Structured Ethical Review for Wastewater-Based Testing in Support of Public Health.

Wastewater-based testing (WBT) for SARS-CoV-2 has rapidly expanded over the past three years due to its ability to provide a comprehensive measurement of disease prevalence independent of clinical testing. The development and simultaneous application of WBT measured biomarkers for research activities and for the pursuit of public health goals, both areas with well-established ethical frameworks. Currently, WBT practitioners do not employ a standardized ethical review process, introducing the potential for adverse outcomes for WBT professionals and community members. To address this deficiency, an interdisciplinary workshop developed a framework for a structured ethical review of WBT. The workshop employed a consensus approach to create this framework as a set of 11 questions derived from primarily public health guidance. This study retrospectively applied these questions to SARS-CoV-2 monitoring programs covering the emergent phase of the pandemic (3/2020-2/2022 (n = 53)). Of note, 43% of answers highlight a lack of reported information to assess. Therefore, a systematic framework would at a minimum structure the communication of ethical considerations for applications of WBT. Consistent application of an ethical review will also assist in developing a practice of updating approaches and techniques to reflect the concerns held by both those practicing and those being monitored by WBT supported programs.

Addressing Ethical Challenges in US-Based HIV Phylogenetic Research.

In recent years, phylogenetic analysis of HIV sequence data has been used in research studies to investigate transmission patterns between individuals and groups, including analysis of data from HIV prevention clinical trials, in molecular epidemiology, and in public health surveillance programs. Phylogenetic analysis can provide valuable information to inform HIV prevention efforts, but it also has risks, including stigma and marginalization of groups, or potential identification of HIV transmission between individuals. In response to these concerns, an interdisciplinary working group was assembled to address ethical challenges in US-based HIV phylogenetic research. The working group developed recommendations regarding (1) study design; (2) data security, access, and sharing; (3) legal issues; (4) community engagement; and (5) communication and dissemination. The working group also identified areas for future research and scholarship to promote ethical conduct of HIV phylogenetic research.

From Scope to Screen: The Evolution of Histology Education.

Histology, the branch of anatomy also known as microscopic anatomy, is the study of the structure and function of the body's tissues. To gain an understanding of the tissues of the body is to learn the foundational underpinnings of anatomy and achieve a deeper, more intimate insight into how the body is constructed, functions, and undergoes pathological change. Histology, therefore, is an integral element of basic science education within today's medical curricula. Its development as a discipline is inextricably linked to the evolution of the technology that allows us to visualize it. This chapter takes us on the journey through the past, present, and future of histology and its education; from technologies grounded in ancient understanding and control of the properties of light, to the ingenuity of crafting glass lenses that led to the construction of the first microscopes; traversing the second revolution in histology through the development of modern histological techniques and methods of digital and virtual microscopy, which allows learners to visualize histology anywhere, at any time; to the future of histology that allows flexible self-directed learning through social media, live-streaming, and virtual reality as a result of the powerful smart technologies we all carry around in our pockets. But, is our continuous pursuit of technological advancement projecting us towards a dystopian world where machines with artificial intelligence learn how to read histological slides and diagnose the diseases in the very humans that built them?

Ethics and subsequent use of electronic health record data.

The digital health landscape in the United States is evolving and electronic health record data hold great promise for improving health and health equity. Like many scientific and technological advances in health and medicine, there exists an exciting narrative about what we can do with the new technology, as well as reflection about what we should do with it based on what we value. Ethical reflections about the use of EHR data for research and quality improvement have considered the important issues of privacy and informed consent for subsequent use of data. Additional ethical aspects are important in the conversation, including data validity, patient obligation to participate in the learning health system, and ethics integration into training for all personnel who interact with personal health data. Attention to these ethical issues is paramount to our realizing the benefits of electronic health data.

A Bridge Back to the Future: Public Health Ethics, Bioethics, and Environmental Ethics.

Contemporary biomedical ethics and environmental ethics share a common ancestry in Aldo Leopold's and Van Rensselaer Potter's initial broad visions of a connected biosphere. Over the past five decades, the two fields have become strangers. Public health ethics, a new subfield of bioethics, emerged from the belly of contemporary biomedical ethics and has evolved over the past 25 years. It has moved from its traditional concern with the tension between individual autonomy and community health to a wider focus on social justice and solidarity. Public health has a broad focus that includes individual, community, and environmental health. Public health ethics attends to these broad commitments reflected in the increasing concern with the connectedness of health of individuals to the health of populations, to the health of animals, to the health of the environment; it is well situated to reconnect all three "fields" of ethics to promote a healthier planet.

Defining the Boundaries of a Right to Adequate Protection: A New Lens on Pediatric Research Ethics.

We argue that the current ethical and regulatory framework for permissible risk levels in pediatric research can be helpfully understood in terms of children's moral right to adequate protection from harm. Our analysis provides a rationale for what we propose as the highest level of permissible risk in pediatric research without the prospect of direct benefit: what we call "relatively minor" risk. We clarify the justification behind the usual standards of "minimal risk" and "a minor increase over minimal risk" and explain why it is permissible to impose any risks at all on child participants who do not stand to benefit directly from enrollment in research. Finally, we illuminate some aspects of the concept of "best interests."

Adding justice to the clinical and public health ethics arguments for mandatory seasonal influenza immunisation for healthcare workers.

Ethical considerations from both the clinical and public health perspectives have been used to examine whether it is ethically permissible to mandate the seasonal influenza vaccine for healthcare workers (HCWs). Both frameworks have resulted in arguments for and against the requirement. Neither perspective resolves the question fully. By adding components of justice to the argument, I seek to provide a more fulsome ethical defence for requiring seasonal influenza immunisation for HCWs. Two critical components of a just society support requiring vaccination: fairness of opportunity and the obligation to follow democratically formulated rules. The fairness of opportunity is informed by Rawls' two principles of justice. The obligation to follow democratically formulated rules allows us to focus simultaneously on freedom, plurality and solidarity. Justice requires equitable participation in and benefit from cooperative schemes to gain or profit socially as individuals and as a community. And to be just, HCW immunisation exemptions should be limited to medical contraindications only. In addition to the HCWs fiduciary duty to do what is best for the patient and the public health duty to protect the community with effective and minimally intrusive interventions, HCWs are members of a just society in which all members have an obligation to participate equitably in order to partake in the benefits of membership.

When a blood donor has sickle cell trait: incidental findings and public health.

There are no national recommendations for routine screening for sickle cell trait, nor is there guidance on whether or how to notify donors that they might be tested or identified as having sickle cell trait. As a result, the organizations that collect blood have implemented variable policies about whether and how to inform prospective donors of the possible screening and discovery of this noncommunicable condition. The question of what they should do is related to the broader question of how to handle incidental and secondary findings. In a recent report, the Presidential Commission for the Study of Bioethical Issues outline a framework for handling such findings in the clinical, research, and direct-to-consumer contexts. While the commission's report did not directly address incidental and secondary findings in the public health context of blood donation, it made several overarching recommendations that apply in all contexts where such findings might arise. This essay outlines the special issues raised by discovering sickle cell trait in blood donation and considers the implications of the commission's framework for that problem.

Teaching bioethics.

From accessible and affordable health care to old or new reproductive technologies, human or animal research, and beyond, the justice and well-being of our society depends on the ability of key groups-such as scientists and health care providers-along with members of the public to identify the key issues, articulate their values and concerns, deliberate openly and respectfully, and together find the most defensible ways forward. The Presidential Commission for the Study of Bioethical Issues and The Hastings Center are committed to improving the ethical literacy of the American public in the domain of bioethics. But what are the best educational practices to spur and support these sorts of societal conversations? And where are the greatest gaps in our collective knowledge of how best to inspire and increase moral understanding, analytical thinking in the moral domain, and professional integrity?

Making waves: The benefits and challenges of responsibly implementing wastewater-based surveillance for rural communities.

The sampling and analysis of sewage for pathogens and other biomarkers offers a powerful tool for monitoring and understanding community health trends and potentially predicting disease outbreaks. Since the early months of the COVID-19 pandemic, the use of wastewater-based testing for public health surveillance has increased markedly. However, these efforts have focused on urban and peri­urban areas. In most rural regions of the world, healthcare service access is more limited than in urban areas, and rural public health agencies typically have less disease outcome surveillance data than their urban counterparts. The potential public health benefits of wastewater-based surveillance for rural communities are therefore substantial - though so too are the methodological and ethical challenges. For many rural communities, population dynamics and insufficient, aging, and inadequately maintained wastewater collection and treatment infrastructure present obstacles to the reliable and responsible implementation of wastewater-based surveillance. Practitioner observations and research findings indicate that for many rural systems, typical implementation approaches for wastewater-based surveillance will not yield sufficiently reliable or actionable results. We discuss key challenges and potential strategies to address them. However, to support and expand the implementation of responsible, reliable, and ethical wastewater-based surveillance for rural communities, best practice guidelines and standards are needed.

Expected ethical competencies of public health professionals and graduate curricula in accredited schools of public health in North America.

OBJECTIVES: We assessed expected ethics competencies of public health professionals in codes and competencies, reviewed ethics instruction at schools of public health, and recommended ways to bridge the gap between them. METHODS: We reviewed the code of ethics and 3 sets of competencies, separating ethics-related competencies into 3 domains: professional, research, and public health. We reviewed ethics course requirements in 2010-2011 on the Internet sites of 46 graduate schools of public health and categorized courses as required, not required, or undetermined. RESULTS: Half of schools (n = 23) required an ethics course for graduation (master's or doctoral level), 21 did not, and 2 had no information. Sixteen of 23 required courses were 3-credit courses. Course content varied from 1 ethics topic to many topics addressing multiple ethics domains. CONCLUSIONS: Consistent ethics education and competency evaluation can be accomplished through a combination of a required course addressing the 3 domains, integration of ethics topics in other courses, and "booster" trainings. Enhancing ethics competence of public health professionals is important to address the ethical questions that arise in public health research, surveillance, practice, and policy.

Research integrity and the regulatory-industrial complex.

Integrity in research is essential so that research can do what it is supposed to do: help us discover - or get closer to - the truth about the world and how it works. Research integrity means conducting oneself in ways that are worthy of the trust that the public invests in science. Efforts over the past five decades to ensure that researchers conduct themselves with integrity have focused on regulating researcher behavior. The suite of regulatory requirements - over 100 of them - is typically managed by an office of research compliance at universities and research institutions. The regulations, and the accompanying rules and policies, have created a regulatory-industrial complex that, while necessary, should give us pause. With the proliferation of regulations, professional organizations and certifications blossom, providing much-needed training and vouching for expertise in particular regulations. This credibility is crucial, but it also gives a false impression that we can regulate our way to ethical science. Creating a regulatory-industrial complex will not achieve our goal of an ethical research enterprise. We need to build ethical institutional cultures, engage the commitment of the entire research enterprise, and do the hard work of holding accountable the entire research ecosystem.

Timing and monitoring of financial disclosures in publications: A cross-institutional assessment of financial conflict of interest reports.

A consistent mitigation strategy used in sponsored research to manage a financial conflict of interest (FCOI) is disclosure in publications. While federal funding regulations require mitigation strategies to be monitored through the end of the project's term, manuscripts are often published after the project term has ended. We examined whether it would be valuable to extend monitoring of publications for compliance with requirements for disclosure beyond the end date of a project's term and, if so, for how long after the term has ended. Using publicly available databases, we identified FCOI reports from public universities and analyzed disclosure completion in the years before and after the end of the project's term. We found that 80.2% of FCOI reports in our sample had a publication in which a conflicted Investigator served as an author, yet less than half (43.6%) of these publications contained disclosure statements acknowledging the known FCOI. We also found that publication most commonly occurred one year after the end of the project's term. These findings indicate that an effective way to support accountability and accuracy of the scientific record would be to extend monitoring of disclosure in publications through one year following the end of the project's term.

Structured Ethical Review for Wastewater-Based Testing.

Wastewater-based testing (WBT) for SARS-CoV-2 has rapidly expanded over the past three years due to its ability to provide a comprehensive measurement of disease prevalence independent of clinical testing. The development and simultaneous application of the field blurred the boundary between measuring biomarkers for research activities and for pursuit of public health goals, both areas with well-established ethical frameworks. Currently, WBT practitioners do not employ a standardized ethical review process (or associated data management safeguards), introducing the potential for adverse outcomes for WBT professionals and community members. To address this deficiency, an interdisciplinary group developed a framework for a structured ethical review of WBT. The workshop employed a consensus approach to create this framework as a set of 11-questions derived from primarily public health guidance because of the common exemption of wastewater samples to human subject research considerations. This study retrospectively applied the set of questions to peer- reviewed published reports on SARS-CoV-2 monitoring campaigns covering the emergent phase of the pandemic from March 2020 to February 2022 (n=53). Overall, 43% of the responses to the questions were unable to be assessed because of lack of reported information. It is therefore hypothesized that a systematic framework would at a minimum improve the communication of key ethical considerations for the application of WBT. Consistent application of a standardized ethical review will also assist in developing an engaged practice of critically applying and updating approaches and techniques to reflect the concerns held by both those practicing and being monitored by WBT supported campaigns. Synopsis: Development of a structured ethical review facilitates retrospective analysis of published studies and drafted scenarios in the context of wastewater-based testing.

Ethical justification for conducting public health surveillance without patient consent.

Public health surveillance by necessity occurs without explicit patient consent. There is strong legal and scientific support for maintaining name-based reporting of infectious diseases and other types of public health surveillance. We present conditions under which surveillance without explicit patient consent is ethically justifiable using principles of contemporary clinical and public health ethics. Overriding individual autonomy must be justified in terms of the obligation of public health to improve population health, reduce inequities, attend to the health of vulnerable and systematically disadvantaged persons, and prevent harm. In addition, data elements collected without consent must represent the minimal necessary interference, lead to effective public health action, and be maintained securely.

How Should Clinicians Own Their Roles as Past and Present Exacerbators of Health Inequity and as Present and Future Contributors to Health Equity?

To improve health outcomes, the science and practice of medicine must move quickly in response to new information. Yet, in other important ways, health professionals must operate slowly and in a mode of intentional stillness to center empathy and light a path from empathy to solidarity. Solidarity, or standing with, prompts efforts to create circumstances in which disadvantaged communities can achieve health equity. This article argues for intentional stillness and solidarity to inspire ethical conduct and structural change. In the case presented, inaction and delay, which are neither virtuous nor antiracist forms of stillness in this context, would leave intact the status quo of disparity and inequity in cardiac medicine.

Transition to Effective Online Anatomical Sciences Teaching and Assessments in the Pandemic Era of COVID-19 Should be Evidence-Based.

The world has changed rapidly since the emergence of the COVID-19 pandemic, and the education community has not been immune to these changes. With abrupt school closings and a rapid transition to online teaching and learning, the educational technologies have been stretched to their limits and pedagogic approaches blossomed. As the world strives to reestablish normalcy, it will be under the influence of the long-lasting impact of the pandemic. This manuscript provides recommendations for the online conversion of anatomical sciences curricula in health sciences programs. Strategic guidelines are emerging for building on these changes to enhance teaching and learning in the current pandemic era.