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It is increasingly recognized that effective and appropriate data sharing requires the development of models of good data-sharing practice capable of taking seriously both the potential benefits to be gained and the importance of ensuring that the rights and interests of participants are respected and that risk of harms is minimized. Calls for the greater sharing of individual-level data from biomedical and public health research are receiving support among researchers and research funders. Despite its potential importance, data sharing presents important ethical, social, and institutional challenges in low-income settings. In this article, we report on qualitative research conducted in five low- and middle-income countries exploring the experiences of key research stakeholders and their views about what constitutes good data-sharing practice.

Consent and community engagement (CE) in health research are two aspects of a single concern—that research is carried out in a respectful manner where social value is maximized. There are important overlaps and interdependencies between consent and CE; for example, CE can provide insights into how best to tailor consent to context and can be an important component of consent processes. Engaging communities can also have intrinsic and instrumental value beyond consent; for example, as a means of showing respect and identifying appropriate ways of working respectfully. In this paper we critically examine how CE and consent processes are characterized, conducted, and evaluated in diverse health research contexts, and propose a preliminary research agenda to support future learning in these critical areas.

The COVID-19 pandemic has both highlighted and exacerbated global health inequities, leading for calls for responses to COVID to promote social justice and ensure that no one is left behind. One key lesson to be learnt from the pandemic is the critical importance of decolonizing global health and global health research so that African countries are better placed to address pandemic challenges in contextually relevant ways. This paper argues that to be successful, programmes of decolonization in complex global health landscapes require a complex three-dimensional approach. Drawing on the broader discourse of political decolonization that has been going on in the African context for over a century, we present a model for unpacking the complex task of decolonization. Our approach suggests a three-dimensional approach which encompasses hegemomic; epistemic; and commitmental elements.

The COVID-19 pandemic has both highlighted and exacerbated global health inequities, leading for calls for responses to COVID to promote social justice and ensure that no one is left behind. One key lesson to be learnt from the pandemic is the critical importance of decolonizing global health and global health research so that African countries are better placed to address pandemic challenges in contextually relevant ways. This paper argues that to be successful, programmes of decolonization in complex global health landscapes require a complex three-dimensional approach. Drawing on the broader discourse of political decolonization that has been going on in the African context for over a century, we present a model for unpacking the complex task of decolonization. Our approach suggests a three-dimensional approach which encompasses hegemomic; epistemic; and commitmental elements.

Given the unprecedented scale of digital surveillance in the COVID-19 pandemic, designing and implementing digital technologies in ways that are equitable is critical now and in future epidemics and pandemics. Yet to date there has been very limited consideration about what is necessary to promote their equitable design and implementation. In this study, literature relating to the use of digital surveillance technologies during epidemics and pandemics was collected and thematically analyzed for ethical norms and concerns related to equity and social justice. Eleven norms are reported, including procedural fairness and inclusive approaches to design and implementation, designing to rectify or avoid exacerbating inequities, and fair access. Identified concerns relate to digital divides, stigma and discrimination, disparate risk of harm, and unfair design processes. We conclude by considering what dimensions of social justice the norms promote and whether identified concerns can be addressed by building the identified norms into technology design and implementation practice.

There is increasing support for sharing individual-level data generated by medical and public health research. This scoping review of empirical research and conceptual literature examined stakeholders' perspectives of ethical best practices in data sharing, particularly in low- and middle-income settings. Sixty-nine empirical and conceptual articles were reviewed, of which, only five were empirical studies and eight were conceptual articles focusing on low- and middle-income settings. We conclude that support for sharing individual-level data is contingent on the development and implementation of international and local policies and processes to support ethical best practices. Further conceptual and empirical research is needed to ensure data sharing policies and processes in low- and middle-income settings are appropriately informed by stakeholders' perspectives.

Guidance requires that consent processes for research be appropriately tailored to their cultural context. This paper discusses the use of rapid assessments to identify cultural and ethical issues arising when explaining research in studies in The Gambia and Ethiopia. The assessments provided insights into appropriate ways of providing information to minimize the risk of stigmatizing vulnerable research populations; research participants' views about the most important information to provide about research and their understandings of research; and perceived constraints upon reaching voluntary decisions about participation. These insights demonstrate that rapid assessments are a relatively quick and inexpensive intervention that can provide valuable information to assist in the tailoring of information provision and consent processes to research context while maintaining and enhancing participants' fundamental protections.

The abundance of South African clinical and public health research data has the potential to unlock important and valuable future advances in biomedical science. Amid increasing calls for more effective sharing of individual-level data, commitment to promote access to research data is evident within South Africa's public research sector, but national guidance and regulation are absent. This qualitative study examined the perceptions, experiences and concerns of 32 research stakeholders about data-sharing practices. There was consensus about the utility of data sharing in publicly funded health research. However, disparate views emerged about the possible harms and benefits of sharing data and how these should be weighed. The relative dearth of policies governing data-sharing practices needs to be addressed and a framework of support developed that incentivizes data-sharing practices for researchers that are both ethical and effective.

Efforts to internalize data sharing in research practice have been driven largely by developing international norms that have not incorporated opinions from researchers in low- and middle-income countries. We sought to identify the issues around ethical data sharing in the context of research involving women and children in urban India. We interviewed researchers, managers, and research participants associated with a Mumbai non-governmental organization, as well as researchers from other organizations and members of ethics committees. We conducted 22 individual semi-structured interviews and involved 44 research participants in focus group discussions. We used framework analysis to examine ideas about data and data sharing in general; its potential benefits or harms, barriers, obligations, and governance; and the requirements for consent. Both researchers and participants were generally in favor of data sharing, although limited experience amplified their reservations. We identified three themes: concerns that the work of data producers may not receive appropriate acknowledgment, skepticism about the process of sharing, and the fact that the terrain of data sharing was essentially uncharted and confusing. To increase data sharing in India, we need to provide guidelines, protocols, and examples of good practice in terms of consent, data preparation, screening of applications, and what individuals and organizations can expect in terms of validation, acknowledgment, and authorship.

Increased global sharing of public health research data has potential to advance scientific progress but may present challenges to the interests of research stakeholders, particularly in low-to-middle income countries. Policies for data sharing should be responsive to public views, but there is little evidence of the systematic study of these from low-income countries. This qualitative study explored views on fair data-sharing processes among 60 stakeholders in Kenya with varying research experience, using a deliberative approach. Stakeholders' attitudes were informed by perceptions of benefit and concerns for research data sharing, including risks of stigmatization, loss of privacy, and undermining scientific careers and validity, reported in detail elsewhere. In this article, we discuss institutional trust-building processes seen as central to perceptions of fairness in sharing research data in this setting, including forms of community involvement, individual prior awareness and agreement to data sharing, independence and accountability of governance mechanisms, and operating under a national framework.

The Thailand Major Overseas Programme coordinates large multi-center studies in tropical medicine and generates vast amounts of data. As the data sharing movement gains momentum, we wanted to understand attitudes and experiences of relevant stakeholders about what constitutes good data sharing practice. We conducted 15 interviews and three focus groups discussions involving 25 participants and found that they generally saw data sharing as something positive. Data sharing was viewed as a means to contribute to scientific progress and lead to better quality analysis, better use of resources, greater accountability, and more outputs. However, there were also important reservations including potential harms to research participants, their communities, and the researchers themselves. Given these concerns, several areas for discussion were identified: data standardization, appropriate consent models, and governance.

Chapter 1: Introduction: Research Ethics and Health Policy in Epidemics and Pandemics -- Chapter 2: Setting Research Priorities -- Chapter 3: Research Quality and Dissemination -- Chapter 4: Boundaries Between Research, Surveillance and Monitored Emergency Use -- Chapter 5: Adapting and adaptive research. Chapter 6: Ethics Review Challenges -- Chapter 7: Ethical Issues Associated with Managing and Sharing Individual-Level Health Data During a Public Health Emergency -- Chapter 8: Dimensions of Vulnerability -- Chapter 9: Participant Recruitment, Consent and Post-Trial Access to Interventions -- Chapter 10: Afterword.

International science funders and publishers are driving a growing trend in data sharing. There is mounting pressure on researchers in low- and middle-income settings to conform to new sharing policies, despite minimal empirically grounded accounts of the ethical challenges of implementing the policies in these settings. This study used in-depth interviews and focus group discussions with 48 stakeholders in Vietnam to explore the experiences, attitudes, and expectations that inform ethical and effective approaches to sharing clinical research data. Distinct views on the role of trust, respect, and reciprocity were among those that emerged to inform culturally appropriate best practices. We conclude by discussing the challenges that authors of data-sharing policies should consider in this unique context.