Why Climate Literacy Is Health Literacy.

Health problems of global warming are daunting in severity and magnitude and will only get worse. Yet literacy about these problems is poor and plans to alleviate them are too early in development to be responsive to current levels of global threat and individual need. Social and ecological determinants of health and illness are exacerbated by excessive heat and flooding; lack of food, safe water, and secure shelter; and loss of arable land for farming. This article considers the nature and scope of ethicists' roles in awakening clinicians and the public to this crisis and offers 4 recommendations to reduce morbidity and mortality from climate change.

Out of This World: re-grounding justice through science fiction.

Good science fiction can be a successful vehicle for portraying justice. Science fiction can stimulate moral imagination in much the same way as the most effective justice theories, connecting the world in which we live with a range of alternative futures deliberately and creatively made plausible. A selective examination of classic and recent science fiction stories and novels provides contextual framing for considering questions of climate justice, virtuous personal action in the face of structural injustice, and the problem of what justice means when some people are regarded as "other." By connecting compelling images of individual responsibility with the complex challenges posed by striving for social justice, science fiction can also help render justice work appealing and achievable-an essential step that is reinforced in closing by a brief set of maxims.

Use of a web-based portal to return normal individual research results in Early Check: Exploring user behaviors and attitudes.

Early Check is a voluntary, large-scale expanded newborn screening study in North Carolina that uses a self-directed web-based portal for return of normal individual research results (IRR). Little is known about participant perspectives in using web-based portals to receive IRR. This study explored user attitudes and behaviors within the Early Check portal using three methods: (1) a feedback survey available to the consenting parent of participating infants (typically mothers), (2) semi-structured interviews conducted with a subset of parents, and (3) Google Analytics. During an approximate 3-year period, 17 936 newborns received normal IRR and there were 27 812 visits to the portal. Most surveyed parents reported viewing their baby's results (86%, 1410/1639). Parents largely found the portal easy to use to get results, and helpful in understanding the results. However, 10% of parents said it was difficult to find enough information to understand their baby's results. In Early Check, providing normal IRR via the portal made a large-scale study practical, and was highly rated by most users. Return of normal IRR may be particularly amenable to web-based portals, as the consequences to participants from not viewing results are modest, and the interpretation of a normal result is relatively straightforward.

Dobbs, the Intrusive State, and the Future of Solidarity.

The intrusive state has long viewed women as fetal containers. The Dobbs decision goes further, essentially causing women to vanish when fetuses are abstracted from their relationships to pregnant persons. The ways in which women are first controlled and then made invisible are clearly connected with the move from obedience to omission that has historically affected black Americans. When personal decisionmaking and participation in democracy are regarded as threats, those threatened restrict decisional freedom and political power, deepening structural injustices relating to sex, race, and poverty. Fear of Dobbs has health effects on conditions unrelated to pregnancy and connects with erasures of human value that are not health-related. We reaffirm solidarity as a countering influence. Taking account of the richly relational context in which issues like abortion and political representation arise should lead to better, more meaningful policies, making so many people impossible to unsee.

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.

Othering and Health Justice.

Bioethics needs to expand its vision. We must examine and interrogate the social and structural barriers that help traditionally privileged communities maintain minoritized groups as inherently inferior "others." Justice requires the field to look beyond the walls of hospitals, clinics, and medical academia to address and ameliorate the structural injustices that give rise to health disparities long before differential access to health services becomes an issue for underserved patients. Doing so means engaging in challenging multidisciplinary collaborations in order to understand the sociohistorical complexities of health and illness, appreciate the factors that contribute to shaming and blaming those "others" who are not "us," and work to lessen the discomfort with uncertainty that impedes equity. All of this necessary work takes bioethics well beyond the well-trodden pathways of our usual scholarship and practice. But we simply have to reach higher to do health justice.

Collaborative decision-making: A framework for decision-making about life-sustaining treatments in children with medical complexity.

OBJECTIVE: Caregivers of children with medical complexity (CMC) face decisions about life-sustaining treatments (LST) like tracheostomy. We sought to develop a clinically relevant and realistic model for decision-making about tracheostomy placement that might apply to other LST in CMC. DESIGN: This qualitative study, conducted between 2013 and 2015, consisted of 41 interviews with 56 caregivers of CMC who had received tracheostomies and 5 focus groups of 33 healthcare providers (HCPs) at a tertiary-care children's hospital in North Carolina. Participants were asked about their perspectives on the tracheostomy decision-making process. Data were transcribed, and coded. Using thematic content analysis, we inductively developed a tracheostomy decision-making framework and process. RESULTS: Many factors influenced caregivers' decisions, including children's well-being and caregivers' values, faith, knowledge, experience, emotional state, and social factors; preserving the child's life was the most important. HCPs consider many clinical and nonclinical factors; recommending tracheostomy for children with limited survival, perceived poor functioning and quality of life, and progressive conditions is ethically difficult. The framework of tracheostomy decision-making has inter-related caregiver- and HCP-level factors that influence the process. The framework contains elements not captured in a shared decision-making model, but better fits a collaborative decision-making (CDM) model. The tracheostomy CDM process that emerged from the data has two nonsequential components that HCPs could use: (1) gaining understanding and (2) holding decision-making conversations. CONCLUSIONS: CDM could be a useful model for clinicians guiding families about tracheostomy for CMC. The applicability of CDM for decision-making about other LSTs needs further exploration.

Tracheostomy decision-making for children with medical complexity: What supports and resources do caregivers need?

OBJECTIVES: Caregivers of children with medical complexity (CMC) face decisions about life-sustaining interventions, such as tracheostomy. Our objective is to describe the support needs of caregivers of CMC and the resources they use surrounding tracheostomy decision-making (TDM) for their children. METHODS: This qualitative study, conducted between 2013 and 2015, consisted of semi-structured interviews with 56 caregivers of 41 CMC who had tracheostomies, and 5 focus groups of 33 clinicians at a tertiary care children's hospital. Participants were asked about their perspectives on the TDM process. Qualitative data were transcribed, coded, and organized into themes. RESULTS: Caregivers used five domains of resources surrounding TDM: (1) social network including extended family members, friends, and clergy; (2) healthcare providers including physicians and nurses; (3) other parents of children with tracheostomy; (4) tangible materials such as print materials, videos, tracheostomy tubes, mannequins, and simulation labs; and (5) internet including websites, social media, and online health communities. Caregivers used these resources for (1) decision-making, (2) becoming knowledgeable and skillful about child's diagnosis, tracheostomy, and home care, and (3) emotional and spiritual well-being. Caregivers agreed that they received enough support, but there were gaps. Clinicians were knowledgeable about these resources, discussed social network and internet less often than the other domains, and identified gaps in supporting caregivers. SIGNIFICANCE OF RESULTS: Caregivers' need for support and use of resources surrounding tracheostomy placement for CMC extended beyond decision-making, and included becoming knowledgeable and getting emotional/spiritual support. Healthcare providers exploring these resources with caregivers could improve the quality of TDM communication.

Education and Consent for Population-Based DNA Screening: A Mixed-Methods Evaluation of the Early Check Newborn Screening Pilot Study.

A challenge in implementing population-based DNA screening is providing sufficient information, that is, understandable and acceptable, and that supports informed decision making. Early Check is an expanded newborn screening study offered to mothers/guardians whose infants have standard newborn screening in North Carolina. We developed electronic education and consent to meet the objectives of feasibility, acceptability, trustworthiness, and supporting informed decisions. We used two methods to evaluate Early Check among mothers of participating infants who received normal results: an online survey and interviews conducted via telephone. Survey and interview domains included motivations for enrollment, acceptability of materials and processes, attitudes toward screening, knowledge recall, and trust. Quantitative analyses included descriptive statistics and assessment of factors associated with knowledge recall and trust. Qualitative data were coded, and an inductive approach was used to identify themes across interviews. Survey respondents (n = 1,823) rated the following as the most important reasons for enrolling their infants: finding out if the baby has the conditions screened (43.0%), and that no additional blood samples were required (20.1%). Interview respondents (n = 24) reported the value of early knowledge, early intervention, and ease of participation as motivators. Survey respondents rated the study information as having high utility for decision making (mean 4.7 to 4.8 out of 5) and 98.2% agreed that they had sufficient information. Knowledge recall was relatively high (71.8-92.5% correct), as was trust in Early Check information (96.2% strongly agree/agree). Attitudes about Early Check screening were positive (mean 0.1 to 0.6 on a scale of 0-4, with lower scores indicating more positive attitudes) and participants did not regret participation (e.g., 98.6% strongly agreed/agreed Early Check was the right decision). Interview respondents further reported positive attitudes about Early Check materials and processes. Early Check provides a model for education and consent in large-scale DNA screening. We found evidence of high acceptability, trustworthiness and knowledge recall, and positive attitudes among respondents. Population-targeted programs need to uphold practices that result in accessible information for those from diverse backgrounds. Additional research on those who do not select screening, although ethically and practically challenging, is important to inform population-based DNA screening practices.

DEI Is Not Enough.

The movement under way to increase diversity, equity, and inclusion (DEI) in every workplace, including academia, medicine, and science, is an essential step toward health justice, but only a first step. Bioethics, health care, and health-related research all need more professionals from minoritized groups, but all of us need to do more to address justice at every level. From inclusive workplace policies and practices to research into structural injustices and health disparities, bioethics can and must lead the way in collaborative efforts. The work belongs to all of us, and DEI is only the beginning.

The role of religion and spirituality in caregiver decision-making about tracheostomy for children with medical complexity.

Children with medical complexity (CMC) receive life-sustaining treatments such as tracheostomy. The objective of this paper is to explore the roles of religion and spirituality (R&S) of caregivers of children with medical complexity (CMC) in their decision to pursue tracheostomy for their children. We conducted 41 in-depth interviews of caregivers of CMC who had received tracheostomies in the prior 5 years. Four themes emerged: (1) Caregivers believed R&S to be powerful for their children's healing, and helped them cope with their children's illnesses; (2) Spirituality was an important factor for caregivers in the decision to pursue tracheostomy for their children; (3) Many caregivers did not discuss their spirituality with clinicians for a variety of reasons; (4) Clergy and hospital chaplains played a major supportive role overall; however, they did not play a significant role in the decision-making process. Our study shows the importance of R&S, and the roles of clergy and chaplains in pediatric tracheostomy decision-making.

Outreach to new mothers through direct mail and email: recruitment in the Early Check research study.

Meeting recruitment targets for clinical trials and health research studies is a notable challenge. Unsuccessful efforts to recruit participants from traditionally underserved populations can limit who benefits from scientific discovery, thus perpetuating inequities in health outcomes and access to care. In this study, we evaluated direct mail and email outreach campaigns designed to recruit women who gave birth in North Carolina for a statewide research study offering expanded newborn screening for a panel of rare health conditions. Of the 54,887 women who gave birth in North Carolina from September 28, 2018, through March 19, 2019, and were eligible to be included on the study's contact lists, we had access to a mailing address for 97.9% and an email address for 6.3%. Rural women were less likely to have sufficient contact information available, but this amounted to less than a one percentage point difference by urbanicity. Native American women were less likely to have an email address on record; however, we did not find a similar disparity when recruitment using direct-mail letters and postcards was concerned. Although we sent letters and emails in roughly equal proportion by urbanicity and race/ethnicity, we found significant differences in enrollment across demographic subgroups. Controlling for race/ethnicity and urbanicity, we found that direct-mail letters and emails were effective recruitment methods. The enrollment rate among women who were sent a recruitment letter was 4.1%, and this rate increased to 5.0% among women who were also sent an email invitation. Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? Under-representation by traditionally underserved populations in clinical trials and health research is a challenge that may in part reflect inequitable opportunities to participate. WHAT QUESTION DID THIS STUDY ADDRESS? Are direct-mail and email outreach strategies effective for reaching and recruiting women from traditionally underserved and rural populations to participate in large-scale, population-based research? WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE? Despite sending recruitment letters and email invitations in roughly equal proportion by urbanicity and race/ethnicity, women living in rural areas were less likely to enroll (2.8%) than women from urban areas (4.2%). Additionally, enrollment rates decreased as the probability that women were members of a racial or ethnic minority group increased. HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE? Results from this study might encourage researchers to take a holistic and participant-centered view of barriers to study enrollment that may disproportionately affect underserved communities, including differences in willingness to participate, trust, and access to resources needed for uptake.

Decision-Making About Tracheostomy for Children With Medical Complexity: Caregiver and Health Care Provider Perspectives.

OBJECTIVE: Caregivers of children with medical complexity (CMC) face decisions about tracheostomy. The objectives of this paper are to identify facilitators and barriers to tracheostomy decision-making (TDM) process for CMC. METHODS: Using phenomenology as its methodologic orientation, this qualitative study conducted in North Carolina between 2013 and 2015 consists of semistructured interviews with 56 caregivers of 41 CMC who received tracheostomies, and 5 focus groups of 33 health care providers (HCP) at a tertiary care children's hospital involved in TDM for CMC. Participants were asked to share their experiences and perspectives on the TDM process. Qualitative data were transcribed, coded, and organized into themes as is consistent with thematic content analysis. RESULTS: Five themes were identified. 1) Caregivers perceived decision about tracheostomy for their children was theirs to make. 2) Strategies that increased caregivers' active participation in the TDM process facilitated the TDM process. 3) Caregiver emotional stress and lack of understanding about tracheostomy were barriers. 4) Good HCP communication during the TDM process was valued; poor communication was a barrier. 5) Collaboration among HCP-facilitated TDM, especially when nurses were involved, whereas fragmentation in care was a barrier. CONCLUSIONS: Caregivers take a primary role in the TDM process. Many caregiver and HCP-level facilitators and barriers for TDM exist. Augmenting the facilitators and reducing the barriers identified in this study could improve the TDM process for CMC.

The Future of Bioethics: It Shouldn't Take a Pandemic.

The Covid-19 pandemic has concentrated bioethics attention on the "lifeboat ethics" of rationing and fair allocation of scarce medical resources, such as testing, intensive care unit beds, and ventilators. This focus drives ethics resources away from persistent and systemic problems-in particular, the structural injustices that give rise to health disparities affecting disadvantaged communities of color. Bioethics, long allied with academic medicine and highly attentive to individual decision-making, has largely neglected its responsibility to address these difficult "upstream" issues. It is time to broaden our teaching, research, and practice to match the breadth of the field in order to help address these significant societal inequities and unmet health needs.

Early Check: translational science at the intersection of public health and newborn screening.

BACKGROUND: Newborn screening (NBS) occupies a unique space at the intersection of translational science and public health. As the only truly population-based public health program in the United States, NBS offers the promise of making the successes of translational medicine available to every infant with a rare disorder that is difficult to diagnose clinically, but for which strong evidence indicates that presymptomatic treatment will substantially improve outcomes. Realistic NBS policy requires data, but rare disorders face a special challenge: Screening cannot be done without supportive data, but adequate data cannot be collected in the absence of large-scale screening. The magnitude and scale of research to provide this expanse of data require working with public health programs, but most do not have the resources or mandate to conduct research. METHODS: To address this gap, we have established Early Check, a research program in partnership with a state NBS program. Early Check provides the infrastructure needed to identify conditions for which there have been significant advances in treatment potential, but require a large-scale, population-based study to test benefits and risks, demonstrate feasibility, and inform NBS policy. DISCUSSION: Our goal is to prove the benefits of a program that can, when compared with current models, accelerate understanding of diseases and treatments, reduce the time needed to consider inclusion of appropriate conditions in the standard NBS panel, and accelerate future research on new NBS conditions, including clinical trials for investigational interventions. TRIAL REGISTRATION: Clinicaltrials.gov registration # NCT03655223 . Registered on August 31, 2018.

Key Information in the New Common Rule: Can It Save Research Consent?

Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly "common" in 1991. This change, the addition of a "key information" requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because it encourages clarity and honesty about research participation, creativity in information disclosure, and mutual learning through the investigator-subject relationship. It is problematic because those goals - which have remained aspirational since the beginning - may be difficult to achieve in what has become an excessively compliance-oriented regulatory regime.