ethics Conference" (Robert Slater); "Healing Our Wounds" (Martha Lentz Walker); "Theories and Values: Ethics and Contrasting Perspectives on Disability" (Harlan Hahn); and "Current Example of Ethical Dilemma" (Susan Lacetti). Selected additional papers include: "High-tech Medicine Is Basic Care" (Frederick Abrams); "Prevention of Disabilities as a Medical Question" (G. Schioler); "The Ethics of Disability Prevention: A Parent's Point of View" (Mrs. J. Baker); "A Reference Matrix for Issues of Life and Personhood" (Mike Miles); "Nazi Scientists and Ethics of Today" (Isabel Wilkerson); "Ethical and Policy Issues in Rehabilitation Medicine (Hastings Center Report)" (Arthur Caplan et al.); and "Differing Approaches to Prevention of Disability and Treatment of Impaired Infants Creates Controversies Worldwide" (Barbara Duncan). (JDD). (shrink)

The particular design of any technology may have profound social implications. Computing technologies are deeply intermeshed with the activities of daily life, playing an ever more central role in how we work, learn, communicate, socialize, and participate in government. Despite the many ways they have improved life, they cannot be regarded as unambiguously beneficial or even value-neutral. Recent experience shows they can lead to unintended but harmful consequences. Some technologies are thought to threaten democracy through the spread of propaganda on (...) online social networks, or to threaten privacy through the aggregation of datasets that include increasingly personal information, or to threaten justice when machine learning is used in such high-stakes, decision-making contexts as loan application reviews, employment procedures, or parole hearings. It is insufficient to ethically assess technology after it has produced negative social impacts, as has happened, for example, with facial recognition software that discriminates against people of color and with self-driving cars that are unable to cope with pedestrians who jay-walk. Developers of new technologies should aim to identify potential harmful consequences early in the design process and take steps to eliminate or mitigate them. This task is not easy. Designers will often have to negotiate among competing values—for instance, between efficiency and accessibility for a diverse user population, or between maximizing benefits and avoiding harm. There is no simple recipe for identifying and solving ethical problems. -/- Computer science education can help meet these challenges by making ethical reasoning about computing technologies a central element in the curriculum. Students can learn to think not only about what technology they could create, but also whether they should create that technology. Learning to reason this way requires courses unlike those currently standard in computer science curricula. A range of university courses on topics in areas of computing, ethics, society and public policy are emerging to meet this need. Some cover computer science broadly, while others focus on specific problems like privacy and security; typically, these classes exist as stand-alone courses in the computer science curriculum. Others have integrated ethics into the teaching of introductory courses on programming, artificial intelligence, and human-computer interaction. (shrink)

my comments focus on jane addams's methode of ethical deliberation, as understood through Dr. Fischer's detailed explication, especially as offered in chapter 2, "An Evolutionary Method of Ethical Deliberation." As Fischer points out, this explication is of one iteration of Jane Addams's method, a particularized response to how Jane Addams believed the settlement residents should respond to the many labor strikes in Chicago during the 1890s. I offer my comments from the perspective of both a scholar, seeking to better apply (...) Addams's insights to my own work, and an educator, seeking to better integrate Addams's work into my teaching. My hope is to flesh out more clearly my own understanding and, in so doing... (shrink)

For a biological anthropologist interested in the prehistory of religion, J. Wentzel van Huyssteen's book is welcome and resonant. Van Huyssteen's central thesis is that humans' capacity for spirituality emerges from a transformation of cognition and emotions that takes place in the symbolic realm, within Homo sapiens and apart from biology. To his thesis I bring to bear three areas of response: the abundant cognitive and emotional capacities of living apes and extinct hominids; the role of symbolic ritual in the (...) evolutionary history of Homo sapiens; and the closely intertwined nature of biology and culture in the workings of evolutionary change. (shrink)

In this article, the author argues that we need to conceptualize gender as a social structure, and by doing so, we can better analyze the ways in which gender is embedded in the individual, interactional, and institutional dimensions of our society. To conceptualize gender as a structure situates gender at the same level of general social significance as the economy and the polity. The author also argues that while concern with intersectionality must continue to be paramount, different structures of inequality (...) have different constructions and perhaps different influential causal mechanisms at any given historical moment. We need to follow a both/and strategy to understand gender structure, race structure, and other structures of inequality as they currently operate while also systematically paying attention to how these axes of domination intersect. Finally, the author suggests we pay more attention to doing research and writing theory with explicit attention to how our work can indeed help transform as well as inform society. (shrink)

The purpose of this article is to re-visit how rationing is defined for a health-care context, Two reasons justify returning to this topic. First, the variability as to how rationing has been defined in the legal, medical, and philosophical literature justifies a careful examination to identify its critical features. Second, I believe that if the definitions typically employed in the literature, several of which are discussed below, are compared to those that would be offered by the American public, ethically weighty (...) dissimilarities would be apparent. Disparate characterizations are worrisome because serious “disconnections” between policymakers’ understandings, rhetoric, and priorities and those of the general public are more likely. (shrink)

The target article tackles an important and complicated issue of the underlying links between curiosity and creativity. Although thought-provoking, the target article overlooks contemporary theories and research on these constructs. Consequently, the proposed model is inconsistent with prior research in the developmental and educational fields and would benefit from better specification and clarity around key constructs and processes.

IPCC SPECIAL REPORT ON CLIMATE CHANGE AND LAND (SRCCL) -/- Chapter 3: Climate Change and Land: An IPCC special report on climate change, desertification, land degradation, sustainable land management, food security, and greenhouse gas fluxes in terrestrial ecosystems.

Relational Ontologies uses the metaphor of a fishing net to represent the epistemological and ontological beliefs that we weave together for our children, to give meaning to their experiences and to help sustain them in their lives. The book describes the epistemological threads we use to help determine what we catch up in our net as the warp threads, and our ontological threads as the weft threads. It asks: what kind of fishing nets are we weaving for our children to (...) help them make sense of their experiences? What weft threads are we including and working to strengthen, and what threads are we removing or leaving out? It is important to carefully re/examine these most basic ways of catching up what sustains us in our ocean of infinite experiences, as the threads we weave for our children will determine what they catch up in their nets, until they are old enough to re/weave their own. Relational Ontologies reweaves America's epistemological and ontological fishing net on a larger scale, turning to indigenous cultures and diverse spiritual beliefs for assistance in reforming American schools. (shrink)

Barbara J. Blodgett proposes a practical sexual ethic for adolescent girls based on a discourse of vulnerability and trust rather than one of erotic liberation. Her work directly challenges feminist theologies of the erotic, which seek to establish the erotic as unquestionably freeing and empowering.Blodgett declares that inconsistent worlds of meaning surround girls' moral deliberation about sexual activity despite their sincere yearning for guidance.This ground-breaking book: -- Critiques feminist theologies of the erotic-- Draws upon actual narratives of adolescent girls (...) about sexuality and romance-- Uses a psychoanalytic theory for Christian ethics-- Points the way to an alternative model of sexual ethics in theological ethics, while factoring in the stark realities of gender, power, and cultureBlodgett suggests relationships are either stabilized by the exercise of trust or friendly distrust. (shrink)

In A Pluralistic Universe, James argues that the world we experience is more than we can describe. Our theories are incomplete, open, and imperfect. Concepts function to try to shape, organize, and describe this open, flowing universe, while the universe continually escapes beyond our artificial boundaries. For James and myself, the universe is unfinished, a “primal stuff” or “pure experience.” However, James starts with parts and moves to wholes, and I want to start from wholes and move to parts and (...) back to wholes again. This is an issue between us I further consider, for while he describes himself as a radical empiricist, emphasizing the parts, my descriptions are in terms of w/holism. I use this opportunity to explore James’s contributions to my metaphor of “pure experience” as being like an infinite Ocean and the fishing nets we create represent our ontologies and epistemologies that help us catch up our experiences and give them meaning. I also make the case for why a better understanding of ontology matters for us as educators, using Maria Montessori’s curriculum and instruction design, Dinè Primary School, and Cajete’s theology of place and culturally based science as examples of relational fishing nets we could be using to teach our children. (shrink)

Clinical ethics consultants represent a multidisciplinary group of scholars and practitioners with varied training backgrounds, who are integrated into a medical environment to assist in the provision of ethically supportable care. Little has been written about the degree to which such consultants are accountable for the patient care outcome of the advice given. We propose a model for examining degrees of internally motivated accountability that range from restricted to unbounded accountability, and support balanced accountability as a goal for practice. Finally, (...) we explore implications of this model for training of clinical ethics consultants from diverse academic backgrounds, including those disciplines that do not have a formal code of ethics relating to clinical practice. (shrink)

Just as Dewey argued during the industrial revolution, from the 1890s–1930s, and Martin argued in the 1960s–1990s with our “second wave” working revolution : today’s times are out of joint, potentially dangerous conflicts exist, and teachers have some responsibility in making things right. We are in another social revolution, as work is changing significantly again, due to advances in technology. Let’s call these current changes in work the technology revolution. Again, we need to rethink our school structures, curriculum, and pedagogy. (...) In an effort to contribute to that process, I direct our attention to the need to redefine work, and re/examine the connections between work and education in this paper. (shrink)