•Quickly finding a safe and effective vaccine against SARS Co-V-2 would be of great value.•Collecting rigorous safety and efficacy data without compromising ethical and scientific norms is ...critical.•The best approach is accelerated individually randomized controlled trials.•Premature distribution could hamper public health and finding safe, effective SARS CoV-2 vaccines.
A sense of urgency exists to develop vaccines against SARS CoV-2, responsible for numerous global cases and deaths, as well as widespread social and economic disruption. Multiple approaches have been proposed to speed up vaccine development, including accelerated randomized controlled trials (RCT), controlled human challenge trials (CHI), and wide distribution through an emergency use authorization after collecting initial data. There is a need to examine how best to accelerate vaccine development in the setting of a pandemic, without compromising ethical and scientific norms.
Trade-offs in scientific and social value between generating reliable evidence about safety and efficacy while promoting rapid vaccine availability are examined along five ethically relevant dimensions: (1) confidence in and generalizability of data, (2) feasibility, (3) speed and cost, (4) participant risks, and (5) social risks.
Accelerated individually randomized RCTs permit expeditious evaluation of vaccine candidates using established methods, expertise, and infrastructure. RCTs are more likely than other approaches to be feasible, increase speed and reduce cost, and generate reliable data about safety and efficacy without significantly increasing risks to participants or undermining societal trust.
Ethical analysis suggests that accelerated RCTs are the best approach to accelerating vaccine development in a pandemic, and more likely than other approaches to enhance social value without compromising ethics or science. RCTs can expeditiously collect rigorous data about vaccine safety and efficacy. Innovative and flexible designs and implementation strategies to respond to shifting incidence and test vaccine candidates in parallel or sequentially would add value, as will coordinated data sharing across vaccine trials. CHI studies may be an important complementary strategy when more is known. Widely disseminating a vaccine candidate without efficacy data will not serve the public health nor achieve the goal of identifying safe and effective SARS Co-V-2 vaccines.
Hundreds of millions of rare biospecimens are stored in laboratories and biobanks around the world. Often, the researchers who possess these specimens do not plan to use them, while other researchers ...limit the scope of their work because they cannot acquire biospecimens that meet their needs. This situation raises an important and underexplored question: how should scientists allocate biospecimens that they do not intend to use? We argue that allocators should aim to maximise the social value of the research enterprise when allocating scarce biospecimens. We provide an ethical framework for assessing the social value of proposed research projects and describe how the framework could be implemented.
Imperfect efficiency in healthcare delivery is sometimes given as a justification for refusing to ration or even discuss how to pursue fair rationing. This paper aims to clarify the relationship ...between inefficiency and rationing, and the conditions under which bedside rationing can be justified despite coexisting inefficiency. This paper first clarifies several assumptions that underlie the classification of a clinical practice as being inefficient. We then suggest that rationing is difficult to justify in circumstances where the rationing agent is or should be aware of and contributes to clinical inefficiency. We further explain the different ethical implications of this suggestion for rationing decisions made by clinicians. We argue that rationing is more legitimate when sufficient efforts are undertaken to decrease inefficiency in parallel with efforts to pursue unavoidable but fair rationing. While the qualifier ‘sufficient’ is crucial here, we explain why ‘sufficient efforts’ should be translated into ‘benchmarks of efficiency’ that address specific healthcare activities where clinical inefficiency can be decreased. Referring to recent consensus papers, we consider some examples of specific clinical situations where improving clinical inefficiency has been recommended and consider how benchmarks for efficiency might apply. These benchmarks should state explicitly how much inefficiency shall be reduced in a reasonable time range and why these efforts are ‘sufficient’. Possible strategies for adherence to benchmarks are offered to address the possibility of non-compliance.
Ethically challenging situations routinely arise in the course of illness and healthcare. However, very few studies have surveyed patients and family members about their experiences with ethically ...challenging situations. To address this gap in the literature, we surveyed patients and family members at three hospitals. We conducted a content analysis of their responses to open-ended questions about their most memorable experience with an ethical concern for them or their family member. Participants (N = 196) described 219 unique ethical experiences that spanned many of the prevailing themes of bioethics, including the patient-physician relationship, end-of-life care, decision-making capacity, healthcare costs, and genetic testing. Participants focused on relational issues in the course of experiencing illness and receiving medical care and concerns regarding the patient-physician encounters. Many concerns arose outside of a healthcare setting. These data indicate areas for improvement for healthcare providers but some concerns may be better addressed outside of the traditional healthcare setting.
Background/aims
Sparse literature exists on the challenges and ethical considerations of including people with limited access to healthcare, such as the uninsured and low-income, in clinical research ...in high-income countries. However, many ethical issues should be considered with respect to working with uninsured and low-income participants in clinical research, including enrollment and retention, ancillary care, and post-trial responsibilities. Attention to the uninsured and low-income is particularly salient in the United States due to the high rates of uninsurance and underinsurance. Thus, we conducted a scoping review on the ethical considerations of biomedical clinical research with uninsured and low-income participants in high-income countries in order to describe what is known and to pinpoint areas of needed research on this issue.
Methods
MEDLINE/PubMed, Embase, and Scopus databases were searched using terms that described main concepts of interest (e.g., uninsured, underinsured, access to healthcare, poverty, ethics, compensation, clinical research). Articles were included if they met four inclusion criteria: (1) English, (2) high-income countries context, (3) about research participants who are uninsured or low-income, which limits their access to healthcare, and in biomedical clinical research that either had a prospect of direct medical benefit or was offered to them on the basis of their ill health, and (4) recognizes and/or addresses challenges or ethical considerations of uninsured or low-income participants in biomedical clinical research.
Results
The searches generated a total of 974 results. Ultimately, 23 papers were included in the scoping review. Of 23 articles, the majority (n = 19) discussed enrollment and retention of uninsured or low-income participants. Several barriers to enrolling uninsured and low-income groups were identified, including limited access to primary or preventive care; lack of access to institutions conducting trials or physicians with enough time or knowledge about trials; overall lack of trust in the government, research, or medical system; and logistical issues. Considerably fewer articles discussed treatment of these participants during the course of research (n = 5) or post-trial responsibilities owed to them (n = 4). Thus, we propose a research agenda that builds upon the existing literature by addressing three broad questions: (1) What is the current status of uninsured research participants in biomedical clinical research in high-income countries? (2) How should uninsured research participants be treated during and after clinical research? (3) How, if at all, should additional protections for uninsured research participants affect their enrollment?
Conclusions
This review reveals significant gaps in both data and thoughtful analysis on how to ethically involve uninsured research participants. To address these gaps, we propose a research agenda to gather needed data and theoretical analysis that addresses three broad research questions.
Abstract
Public engagement in priority-setting for health is increasingly recognized as a means to ensure more ethical, inclusive and legitimate decision-making processes, especially in the context ...of Universal Health Coverage where demands outweigh the available resources and difficult decisions need to be made. Deliberative approaches are often viewed as especially useful in considering social values and balancing trade-offs, however, implementation of deliberative engagement tools for priority-setting is scant, especially in low- and middle-income settings. In order to address this gap, we implemented a context-specific public deliberation tool in a rural community in South Africa to determine priorities for a health services package. Qualitative data were analysed from seven group deliberations using the engagement tool. The analysis focused on understanding the deliberative process, what the participants prioritized, the reasons for these selections and how negotiations took place within the groups. The deliberations demonstrated that the groups often considered curative services to be more important than primary prevention which related to the perceived lack of efficacy of existing health education and prevention programmes in leading to behaviour change. The groups engaged deeply with trade-offs between costly treatment options for HIV/AIDS and those for non-communicable disease. Barriers to healthcare access were considered especially important by all groups and some priorities included investing in more mobile clinics. This study demonstrates that deliberative engagement methods can be successful in helping communities balance trade-offs and in eliciting social values around health priorities. The findings from such deliberations, alongside other evidence and broader ethical considerations, have the potential to inform decision-making with regard to health policy design and implementation.
Health in the United States is characterized by sizable inequalities by race, class, and geography; declining life expectancy; and a "health disadvantage" that makes the nation as a whole less ...healthy than other high-income countries.1 Although explanations are multifactorial, numerous studies point upstream to federal and state policies that shape the social, economic, and environmental conditions in which people learn, live, work, play, and age.1-4 Most Americans are unaware of these facts except as lived realities. We think they should have more meaningful opportunities to learn about and participate in policy decisions that affect their health and longevity.Although citizens elect officials at state and federal levels to represent their policy preferences and values, voting is only one form of democracy, and often an imperfect one. Policy debate and the politics that shape it may lack credible evidence, be framed to persuade or incite, and reinforce stereotypes and "us" versus "them" narratives. For example, the politicization of COVID-19 vaccines and other mitigation measures generated significant disinformation, distrust, and resistance, helping to fuel the nation's outsized death toll.5 But studies have also demonstrated that an association between deepening political divisions and statelevel variations in health outcomes- life expectancy, infant mortality, and working-age mortality-predate the pandemic.2-4 Made possible by shifts in power from the federal government to state governments over the last four decades, states have moved toward opposite ends of the political spectrum and remade policies on labor, welfare, guns, health care access, health behaviors (e.g., use of tobacco, marijuana), the environment, immigration, and civil rights, all of which affect residents' health.A more deliberative democracy would offer a viable supplement to formal political processes of representation, better inform citizens, and serve as an antidote to the nation's polarizing policy and political discourse. In practice, deliberative democracy takes the form of "public deliberations" that convene people of varied backgrounds to learn and talk together about a social problem in search of solutions.6 Studies have shown that participants gain knowledge, regardless of education level; get insight into others' lives and perspectives; develop trust in fellow participants and society; become more public spirited in reasoning and views; and exhibit less partisan animosity, even in deeply divided societies such as the United States.7-14 We believe that deliberation designed and operationalized to address worrisome health trends has the potential to build a "we" in the pursuit of a healthier, more equitable nation.
Home care is one of the fastest‐growing industries in the United States, providing valuable opportunities for millions of older adults and people with disabilities to live at home rather than in ...institutional settings. Home care workers assist clients with essential activities of daily living, but their wages and working conditions generally fail to reflect the importance of their work. Drawing on the work of Eva Feder Kittay and other care ethicists, we argue that good care involves attending to the needs of another out of a concern for their well‐being. Such care should be standard in the home care system. Yet, because of the pervasive racial, gender, and economic inequalities that the home care industry perpetuates, home care workers and their clients cannot reasonably be expected to care about each other. We endorse reforms aimed at enabling home care workers and their clients to form and maintain professional relationships that cultivate care..
Purpose
The objective of this study was to explore abuse survivor perspectives on optimal physician approaches to trauma inquiry in prenatal care.
Methods
Focus group involving six adult female abuse ...survivors.
Results
Five themes emerged for framing “safe” trauma inquiry: (1) a clear definition of trauma, (2) clear purpose for inquiry, (3) reassurance that inquiry was routine, (4) confidentiality, and (5) mention of helpful resources other than psychiatric therapy.
Conclusions
Explaining the purpose of trauma inquiry may be important for effectively engaging abuse survivors in obstetrics.
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