Doing Justice: Ethical Considerations Identifying and Researching Transgender and Gender Diverse People in Insurance Claims Data.

Data on the health of transgender and gender diverse (TGD) people are scarce. Researchers are increasingly turning to insurance claims data to investigate disease burden among TGD people. Since claims do not include gender self-identification or modality (i.e., TGD or not), researchers have developed algorithms to attempt to identify TGD individuals using diagnosis, procedure, and prescription codes, sometimes also inferring sex assigned at birth and gender. Claims-based algorithms introduce epistemological and ethical complexities that have yet to be addressed in data informatics, epidemiology, or health services research. We discuss the implications of claims-based algorithms to identify and categorize TGD populations, including perpetuating cisnormative biases and dismissing TGD individuals' self-identification. Using the framework of epistemic injustice, we outline ethical considerations when undertaking claims-based TGD health research and provide suggestions to minimize harms and maximize benefits to TGD individuals and communities.

Ethical Imperatives for Working With Diverse Populations in Digital Research.

Digital research methodologies are driving a revolution in health technology but do not yet fully engage diverse and historically underrepresented populations. In this paper, we explore the ethical imperative for such engagement alongside accompanying challenges related to recruitment, appreciation of risk, and confidentiality, among others. We critically analyze existing research ethics frameworks and find that their reliance on individualistic and autonomy-focused models of research ethics does not offer adequate protection in the context of the diversity imperative. To meet the requirements of justice and inclusivity in digital research, methods will benefit from a reorientation toward more participatory practices.

How Do Scientists Perceive the Relationship Between Ethics and Science? A Pilot Study of Scientists' Appeals to Values.

Efforts to promote responsible conduct of research (RCR) should take into consideration how scientists already conceptualize the relationship between ethics and science. In this study, we investigated how scientists relate ethics and science by analyzing the values expressed in interviews with fifteen science faculty members at a large midwestern university. We identified the values the scientists appealed to when discussing research ethics, how explicitly they related their values to ethics, and the relationships between the values they appealed to. We found that the scientists in our study appealed to epistemic and ethical values with about the same frequency, and much more often than any other type of value. We also found that they explicitly associated epistemic values with ethical values. Participants were more likely to describe epistemic and ethical values as supporting each other, rather than trading off with each other. This suggests that many scientists already have a sophisticated understanding of the relationship between ethics and science, which may be an important resource for RCR training interventions.

The Ethics of Implementing Emergency Resource Allocation Protocols.

AbstractWe explore the various ethical challenges that arise during the practical implementation of an emergency resource allocation protocol. We argue that to implement an allocation plan in a crisis, a hospital system must complete five tasks: (1) formulate a set of general principles for allocation, (2) apply those principles to the disease at hand to create a concrete protocol, (3) collect the data required to apply the protocol, (4) construct a system to implement triage decisions with those data, and (5) create a system for managing the consequences of implementing the protocol, including the effects on those who must carry out the plan, the medical staff, and the general public. Here we illustrate the complexities of each task and provide tentative solutions, by describing the experiences of the Coronavirus Ethics Response Group, an interdisciplinary team formed to address the ethical issues in pandemic resource planning at the University of Rochester Medical Center. While the plan was never put into operation, the process of preparing for emergency implementation exposed ethical issues that require attention.

Health Security and Risk Aversion.

Health security has become a popular way of justifying efforts to control catastrophic threats to public health. Unfortunately, there has been little analysis of the concept of health security, nor the relationship between health security and other potential aims of public health policy. In this paper I develop an account of health security as an aversion to risky policy options. I explore three reasons for thinking risk avoidance is a distinctly worthwhile aim of public health policy: (i) that security is intrinsically valuable, (ii) that it is necessary for social planning and (iii) that it is an appropriate response to decision-making in contexts of very limited information. Striking the right balance between securing and maximizing population health thus requires a substantive, and hitherto unrecognized, value judgment. Finally, I critically evaluate the current health security agenda in light of this new account of the concept and its relationship to the other aims of public health policy.

The limits of global health diplomacy: Taiwan's observer status at the world health assembly.

In 2009, health authorities from Taiwan (under the name "Chinese Taipei")a formally attended the 62nd World Health Assembly (WHA) of the World Health Organization as observers, marking the country's participation for the first time since 1972. The long process of negotiating this breakthrough has been cited as an example of successful global health diplomacy. This paper analyses this negotiation process, drawing on government documents, formal representations from both sides of the Taiwan Strait, and key informant interviews. The actors and their motivations, along with the forums, practices and outcomes of the negotiation process, are detailed. While it is argued that non-traditional diplomatic action was important in establishing the case for Taiwan's inclusion at the WHA, traditional concerns regarding Taiwanese sovereignty and diplomatic representation ultimately played a decisive role. The persistent influence of these traditional diplomatic questions illustrates the limits of global health diplomacy.

Live liver donation, ethics and practitioners: 'I am between the two and if I do not feel comfortable about this situation, I cannot proceed'.

This paper discusses the views of 17 healthcare practitioners involved with transplantation on the ethics of live liver donations (LLDs). Donations between emotionally related donor and recipients (especially from parents to their children) increased the acceptability of an LLD compared with those between strangers. Most healthcare professionals (HCPs) disapproved of altruistic stranger donations, considering them to entail an unacceptable degree of risk taking. Participants tended to emphasise the need to balance the harms of proceeding against those of not proceeding, rather than calculating the harm-to-benefits ratio of donor versus recipient. Participants' views suggested that a complex process of negotiation is required, which respects the autonomy of donor, recipient and HCP. Although they considered that, of the three, donor autonomy is of primary importance, they also placed considerable weight on their own autonomy. Our participants suggest that their opinions about acceptable risk taking were more objective than those of the recipient or donor and were therefore given greater weight. However, it was clear that more subjective values were also influential. Processes used in live kidney donation (LKD) were thought to be a good model for LLD, but our participants stressed that there is a danger that patients may underestimate the risks involved in LLD if it is too closely associated with LKD.

Academic freedom and the professional responsibilities of applied ethicists: a comment on Minerva.

Academic freedom is an important good, but it comes with several responsibilities. In this commentary we seek to do two things. First, we argue against Francesca Minerva's view of academic freedom as presented in her article 'New threats to academic freedom' on a number of grounds. We reject the nature of the absolutist moral claim to free speech for academics implicit in the article; we reject the elitist role for academics as truth-seekers explicit in her view; and we reject a possible more moderate re-construction of her view based on the harm/offence distinction. Second, we identify some of the responsibilities of applied ethicists, and illustrate how they recommend against allowing for anonymous publication of research. Such a proposal points to the wider perils of a public discourse which eschews the calm and careful discussion of ideas.

Expanding the role of justice in secondary research using digital psychological data.

Secondary analysis of digital psychological data (DPD) is an increasingly popular method for behavioral health research. Under current practices, secondary research does not require human subjects research review so long as data are de-identified. We argue that this standard approach to the ethics of secondary research (i.e., de-identification) does not address a range of ethical risks and that greater emphasis should be placed on the ethical principle of justice. We outline the inadequacy of an individually focused research ethic for DPD and describe unaddressed "social risks" generated by secondary research of DPD. These risks exist in the "circumstances of justice": that is, a circumstance where individuals must cooperate to create a public good (e.g., research knowledge), and where it is impractical to individually exempt individuals. This requires researchers to emphasize the just allocation of benefits and burdens against a background of social cooperation. We explore six considerations for researchers who wish to conduct research with DPD without explicit consent: (a) create socially valuable knowledge, (b) fairly share the benefits and burdens of research, (c) be transparent about data use, (d) create mechanisms for withdrawal of data, (e) ensure that stakeholders can provide input into the design and implementation of the research, and (f) responsibly report results. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Investigating ethical tradeoffs in crisis standards of care through simulation of ventilator allocation protocols.

INTRODUCTION: Arguments over the appropriate Crisis Standards of Care (CSC) for public health emergencies often assume that there is a tradeoff between saving the most lives, saving the most life-years, and preventing racial disparities. However, these assumptions have rarely been explored empirically. To quantitatively characterize possible ethical tradeoffs, we aimed to simulate the implementation of five proposed CSC protocols for rationing ventilators in the context of the COVID-19 pandemic. METHODS: A Monte Carlo simulation was used to estimate the number of lives saved and life-years saved by implementing clinical acuity-, comorbidity- and age-based CSC protocols under different shortage conditions. This model was populated with patient data from 3707 adult admissions requiring ventilator support in a New York hospital system between April 2020 and May 2021. To estimate lives and life-years saved by each protocol, we determined survival to discharge and estimated remaining life expectancy for each admission. RESULTS: The simulation demonstrated stronger performance for age-sensitive protocols. For a capacity of 1 bed per 2 patients, ranking by age bands saves approximately 29 lives and 3400 life-years per thousand patients. Proposed protocols from New York and Maryland which allocated without considering age saved the fewest lives (~13.2 and 8.5 lives) and life-years (~416 and 420 years). Unlike other protocols, the New York and Maryland algorithms did not generate significant disparities in lives saved and life-years saved between White non-Hispanic, Black non-Hispanic, and Hispanic sub-populations. For all protocols, we observed a positive correlation between lives saved and life-years saved, but also between lives saved overall and inequality in the number of lives saved in different race and ethnicity sub-populations. CONCLUSION: While there is significant variance in the number of lives saved and life-years saved, we did not find a tradeoff between saving the most lives and saving the most life-years. Moreover, concerns about racial discrimination in triage protocols require thinking carefully about the tradeoff between enforcing equality of survival rates and maximizing the lives saved in each sub-population.

Investigating Ethical Tradeoffs in Crisis Standards of Care through Simulation of Ventilator Allocation Protocols.

Introduction: Arguments over the appropriate Crisis Standards of Care (CSC) for public health emergencies often assume that there is a tradeoff between saving the most lives, saving the most life-years, and preventing racial disparities. However, these assumptions have rarely been explored empirically. To quantitatively characterize possible ethical tradeoffs, we aimed to simulate the implementation of five proposed CSC protocols for rationing ventilators in the context of the COVID-19 pandemic. Methods: A Monte Carlo simulation was used to estimate the number of lives saved and life-years saved by implementing clinical acuity-, comorbidity- and age-based CSC protocols under different shortage conditions. This model was populated with patient data from 3707 adult admissions requiring ventilator support in a New York hospital system between April 2020 and May 2021. To estimate lives and life-years saved by each protocol, we determined survival to discharge and estimated remaining life expectancy for each admission. Results: The simulation demonstrated stronger performance for age- and comorbidity-sensitive protocols. For a capacity of 1 bed per 2 patients, ranking by age bands saves approximately 28.7 lives and 3408 life-years per thousand patients, while ranking by Sequential Organ Failure Assessment (SOFA) bands saved the fewest lives (13.2) and life-years (416). For all protocols, we observed a positive correlation between lives saved and life-years saved. For all protocols except lottery and the banded SOFA, significant disparities in lives saved and life-years saved were noted between White non-Hispanic, Black non-Hispanic, and Hispanic sub-populations. Conclusion: While there is significant variance in the number of lives saved and life-years saved, we did not find a tradeoff between saving the most lives and saving the most life-years. Moreover, concerns about racial discrimination in triage protocols require thinking carefully about the tradeoff between enforcing equality of survival rates and maximizing the lives saved in each sub-population.

Ventilation during COVID-19 in a school for students with intellectual and developmental disabilities (IDD).

BACKGROUND: This study examined the correlation of classroom ventilation (air exchanges per hour (ACH)) and exposure to CO2 ≥1,000 ppm with the incidence of SARS-CoV-2 over a 20-month period in a specialized school for students with intellectual and developmental disabilities (IDD). These students were at a higher risk of respiratory infection from SARS-CoV-2 due to challenges in tolerating mitigation measures (e.g. masking). One in-school measure proposed to help mitigate the risk of SARS-CoV-2 infection in schools is increased ventilation. METHODS: We established a community-engaged research partnership between the University of Rochester and the Mary Cariola Center school for students with IDD. Ambient CO2 levels were measured in 100 school rooms, and air changes per hour (ACH) were calculated. The number of SARS-CoV-2 cases for each room was collected over 20 months. RESULTS: 97% of rooms had an estimated ACH ≤4.0, with 7% having CO2 levels ≥2,000 ppm for up to 3 hours per school day. A statistically significant correlation was found between the time that a room had CO2 levels ≥1,000 ppm and SARS-CoV-2 PCR tests normalized to room occupancy, accounting for 43% of the variance. No statistically significant correlation was found for room ACH and per-room SARS-CoV-2 cases. Rooms with ventilation systems using MERV-13 filters had lower SARS-CoV-2-positive PCR counts. These findings led to ongoing efforts to upgrade the ventilation systems in this community-engaged research project. CONCLUSIONS: There was a statistically significant correlation between the total time of room CO2 concentrations ≥1,000 and SARS-CoV-2 cases in an IDD school. Merv-13 filters appear to decrease the incidence of SARS-CoV-2 infection. This research partnership identified areas for improving in-school ventilation.

Ethical Considerations for Artificial Intelligence in Medical Imaging: Data Collection, Development, and Evaluation.

The development of artificial intelligence (AI) within nuclear imaging involves several ethically fraught components at different stages of the machine learning pipeline, including during data collection, model training and validation, and clinical use. Drawing on the traditional principles of medical and research ethics, and highlighting the need to ensure health justice, the AI task force of the Society of Nuclear Medicine and Molecular Imaging has identified 4 major ethical risks: privacy of data subjects, data quality and model efficacy, fairness toward marginalized populations, and transparency of clinical performance. We provide preliminary recommendations to developers of AI-driven medical devices for mitigating the impact of these risks on patients and populations.

Ethical Considerations for Artificial Intelligence in Medical Imaging: Deployment and Governance.

The deployment of artificial intelligence (AI) has the potential to make nuclear medicine and medical imaging faster, cheaper, and both more effective and more accessible. This is possible, however, only if clinicians and patients feel that these AI medical devices (AIMDs) are trustworthy. Highlighting the need to ensure health justice by fairly distributing benefits and burdens while respecting individual patients' rights, the AI Task Force of the Society of Nuclear Medicine and Molecular Imaging has identified 4 major ethical risks that arise during the deployment of AIMD: autonomy of patients and clinicians, transparency of clinical performance and limitations, fairness toward marginalized populations, and accountability of physicians and developers. We provide preliminary recommendations for governing these ethical risks to realize the promise of AIMD for patients and populations.

Ventilation during COVID-19 in a school for students with intellectual and developmental disabilities (IDD).

Background: This study examined the correlation of classroom ventilation (air exchanges per hour (ACH)) and exposure to CO2 ≥1,000 ppm with the incidence of SARS-CoV-2 over a 20-month period in a specialized school for students with intellectual and developmental disabilities (IDD). These students were at a higher risk of respiratory infection from SARS-CoV-2 due to challenges in tolerating mitigation measures (e.g. masking). One in-school measure proposed to help mitigate the risk of SARS-CoV-2 infection in schools is increased ventilation. Methods: We established a community-engaged research partnership between the University of Rochester and the Mary Cariola Center school for students with IDD. Ambient CO2 levels were measured in 100 school rooms, and air changes per hour (ACH) were calculated. The number of SARS-CoV-2 cases for each room was collected over 20 months. Results: 97% of rooms had an estimated ACH ≤4.0, with 7% having CO2 levels ≥2,000 ppm for up to 3 hours per school day. A statistically significant correlation was found between the time that a room had CO2 levels ≥1,000 ppm and SARS-CoV-2 PCR tests normalized to room occupancy, accounting for 43% of the variance. No statistically significant correlation was found for room ACH and per-room SARS-CoV-2 cases. Rooms with ventilation systems using MERV-13 filters had lower SARS-CoV-2-positive PCR counts. These findings led to ongoing efforts to upgrade the ventilation systems in this community-engaged research project. Conclusions: There was a statistically significant correlation between the total time of room CO2 concentrations ≥1,000 and SARS-CoV-2 cases in an IDD school. Merv-13 filters appear to decrease the incidence of SARS-CoV-2 infection. This research partnership identified areas for improving in-school ventilation.

The Social Risks of Science.

Many instances of scientific research impose risks, not just on participants and scientists but also on third parties. This class of social risks unifies a range of problems previously treated as distinct phenomena, including so-called bystander risks, biosafety concerns arising from gain-of-function research, the misuse of the results of dual-use research, and the harm caused by inductive risks. The standard approach to these problems has been to extend two familiar principles from human subjects research regulations-a favorable risk-benefit ratio and informed consent. We argue, however, that these moral principles will be difficult to satisfy in the context of widely distributed social risks about which affected parties may reasonably disagree. We propose that framing these risks as political rather than moral problems may offer another way. By borrowing lessons from political philosophy, we propose a framework that unifies our discussion of social risks and the possible solutions to them.

Securitization of infectious diseases in Vietnam: the cases of HIV and avian influenza.

The frequent and swift emergence of new and devastating infectious diseases has brought renewed attention to health as an issue of international importance. Some states and regional organizations, including in Asia, have begun to regard infectious disease as a national and international security issue. This article seeks to examine the Vietnamese government's response to the epidemics of avian influenza and Human immunodeficiency virus. Both diseases have been recognized at different times as threats to international security and both are serious infectious disease problems in Vietnam. Yet, the character of the central government's response to these two epidemics has been starkly different. How and why this disparity in policy approaches occurs depends largely on the epidemiological, economic and political context in which they occur. Although epidemiological factors are frequently explored when discussing disease as a security issue, seldom are the political, social and economic characteristics of the state invoked. These dimensions, and their interaction with the epidemiology of the disease, are central to understanding which diseases are ultimately treated by states as security issues. In particular, the role of economic security as a powerful motivator for resistance to control measures and the role that local implementation of policies can have in disrupting the effect of central government policy are explored. In exploring both the outcomes of securitization, and its facilitating conditions, I suggest some preliminary observations on the potential costs and benefits of securitizing infectious disease and its utility as a mechanism for protecting health in Asia.