AbstractDuring the Covid-19 pandemic, ethicists and researchers proposed human challenge studies as a way to speed development of a vaccine that could prevent disease and end the global public health crisis. The risks to healthy volunteers of being deliberately infected with a deadly and novel pathogen were not low, but the benefits could have been immense. This essay is a history of the three major efforts to set up a challenge model and run challenge studies in 2020 and 2021. The (...) pharmaceutical company Johnson and Johnson, the National Institutes of Health in the United States, and a private-public partnership of industry, university, and government partners in Britain all undertook preparations. The United Kingdom’s consortium began their Human Challenge Programme in March of 2021.Beyond documenting each effort, the essay puts these scientific and ethical debates in dialogue with the social, epidemiological, and institutional conditions of the pandemic as well as the commercial, intellectual, and political systems in which medical research and Covid-19 challenge studies operated. It shows how different institutions understood risk, benefit, and social value depending on their specific contexts. Ultimately the example of Covid-19 challenge studies highlights the constructedness of such assessments and reveals the utility of deconstructing them retrospectively so as to better understand the interplay of medical research and research ethics with larger social systems and historical contexts. (shrink)

In controlled human infection (CHI) studies, investigators deliberately infect healthy individuals with pathogens in order to study mechanisms of disease or obtain preliminary efficacy data on investigational vaccines and medicines. CHI studies offer a fast and cost‐effective way of generating new scientific insights, prioritizing investigational products for clinical testing, and reducing the risk that large numbers of people are exposed to ineffective or harmful substances in research or in practice. Yet depending on the pathogen, CHI studies can involve significant risks (...) or burdens for participants, pose risks to individuals or communities not involved in the research, and lead to public controversy. It is therefore essential to ensure that the risks of CHI studies are justified by their social value—that is, their potential to generate benefits for society—and that public trust can be maintained. In this paper, we aim to clarify how research sponsors, research ethics committees and other reviewers should judge the social value of CHI studies. We develop a list of relevant considerations for making social value judgments based on the standard view of social value. We then use this list to discuss the example of potentially conducting dengue virus CHI studies in endemic settings. We argue that dengue virus CHI studies in endemic settings would fall on the higher end of the spectrum of social value, mostly because of their potential to redirect all fields of future dengue research. Drawing on this discussion, we derive several general recommendations for how reviewers should judge the social value of CHI studies. (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)

Thus far, little work in bioethics has specifically focused on global health research priority-setting. Yet features of global health research priority-setting raise ethical considerations and concerns related to health justice. For example, such processes are often exclusively disease-driven, meaning they rely heavily on burden of disease considerations. They, therefore, tend to undervalue non-biomedical research topics, which have been identified as essential to helping reduce health disparities. In recognition of these ethical concerns and the limited scholarship and dialogue addressing them, we (...) convened an international workshop in September 2015. The workshop aimed to initiate discussion on the appropriate relationship between global and national levels of health research priority-setting and to begin exploring what might be ethically required for priority-setting at each of those levels. This paper comprises our reflections following the workshop. Its main objective is to launch a research agenda for the ethics of global health research priority-setting. We identify three domains of global health research priority-setting—scope, underlying values and substantive requirements, and procedural considerations. For each domain, specific research questions are highlighted and why they need to be explored is explained. Some preliminary thoughts and normative arguments as to how the research questions might be answered are also offered. For example, we provide initial ideas about the appropriate relationship between different priority-setting levels and what values and substantive considerations should guide or underpin global health research priority-setting as a matter of justice. We anticipate that framing a new research agenda for the ethics of global health research priority-setting will spur ethicists, researchers, and policymakers to refocus their efforts on developing more rigorous and ethically sound approaches to priority-setting. (shrink)

The vast majority of health research resources are used to study conditions that affect a small, advantaged portion of the global population. This distribution has been widely criticized as inequitable and threatens to exacerbate health disparities. However, there has been little systematic work on what individual health research funders ought to do in response. In this article, we analyze the general and special duties of research funders to the different populations that might benefit from health research. We assess how these (...) duties apply to governmental, multilateral, nonprofit, and for-profit organizations. We thereby derive a framework for how different types of funders should take the beneficiaries of research into account when they allocate scarce research resources. (shrink)

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. (shrink)

Protecting human subjects from being exploited is one of the main ethical challenges for clinical research. However, there is also a responsibility to protect and respect the communities who are hosting the research. Recently, attention has focused on the most efficient way of carrying out clinical research, so that it benefits society by providing valuable research while simultaneously protecting and respecting the human subjects and the communities where the research is conducted. Collaboration between partners plays an important role and that (...) is why we carried out a study to describe how collaborative partnership and social value are emerging in clinical research. A supra-analysis design for qualitative descriptive secondary analysis was employed to consider a novel research question that pertained to nurse leaders’ perceptions of ethical recruitment in clinical research and the ethics-related aspects of clinical research from the perspective of administrative staff. The data consisted of two separate pre-existing datasets, comprising 451 pages from 41 interviews, and we considered the research question by using deductive-inductive content analysis with NVivo software. A deductive analysis matrix was generated on the basis of two requirements, namely collaborative partnership and social value, as presented in An Ethical Framework for Biomedical Research by Emanuel et al. The findings showed that collaborative partnership was a cornerstone for ethical clinical research and ways to foster inter-partner collaboration were indicated, such as supporting mutual respect and equality, shared goals and clearly defined roles and responsibilities. In addition, the social value of clinical research was an important precondition for ethical clinical research and its realisation required the research partners to demonstrate collaboration and shared responsibility during the research process. However, concerns emerged that the multidimensional meaning of clinical research for society was not fully recognised. Achieving greater social value for clinical research required greater transparency, setting research priorities, shared responsibility for the dissemination and use of the findings and stronger community awareness of the ethics-related aspects of clinical research. Collaborative partnership and social values are essential for protecting the human subjects and communities involved in clinical research. (shrink)

Technology corporations and the emerging digital health market are exerting increasing influence over the public healthcare agendas forming around the application of mobile medical devices. By promising quick and cost-effective technological solutions to complex healthcare problems, they are attracting the interest of funders, researchers, and policymakers. They are also shaping the public facing discourse, advancing an overwhelmingly positive narrative predicting the benefits of wearable medical devices to include personalised medicine, improved efficiency and quality of care, the empowering of under-resourced communities, (...) and delivery of health services previously unavailable to the citizens of developing countries. Typically techno-optimist in their description, the key barriers to this impending inflection point in healthcare are identified as technical issues such as short battery life and a lack of data protection. However, this tech innovation narrative is consistent with problematic ethical, social, and political assumptions that have practical and normative effects, and risk, one, undermining the real clinical potential of wearable devices and, two, designing social inequality and injustice into our mobile health interventions in global healthcare. I argue that the foundational assumptions dealing with the just distribution of healthcare ‘goods’, the individual as part of society, and the political framing of future healthcare policy devalue equity and despite what they promise cannot meet the distinctive needs of individuals and groups that do not conform to a standardised concept of care-receiver. (shrink)

The future of health research will be characterised by three continuing trends: rising demand for health data; increasing impracticability of obtaining specific consent for secondary research; and decreasing capacity to effectively anonymise data. In this context, governments, clinicians and the research community must demonstrate that they can be responsible stewards of health data. IRBs and RECs sit at heart of this process because in many jurisdictions they have the capacity to grant consent waivers when research is judged to be of (...) particular value. However, several different terms are used to refer to this value, indicating a lack of conceptual clarity regarding the appropriate test for access to health data for research without consent. In this paper we do three things. First we describe the current confusion and instability in terminology relating to public interest in the context of consent waivers. Second we argue for harmonisation of terminology on the grounds of clarity, transparency and consistency. Third we argue that the term ‘public interest’ best reflects the normative work required to justify consent waivers because it is the broadest of the competing terms. ‘Public interest’ contains within its scope positive and negative implications of a study, as well as welfare, justice and rights considerations. In making this argument, we explain the normative basis for consent waivers, and provide a starting place for further discussion about the precise conditions in which a given study can be said to advance the public interest. Ipsos MORI study found that: … the public would be broadly happy with administrative data linking for research projects provided Those projects have social value, broadly defined. Data are de-identified. Data are kept secure. Businesses are not able to access the data for profit. (shrink)