Enacting Relational Public Health: Federally Qualified Health Centers During the COVID-19 Pandemic.

Federally Qualified Health Centers (FQHCs) proved to be critical points of access for people of color and other underserved populations during the COVID-19 pandemic, administering 61% of their COVID-19 vaccinations to people of color, compared to the 40% rate for the overall United States' vaccination effort. To better understand the approaches and outcomes of FQHCs in pandemic response, we conducted semi-structured interviews with FQHC health care providers and outreach workers and analyzed them using an inductive qualitative methodology.

"We're Here to Take Care of Our Community": Lessons Learned From the U.S. Federal Health Center Covid-19 Vaccine Program.

Equitable access to vaccination is crucial to mitigating the disproportionate impact of Covid-19 on low-income communities and people of color in the United States. As primary care clinics for medically underserved patients, Federally Qualified Health Centers (FQHCs) emerged as a success story in the national effort to vaccinate the U.S. public against Covid-19. In February 2021, the Federal Health Center Covid-19 Vaccine Program began allocating vaccine supply directly to FQHCs in an effort to improve vaccine equity. This qualitative study documents how FQHCs in two states successfully mitigated barriers to vaccine access, responded to patient concerns about vaccination, and worked to maintain and grow community trust in a climate of uncertainty and fear during early vaccine roll-out to the general population. Using a socio-ecological model, we show how FQHCs intervened at multiple levels to advance vaccine equity, revealing valuable lessons for health promotion practice in primary care settings or underserved communities. Our findings provide descriptive context for existing quantitative evidence showing FQHCs' greater success in vaccinating people of color, and foreground valuable and innovative strategies for trustworthy health communication practices and equitable resource allocation to medically underserved patients and populations.

Cultivating Peace and Health at Community Health Centers.

Founded on a commitment to social justice and health equity, community health centers in the United States provide high-quality primary care to underserved populations and address social drivers of health disparities. Through an examination of two books on the history of community health centers, Peace & Health: How a Group of Small-Town Activists and College Students Set Out to Change Healthcare, by Charles Barber, and Community Health Centers: A Movement and the People Who Made It Happen, by Bonnie Lefkowitz, this essay provides insight into what it takes to center social justice in community-based health care organizations. As bioethics reorganizes itself around an emphasis on justice, scholars in bioethics have much to learn from colleagues in community health.

All of Us and the Promise of Precision Medicine: Achieving Equitable Access for Federally Qualified Health Center Patients.

The United States National Institutes of Health's (NIH) All of Us (AoU) initiative recruits participants from diverse backgrounds to improve the makeup of biobanks, considering nearly all biospecimens used in research come from people of European ancestry. Participants who join AoU consent to provide samples of blood, urine, and/or saliva and to submit their electronic health record to the program. In addition to diversifying precision medicine research studies, AoU will return genetic results back to many participants, which may require further follow-up care (i.e., more frequent cancer screening or mastectomy after a BRCA result). To help achieve its goals, AoU has partnered with Federally Qualified Health Centers (FQHCs), which is a type of community health center whose patient base is comprised largely of people who are uninsured, underinsured, or on Medicaid. Our NIH-funded study convened FQHC providers involved in AoU to better understand precision medicine in community health settings. Drawing from our findings, we present barriers community health patients and their providers face when accessing diagnostics and specialty care after genetic results necessitate medical follow-up care. We also propose several policy and financial recommendations to help overcome the challenges discussed, stemming from a commitment to equitable access to precision medicine advances.

Threats to Benefits: Assessing Knowledge Production in Nonhuman Models of Human Neuropsychiatric Disorders.

Recent reports and papers on chimeric research highlight the promise of chimeric models of human neuropsychiatric disorders to ameliorate human suffering due to autism spectrum disorders, depression, and schizophrenia. These calls, however, typically do not acknowledge, much less address, criticisms of model creation and validation, or concerns about scientific conduct more generally. The ethical justification for the use of nonhuman animals in research depends on the production of benefits to humans based on such research. But the assessment and production of benefits are highly uncertain and rife with both practical and conceptual challenges. This essay provides a general framework for classifying the benefits of biomedical research and then focuses on two factors that directly impact-and threaten-the production of knowledge in research that models neuropsychiatric disorders.

Clarifying the Ethics and Oversight of Chimeric Research.

This article is the lead piece in a special report that presents the results of a bioethical investigation into chimeric research, which involves the insertion of human cells into nonhuman animals and nonhuman animal embryos, including into their brains. Rapid scientific developments in this field may advance knowledge and could lead to new therapies for humans. They also reveal the conceptual, ethical, and procedural limitations of existing ethics guidance for human-nonhuman chimeric research. Led by bioethics researchers working closely with an interdisciplinary work group, the investigation focused on generating conceptual clarity and identifying improvements to governance approaches, with the goal of helping scholars, funders, scientists, institutional leaders, and oversight bodies (embryonic stem cell research oversight [ESCRO] committees and institutional animal care and use committees [IACUCs]) deliver principled and trustworthy oversight of this area of science. The article, which focuses on human-nonhuman animal chimeric research that is stem cell based, identifies key ethical issues in and offers ten recommendations regarding the ethics and oversight of this research. Turning from bioethics' previous focus on human-centered questions about the ethics of "humanization" and this research's potential impact on concepts like human dignity, this article emphasizes the importance of nonhuman animal welfare concerns in chimeric research and argues for less-siloed governance and oversight and more-comprehensive public communication.

Public Deliberation about Gene Editing in the Wild.

Genetic editing technologies have long been used to modify domesticated nonhuman animals and plants. Recently, attention and funding have also been directed toward projects for modifying nonhuman organisms in the shared environment-that is, in the "wild." Interest in gene editing nonhuman organisms for wild release is motivated by a variety of goals, and such releases hold the possibility of significant, potentially transformative benefit. The technologies also pose risks and are often surrounded by a high uncertainty. Given the stakes, scientists and advisory bodies have called for public engagement in the science, ethics, and governance of gene editing research in nonhuman organisms. Most calls for public engagement lack details about how to design a broad public deliberation, including questions about participation, how to structure the conversations, how to report on the content, and how to link the deliberations to policy. We summarize the key design elements that can improve broad public deliberations about gene editing in the wild.

Civic Learning for a Democracy in Crisis.

This essay introduces a special report from The Hastings Center entitled Democracy in Crisis: Civic Learning and the Reconstruction of Common Purpose, which grew out of a project supported by the John S. and James L. Knight Foundation. This multiauthored report offers wide-ranging assessments of increasing polarization and partisanship in American government and politics, and it proposes constructive responses to this in the provision of objective information, institutional reforms in government and the electoral system, and a reexamination of cultural and political values needed if democracy is to function well in a pluralistic and diverse society. The essays in the special report explore the norms of civic learning and institutions, social movements, and communal innovations that can revitalize civic learning in practice. This introductory essay defines and explains the notion of civic learning, which is a lynchpin connecting many of the essays in the report. Civic learning pertains to the ways in which citizens learn about collective social problems and make decisions about them that reflect the duties and responsibilities of citizenship. Such learning can occur in many social settings in everyday life, and it can also be facilitated through participation in the processes of democratic governance on many levels. Civic learning is not doctrinaire and is compatible with a range of public goals and policies. It is an activity that increases what might be called the democratic capability of a people.

Recommendations for Better Civic Learning: Building and Rebuilding Democracy.

This is the concluding essay for a special report from The Hastings Center entitled Democracy in Crisis: Civic Learning and the Reconstruction of Common Purpose, which grew out of a project supported by the John S. and James L. Knight Foundation. This essay provides an integrative discussion of various theoretical and practical reform perspectives offered by other essays in the report. It also offers a number of recommendations. It notes that the aim of the special report is not to propose specific reform measures but, rather, to consider larger, more theoretic concerns related to political and economic questions, which are personal and structural-psychological, cultural, and institutional-at the same time. In response, this essay argues that the best relationship between the citizenry and government in a democracy is not one of deference, nor one of contestation, but one that is critically constructive, which in turn is linked to practices of civic learning. To be constructive, citizens need scientific literacy, an understanding of how government and other institutions work, critical thinking abilities, and many open and diverse forums for civic learning to offset the increasingly isolating media "bubbles" that are the only source of information for many. The essay then formulates five recommendations designed to facilitate critically constructive citizenship and civic learning. These are creating a basis for civic participation, acquiring information, talking to each other, designing institutional change, and achieving deliberation.

Does Solidarity Require "All of Us" to Participate in Genomics Research?

In this paper, I interrogate an ethical obligation to participate in genomics research on the basis of solidarity. I explore two different ways in which solidarity is used to motivate participation in genomics research: as an appeal to participate in genomic research because it cultivates solidarity and as an appeal to participate in genomic research because it expresses solidarity. I critique those appeals and draw lessons from them for how we ought to understand solidarity. The working definition of solidarity that I defend is that solidarity involves recognizing another creature, person, or persons as, like ourselves, vulnerable to injustice and entails acting in ways that contribute to creating, reforming, and participating in institutions that are aimed at enhancing their flourishing. I argue that participating in genomics research is not an expression of solidarity. Participation in research may be praiseworthy, a "good thing to do," but actually cultivating and expressing solidarity requires much more of us.

Reevaluating Benefits in the Moral Justification of Animal Research: A Comment on "Necessary Conditions for Morally Responsible Animal Research".

In a recent paper in Cambridge Quarterly of Healthcare Ethics on the necessary conditions for morally responsible animal research David DeGrazia and Jeff Sebo claim that the key requirements for morally responsible animal research are (1) an assertion of sufficient net benefit, (2) a worthwhile-life condition, and (3) a no-unnecessary-harm condition. With regards to the assertion (or expectation) of sufficient net benefit (ASNB), the authors claim that morally responsible research offers unique benefits to humans that outweigh the costs and harms to humans and animals. In this commentary we will raise epistemic, practical, and ethical challenges to DeGrazia and Sebo's emphasis on benefits in the prospective assessment of research studies involving animals. We do not disagree with DeGrazia and Sebo that, at the theoretical level, the benefits of research justify our using animals. Our contribution intends to clarify, at the practical level, how we should understand benefits in the prospective assessment and moral justification of animal research. We argue that ASNB should be understood as an assessment of Expectation of Knowledge Production (EKP) in the prospective assessment and justification of animal research. EKP breaks down into two further claims: (1) that morally responsible research generates knowledge worth having and (2) that morally responsible research is designed and executed to produce generalizable knowledge. We understand the condition called knowledge worth having as scientists' testing a hypothesis that, whether verified or falsified, advances an important interest, and production of generalizable knowledge in terms of scientific integrity. Generalizable knowledge refers to experimental results that generalize to a larger population beyond the animals studied. Generalizable scientific knowledge is reliable, replicable, and accurately descriptive. In sum, morally responsible research will be designed and carefully executed to successfully test a hypothesis that, whether verified or falsified, advances important interests. Our formulation of EKP, crucially, does not require further showing that an experiment involving animals will produce societal benefits.

Gene Doping-in Animals? Ethical Issues at the Intersection of Animal Use, Gene Editing, and Sports Ethics.

Gene editors such as CRISPR could be used to create stronger, faster, or more resilient nonhuman animals. This is of keen interest to people who breed, train, race, and profit off the millions of animals used in sport that contribute billions of dollars to legal and illegal economies across the globe. People have tried for millennia to perfect sport animals; CRISPR proposes to do in one generation what might have taken decades previously. Moreover, gene editing may facilitate enhancing animals' capacities beyond their typical limits. This paper describes the state of animal use and engineering for sport, examines the moral status of animals, and analyzes current and future ethical issues at the intersection of animal use, gene editing, and sports. We argue that animal sport enthusiasts and animal welfarists alike should be concerned about the inevitable use of CRISPR in sport animals. Though in principle CRISPR could be used to improve sport animals' well-being, we think it is unlikely in practice to do so.

Compassionate use of gene therapies in pediatrics: An ethical analysis.

In this commentary, we raise concerns about the compassionate use of CRISPR-mediated gene therapies in pediatric and perinatal patients. There is already a precedent for obtaining gene therapies for pediatric patients through compassionate use programs, and the recent passage of a federal Right to Try law may contribute to an increase in the number of patients who seek access to investigational products outside of a clinical trial. Clinicians, nurses, drug companies, and parents need support as they grapple with whether compassionate use of CRISPR-mediated gene therapies is the right thing to pursue for a child. We raise three issues to consider in that decision: (1) the effects of compassionate use on scientific research; (2) hype and harms of gene therapies; and (3) the limits and scope of parental authority.

National Standards for Public Involvement in Research: missing the forest for the trees.

Biomedical research funding bodies across Europe and North America increasingly encourage-and, in some cases, require-investigators to involve members of the public in funded research. Yet there remains a striking lack of clarity about what 'good' or 'successful' public involvement looks like. In an effort to provide guidance to investigators and research organisations, representatives of several key research funding bodies in the UK recently came together to develop the National Standards for Public Involvement in Research. The Standards have critical implications for the future of biomedical research in the UK and in other countries as researchers and funders abroad look to the Standards as a model for their own policy development. We assess the Standards and find that despite offering useful suggestions for dealing with practical challenges associated with public involvement, the Standards fail to address fundamental questions about when, why and with whom public involvement should be undertaken in the first place. We show that presented without this justificatory context, many of the recommendations in the Standards are, at best, fragments that require substantial elaboration by those looking to apply the Standards in their own work and, at worst, subject to potentially harmful misapplication by well-meaning investigators. As funding bodies increasingly push for public involvement in research, the key lesson of our analysis is that future recommendations about how public involvement should be conducted cannot be coherently formulated without a clear sense of the underlying goals and rationales for public involvement.

A Radical Approach to Ebola: Saving Humans and Other Animals.

As the usual regulatory framework did not fit well during the last Ebola outbreak, innovative thinking still needed. In the absence of an outbreak, randomised controlled trials of clinical efficacy in humans cannot be done, while during an outbreak such trials will continue to face significant practical, philosophical, and ethical challenges. This article argues that researchers should also test the safety and effectiveness of novel vaccines in wild apes by employing a pluralistic approach to evidence. There are three reasons to test vaccines in wild populations of apes: i) protect apes; ii) reduce Ebola transmission from wild animals to humans; and iii) accelerate vaccine development and licensing for humans. Data obtained from studies of vaccines among wild apes and chimpanzees may even be considered sufficient for licensing new vaccines for humans. This strategy will serve to benefit both wild apes and humans.