Background: This article describes the types of community‐wide benefits provided by investigators conducting public health research in South Asia as well as their self‐reported reasons for providing such benefits.Methods: We conducted 52 in‐depth interviews to explore how public health investigators in low‐resource settings make decisions about the delivery of ancillary care to research subjects. In 39 of the interviews respondents described providing benefits to members of the community in which they conducted their study. We returned to our narrative dataset to (...) find answers to two questions: What types of community‐wide benefits do researchers provide when conducting public health intervention studies in the community setting, and what reasons do researchers give when asked why they provided community‐wide benefits?Findings: The types of community‐wide benefits delivered were directed to the health and well‐being of the population. The most common types of benefits delivered were the facilitation of access to health care for individuals in acute medical need and emergency response to natural disasters. Respondents' self‐reported reasons when asked why they provided such benefits fell into 2 general categories: intrinsic importance and instrumental importance. (shrink)

This article proposes an action guide to making decisions regarding the ethical allocation of resources that affect access to healthcare services offered by community-based healthcare organizations. Using the filter of empirical data from a study of decision making in two community-based healthcare organizations, we identify potentially relevant conceptual guidance from a review of frameworks and action guides in the public health, health policy, and organizational ethics literature. We describe the development of this action guide. We used data from a prior (...) empirical study of the values that influence decision making about the allocation of resources in particular types of community-based healthcare organizations. We evaluated, organized, and specified the conceptual guidance we found in 14 frameworks for ethical decision making. The result is an action guide that includes four domains that are relevant to the context of the decision to be made, eight domains that are relevant to the process of the decision to be made, and 15 domains that are relevant to the criteria of the decision to be made. We demonstrate the potential use of this action guide by walking through an illustrative resource allocation decision. The action guide provides community-based healthcare organizations with a conceptually grounded, empirically informed framework for ethical decision making. (shrink)

Background: This article describes the types of community-wide benefits provided by investigators conducting public health research in South Asia as well as their self-reported reasons for providing such benefits. Methods: We conducted 52 in-depth interviews to explore how public health investigators in low-resource settings make decisions about the delivery of ancillary care to research subjects. In 39 of the interviews respondents described providing benefits to members of the community in which they conducted their study. We returned to our narrative dataset (...) to find answers to two questions: What types of community-wide benefits do researchers provide when conducting public health intervention studies in the community setting, and what reasons do researchers give when asked why they provided community-wide benefits? Findings: The types of community-wide benefits delivered were directed to the health and well-being of the population. The most common types of benefits delivered were the facilitation of access to health care for individuals in acute medical need and emergency response to natural disasters. Respondents' self-reported reasons when asked why they provided such benefits fell into 2 general categories: intrinsic importance and instrumental importance. (shrink)

Health researchers working in low-resource settings routinely encounter serious unmet health needs for which research participants have, at best, limited treatment options through the local health system (Taylor, Merritt, and Mullany 2011). A recent case discussion features a study conducted in Bamako, Mali (Dickert and Wendler 2009). The study objective was to see whether children with severe malaria develop pulmonary hypertension in order to improve the general understanding of morbidity and mortality associated with malaria. In the study team's (...) interactions with participating children, they encountered not only malaria but also "eye infections, upper respiratory tract illnesses, rashes, pericardial effusions," .. (shrink)

We sought to assess formally the extent to which different control and elimination strategies for human African trypanosomiasis Trypanosoma brucei gambiense would exacerbate or alleviate experiences of societal disadvantage that traditional economic evaluation does not take into account. Justice-enhanced cost-effectiveness analysis is a normative approach under development to address social justice considerations in public health decision-making alongside other types of analyses. It aims to assess how public health interventions under analysis in comparative evaluation would be expected to influence the clustering (...) of disadvantage across three core dimensions of well-being: agency, association and respect. As a case study to test the approach, we applied it to five strategies for Gambiense HAT control and elimination, in combination with two different other evaluations: a cost-effectiveness analysis and a probability of elimination analysis. We have demonstrated how JE-CEA highlights the ethical importance of adverse social justice impacts of otherwise attractive options and how it indicates specific modifications to policy options to mitigate such impacts. JE-CEA holds promise as an approach to help decision makers and other stakeholders consider social justice more fully, explicitly and systematically in evaluating public health programs. (shrink)

Researchers conducting large community-based studies among underserved populations may collect data on health conditions that are little-acknowledged in the local setting, and for which there are few if any services for referral of participants who need follow-up diagnosis and care. In the design and planning of studies for such settings, investigators and research ethics committees may struggle to determine what constitutes effective referral and whether it is reasonably available. We offer a guiding framework for referral planning, informed by our experiences (...) of research in the field and of service on research ethics committees, to support evaluation of local referral resources and consideration of the benefits, burdens and risks of referral in the local setting. The framework addresses both the impact of referral on the well-being of the people who would be referred and the impact that referral of study participants would have on local people outside the study. We use a sustained discussion of three field-based case examples to illustrate the ethical concerns at issue and to demonstrate the use of the referral planning framework. (shrink)

Ethics guidance increasingly recognises that researchers and sponsors have obligations to consider provisions for post-trial access to interventions that are found to be beneficial in research. Yet, there is little information regarding whether and how such plans can actually be implemented. Understanding practical experiences of developing and implementing these plans is critical to both optimising their implementation and informing conceptual work related to PTA. This viewpoint is informed by experiences with developing and implementing PTA plans for six large-scale multicentre HIV (...) prevention trials supported by the HIV Prevention Trials Network. These experiences suggest that planning and implementing PTA often involve challenges of planning under uncertainty and confronting practical barriers to accessing healthcare systems. Even in relatively favourable circumstances where a tested intervention medication is approved and available in the local healthcare system, system-level barriers can threaten the viability of PTA plans. The aggregate experience across these HIV prevention trials suggests that simply referring participants to local healthcare systems for PTA will not necessarily result in continued access to beneficial interventions for trial participants. Serious commitments to PTA will require additional efforts to learn from future approaches, measuring the success of PTA plans with dedicated follow-up and further developing normative guidance to help research stakeholders navigate the complex practical challenges of realising PTA. (shrink)

Biomedical research is increasingly globalized with ever more research conducted in low and middle-income countries. This trend raises a host of ethical concerns and critiques. While community engagement has been proposed as an ethically important practice for global biomedical research, there is no agreement about what these practices contribute to the ethics of research, or when they are needed.

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)

Background Institutional Review Boards (IRBs) are federally mandated to include both nonscientific and unaffiliated representatives in their membership. Despite this, there is no guidance or policy on the selection of unaffiliated or non-scientist members and reports indicate a lack of clarity regarding members’ roles. In the present study we sought to explore processes of recruitment, training, and the perceived roles for unaffiliated and non-scientist members of IRBs.Methods We distributed a self-administered REDCap survey of members of the Association for the Accreditation (...) of Human Research Protection Programs familiar with IRB member recruitment. The survey included closed and open-ended questions regarding: the operation of the HRPP/IRB(s), how unaffiliated and non-scientist members are recruited, whether they had faced challenges recruiting for these roles, and training and mentorship offered. The survey also collected information regarding the perceived value and roles of unaffiliated and non-scientist members.Results 76 responses were included in the analysis (38% completion rate). The most common approach for recruitment was referral from current IRB members, with almost half of respondents indicating challenges recruiting unaffiliated members. Over 75% indicated no additional training was provided to unaffiliated or non-scientist members compared to affiliated or scientist members. Most common supports provided were travel/parking expenses and honoraria. Commonly perceived roles were to provide an independent voice from the participant perspective, notably regarding consent processes and materials.Conclusions Respondents indicated challenges in defining unaffiliated and non-scientist members and limited practices toward recruitment and support. Future work should more closely examine the challenges in defining these roles and applying the definitions in practice, as well as strategies that may improve recruitment and retention of unaffiliated and non-scientist members. (shrink)

First, the authors should be congratulated for bringing our attention to this important issue. They have made important observations about what may be holding us back in efforts to make progress in...

Introduction The goal of this project was to develop and validate a new tool to evaluate learners' knowledge and skills related to research ethics. Methods A core set of 50 questions from existing computer-based online teaching modules were identified, refined and supplemented to create a set of 74 multiple-choice, true/false and short answer questions. The questions were pilot-tested and item discrimination was calculated for each question. Poorly performing items were eliminated or refined. Two comparable assessment tools were created. These assessment (...) tools were administered as a pre-test and post-test to a cohort of 58 Indian junior health research investigators before and after exposure to a new course on research ethics. Half of the investigators were exposed to the course online, the other half in person. Item discrimination was calculated for each question and Cronbach's α for each assessment tool. A final version of the assessment tool that incorporated the best questions from the pre-/post-test phase was used to assess retention of research ethics knowledge and skills 3 months after course delivery. Results The final version of the REKASA includes 41 items and had a Cronbach's α of 0.837. Conclusion The results illustrate, in one sample of learners, the successful, systematic development and use of a knowledge and skills assessment tool in research ethics capable of not only measuring basic knowledge in research ethics and oversight but also assessing learners' ability to apply ethics knowledge to the analytical task of reasoning through research ethics cases, without reliance on essay or discussion-based examination. These promising preliminary findings should be confirmed with additional groups of learners. (shrink)

This paper considers the morally relevant ways in which population-based research is a distinct type of human subjects research that have unique moral considerations relevant for public health practitioners and researchers. By defining population-based research, the authors distinguish it from public health practice and then consider, in more detail, the ways in which population-based research differs from clinical human subjects research. Based upon the distinctions between these types of research and practice, they identify five important issues that arise in the (...) design and conduct of certain kinds of population-based research. The authors hope that public health practitioners find these distinctions useful in determining when their work may actually be population-based research and that public health researchers use them to identify the areas where ethical issues in their research may arise. (shrink)

Multiple scholars and institutions have asked what distinguishes public health research from public health practice. Most often, they ask in order to have a clear definition of what one does in various public health settings to assess oversight and/or regulation of human subjects research. More importantly, however, whether something is considered public health research or public health practice has real ethical implications in terms of the general moral considerations at stake and the obligations of public health researchers/practitioners to the populations (...) they serve or study.Numerous examples in recent history of research ethics, including the Kennedy Krieger Lead Abatement Study and EPA’s Children’s Environmental Exposure Research Study, suggest that an exploration of the ethics of public health, or more generally population-based research, may be warranted. Although we acknowledge that there are important ethical issues to consider in the implementation of public health practice, we leave that discussion for other authors. (shrink)

Background Meaningfully evaluating the quality of institutional review boards (IRBs) and human research protection programs (HRPPs) is a long-recognized challenge. To be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), organizations must demonstrate that they measure and improve HRPP “quality, effectiveness, and efficiency” (QEE). We sought to learn how AAHRPP-accredited organizations interpret and satisfy this standard, in order to assess strengths, weaknesses, and gaps in current approaches and to inform recommendations for improvement.Methods We conducted 3 (...) small-group interviews with a total of 19 participant representatives of accredited organizations at the 2019 AAHRPP annual meeting. Participants were eligible if they had familiarity with their organization’s approach to satisfying the relevant QEE standard.Results Participants reported lacking clear definitions for HRPP quality or effectiveness but described various approaches to assessing QEE, typically focused on turnaround time, compliance, and researcher satisfaction. Evaluation of IRB members was described as relatively superficial and information regarding research subject experience was not reported as central to QEE assessment, although participants described several efforts to improve consideration of patient, subject, and community perspectives in IRB review. Participants also described efforts to educate and build relationships with key stakeholders as important features of a high-quality HRPP. While generally satisfied with their approaches, participants expressed concern about resource and time constraints that pushed them to be reactive and automatic about QEE, rather than proactive and critical.Conclusions The relevant AAHRPP accreditation standard may obscure critical gaps in defining and measuring QEE elements. We recommend that AAHRPP: (1) offer a definition of QEE or require accredited organizations to provide their own, to help clarify the rationale and goals behind assessment and improvement efforts, and (2) require accredited organizations to establish QEE objectives and measures focused on participant outcomes and deliberative quality during protocol review. (shrink)

Since the beginning of the AIDS epidemic, the proportion of AIDS cases among women has continued to rise. Women constituted 23 percent of the AIDS cases reported to the Centers for Disease Control and Prevention in 1995, and 81 percent of these women were of childbearing age. It was not until 1991, however, that epidemiological studies of women were initiated. By comparison, the representation of HIV-infected women in clinical trials gradually has grown. Undoubtedly, a consequence of the increased numbers of (...) women in clinical and epidemiological research is the earlier identification of and more appropriate treatments for HIV-related syndromes when women present in the clinical setting. Despite this expanded focus on women, however, clear information to guide the treatment of HIV-infected women who are pregnant is still lagging behind. (shrink)

Since the beginning of the AIDS epidemic, the proportion of AIDS cases among women has continued to rise. Women constituted 23 percent of the AIDS cases reported to the Centers for Disease Control and Prevention in 1995, and 81 percent of these women were of childbearing age. It was not until 1991, however, that epidemiological studies of women were initiated. By comparison, the representation of HIV-infected women in clinical trials gradually has grown. Undoubtedly, a consequence of the increased numbers of (...) women in clinical and epidemiological research is the earlier identification of and more appropriate treatments for HIV-related syndromes when women present in the clinical setting. Despite this expanded focus on women, however, clear information to guide the treatment of HIV-infected women who are pregnant is still lagging behind. (shrink)

A limiting factor in ethics education in medical training has been difficulty in assessing competence in ethics. This study was conducted to test the concept that content analysis of pediatric residents’ personal reflections about ethics experiences can identify changes in ethical sensitivity and reasoning over time. Analysis of written narratives focused on two of our ethics curriculum’s goals: 1) To raise sensitivity to ethical issues in everyday clinical practice and 2) to enhance critical reflection on personal and professional values as (...) they affect patient care. Content analysis of written reflections was guided by a tool developed to identify and assess the level of ethical reasoning in eight domains determined to be important aspects of ethical competence. Based on the assessment of narratives written at two times (12 to 16 months/apart) during their training, residents showed significant progress in two specific domains: use of professional values, and use of personal values. Residents did not show decline in ethical reasoning in any domain. This study demonstrates that content analysis of personal narratives may provide a useful method for assessment of developing ethical sensitivity and reasoning. (shrink)

This case looks at the question of how to consider obligations of confidentiality by a mental health professional who works for an institution and learns that a student has been using a drug intended for an animal research project. Dr. Paul Appelbaum, MD, a psychiatrist at Columbia University, examines the issue of the limits of confidentiality. Nicholas Steneck, PhD, a scholar in research misconduct at the University of Michigan, explores the obligations to report research misconduct. Walter Limehouse, MD, an ethicist (...) at the Medical University of South Carolina, considers the systems issues raised by this case and offers some suggestions that might change the institutional environment. (shrink)

This case explores the ethical landscape around recontacting a subject's relatives to return genetic research results when the informed consent form signed by the original cohort of subjects is silent on whether investigators may share new information with the research subject's family. As a result of rapid advances in genetic technology, methods to identify genetic markers can mature during the life course of a study. In this case, the investigators identified the genetic mutation responsible for the disorder after a number (...) of their original subjects had died. The researchers now have the ability to inform relatives of the subject about their risk of developing the same disease. Mark Rothstein, JD, from the University of Louisville School of Medicine, provides an overview of the medical/scientific, legal, and ethical issues underlying this case. Lauren Milner, PhD, and colleagues at Stanford University explore how the relationship between researcher and subject affect this debate. Seema Shah, JD, and colleagues at the National Institutes of Health and University of California, Los Angeles discuss whether and how requirements of the duty to warn are applicable in this case. (shrink)

Volume 20, Issue 10, October 2020, Page 84-85.

Local health departments and their employees are at the forefront of emergency preparedness and response. Yet, recent studies have found that some local public health workers are unwilling to report to work in a variety of disaster scenarios. This can greatly compromise a response, as many local health departments need “all hands on deck” to effectively meet increased demands. To address these concerns, local health departments have employed varied policy strategies to ensure that employees do report to work. After describing (...) different approaches taken by local health departments throughout the United States, we briefly identify and explore key ethics considerations that arise for local health departments when employees are required to report to work for emergency responses. We then discuss how these ethics considerations may inform local health department practices intended to promote a robust emergency response. (shrink)

In an emergency, challenges faced by disabled individuals may be exacerbated by ineffective communication, power outages, transportation shortcomings, and inhospitable shelters. During Hurricanes Katrina and Rita, Gulf Coast shelters did not routinely provide closed captioning or sign language interpreters; for individuals with auditory disabilities, understanding instructions issued in these shelters was extremely difficult. Individuals with mobility-related disabilities experienced challenges evacuating from their homes due to public transportation that could not accommodate wheelchairs. After the hurricanes, difficulties arose in identifying wheelchair-accessible trailers (...) and in communicating with disabled trailer residents. Failing to anticipate these challenges intensifies the disadvantaged situation of those with disabilities during an emergency. (shrink)