Johns Hopkins Berman Institute of Bioethics

More than 100 years ago, public health began as an organized discipline, its purpose being to improve the health of populations rather than of individuals. Given its population-based focus, however, public health perennially faces dilemmas concerning the appropriate extent of its reach and whether its activities infringe on individual liberties in ethically troublesome ways. In this article a framework for ethics analysis of public health programs is proposed. To advance traditional public health goals while maximizing individual liberties and furthering social justice, public health interventions should reduce morbidity or mortality; data must substantiate that a program (or the series of programs of which a program is a part) will reduce morbidity or mortality; burdens of the program must be identified and minimized; the program must be implemented fairly and must, at times, minimize preexisting social injustices; and fair procedures must be used to determine which burdens are acceptable to a community.

OBJECTIVE: We sought to synthesize the findings of studies evaluating interventions to improve the cultural competence of health professionals. DESIGN: This was a systematic literature review and analysis. METHODS: We performed electronic and hand searches from 1980 through June 2003 to identify studies that evaluated interventions designed to improve the cultural competence of health professionals. We abstracted and synthesized data from studies that had both a before- and an after-intervention evaluation or had a control group for comparison and graded the strength of the evidence as excellent, good, fair, or poor using predetermined criteria. MAIN OUTCOME MEASURES: We sought evidence of the effectiveness and costs of cultural competence training of health professionals. RESULTS: Thirty-four studies were included in our review. There is excellent evidence that cultural competence training improves the knowledge of health professionals (17 of 19 studies demonstrated a beneficial effect), and good evidence that cultural competence training improves the attitudes and skills of health professionals (21 of 25 studies evaluating attitudes demonstrated a beneficial effect and 14 of 14 studies evaluating skills demonstrated a beneficial effect). There is good evidence that cultural competence training impacts patient satisfaction (3 of 3 studies demonstrated a beneficial effect), poor evidence that cultural competence training impacts patient adherence (although the one study designed to do this demonstrated a beneficial effect), and no studies that have evaluated patient health status outcomes. There is poor evidence to determine the costs of cultural competence training (5 studies included incomplete estimates of costs). CONCLUSIONS: Cultural competence training shows promise as a strategy for improving the knowledge, attitudes, and skills of health professionals. However, evidence that it improves patient adherence to therapy, health outcomes, and equity of services across racial and ethnic groups is lacking. Future research should focus on these outcomes and should determine which teaching methods and content are most effective.

OBJECTIVES: Improvements in survival for children with sickle cell disease (SCD) during the last 30 years have been well established. Whether similar improvements for adults with the disease have occurred is unknown. We investigated mortality rates for children and adults with SCD. METHODS: We used the National Center for Health Statistics multiple-cause-of-death files to examine age at death and calculate mortality rates from 1979 to 2005. We examined trends in mortality rates using negative binomial regression, and we examined age at death using t-tests and linear regression. RESULTS: We identified 16,654 sickle cell-related deaths. Mean age at death was significantly different for males (33.4 years, 95% confidence interval [CI] 33.0, 33.7) than for females (36.9 years, 95% CI 36.5, 37.4). In a regression model controlling for gender, the mean age at death increased by 0.36 years for each year of the study. The median age at death in 2005 was 42 years for females and 38 years for males. The overall mortality rate increased 0.7% (p<0.001) each year during the time period studied. The adult (>19 years of age) mortality rate increased by 1% (p<0.001) each year during the time period studied. The pediatric mortality rate decreased by 3% (p<0.001) each year during the time period studied. CONCLUSIONS: These data confirm prior findings of a significant decrease in mortality for children with SCD. The mortality rate for adults appears to have increased during the same time period. It seems unlikely that this increase is due merely to an influx of younger patients surviving to adulthood and may reflect a lack of access to high-quality care for adults with SCD.

The food environment is a critical place in the food system to implement interventions to support sustainable diets and address the global syndemic of obesity, undernutrition, and climate change, because it contains the total scope of options within which consumers make decisions about which foods to acquire and consume. In this paper, we build on existing definitions of the food environment, and provide an expanded definition that includes the parameter of sustainability properties of foods and beverages, in order to integrate linkages between food environments and sustainable diets. We further provide a graphical representation of the food environment using a socio-ecological framework. Next, we provide a typology with descriptions of the different types of food environments that consumers have access to in low-, middle-, and high-income countries including wild, cultivated, and built food environments. We characterize the availability, affordability, convenience, promotion and quality (previously termed desirability), and sustainability properties of food and beverages for each food environment type. Lastly, we identify a methodological approach with potential objective and subjective tools and metrics for measuring the different properties of various types of food environments. The definition, framework, typology, and methodological toolbox presented here are intended to facilitate scholars and practitioners to identify entry points in the food environment for implementing and evaluating interventions that support sustainable diets for enhancing human and planetary health.

With more than two million cases globally, the coronavirus disease 2019 (COVID-19) pandemic has resulted in unprecedented disruption to human society. Leaders from around the world have escalated from states of reluctant acceptance to states of emergency. Unlike historical pandemics, such as the 1918 H1N1 pandemic, COVID-19 is spreading across a highly connected world, in which virtually all individuals are linked to each other through the mobile phone in their pockets. Because of strict physical distancing measures, people are heavily reliant on maintaining connectivity using global digital social networks, such as Facebook or Twitter, to facilitate human interaction and information sharing about the virus. In what follows, we discuss some ways in which social media has undermined effective responses to COVID-19. We consider how various groups could respond to these challenges—especially government leaders, social media companies, and health-care providers. Ultimately, these actors each have roles to play in preventing social media from being weaponised to sow distrust and further endanger public health, while also ensuring that social media can fulfill its essential civic function of facilitating good faith political expression and discourse. The idea of legitimacy has changed in the context of social media platforms. Users increasingly see trusted individuals within their peer networks who support production and exchange of valued information as authoritative sources of information. As that information is further disseminated, it often increases in its perceived legitimacy. This method of sharing and validating information contrasts with methods more directly controlled by intermediaries (eg, traditional media), who have specialised knowledge and specific responsibilities related to information verification and sharing.1Eysenbach G From intermediation to disintermediation and apomediation: new models for consumers to access and assess the credibility of health information in the age of Web2.Stud Health Technol Inform. 2007; 129: 162-166PubMed Google Scholar This model of information sharing has become a driving feature of how public information related to health and medicine is produced and disseminated. In the COVID-19 pandemic, individuals are, not surprisingly, turning to this new digital reality for guidance. Digital social networks have facilitated the spread of a different viral entity—misinformation. Scientific misinformation has been actively propagated as a means to destabilise trust in governments and as a political weapon.2Guess A Nyhan B Reifler J Selective exposure to misinformation: evidence from the consumption of fake news during the 2016 US presidential campaign.https://about.fb.com/wp-content/uploads/2018/01/fake-news-2016.pdfDate: 2018Date accessed: March 20, 2020Google Scholar, 3Singer PW Brooking ET LikeWar: the weaponization of social media. Eamon Dolan Books, New York, NY2018Google Scholar In the few months since the first COVID-19 cases, a broad range of misinformation has spread across traditional media and social media in what WHO has called an infodemic (ie, excessive amounts misinformation, disinformation, and rumours that make it difficult identify reliable sources of information),4Garrett L COVID-19: the medium is the message.Lancet. 2020; 395: 942-943Summary Full Text Full Text PDF PubMed Scopus (209) Google Scholar including the Trump administration referring to the epidemic as a hoax and political attack by opposition politicians.5Egan L Trump calls coronavirus Democrats' ‘new hoax’. NBC News.https://www.nbcnews.com/politics/donald-trump/trump-calls-coronavirus-democrats-new-hoax-n1145721Date: 2020Date accessed: March 20, 2020Google Scholar Misinformation can have fatal consequences, as shown by the spread of premature evidence suggesting chloroquine is an effective treatment for COVID-19.6Man fatally poisons himself while self-medicating for coronavirus. Doctor Says.The New York Times. 2020; https://www.nytimes.com/2020/03/24/us/chloroquine-poisoning-coronavirus.html?smtyp=cur&smid=fb-nytimes&fbclid=IwAR3DvxiVrr_BbgGNqAmptMLC8RhiW4btzE4ruCRznkFYpj-oLIqtI8ELpxk&fbclid=IwAR2wultjKE4yzoHKKGynjmy-ODslfV7DIzF8surA5ZkpHDP0rKVPz2SFwUIDate accessed: March 24, 2020Google Scholar Given the exponential growth of the COVID-19 pandemic, the unchecked and rapid spread of misinformation, primarily fuelled by social media, presents a pressing public health challenge for COVID-19 control and mitigation measures, as confusion sowed by misinformation hinders public trust, consensus, and subsequent action. Unlike the litany of debunked misinformation perpetuated by anti-vaccine activists, our understanding of COVID-19 is evolving continuously. As such, what qualifies as misinformation will be sensitive to new scientific discoveries and insights, making it in turn, harder to eliminate misinformation. That is, distinguishing misinformation from legitimate information is, at present, a moving target. The stakes are exceptionally high. With the scale and reach of the pandemic increasing exponentially, there is an urgent need to establish practices to effectively disseminate current, accurate information and quickly identify and root out outdated guidance or misinformation. Actions taken by government agencies to partner with the social media giants Facebook, Twitter, and Instagram show how public–private cooperation to flag, fact-check, and even remove false or outdated information can be an effective way to inoculate these networks from impeding and actually worsening public health efforts. Social media companies have committed to regulate content in light of the pandemic.7Shu C Schieber J Facebook, Reddit, Google, LinkedIn, Microsoft, Twitter and YouTube issue joint statement on misinformation. TechCrunch.https://techcrunch.com/2020/03/16/facebook-reddit-google-linkedin-microsoft-twitter-and-youtube-issue-joint-statement-on-misinformation/Date: 2020Date accessed: March 24, 2020Google Scholar Eliminating misinformation can help social media users gather and disseminate accurate information, helping them stay safe and reduce risk to others. Emerging tools, including crowd intelligence-based misinformation detection, can support social media platforms to root out misinformation.8Guo B Ding Y Yao L Liang Y Yu Z The future of misinformation detection: new perspectives and trends.arXiv. 2019; (DOI: 1909.03654 published online Sept 9. (preprint).)Google Scholar A more ambitious role for social media platforms would be to boost efforts by public health authorities by, for example, upranking links to recommendations from recognised health authorities, and downranking ads for essential limited medical supplies, such as face masks, to prevent hoarding. Removing false claims about COVID-19 and elevating authoritative information are welcome steps to help protect public health in this extraordinary time. Content standards should be designed to allow diverse voices, including voices critical of government policy, while maintaining controls on the validity and authenticity of claims and recommendations. This aim is understandably complicated. In setting these standards, it is paramount to preserve social media's role as a platform for open, critical public discussion of policies, including good faith disagreements about how government or global health agencies are responding to the pandemic. We anticipate that critiques will only become louder as citizens increasingly question the overall benefits, for example, of physical distancing. The risk of misinformation spreading will probably increase, as these tensions between public health authorities and the public increase. Social media provides an important platform to ensure that citizens have a voice and promote public trust in the transparency and accountability of policy making.9Song C Lee J Citizens' use of social media in government, perceived transparency, and trust in government.Public Perform Manag Rev. 2016; 39: 430-453Crossref Scopus (204) Google Scholar As public health practitioners, we must ensure that measures strike an ethically appropriate balance between protecting speech and preserving and promoting public health. Finally, because many are turning to social media for information and advice, the differentiation between individuals who are qualified to provide accurate information online and so-called armchair epidemiologists is increasingly difficult. Members of the lay public might try to identify the most seemingly qualified member of their close network as a trusted resource to vet information. These individuals might feel unequipped to respond effectively to misinformation that individuals are exposed to on social media. To dispel myths, one strategy for the lay public and trusted sources of information (ie, epidemiologists) is inoculation. Inoculation, in this sense, focuses on strengthening a person's attitudes and opinions to protect them from misinformation.10Cook J Lewandowsky S Ecker UKH Neutralizing misinformation through inoculation: exposing misleading argumentation techniques reduces their influence.PLoS One. 2017; 12e0175799Crossref PubMed Scopus (459) Google Scholar For example, a common myth circulating on social media is that COVID-19 was engineered in a lab. By affirming the proliferation of misinformation about COVID-19, one can also point to the use of conspiracy theory rhetoric. Such rhetoric characteristically suggests unsubstantiated links and invokes themes of unseen nefarious networks that act behind the scenes of the pandemic. Because of the ubiquitous nature of misinformation related to COVID-19, all members of these broad digital social networks (including government agencies, social media companies, health-care providers, and the consumers or propagators of information themselves) share in the responsibility to help address the broader implications of this pandemic and the underlying infodemic to strengthen community resiliency. We declare no competing interests.

The International Society for Stem Cell Research has updated its Guidelines for Stem Cell Research and Clinical Translation in order to address advances in stem cell science and other relevant fields, together with the associated ethical, social, and policy issues that have arisen since the last update in 2016. While growing to encompass the evolving science, clinical applications of stem cells, and the increasingly complex implications of stem cell research for society, the basic principles underlying the Guidelines remain unchanged, and they will continue to serve as the standard for the field and as a resource for scientists, regulators, funders, physicians, and members of the public, including patients. A summary of the key updates and issues is presented here.

Food systems that support healthy diets in sustainable, resilient, just, and equitable ways can engender progress in eradicating poverty and malnutrition; protecting human rights; and restoring natural resources. Food system activities have contributed to great gains for humanity but have also led to significant challenges, including hunger, poor diet quality, inequity, and threats to nature. While it is recognized that food systems are central to multiple global commitments and goals, including the Sustainable Development Goals, current trajectories are not aligned to meet these objectives. As mounting crises further stress food systems, the consequences of inaction are clear. The goal of food system transformation is to generate a future where all people have access to healthy diets, which are produced in sustainable and resilient ways that restore nature and deliver just, equitable livelihoods. A rigorous, science-based monitoring framework can support evidence-based policymaking and the work of those who hold key actors accountable in this transformation process. Monitoring can illustrate current performance, facilitate comparisons across geographies and over time, and track progress. We propose a framework centered around five thematic areas related to (1) diets, nutrition, and health; (2) environment and climate; and (3) livelihoods, poverty, and equity; (4) governance; and (5) resilience and sustainability. We hope to call attention to the need to monitor food systems globally to inform decisions and support accountability for better governance of food systems as part of the transformation process. Transformation is possible in the next decade, but rigorous evidence is needed in the countdown to the 2030 SDG global goals.

Food system innovations will be instrumental to achieving multiple Sustainable Development Goals (SDGs). However, major innovation breakthroughs can trigger profound and disruptive changes, leading to simultaneous and interlinked reconfigurations of multiple parts of the global food system. The emergence of new technologies or social solutions, therefore, have very different impact profiles, with favourable consequences for some SDGs and unintended adverse side-effects for others. Stand-alone innovations seldom achieve positive outcomes over multiple sustainability dimensions. Instead, they should be embedded as part of systemic changes that facilitate the implementation of the SDGs. Emerging trade-offs need to be intentionally addressed to achieve true sustainability, particularly those involving social aspects like inequality in its many forms, social justice, and strong institutions, which remain challenging. Trade-offs with undesirable consequences are manageable through the development of well planned transition pathways, careful monitoring of key indicators, and through the implementation of transparent science targets at the local level.

Importance: Extenuating circumstances can trigger unplanned changes to randomized trials and introduce methodological, ethical, feasibility, and analytical challenges that can potentially compromise the validity of findings. Numerous randomized trials have required changes in response to the COVID-19 pandemic, but guidance for reporting such modifications is incomplete. Objective: As a joint extension for the CONSORT and SPIRIT reporting guidelines, CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstances) aims to improve reporting of trial protocols and completed trials that undergo important modifications in response to extenuating circumstances. Evidence: A panel of 37 international trial investigators, patient representatives, methodologists and statisticians, ethicists, funders, regulators, and journal editors convened to develop the guideline. The panel developed CONSERVE following an accelerated, iterative process between June 2020 and February 2021 involving (1) a rapid literature review of multiple databases (OVID Medline, OVID EMBASE, and EBSCO CINAHL) and gray literature sources from 2003 to March 2021; (2) consensus-based panelist meetings using a modified Delphi process and surveys; and (3) a global survey of trial stakeholders. Findings: The rapid review yielded 41 673 citations, of which 38 titles were relevant, including emerging guidance from regulatory and funding agencies for managing the effects of the COVID-19 pandemic on trials. However, no generalizable guidance for all circumstances in which trials and trial protocols might face unanticipated modifications were identified. The CONSERVE panel used these findings to develop a consensus reporting guidelines following 4 rounds of meetings and surveys. Responses were received from 198 professionals from 34 countries, of whom 90% (n = 178) indicated that they understood the concept definitions and 85.4% (n = 169) indicated that they understood and could use the implementation tool. Feedback from survey respondents was used to finalize the guideline and confirm that the guideline's core concepts were applicable and had utility for the trial community. CONSERVE incorporates an implementation tool and checklists tailored to trial reports and trial protocols for which extenuating circumstances have resulted in important modifications to the intended study procedures. The checklists include 4 sections capturing extenuating circumstances, important modifications, responsible parties, and interim data analyses. Conclusions and Relevance: CONSERVE offers an extension to CONSORT and SPIRIT that could improve the transparency, quality, and completeness of reporting important modifications to trials in extenuating circumstances such as COVID-19.

Vaccination policies have shifted dramatically during COVID-19 with the rapid emergence of population-wide vaccine mandates, domestic vaccine passports and differential restrictions based on vaccination status. While these policies have prompted ethical, scientific, practical, legal and political debate, there has been limited evaluation of their potential unintended consequences. Here, we outline a comprehensive set of hypotheses for why these policies may ultimately be counterproductive and harmful. Our framework considers four domains: (1) behavioural psychology, (2) politics and law, (3) socioeconomics, and (4) the integrity of science and public health. While current vaccines appear to have had a significant impact on decreasing COVID-19-related morbidity and mortality burdens, we argue that current mandatory vaccine policies are scientifically questionable and are likely to cause more societal harm than good. Restricting people's access to work, education, public transport and social life based on COVID-19 vaccination status impinges on human rights, promotes stigma and social polarisation, and adversely affects health and well-being. Current policies may lead to a widening of health and economic inequalities, detrimental long-term impacts on trust in government and scientific institutions, and reduce the uptake of future public health measures, including COVID-19 vaccines as well as routine immunisations. Mandating vaccination is one of the most powerful interventions in public health and should be used sparingly and carefully to uphold ethical norms and trust in institutions. We argue that current COVID-19 vaccine policies should be re-evaluated in light of the negative consequences that we outline. Leveraging empowering strategies based on trust and public consultation, and improving healthcare services and infrastructure, represent a more sustainable approach to optimising COVID-19 vaccination programmes and, more broadly, the health and well-being of the public.

In response to the traditional emphasis on the rights, interests, and well-being of individual research subjects, there has been growing attention focused on the importance of involving communities in research development and approval. Community consultation is a particularly common method of involving communities. However, the fundamental ethical goals of community consultation have not been delineated, which makes it difficult for investigators, sponsors, and institutional review boards to design and evaluate consultation efforts. Community consultation must be tailored to the communities in which it is conducted, but the purposes of consultation-the ethical goals it is designed to achieve-should be universal. We propose 4 ethical goals that give investigators, sponsors, institutional review boards, and communities a framework for evaluating community consultation processes.

PURPOSE: To provide an overview of PCORI's approach to engagement in research. METHODS: The Patient-Centered Outcomes Research Institute (PCORI) was established in 2010 to fund patient-centered comparative effectiveness research. Requirements for research funding from PCORI include meaningful engagement of patients and other stakeholders in the research. PCORI's approach to engagement in research is guided by a conceptual model of patient-centered outcomes research (PCOR), that provides a structure for understanding engagement in research. RESULTS: To understand and improve engagement in research PCORI is learning from awardees and other stakeholders. Those efforts are described along with PCORI's capacity building and guidance to awardees via the Engagement Rubric. PCORI's unique model of engaging patients and other stakeholders in merit review of funding applications is also described. Additional support for learning about engagement in research is provided through specific research funding and through PCORI's major infrastructure initiative, PCORnet. CONCLUSION: PCORI requires engagement of stakeholders in the research it funds. In addition PCORI engages stakeholders in activities including review of funding applications and establishment of CER research infrastructure through PCORnet. The comprehensive approach to engagement is being evaluated to help guide the field toward promising practices in research engagement.

The National Institutes of Health and other federal health agencies are considering establishing a national biobank to study the roles of genes and environment in human health. A preliminary public engagement study was conducted to assess public attitudes and concerns about the proposed biobank, including the expectations for return of individual research results. A total of 141 adults of different ages, incomes, genders, ethnicities, and races participated in 16 focus groups in six locations across the country. Focus group participants voiced a strong desire to be able to access individual research results. Recognizing the wide range of possible research results from a large cohort study, they repeatedly and spontaneously suggested that cohort study participants be given ongoing choices as to which results they received.

E challenges are commonplace in critical care settings. Questions about the boundaries of ethically permissible treatment, assessment of decisionmaking capacity, determining who ought to decide on the ultimate treatment plan, or potentially medically inappropriate treatment are part of everyday practice. Contradictory views can result in lack of consensus or unsatisfactory decisions between patients and family members, within interprofessional teams, or among patients, patients’ families, and critical care teams. Often at stake are each person’s central ethical values, obligations, and commitments. When confronted with these challenges, many clinicians experience moral distress in response to threats or violations of their integrity.1-5 Moral distress ensues when clinicians recognize ethical conflicts and their responsibility to respond to them but are unable to translate their moral choices into ethically grounded action that preserves integrity.5 Although controversies persist regarding the definition and contours of moral distress, the literature is replete with data that documents the pervasive experience of moral distress by critical care clinicians and the profound human costs that accompany it.6-14 Spiraling rates of burnout, turnover, and shortages of critical care clinicians and diminished employee engagement threaten the quality and safety of patient care and the overall stability of the health care system.15-22 Moral distress is not likely to be extinguished, and given the complexities of the health care system, will continue to escalate in the future. Why is it that some people are able to navigate ethical dilemmas and moral distress without the deep sense of despair and hopelessness that others experience? What individual qualities and capacities do they possess? What is it that supports them to find meaning in situations that appear senseless? How do they transform their experiences into growth-producing transformations? These are some of the questions to which answers are needed in order to more fully understand how clinicians, particularly critical care clinicians, address moral distress. So far, strategies to address moral distress focused on building skills in ethical decision making, conflict resolution, interdisciplinary collaboration, system reforms, mediation, and ethics consultation have been only partial solutions.23-26 Much of what has been tried has been done on a small scale and has not sufficiently shifted the incidence or consequences of moral distress.27-30 Moreover, while clinicians resonate with data that verifies the existence of moral distress and its negative consequences, the accompanying narrative of disempowerment, despair, and hopelessness may have inadvertently

Over the last several decades, voluntary certification programs have become a key approach to promote sustainable supply chains for agricultural commodities. These programs provide premiums and other benefits to producers for adhering to environmental and labor practices established by the certifying entities. Following the principles of Cochrane Reviews used in health sciences, we assess evidence to evaluate whether voluntary certification of tropical agricultural commodities (bananas, cocoa, coffee, oil palm, and tea) has achieved environmental benefits and improved economic and social outcomes for small-scale producers at the level of the farm household. We reviewed over 2600 papers in the peer-review literature and identified 24 cases of unique combinations of study area, certification program, and commodity in 16 papers that rigorously analyzed differences between treatment (certified households) and control groups (uncertified households) for a wide range of response variables. Based on analysis of 347 response variables reported in these papers, we conclude that certification is associated on average with positive outcomes for 34% of response variables, no significant difference for 58% of variables, and negative outcomes for 8% of variables. No significant differences were observed for different categories of responses (environmental, economic and social) or for different commodities (banana, coffee and tea), except negative outcomes were significantly less for environmental than other outcome categories (p = 0.01). Most cases (20 out of 24) investigated coffee certification and response variables were inconsistent across cases, indicating the paucity of studies to conduct a conclusive meta-analysis. The somewhat positive results indicate that voluntary certification programs can sometimes play a role in meeting sustainable development goals and do not support the view that such programs are merely greenwashing. However, results also indicate that certification is not a panacea to improve social outcomes or overall incomes of smallholder farmers. Rigorous analysis, standardized criteria, and independent evaluation are needed to assess effectiveness of certification programs in the future.

Palliative care has been one of the most rapidly growing fields of health care in the United States in the past decade. The benefits of palliative care have now been shown in multiple clinical trials, with increased patient and provider satisfaction, equal or better symptom control, more discernment of and honoring choices about place of death, fewer and less intensive hospital admissions in the last month of life, less anxiety and depression, less caregiver distress, and cost savings. The cost savings come from cost avoidance, or movement of a patient from a high cost setting to a lower cost setting. Barriers to expanded use include physician resistance, unrealistic expectations of patients and families, and lack of workforce. The future of palliative care includes more penetration into other fields such as nephrology, neurology, and surgery; further discernment of the most effective and cost-effective models; and establishment of more outpatient services.

Recent advances in human stem cell-derived brain organoids promise to replicate critical molecular and cellular aspects of learning and memory and possibly aspects of cognition in vitro . Coining the term “organoid intelligence” (OI) to encompass these developments, we present a collaborative program to implement the vision of a multidisciplinary field of OI. This aims to establish OI as a form of genuine biological computing that harnesses brain organoids using scientific and bioengineering advances in an ethically responsible manner. Standardized, 3D, myelinated brain organoids can now be produced with high cell density and enriched levels of glial cells and gene expression critical for learning. Integrated microfluidic perfusion systems can support scalable and durable culturing, and spatiotemporal chemical signaling. Novel 3D microelectrode arrays permit high-resolution spatiotemporal electrophysiological signaling and recording to explore the capacity of brain organoids to recapitulate the molecular mechanisms of learning and memory formation and, ultimately, their computational potential. Technologies that could enable novel biocomputing models via stimulus-response training and organoid-computer interfaces are in development. We envisage complex, networked interfaces whereby brain organoids are connected with real-world sensors and output devices, and ultimately with each other and with sensory organ organoids (e.g. retinal organoids), and are trained using biofeedback, big-data warehousing, and machine learning methods. In parallel, we emphasize an embedded ethics approach to analyze the ethical aspects raised by OI research in an iterative, collaborative manner involving all relevant stakeholders. The many possible applications of this research urge the strategic development of OI as a scientific discipline. We anticipate OI-based biocomputing systems to allow faster decision-making, continuous learning during tasks, and greater energy and data efficiency. Furthermore, the development of “intelligence-in-a-dish” could help elucidate the pathophysiology of devastating developmental and degenerative diseases (such as dementia), potentially aiding the identification of novel therapeutic approaches to address major global unmet needs.

There is considerable confusion regarding the ethical appropriateness of using incentives in research with human subjects. Previous work on determining whether incentives are unethical considers them as a form of undue influence or coercive offer. We understand the ethical issue of undue influence as an issue, not of coercion, but of corruption of judgment. By doing so we find that, for the most part, the use of incentives to recruit and retain research subjects is innocuous. But there are some instances where it is not. Specifically, incentives become problematic when conjoined with the following factors, singly or in combination with one another: where the subject is in a dependency relationship with the researcher, where the risks are particularly high, where the research is degrading, where the participant will only consent if the incentive is relatively large because the participant's aversion to the study is strong, and where the aversion is a principled one. The factors we have identified and the kinds of judgments they require differ substantially from those considered crucial in most previous discussions of the ethics of employing incentives in research with human subjects.

BACKGROUND: The medical research enterprise depends on public recognition of its societal value. In light of evidence indicating public mistrust, especially among minorities, inadequate enrollment as well as diversity of research participants, and poor uptake of findings, medical research seems to fall short of sufficient public regard. Community engagement in medical research, with special attention to minority communities, may help to remedy this shortfall by demonstrating respect for the communities in practical ways. APPROACH: We provided 3 case examples that illustrate how specific approaches to community-engaged research can build trust between researchers and communities, encourage participation among underrepresented groups, and enhance the relevance as well as the uptake of research findings. DISCUSSION: A common attribute of the specific approaches discussed here is that they enable the researchers to demonstrate respect by recognizing community values and interests. The demonstration of respect for the communities has intrinsic ethical importance. CONCLUSIONS: The 2 potential outgrowths of demonstrating respect specifically through community engagement are (1) the production of research that is more relevant to the community and (2) the mitigation of asymmetry in the researcher-community relationship. We summarized practical resources available to researchers who seek to incorporate community engagement in their research.

The International Society for Stem Cell Research (ISSCR) presents its 2016 Guidelines for Stem Cell Research and Clinical Translation (ISSCR, 2016). The 2016 guidelines reflect the revision and extension of two past sets of guidelines (ISSCR, 2006; ISSCR, 2008) to address new and emerging areas of stem cell discovery and application and evolving ethical, social, and policy challenges. These guidelines provide an integrated set of principles and best practices to drive progress in basic, translational, and clinical research. The guidelines demand rigor, oversight, and transparency in all aspects of practice, providing confidence to practitioners and public alike that stem cell science can proceed efficiently and remain responsive to public and patient interests. Here, we highlight key elements and recommendations in the guidelines and summarize the recommendations and deliberations behind them.