Community engagement is increasingly promoted as a marker of good, ethical practice in the context of international collaborative research in low-income countries. There is, however, no widely agreed definition of community engagement or of approaches adopted. Justifications given for its use also vary. Community engagement is, for example, variously seen to be of value in: the development of more effective and appropriate consent processes; improved understanding of the aims and forms of research; higher recruitment rates; the identification of important ethical (...) issues; the building of better relationships between the community and researchers; the obtaining of community permission to approach potential research participants; and, the provision of better health care. Despite these diverse and potentially competing claims made for the importance of community engagement, there is very little published evidence on effective models of engagement or their evaluation. (shrink)

In order to involve children in the decision-making process about participation in medical research it is widely recommended that the child’s assent be sought in addition to parental consent. However, the concept of assent is fraught with difficulties, resulting in confusion among researchers and ethics committees alike.

In response to calls to expand the scope of research ethics to address justice in global health, recent scholarship has sought to clarify how external research actors from high-income countries might discharge their obligation to reduce health disparities between and within countries. An ethical framework—‘research for health justice’—was derived from a theory of justice (the health capability paradigm) and specifies how international clinical research might contribute to improved health and research capacity in host communities. This paper examines whether and how (...) external funders, sponsors, and researchers can fulfill their obligations under the framework. (shrink)

BackgroundCommunity engagement is increasingly promoted as a marker of good, ethical practice in the context of international collaborative research in low-income countries. There is, however, no widely agreed definition of community engagement or of approaches adopted. Justifications given for its use also vary. Community engagement is, for example, variously seen to be of value in: the development of more effective and appropriate consent processes; improved understanding of the aims and forms of research; higher recruitment rates; the identification of important ethical (...) issues; the building of better relationships between the community and researchers; the obtaining of community permission to approach potential research participants; and, the provision of better health care. Despite these diverse and potentially competing claims made for the importance of community engagement, there is very little published evidence on effective models of engagement or their evaluation.MethodsIn this paper, drawing upon interviews with the members of a Community Advisory Board on the Thai-Myanmar border, we describe and critically reflect upon an approach to community engagement which was developed in the context of international collaborative research in the border region.Results and conclusionsDrawing on our analysis, we identify a number of considerations relevant to the development of an approach to evaluating community engagement in this complex research setting. The paper also identifies a range of important ways in which the Community Advisory Board is in practice understood by its members to have morally significant roles and responsibilities beyond those usually associated with the successful and appropriate conduct of research. (shrink)

Since January 2016, the Mahidol Oxford Tropical Medicine Research Unit has trialled a data-sharing policy where requests to access research datasets are processed through a Data Access Committee. In this paper, we share our experiences establishing data management systems and data-sharing infrastructure including a data-sharing policy, data access committee and related procedures. We identified a number of practical and ethical challenges including requests for datasets collected without specific or broad consent to data sharing and requests from pharmaceutical companies for data (...) to support drug registration applications. We also encountered significant resource constraints which required the development of appropriate human resources and infrastructure. We suggest a research agenda to promote responsible and equitable data sharing while safeguarding the rights and interests of research participants and researchers. (shrink)

The use of placebos in randomised controlled trials is a subject of considerable ethical debate. In this paper we present a set of considerations to evaluate the ethics of placebo controlled trials that includes: social value of the study; need for a randomised controlled trial and placebo; standards of care; risks of harm due to administration of placebo and the harm benefit balance; clinical equipoise; and double standards. We illustrate the application of these considerations using a case study of a (...) large ongoing multicentre, placebo-controlled, double-blinded, randomised trial to determine primaquine anti-relapse efficacy in vivax malaria. There is an urgent need for primaquine anti-relapse studies in order to rationalise the management of a potentially fatal disease. An ethical justification for the use of the placebo arm is provided on the grounds that the actual current applied standard of care in most endemic places does not include primaquine. It has also been argued that there is clinical equipoise among the primaquine study arms and that the risk of harms of being in the placebo arm is the risk of having relapse, which is no more than not being included in the trial, and that there are no double standards. Based on our set of considerations, we conclude that a placebo arm is not only justified but imperative in this study. We propose that similar considerations should be prospectively applied to other placebo controlled trials and observational control arms where no treatment is offered. (shrink)

Research funders, regulatory agencies, and journals are increasingly expecting that individual-level data from health research will be shared. Broad consent to such sharing is considered appropriate, feasible and acceptable in low- and middle-income settings, but to date limited empirical research has been conducted to inform the design of such processes. We examined stakeholder perspectives about how best to seek broad consent to sharing data from the Mahidol Oxford Tropical Medicine Research Unit, which implemented a data sharing policy and broad consent (...) to data sharing in January 2016. Between February and August 2017 qualitative data were collected at two sites, Bangkok and the Thai-Myanmar border town of Mae Sot. We conducted eighteen semi-structured interviews. We also conducted four focus group discussions with a total of nineteen people. Descriptive and thematic coding informed analysis of aspects of data sharing that are considered most important to inform participants about, and the best ways to explain complex and abstract topics relating to data sharing. The findings demonstrated that clinical trial participants prioritise information about the potential benefits and harms of data sharing. Stakeholders made multiple suggestions for clarifying information provided about data sharing on such topics. There was significant variation amongst stakeholders’ perspectives about how much information should be provided about data sharing, and it was clear that effective information provision should be responsive to the study, the study population, the individual research participant and the research context. Effectively communicating about data sharing with research participants is challenging in practice, highlighting the importance of robust and effective data sharing governance in this context. Broad consent should incorporate effective and efficient explanations of data sharing to promote informed decision-making, without impeding research participants’ understandings of key aspects of the research from which data will be shared. Further work is required to refine both the development of core information about data sharing to be provided to all research participants, and appropriate solutions for context specific-challenges arising when explaining data sharing. (shrink)

Community engagement is increasingly recognized as a critical element of medical research, recommended by ethicists, required by research funders and advocated in ethics guidelines. The benefits of community engagement are often stressed in instrumental terms, particularly with regard to promoting recruitment and retention in studies. Less emphasis has been placed on the value of community engagement with regard to ethical good practice, with goals often implied rather than clearly articulated. This article outlines explicitly how community engagement can contribute to ethical (...) global health research by complementing existing established requirements such as informed consent and independent ethics review. The overarching and interlinked areas are respecting individuals, communities and stakeholders; building trust and social relationships; determining appropriate benefits; minimizing risks, burdens and exploitation; supporting the consent process; understanding vulnerabilities and researcher obligations; gaining permissions, approvals and building legitimacy and achieving recruitment and retention targets. (shrink)

BackgroundSharing de-identified individual-level health research data is widely promoted and has many potential benefits. However there are also some potential harms, such as misuse of data and breach of participant confidentiality. One way to promote the benefits of sharing while ameliorating its potential harms is through the adoption of a managed access approach where data requests are channeled through a Data Access Committee (DAC), rather than making data openly available without restrictions. A DAC, whether a formal or informal group of (...) individuals, has the responsibility of reviewing and assessing data access requests. Many individual groups, consortiums, institutional and independent DACs have been established but there is currently no widely accepted framework for their organization and function.Main textWe propose that DACs, should have the role of both promotion of data sharing and protection of data subjects, their communities, data producers, their institutions and the scientific enterprise. We suggest that data access should be granted by DACs as long as the data reuse has potential social value and provided there is low risk of foreseeable harms. To promote data sharing and to motivate data producers, DACs should encourage secondary uses that are consistent with the interests of data producers and their own institutions. Given the suggested roles of DACs, there should be transparent, simple and clear application procedures for data access. The approach to review of applications should be proportionate to the potential risks involved. DACs should be established within institutional and legal frameworks with clear lines of accountability, terms of reference and membership. We suggest that DACs should not be modelled after research ethics committees (RECs) because their functions and goals of review are different from those of RECs. DAC reviews should be guided by the principles of public health ethics instead of research ethics.ConclusionsIn this paper we have suggested a framework under which DACs should operate, how they should be organised, and how to constitute them. (shrink)

Photo ID 72893750 © Rawpixelimages|Dreamstime.com ABSTRACT Solidarity is a concept increasingly employed in bioethics whose application merits further clarity and explanation. Given how vital cooperation and community-level care are to mitigating communicable disease transmission, we use lessons from the COVID-19 pandemic to reveal how solidarity is a useful descriptive and analytical tool for public health scholars, practitioners, and policymakers. Drawing upon an influential framework of solidarity that highlights how solidarity arises from the ground up, we reveal how structural forces can (...) impact the cultivation of solidarity from the top down, particularly through ensuring robust access to important social determinants of health. Public health institutions can support solidarity movements among individuals and communities by adopting a lens of social justice when considering public health priorities and, in turn, promote health equity. INTRODUCTION Over the past two decades, scholars have invoked the concept of solidarity when assessing a wide range of topics in bioethics, from CRISPR-Cas9 technology to organ donation to structural racism.[1] However, the growing literature on solidarity has not fully examined the roles and responsibilities of institutions and governments in fostering solidarity, especially regarding public health measures that implicate entire populations. We argue that it remains unclear how public health institutions should engage with solidarity and how their engagement will affect public health and its ethics. We first take Prainsack and Buyx’ three-tiered framework as an analytical starting point.[2] We then explore how public health institutions can foster solidarity by carefully considering factors that may bolster it on an interpersonal, community, and national scale. We conclude that public health institutions should adopt a lens of social justice to promote solidarity at the interpersonal and community levels, thereby promoting equity in future public health efforts. BACKGROUND Calls for solidarity in bioethics raise longstanding normative questions about the nature and limits of our duties to one another and how to weigh autonomy over considerations of justice.[3] Though the term is diversely applied, Prainsack and Buyx propose a potentially unifying definition in the 2011 Nuffield Council report, “Solidarity: Reflections On An Emerging Concept in Bioethics.” The report defines solidarity as an activity involving “shared practices reflecting a collective commitment to carry financial, social, emotional, and or other ‘costs’ to assist others.” Their conceptualization also includes important features that distinguish solidarity from other values like empathy or altruism: solidarity emphasizes action rather than mere internal feeling and recognition of connection as motivation.[4] Bioethicists have since applied this conceptualization when analyzing issues in public and global health, given that population-level efforts need cooperation from individuals and communities. Prainsack and Buyx further note that solidarity is relevant in bioethics discourses about justice and equity, in support of providing aid to low- and middle-income countries, and as a value exemplified by European welfare states.[5] Other bioethicists have argued that promoting solidarity can contribute to community engagement, partnership with Tribal communities, and global health equity.[6] Most recently, scholars have applied solidarity as a lens to assess the COVID-19 pandemic, highlighting the pitfalls of national mitigation efforts and global disparities in disease outcomes.[7] I. Solidarity at Three Levels It seems impossible to foster solidarity in public health if we cannot identify it in general contexts. Prainsack and Buyx articulate three levels of solidarity: interpersonal solidarity, group solidarity, and legal or contractual codifications of solidarity.[8] They argue that each level inherently informs the one ‘above’ it in a unilateral direction. In other words, solidarity is fundamentally a bottom-up phenomenon. Solidarity among individuals influences group norms, which then have the potential to shape policy and institutional practice.[9] Within the Prainsack and Buyx framework, it would seem nonsensical to posit how solidarity might be expressed vertically or from the “top down.” It appears intuitively odd to imagine how a government entity might ‘be’ in solidarity with a person or group if solidarity requires some cognition about their condition per Prainsack and Buyx’ definition. Some have argued that solidarity does not seem like something that one can impose, as instances of it arise from agents recognizing and acting upon some bond rather than in response to a command. Indeed, people may be rightfully hesitant to engage in solidarity if the official messaging is overly paternalistic or coercive.[10] However, some authors have countered that governments can express solidarity through enacting structural and policy changes, though it is ambiguous how these actions are distinct from a justice-driven approach.[11] If a bottom-up approach is thus the most practical means of achieving policy that reflects solidarity, then it does not add much to public health. Institutions would be ineffective without the population’s initiation of the corresponding social norms. However, we find this conclusion overly pessimistic. Fostering a culture of solidarity to improve public health has potential merit. Prainsack and Buyx’ framework overlooks how public health actors can influence solidarity between individuals and across communities. To clarify, we agree with the view that solidarity is a bottom-up phenomenon. Solidarity may not be able to originate in a top-down fashion, but we suggest that public health institutions can take a more active role in providing the public with accurate information, promoting social justice, and intervening in the social determinants of health. II. The COVID-19 Pandemic as a Case Study Lessons learned from the ongoing COVID-19 pandemic support our argument. The pandemic deepened socioeconomic disparities in the US and hindered access to vital resources such as food, housing, and healthcare.[12] Prainsack recently noted: “[n]ext to the immediate health effects of the virus, poverty and grave inequalities have been the root causes of human suffering during the pandemic.”[13] Prior to the pandemic, many rural and low-income populations lacked reliable access to the internet and devices like laptops or smartphones. This continued lack of access restricts the flow of information and prevents people from accessing telemedicine services.[14] Preexisting social, political, and health inequities worsened health outcomes among many marginalized racial and ethnic groups. It is well-documented that communities of color, including Black, American Indian or Alaska Native, and Latinx populations, had greater COVID-related mortality and morbidity due to the effects of structural racism.[15] Although federal US agencies such as the Centers for Disease Control and Prevention enacted laws that provided safety nets (e.g., the Federal Eviction Moratorium), the majority of such programs have ended, leaving many with little assistance and the threat of further hardship.[16] These disparities are relevant because Prainsack, Buyx, and others note that solidarity arises from agents recognizing and acting on some perceived attainable collective goal(s). Income inequality and disparate access to food, education, and health care may lead people to consider public health goals unattainable. This could limit the desire to work toward those goals collectively.[17] The existing literature on collective action theory supports this intuition. It emphasizes that structural conditions, such as an absence of perceived hope for social change among a group, can lead to low ‘group efficacy’ and little willingness to cooperate, both within and across socioeconomic strata.[18] The pandemic spurred countless messages from public health agencies. The messaging did not recognize or attend to the different material realities and circumstances of the US population. How can people feel comfortable getting vaccinated if they deeply distrust the government, including public health institutions? How can people remain motivated to wear masks and distance themselves if they cannot afford basic necessities and work jobs without adequate pay and leave policies? We ask these questions to illustrate how socioeconomic disparities can marginalize people if they feel ignored, apathetic, or resentful of those better off or those in power whom they perceive to “not be doing enough.” This marginalization precludes the formation of solidarity. There are instances when a population has disparate access to resources and social capital, but solidarity may still emerge from a shared goal or vision for the future. For example, a heterogeneous population living in the same town may come together to protest an environmental injustice that impacts their water supply with the common goal of securing access to safe drinking water. However, many populations in the US failed to recognize shared goals of this kind during the COVID-19 pandemic. A significant minority of the US population was reluctant to acknowledge the severity of COVID-19 infection and thus refused to participate in efforts to mitigate its spread. Even between groups who shared the goal of slowing COVID-19 transmission, the methods were widely debated. Approximately 20 percent of the adult population eligible for vaccination remains unvaccinated.[19] Governmental bodies responsible for disseminating information, coordinating the allocation of resources, and establishing guidelines have a large role in mediating these disagreements and intervening in socioeconomic conditions that impact people's ability and willingness to engage in solidarity. III. Solidarity, Social Justice, and the Role of Public Health Institutions Adopting a lens of social justice provides further insights into how public health actors impact solidarity. Powers and Faden argue that the “foundational moral justification for the social institution of public health is social justice.”[20] Their theory of social justice has two aims. First, it ensures that everyone has a sufficient amount of the six core elements of well-being and that public health institutions are responsible for “adopting policies and creating environments” where all can flourish.[21] Second, public health institutions should distribute resources meant to promote well-being and focus on the “needs of those who are the most disadvantaged.”[22] Public health institutions should enact policies that address injustice. In doing so, public health institutions can seed the opportunity to build solidarity from the bottom up. Equipping individuals and communities with resources will foster cooperation and adherence to policies that require solidarity, such as masking and vaccination. This is consistent with arguments illustrating how institutions such as Tribal governments promote the conditions needed for their group, and especially its most vulnerable members, to flourish.[23] Addressing social determinants of health with a social justice lens will create the circumstances under which more individuals and groups can find common causes and foster solidarity. In the long run, such efforts may result in the establishment of values and practices from the bottom up. There are societal and public health preconditions required before institutions can expect their audience to act in solidarity with one another. Through their great influence over information and resources, public institutions do have the power to impact what values are most widespread. Furthermore, public health may foster trust and hope, which are important psychosocial factors that influence collective action,[24] if policies increase access to resources that promote well-being. Messaging efficacy also depends on the context of public trust, education, and whether the institutions meet one’s basic needs. Disparate messaging across different public institutions may confuse or disillusion individuals. To apply our theory of solidarity to the decision to vaccinate, a policy would be to foster conditions that facilitate access to vaccines and information about vaccine efficacy instead of imposing a top-down mandate without first eliciting public trust. IV. Counterargument Some argue that discordant public health messaging, ineffective government, and inadequate social programs can also bring people together under pressure and foster solidarity. One may argue that the most powerful motivators towards solidarity are strife and disparity, as evidenced throughout history. During the pandemic alone, political struggle and personal hardship inspired solidarity in the US, from individual neighbors helping each other to mutual aid groups forming across communities. We thus do not claim that solidarity is possible only when our government programs and public health institutions are most effective. We instead point out that solidarity can be further hindered when people feel alienated, hopeless, and pitted against each other. CONCLUSION Many competing conceptualizations of solidarity persist in the bioethics literature, and Prainsack and Buyx offer one compelling framework that public health ethicists continue to draw upon.[25] However, their framework fails to acknowledge how public health institutions impact interpersonal and group solidarity. Public health institutions can foster solidarity through actions other than mere messaging, invoking catchphrases like “we are all in this together.” Efforts to address socioeconomic preconditions and alleviate health disparities can cultivate group solidarity. As we saw during the pandemic, cooperation and solidarity go hand-in-hand with disease mitigation efforts; solidarity has clear intrinsic value.[26] As this relationship becomes more apparent, we will continue to see attempts from public health institutions to foster or invoke solidarity. Therefore, public health institutions would be remiss to ignore their role in addressing the social determinants of health. Adopting a social justice lens when planning public health interventions will clarify and strengthen their role in facilitating solidarity. Ultimately, if health disparities continue to persist or widen, it is very hard to imagine how group solidarity can ever be achieved. The widescale adoption of many public health measures needed to promote health and well-being would be conducive to solidarity. - Disclaimer: The opinions expressed are the authors’ and do not represent the views of the NIH, DHHS, or the U.S. government. Funding Disclosure: This work was supported in part by the Intramural Program of the National Institutes of Health Clinical Center. - [1] John J Mulvihill et al., “Ethical Issues of CRISPR Technology and Gene Editing through the Lens of Solidarity,” British Medical Bulletin 122 (2017): 17–29, https://doi.org/10.1093/bmb/ldx002; Ben Saunders, “Altruism or Solidarity? The Motives for Organ Donation and Two Proposals,” Bioethics 26, no. 7 (September 2012): 376–81, https://doi.org/10.1111/j.1467-8519.2012.01989.x; -Vanessa Y Hiratsuka, “SPECIAL REPORT: A Critical Moment in Bioethics: Reckoning with Anti-Black Racism through Intergenerational Dialogue A Call for Solidarity in Bioethics: Confronting Anti-Black Racism Together,” 2022, https://doi.org/10.1002/hast.1380. [2] Prainsack and Buyx, Solidarity: Reflections on an Emerging Concept in Bioethics London: Nuffield Council on Bioethics, 2011; Prainsack and Buyx, “Solidarity in Contemporary Bioethics--towards a New Approach.” Bioethics 26, no. 7 (September 2012): 343–50. https://doi.org/10.1111/J.1467-8519.2012.01987.X. [3] Bob Simpson, “A ‘We’ Problem for Bioethics and the Social Sciences: A Response to Barbara Prainsack,” Science, Technology, & Human Values 43, no. 1 (January 12, 2018): 45–55, https://doi.org/10.1177/0162243917735899. [4] Barbara Prainsack and Alena Buyx, Solidarity: Reflections on an Emerging Concept in Bioethics (London: Nuffield Council on Bioethics, 2011). [5] Barbara Prainsack and Alena Buyx, “Solidarity in Contemporary Bioethics--towards a New Approach,” Bioethics 26, no. 7 (September 2012): 343–50, https://doi.org/10.1111/J.1467-8519.2012.01987.X. [6] Bridget Pratt, Phaik Yeong Cheah, and Vicki Marsh, “Solidarity and Community Engagement in Global Health Research,” The American Journal of Bioethics : AJOB 20, no. 5 (May 3, 2020): 43–56, https://doi.org/10.1080/15265161.2020.1745930; Sara Chandros Hull, F. Leah Nez (Diné), and Juliana M. Blome, “Solidarity as an Aspirational Basis for Partnership with Tribal Communities,” The American Journal of Bioethics 21, no. 10 (October 3, 2021): 14–17, https://doi.org/10.1080/15265161.2021.1965258; Mbih J. Tosam et al., “Global Health Inequalities and the Need for Solidarity: A View from the Global South,” Developing World Bioethics 18, no. 3 (September 1, 2018): 241–49, https://doi.org/10.1111/DEWB.12182. [7] Peter West-Oram, “Solidarity Is for Other People: Identifying Derelictions of Solidarity in Responses to COVID-19,” Journal of Medical Ethics 47, no. 2 (February 1, 2021): 65–68, https://doi.org/10.1136/MEDETHICS-2020-106522; Barbara Prainsack, “Solidarity in Times of Pandemics,” Democratic Theory 7, no. 2 (December 1, 2020): 124–33, https://doi.org/10.3167/DT.2020.070215; F. Marijn Stok et al., “Social Inequality and Solidarity in Times of COVID-19,” International Journal of Environmental Research and Public Health 18, no. 12 (June 2, 2021), https://doi.org/10.3390/IJERPH18126339; Ming Jui Yeh, “Solidarity in Pandemics, Mandatory Vaccination, and Public Health Ethics,” American Journal of Public Health 112, no. 2 (February 1, 2022): 255–61, https://doi.org/10.2105/AJPH.2021.306578; Barbara Prainsack, “Beyond Vaccination Mandates: Solidarity and Freedom During COVID-19.,” Am J Public Health 112, no. 2 (February 1, 2022): 232–33, https://doi.org/10.2105/AJPH.2021.306619. [8] Prainsack and Buyx, Solidarity: Reflections on an Emerging Concept in Bioethics London: Nuffield Council on Bioethics, 2011; Prainsack and Buyx, “Solidarity in Contemporary Bioethics--towards a New Approach.” Bioethics 26, no. 7 (September 2012): 343–50. https://doi.org/10.1111/J.1467-8519.2012.01987.X. [9] Prainsack and Buyx, Solidarity: Reflections on an Emerging Concept in Bioethics London: Nuffield Council on Bioethics, 2011; Prainsack and Buyx, “Solidarity in Contemporary Bioethics--towards a New Approach.” Bioethics 26, no. 7 (September 2012): 343–50. https://doi.org/10.1111/J.1467-8519.2012.01987.X. [10] Yeh, “Solidarity in Pandemics, Mandatory Vaccination, and Public Health Ethics”; Prainsack, “Beyond Vaccination Mandates: Solidarity and Freedom During COVID-19.” [11] Ho, Anita, and Iulia Dascalu. "Relational solidarity and COVID-19: an ethical approach to disrupt the global health disparity pathway." Global Bioethics 32, no. 1 (2021): 34-50; West-Oram, Peter. "Solidarity is for other people: identifying derelictions of solidarity in responses to COVID-19." Journal of Medical Ethics 47, no. 2 (2021): 65-68. [12] Monica Webb Hooper, Anna María Nápoles, and Eliseo J. Pérez-Stable, “COVID-19 and Racial/Ethnic Disparities,” JAMA 323, no. 24 (June 23, 2020): 2466, https://doi.org/10.1001/jama.2020.8598. [13] Prainsack, Barbara. “Beyond Vaccination Mandates: Solidarity and Freedom During COVID-19.” Am J Public Health 112, no. 2 (February 1, 2022): 232–33. https://doi.org/10.2105/AJPH.2021.306619. [14] Camille A Clare, “Telehealth and the Digital Divide as a Social Determinant of Health during the COVID-19 Pandemic,” Network Modeling Analysis in Health Informatics and Bioinformatics 10 (2021): 26, https://doi.org/10.1007/s13721-021-00300-y. [15] Patrick Nana-Sinkam et al., “Health Disparities and Equity in the Era of COVID-19,” Journal of Clinical and Translational Science 5, no. 1 (March 16, 2021): e99, https://doi.org/10.1017/cts.2021.23. [16] Kathryn M Leifheit et al., “Expiring Eviction Moratoriums and COVID-19 Incidence and Mortality,” American Journal of Epidemiology 190, no. 12 (December 1, 2021): 2503–10, https://doi.org/10.1093/aje/kwab196. [17] Barbara Prainsack, “Solidarity in Times of Pandemics,” Democratic Theory 7, no. 2 (December 1, 2020): 124–33, https://doi.org/10.3167/DT.2020.070215 [18] Maximilian Agostini and Martijn van Zomeren, “Toward a Comprehensive and Potentially Cross-Cultural Model of Why People Engage in Collective Action: A Quantitative Research Synthesis of Four Motivations and Structural Constraints.,” Psychological Bulletin 147, no. 7 (July 2021): 667–700, https://doi.org/10.1037/bul0000256. [19] Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (HHS/CDC), “COVID Data Tracker,” 2023, https://covid.cdc.gov/covid-data-tracker. [20] Powers, Madison, and Ruth Faden. Social Justice: The Moral Foundation of Public Health and Health Policy. 1st editio. New York: Oxford Press, 2006, p. 9 and Chapter 4 [21] Powers and Faden, Social Justice: The Moral Foundation of Public Health and Health Policy; Madison Powers and Ruth Faden, Structural Injustice: Power, Advantage, and Human Rights (New York: Oxford University Press, 2019). [22] Powers, Madison, and Ruth Faden. Social Justice: The Moral Foundation of Public Health and Health Policy. 1st editio. New York: Oxford Press, 2006, p. 10 [23] Bobby Saunkeah et al., “Extending Research Protections to Tribal Communities,” The American Journal of Bioethics 21, no. 10 (October 3, 2021): 5–12, https://doi.org/10.1080/15265161.2020.1865477. [24] Agostini and van Zomeren, “Toward a Comprehensive and Potentially Cross-Cultural Model of Why People Engage in Collective Action: A Quantitative Research Synthesis of Four Motivations and Structural Constraints.” [25] Prainsack and Buyx, Solidarity: Reflections on an Emerging Concept in Bioethics. [26] Ruth Chadwick, “COVID‐19 and the Possibility of Solidarity,” Bioethics 34, no. 7 (September 8, 2020): 637–637, https://doi.org/10.1111/bioe.12813. (shrink)

Community engagement (CE) is gaining prominence in global health research. A number of ethical goals–spanning the instrumental, intrinsic, and transformative–have been ascribed to CE in global health research. This paper draws attention to an additional transformative value that CE is not typically linked to but that seems very relevant: solidarity. Both are concerned with building relationships and connecting parties that are distant from one another. This paper first argues that furthering solidarity should be recognized as another ethical goal for CE (...) in global health research. It contends that, over time, CE can build the bases of solidaristic relationships—moral imagination, recognition, understanding, empathy—between researchers and community members. Applying concepts from existing accounts of solidarity, the paper develops preliminary ideas about who should be engaged and how to advance solidarity. The proposed approach is compared to current CE practice in global health research. Finally, the paper briefly considers how solidaristic CE could affect how global health research is performed. (shrink)

Background The ownership status of individual-level health data affects the manner in which it is used. In this paper we analyze two competing models of the ownership status of the data discussed in the literature recently: private ownership and public ownership. Main body In this paper we describe the limitations of these two models of data ownership with respect to individual-level health data, in particular in terms of ethical principles of justice and autonomy, risk mitigation, as well as technological, economic, (...) and conceptual issues. We argue that undifferentiated application of neither private ownership nor public ownership will allow us to resolve all the problems associated with effective, equitable, and ethical use of data. We suggest that, instead of focusing on data ownership, we should focus on the institutional and procedural aspects of data governance, such as using Data Access Committees (DACs) or equivalent managed access processes, which can balance the elements of these two ownership frameworks. Conclusion Undifferentiated application of the ownership concept (private or public) is not helpful in resolving problems associated with sharing individual-level health data. DACs or equivalent managed access processes should be an integral part of data governance. They can approve or disapprove data access requests after considering the potential benefits and harms to data subjects, their communities, primary researchers, and the wider society. (shrink)

Volume 20, Issue 8, August 2020, Page W14-W16.

ABSTRACTThis article describes our experience using art and theatre to engage rural communities in western Cambodia to understand malaria and support malaria control and elimination. The project was a pilot science–arts initiative to supplement existing engagement activities conducted by local authorities. In 2016, the project was conducted in 20 villages, involved 300 community members and was attended by more than 8000 people. Key health messages were to use insecticide-treated bed-nets and repellents, febrile people should attend village malaria workers, and to (...) raise awareness about the risk of forest-acquired malaria. Building on the experience and lessons learnt in the year prior, the 2017 project which was conducted in 15 villages involved 600 community members and attracted more than 12,000 people. In addition to the malaria theme, upon discussion with local health authorities, secondary theme was added to the 2017 project. We learnt the following lessons from our experience in... (shrink)

It has been suggested that community advisory boards can play a role in minimising exploitation in international research. To get a better idea of what this requires and whether it might be achievable, the paper first describes core elements that we suggest must be in place for a CAB to reduce the potential for exploitation. The paper then examines a CAB established by the Shoklo Malaria Research Unit under conditions common in resource-poor settings – namely, where individuals join with a (...) very limited understanding of disease and medical research and where an existing organisational structure is not relied upon to serve as the CAB. Using the Tak Province Border Community Ethics Advisory Board as a case study, we assess the extent to which it might be able to take on a role minimising exploitation were it to decide to do so. We investigate whether, after two years in operation, T-CAB is capable of assessing clinical trials for exploitative features and addressing those found to have them. The findings show that, although T-CAB members have gained knowledge and developed capacities that are foundational for one-day taking on a role to reduce exploitation, their ability to critically evaluate studies for the presence of exploitative elements has not yet been strongly demonstrated. In light of this example, we argue that CABs may not be able to perform such a role for a number of years after initial formation, making it an unsuitable responsibility for many short-term CABs. (shrink)

Bioethicists have long debated the content of sponsors and researchers' obligations of justice in international clinical research. However, there has been little empirical investigation as to whether and how obligations of responsiveness, ancillary care, post-trial benefits and research capacity strengthening are upheld in low- and middle-income country settings. In this paper, the authors argue that research ethics guidelines need to be more informed by international research practice. Practical guidance on how to fulfil these obligations is needed if research groups and (...) other actors are to successfully translate them into practice because doing so is often a complicated, context-specific process. Case study research methods offer one avenue for collecting data to develop this guidance. The authors describe how such methods have been used in relation to the Shoklo Malaria Research Unit's vivax malaria treatment (VHX) trial (NCT01074905). Relying on the VHX trial example, the paper shows how information can be gathered from not only international clinical researchers but also trial participants, community advisory board members and research funder representatives in order to: (1) measure evidence of responsiveness, provision of ancillary care, access to post-trial benefits and research capacity strengthening in international clinical research; and (2) identify the contextual factors and roles and responsibilities that were instrumental in the fulfilment of these ethical obligations. Such empirical work is necessary to inform the articulation of obligations of justice in international research and to develop guidance on how to fulfil them in order to facilitate better adherence to guidelines' requirements. (shrink)

Informed consent is an essential requirement for the ethical conduct of research. It is also a necessary requirement for the lawful conduct of research. Informed consent provides a legal basis to enrol human subjects in clinical research. In paediatric research, where children do not generally enjoy a presumption of competence, a legal representative must authorise a child's enrolment. Determining who should act on behalf of the child is a matter of law, rather than ethical principle. But, if national laws are (...) lacking or do not reflect socio-cultural realities, legal uncertainty can arise, which can have implications for children's enrolment in clinical research. Using Thailand as its case study, this paper contemplates how international legal frameworks, such as the UN Convention on the Rights of the Child, could be leveraged to navigate legal uncertainty in the informed consent process, enabling more children to access and participate in paediatric clinical research. (shrink)

Informed consent is an essential requirement for the ethical conduct of research. It is also a necessary requirement for the lawful conduct of research. Informed consent provides a legal basis to enrol human subjects in clinical research. In paediatric research, where children do not generally enjoy a presumption of competence, a legal representative must authorise a child's enrolment. Determining who should act on behalf of the child is a matter of law, rather than ethical principle. But, if national laws are (...) lacking or do not reflect socio-cultural realities, legal uncertainty can arise, which can have implications for children's enrolment in clinical research. Using Thailand as its case study, this paper contemplates how international legal frameworks, such as the UN Convention on the Rights of the Child, could be leveraged to navigate legal uncertainty in the informed consent process, enabling more children to access and participate in paediatric clinical research. (shrink)

Informed consent is an essential requirement for the ethical conduct of research. It is also a necessary requirement for the lawful conduct of research. Informed consent provides a legal basis to enrol human subjects in clinical research. In paediatric research, where children do not generally enjoy a presumption of competence, a legal representative must authorise a child's enrolment. Determining who should act on behalf of the child is a matter of law, rather than ethical principle. But, if national laws are (...) lacking or do not reflect socio-cultural realities, legal uncertainty can arise, which can have implications for children's enrolment in clinical research. Using Thailand as its case study, this paper contemplates how international legal frameworks, such as the UN Convention on the Rights of the Child, could be leveraged to navigate legal uncertainty in the informed consent process, enabling more children to access and participate in paediatric clinical research. (shrink)

How international research might contribute to justice in global health has not been substantively addressed by bioethics. This article describes how the provision of ancillary care can link international clinical research to the reduction of global health disparities. It identifies the ancillary care obligations supported by a theory of global justice, showing that Jennifer Ruger’s health capability paradigm requires the delivery of ancillary care to trial participants for a limited subset of conditions that cause severe morbidity and mortality. Empirical research (...) on the Shoklo Malaria Research Unit’s (SMRU) vivax malaria treatment trial was then undertaken to demonstrate whether and how these obligations might be upheld in a resource-poor setting. Our findings show that fulfilment of the ancillary care obligations is feasible where there is commitment from chief investigators and funders and is strongly facilitated by SMRU’s dual role as a research unit and medical non-governmental organization. (shrink)

Planteamiento de la naturaleza, de la filosof a y de su raz n hist rica, al contemplar panor micamente la totalidad de su pasado e intentar reconstruir el dram tico suceso de su origen.

DICTIONARY OF SPANISH VERBS WITH THEIR ENGLISH EQUIVALENTS AND MODELS OF CONJUGATION/DICCIONARIO CON LOS VERBOS EN ESPAÑOL, SU TRADUCCIÓN AL INGLÉS Y CONJUGACIONES.

Fanatismo y misticismo.--Nietzsche y Calicles.--Nuestro sentido del ridículo.--El surrealismo.

Pidiendo un Ortega y Gasset desde dentro, por J.D. García Bacca.--El sistema de Ortega, por M. Granell.--Las fundaciones de Ortega y Gasset, por L. Luzuriaga.--Ortega y su ideología universitaria, por E. Mayz Vallenilla.--Ortega y Gasset: lengua y estilo, por A. Rosenblat.

I. El hombre y la epoca.--II. Las doctrinas.--III. Notas. Apendices. Bibliografía.

Maquiavelo y su tiempo.--Reacción de algunos escritores españoles de los siglos XVII y XVIII ante la doctrina de Maquiavelo.--El maquiavelismo y las prácticas de gobierno.