Precision medicine research with American Indian and Alaska Native communities: Results of a deliberative engagement with tribal leaders.

PURPOSE: Amid calls for greater diversity in precision medicine research, the perspectives of Indigenous people have been underexplored. Our goals were to understand tribal leaders' views regarding the potential benefits and risks of such research, explore its priority for their communities, and identify the policies and safeguards they consider essential. This article reports on the participants' perspectives regarding governance and policy, stewardship and sharing of information and biospecimens, and informed consent. METHODS: After informal local dialogs with 21 tribal leaders, we convened a 2.5-day deliberation with tribal leaders (N = 10) in Anchorage, Alaska, in June 2019 using a combination of small group and plenary discussion, ranking, and voting exercises to explore the perspectives on precision medicine research. RESULTS: Tribal sovereignty was central to participants' ideas about precision medicine research. Although views were generally positive, provided that the appropriate controls were in place, some kinds of research were deemed unacceptable, and the collection of certain biospecimens was rejected by some participants. Differences were observed regarding the acceptability of broad consent. CONCLUSION: Tribal leaders in this study were generally supportive of precision medicine research, with the caveat that tribal oversight is essential for the establishment of research repositories and the conduct of research involving Indigenous participants.

Diagnosis, Education, and Care of Patients with APOL1-Associated Nephropathy: A Delphi Consensus and Systematic Review.

BACKGROUND: APOL1 variants contribute to the markedly higher incidence of ESKD in Blacks compared with Whites. Genetic testing for these variants in patients with African ancestry who have nephropathy is uncommon, and no specific treatment or management protocol for APOL1-associated nephropathy currently exists. METHODS: A multidisciplinary, racially diverse group of 14 experts and patient advocates participated in a Delphi consensus process to establish practical guidance for clinicians caring for patients who may have APOL1-associated nephropathy. Consensus group members took part in three anonymous voting rounds to develop consensus statements relating to the following: (1) counseling, genotyping, and diagnosis; (2) disease awareness and education; and (3) a vision for management of APOL1-associated nephropathy in a future when treatment is available. A systematic literature search of the MEDLINE and Embase databases was conducted to identify relevant evidence published from January 1, 2009 to July 14, 2020. RESULTS: The consensus group agreed on 55 consensus statements covering such topics as demographic and clinical factors that suggest a patient has APOL1-associated nephropathy, as well as key considerations for counseling, testing, and diagnosis in current clinical practice. They achieved consensus on the need to increase awareness among key stakeholders of racial health disparities in kidney disease and of APOL1-associated nephropathy and on features of a successful education program to raise awareness among the patient community. The group also highlighted the unmet need for a specific treatment and agreed on best practice for management of these patients should a treatment become available. CONCLUSIONS: A multidisciplinary group of experts and patient advocates defined consensus-based guidance on the care of patients who may have APOL1-associated nephropathy.

Using Public Deliberation to Set Priorities: The Case of COVID-19 Vaccine Access in New York City.

CONTEXT: The COVID-19 pandemic has resulted in a record number of deaths in the United States and tremendous economic and personal strain. During 2020, in anticipation of a vaccine to slow the spread of disease, local and state governments in the United States developed plans for vaccine prioritization, given a limited initial supply. Recognizing the challenges inherent in prioritization, the New York City (NYC) health department sought guidance from members of the public about the fairest approach to early-stage vaccine distribution. OBJECTIVE: To solicit recommendations from NYC residents on priorities regarding vaccine access for essential worker occupations, considering risk factors and preferred approaches to fairness. IMPLEMENTATION: Five public deliberations were conducted with NYC residents (N = 91). Participants heard presentations on the COVID-19 vaccine, the local distribution of illness and death, and approaches to fairness in the context of deliberating on priorities for 6 essential worker occupations and 4 risk factors. Discussions were transcribed, and transcriptions were coded and analyzed using preidentified and emergent themes. Pre- and post-surveys, focused on factors relevant to prioritization, were administered during each public deliberation. RESULTS: Recommendations for prioritization emphasized risk of severe morbidity and mortality, and work and neighborhood conditions with fewer protections (eg, in-person work, exposure to many people). Participants prioritized elementary schoolteachers, grocery store workers, and bus drivers, underlying health conditions, and neighborhood of residence. Participants focused on equity, recognizing that those at highest risk were largely low-income populations of color and individuals living in low-resourced neighborhoods. CONCLUSIONS: Participants' focus on equity, and acknowledgment of racial and ethnic disparities, revealed a nuanced understanding of the broader determinants of health. Recommendations reinforced the NYC health department's approach to vaccine distribution. PUBLIC HEALTH IMPLICATIONS: Results from these public deliberations confirmed community support for approaches prioritizing health equity, recognizing both societal and personal factors affecting vulnerability to poor health.

Apolipoprotein L1 Testing in African Americans: Involving the Community in Policy Discussions.

BACKGROUND: Apolipoprotein A1 (APOL1) gene variants occurring in people of West African descent contribute to the greater burden of kidney disease among African Americans. These variants are associated with increased risk of nondiabetic nephropathy, more rapid progression of chronic kidney disease, and shorter survival of donor kidneys after transplantation. However, only a minority of people with APOL1-associated risk develops kidney disease and specific clinical measures to address APOL1-associated risk are lacking. Given these uncertainties, we sought to engage members of the African American public in discussions with other stakeholders about the appropriate use of APOL1 testing. METHODS: Formative interviews with community members, researchers, and clinicians in Seattle WA, Nashville TN, and Jackson MS, provided baseline information about views toward APOL1 testing and informed the design of 3 community-based deliberations among African Americans. A national meeting held in March 2018 included 13 community members, 7 scientific advisors and 26 additional researchers, clinicians, bioethicists, patient advocates, and representatives from professional organizations and federal funding agencies. Using small break-out and plenary discussion, the group agreed on recommendations based on current knowledge about APOL1-associated risk. RESULTS: Meeting outcomes included recommendations to develop educational materials about APOL1 for community members and clinicians; to offer APOL1 research results to participants; and on the use of APOL1testing in kidney transplant programs. The group recommended against the routine offer of APOL1 testing in clinical care. Areas of disagreement included whether kidney transplant programs should require APOL1 testing of prospective living donors or bar individuals with APOL1 risk from donating kidneys and whether testing should be available on request in routine clinical care. CONCLUSION: We recommend continued discussion among stakeholders and concerted efforts to ensure active and informed participation of members of the affected community to guide research on APOL1 and kidney disease.

Shrinking Poor White Life Spans: Class, Race, and Health Justice.

An absolute decline in US life expectancy in low education whites has alarmed policy makers and attracted media attention. Depending on which studies are correct, low education white women have lost between 3 and 5 years of lifespan; men, between 6 months and 3 years. Although absolute declines in life expectancy are relatively rare, some commentators see the public alarm as reflecting a racist concern for white lives over black ones. How ought we ethically to evaluate this lifespan contraction in low education whites? Should we care, or is it racist to care? Does it constitute an injustice or reflect justice being done? I argue that the lifespan contraction in low education whites violates key normative criteria used to make determinations of health justice, and that these judgments do not vitiate concerns about racism. I conclude with reflections on US population health policy and building an inclusive health equity movement.

Health Disparities Research Among Small Tribal Populations: Describing Appropriate Criteria for Aggregating Tribal Health Data.

In response to community concerns, we used the Tribal Participatory Research framework in collaboration with 5 American-Indian communities in Washington, Idaho, and Montana to identify the appropriate criteria for aggregating health data on small tribes. Across tribal sites, 10 key informant interviews and 10 focus groups (n = 39) were conducted between July 2012 and April 2013. Using thematic analysis of focus group content, we identified 5 guiding criteria for aggregating tribal health data: geographic proximity, community type, environmental exposures, access to resources and services, and economic development. Preliminary findings were presented to focus group participants for validation at each site, and a culminating workshop with representatives from all 5 tribes verified our final results. Using this approach requires critical assessment of research questions and study designs by investigators and tribal leaders to determine when aggregation or stratification is appropriate and how to group data to yield robust results relevant to local concerns. At project inception, tribal leaders should be consulted regarding the validity of proposed groupings. After regular project updates, they should be consulted again to confirm that findings are appropriately contextualized for dissemination.

Health policy, ethics, and the Kansas Legislative Health Academy.

We describe a unique program, the Kansas Legislative Health Academy, that brings together state legislators from across the political spectrum to build their capacity in advancing policies that can improve the health of Kansans. To that end, the academy helps legislators develop new skills to deliberate the ethics of health policy, use systems thinking to understand the long- and short-term effects of policy action and inaction, and engage in acts of civic leadership. The academy also seeks to foster an environment of respectful open dialogue and to build new cross-chamber and cross-party relationships. Among the most important outcomes cited by program participants is the value of sustained, personal interaction and problem solving with individuals holding differing political views.

Finding A Seat at the Table Together: Recommendations for Improving Collaboration between Social Work and Bioethics.

Social work and bioethics are fields deeply committed to cross-disciplinary collaboration to do their respective work. While scholars and practitioners from both fields share a commitment to social justice and to respecting the dignity, integrity and the worth of all persons, the overlap between the fields, including shared values, has received little attention. The purpose of this article is to describe the ways in which greater collaboration between the two fields can broaden their scope, enrich their scholarship, and better ground their practice. We describe the potential for realizing such benefits in two areas - health care ethics consultation and social inequalities in health - arguing that the fields both complement and challenge one another, making them ideal partners for the interdisciplinary inquiry and problem-solving so often called for today in health and health care.

Ethics of Predicting and Preventing Preterm Birth.

Preterm birth (PTB) occurs disproportionately among women who are minoritized and who live and work in poverty. This disadvantage occurs as a result of societal norms and policies that affect how people are treated and determine their access to a broad range of resources. Research that takes social context into account offers the best opportunity for identifying approaches to prevent PTB. The experience and knowledge of women from groups experiencing high rates of PTB can provide important insights for research design and for determining the feasibility and acceptability of potential interventions.

Tribal Deliberations about Precision Medicine Research: Addressing Diversity and Inequity in Democratic Deliberation Design and Evaluation.

Deliberative democratic engagement is used around the globe to gather informed public input on contentious collective questions. Yet, rarely has it been used to convene individuals exclusively from Indigenous communities. The relative novelty of using this approach to engage tribal communities and concerns about diversity and inequities raise important methodological questions. We describe the design and quality outcomes for a 2.5-day deliberation that elicited views of American Indian and Alaska Native (AIAN) leaders about the potential value and ethical conduct of precision medicine research (PMR), an emerging approach to research that investigates the health effects of individual genetic variation in tandem with variation in health-relevant practices, social determinants, and environmental exposures. The event met key goals, such as relationship and rapport formation, cross-site learning, equality of opportunity to participate, and respect among participants in the context of disagreement.

Stakeholder Perspectives on Returning Nonactionable Apolipoprotein L1 (APOL1) Genetic Results to African American Research Participants.

The ethics of returning nonactionable genetic research results to individuals are unclear. Apolipoprotein L1 (APOL1) genetic variants are nonactionable, predominantly found in people of West African ancestry, and contribute to kidney disease disparities. To inform ethical research practice, we interviewed researchers, clinicians, and African American community members (n = 76) about the potential risks and benefits of returning APOL1 research results. Stakeholders strongly supported returning APOL1 results. Benefits include reciprocity for participants, community education and rebuilding trust in research, and expectation of future actionability. Risks include analytic validity, misunderstanding, psychological burdens, stigma and discrimination, and questionable resource tradeoffs.Conclusions:APOL1 results should be offered to participants. Responsibly fulfilling this offer requires careful identification of best communication practices, broader education about the topic, and ongoing community engagement.

Communicating Precision Medicine Research: Multidisciplinary Teams and Diverse Communities.

INTRODUCTION: Precision medicine research investigates the differences in individuals' genetics, environment, and lifestyle to tailor health prevention and treatment options as part of an emerging model of health care delivery. Advancing precision medicine research will require effective communication across a wide range of scientific and health care disciplines and with research participants who represent diverse segments of the population. METHODS: A multidisciplinary group convened over the course of a year and developed precision medicine research case examples to facilitate precision medicine research discussions with communities. RESULTS: A shared definition of precision medicine research as well as six case examples of precision medicine research involving genetic risk, pharmacogenetics, epigenetics, the microbiome, mobile health, and electronic health records were developed. DISCUSSION/CONCLUSION: The precision medicine research definition and case examples can be used as planning tools to establish a shared understanding of the scope of precision medicine research across multidisciplinary teams and with the diverse communities in which precision medicine research will take place. This shared understanding is vital for successful and equitable progress in precision medicine.

White Privilege, White Poverty: Reckoning with Class and Race in America.

This essay argues that a failure to think and talk critically and candidly about White privilege and White poverty is a key threat to the United States of America's precarious democracy. Whiteness frames one of America's most pressing collective challenges-the poor state of the nation's health, which lags behind other wealthy nations and is marred by deep and entrenched class- and race-based inequities. The broadscale remedies experts recommend demand what is in short supply: trust in evidence, experts, government, and one another. The authors' prescription is threefold, beginning with a call for intersectional health studies and reports that avoid one-dimensional misrepresentations of widespread health problems as simply Black or White problems. Second, there is the need for a "critical consciousness" about race and class. Lastly, the essay calls for widescale opportunities for Americans to engage in cross-racial and cross-class democratic conversations about their struggles and aspirations in search of common ground.

Deliberations with American Indian and Alaska Native People about the Ethics of Genomics: An Adapted Model of Deliberation Used with Three Tribal Communities in the United States.

BACKGROUND: This paper describes the design, implementation, and process outcomes from three public deliberations held in three tribal communities. Although increasingly used around the globe to address collective challenges, our study is among the first to adapt public deliberation for use with exclusively Indigenous populations. In question was how to design deliberations for tribal communities and whether this adapted model would achieve key deliberative goals and be well received. METHODS: We adapted democratic deliberation, an approach to stakeholder engagement, for use with three tribal communities to respect tribal values and customs. Public deliberation convenes people from diverse backgrounds in reasoned reflection and dialogue in search of collective solutions. The deliberation planning process and design were informed by frameworks of enclave deliberation and community-based participatory research, which share key egalitarian values. The deliberations were collaboratively designed with tribal leadership and extensive partner input and involvement in the deliberations. Each deliberation posed different, locally relevant questions about genomic research, but used the same deliberation structure and measures to gauge the quality and experience of deliberation. RESULTS: A total of 52 individuals participated in the deliberations across all three sites. Deliberants were balanced in gender, spanned decades in age, and were diverse in educational attainment and exposure to health research. Overall, the deliberations were positively evaluated. Participant perceptions and external observer datasets depict three deliberations that offered intensive conversation experiences in which participants learned from one another, reported feeling respected and connected to one another, and endorsed this intensive form of engagement. CONCLUSION: The adapted deliberations achieved key deliberative goals and were generally well received. Limitations of the study are described.

Public values, health inequality, and alternative notions of a "fair" response.

The fact that disadvantaged people generally die younger and suffer more disease than those with more resources is gaining ground as a major policy concern in the United States. Yet we know little about how public values inform public opinion about policy interventions to address these disparities. This article presents findings from an exploratory study of the public's values and priorities as they relate to social inequalities in health. Forty-three subjects were presented with a scenario depicting health inequalities by social class and were given the opportunity to alter the distribution of health outcomes. Participants' responses fell into one of three distributive preferences: (1) prioritize the disadvantaged, (2) equalize health outcomes between advantaged and disadvantaged groups, and (3) equalize health resources between advantaged and disadvantaged groups. These equality preferences were reflected in participants' responses to a second, more complex scenario in which trade-offs with other health-related values - maximizing health and prioritizing the sickest - were introduced. In most cases, participants moderated their distributive preferences to accommodate these other health goals, particularly to prioritize the allocation of resources to the very sick regardless of their socioeconomic status.