Michael Parker

In this paper we discuss ethical implications of the use of mobile phone apps in the control of the COVID-19 pandemic. Contact tracing is a well-established feature of public health practice during infectious disease outbreaks and epidemics. However, the high proportion of pre-symptomatic transmission in COVID-19 means that standard contact tracing methods are too slow to stop the progression of infection through the population. To address this problem, many countries around the world have deployed or are developing mobile phone apps capable of supporting instantaneous contact tracing. Informed by the on-going mapping of ‘proximity events’ these apps are intended both to inform public health policy and to provide alerts to individuals who have been in contact with a person with the infection. The proposed use of mobile phone data for ‘intelligent physical distancing’ in such contexts raises a number of important ethical questions. In our paper, we outline some ethical considerations that need to be addressed in any deployment of this kind of approach as part of a multidimensional public health response. We also, briefly, explore the implications for its use in future infectious disease outbreaks.

Background Increase in global health research undertaken in resource poor settings in the last decade though a positive development has raised ethical concerns relating to potential for exploitation. Some of the suggested strategies to address these concerns include calls for providing universal standards of care, reasonable availability of proven interventions and more recently, promoting the overall social value of research especially in clinical research. Promoting the social value of research has been closely associated with providing fair benefits to various stakeholders involved in research. The debate over what constitutes fair benefits; whether those that addresses micro level issues of justice or those focusing on the key determinants of health at the macro level has continued. This debate has however not benefited from empirical work on what stakeholders consider fair benefits. This study explores practical experiences of stakeholders involved in global health research in Kenya, over what benefits are fair within a developing world context. Methods and results We conducted in-depth interviews with key informants drawn from within the broader health research system in Kenya including researchers from the mainstream health research institutions, networks and universities, teaching hospitals, policy makers, institutional review boards, civil society organisations and community representative groups. The range of benefits articulated by stakeholders addresses both micro and macro level concerns for justice by for instance, seeking to engage with interests of those facilitating research, and the broader systemic issues that make resource poor settings vulnerable to exploitation. We interpret these views to suggest a need for global health research to engage with current crises that face people in these settings as well as the broader systemic issues that produce them. Conclusion Global health research should provide benefits that address both the micro and macro level issues of justice in order to forestall exploitation. Embracing the two is however challenging in terms of how the various competing interests/needs should be balanced ethically, especially in the absence of structures to guide the process. This challenge should point to the need for greater dialogue to facilitate value clarification among stakeholders.

Design: Qualitative interview study. Participants: Fifty-nine patients with a family history of cancer who attend a regional cancer genetics clinic in the UK were interviewed about their current and previous research experiences. Findings: Interviewees gave a range of explanations for research participation. These were categorised as social—research participation benefits the wider society by progressing science and improving treatment for everyone; familial—research participation may improve healthcare and benefit current or future generations of the participant’s family; and personal—research participation provides therapeutic or non-therapeutic benefits for oneself. Conclusions: We discuss the distinction drawn between motives for research participation focused upon self and others, and observe that personal, social and familial motives can be seen as interdependent. For example, research participation that is undertaken to benefit others, particularly relatives, may also offer a number of personal benefits for self, such as enabling participants to feel that they have discharged their social or familial obligations. We argue for the need to move away from simple, static, individualised notions of research participation to a more complex, dynamic and inherently social account.

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.

ABSTRACT The use of broad consent for genomics research raises important ethical questions for the conduct of genomics research, including relating to its acceptability to research participants and comprehension of difficult scientific concepts. To explore these and other challenges, we conducted a study using qualitative methods with participants enrolled in an H3Africa Rheumatic Heart Disease genomics study (the RHDGen network) in Zambia to explore their views on broad consent, sample and data sharing and secondary use. In-depth interviews were conducted with RHDGen participants (n = 18), study staff (n = 5) and with individuals who refused to participate (n = 3). In general, broad consent was seen to be reasonable if reasons for storing the samples for future research use were disclosed. Some felt that broad consent should be restricted by specifying planned future studies and that secondary research should ideally relate to original disease for which samples were collected. A few participants felt that broad consent would delay the return of research results to participants. This study echoes findings in other similar studies in other parts of the continent that suggested that broad consent could be an acceptable consent model in Africa if careful thought is given to restrictions on re-use.

Misattributed paternity or ‘false’ paternity is when a man is wrongly thought, by himself and possibly by others, to be the biological father of a child. Nowadays, because of the progression of genetics and genomics the possibility of finding misattributed paternity during familial genetic testing has increased. In contrast to other medical information, which pertains primarily to individuals, information obtained by genetic testing and/or pedigree analysis necessarily has implications for other biologically related members in the family. Disclosing or not a misattributed paternity has a number of different biological and social consequences for the people involved. Such an issue presents important ethical and deontological challenges. The debate centres on whether or not to inform the family and, particularly, whom in the family, about the possibility that misattributed paternity might be discovered incidentally, and whether or not it is the duty of the healthcare professional to disclose the results and to whom. In this paper, we consider the different perspectives and reported problems, and analyse their cultural, ethical and legal dimensions. We compare the position of HCPs from an Italian and British point of view, particularly their role in genetic counselling. We discuss whether the Oviedo Convention of the Council of Europe can be seen as a basis for enriching the debate

BackgroundPromoting the social value of global health research undertaken in resource poor settings has become a key concern in global research ethics. The consideration for benefit sharing, which concerns the elucidation of what if anything, is owed to participants, their communities and host nations that take part in such research, and the obligations of researchers involved, is one of the main strategies used for promoting social value of research. In the last decade however, there has been intense debate within academic bioethics literature seeking to define the benefits, the beneficiaries, and the scope of obligations for providing these benefits. Although this debate may be indicative of willingness at the international level to engage with the responsibilities of researchers involved in global health research, it remains unclear which forms of benefits or beneficiaries should be considered. International and local research ethics guidelines are reviewed here to delineate the guidance they provide.MethodsWe reviewed documents selected from the international compilation of research ethics guidelines by the Office for Human Research Protections under the US Department of Health and Human Services.ResultsAccess to interventions being researched, the provision of unavailable health care, capacity building for individuals and institutions, support to health care systems and access to medical and public health interventions proven effective, are the commonly recommended forms of benefits. The beneficiaries are volunteers, disease or illness affected communities and the population in general. Interestingly however, there is a divide between "global opinion" and the views of particular countries within resource poor settings as made explicit by differences in emphasis regarding the potential benefits and the beneficiaries.ConclusionAlthough in theory benefit sharing is widely accepted as one of the means for promoting the social value of international collaborative health research, there is less agreement amongst major guidelines on the specific responsibilities of researchers over what is ethical in promoting the social value of research. Lack of consensus might have practical implications for efforts aimed at enhancing the social value of global health research undertaken in resource poor settings. Further developments in global research ethics require more reflection, paying attention to the practical realities of implementing the ethical principles in real world context.

ABSTRACT The use of broad consent for genomics research raises important ethical questions for the conduct of genomics research, including relating to its acceptability to research participants and comprehension of difficult scientific concepts. To explore these and other challenges, we conducted a study using qualitative methods with participants enrolled in an H3Africa Rheumatic Heart Disease genomics study (the RHDGen network) in Zambia to explore their views on broad consent, sample and data sharing and secondary use. In-depth interviews were conducted with RHDGen participants (n = 18), study staff (n = 5) and with individuals who refused to participate (n = 3). In general, broad consent was seen to be reasonable if reasons for storing the samples for future research use were disclosed. Some felt that broad consent should be restricted by specifying planned future studies and that secondary research should ideally relate to original disease for which samples were collected. A few participants felt that broad consent would delay the return of research results to participants. This study echoes findings in other similar studies in other parts of the continent that suggested that broad consent could be an acceptable consent model in Africa if careful thought is given to restrictions on re-use.

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance.

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.

Within the research community, it is generally accepted that consent processes for research should be culturally appropriate and tailored to the context, yet researchers continue to grapple with what valid consent means within specific stakeholder groups. In this study, we explored the consent practices and attitudes regarding essential information required for the consent process within hospital-based trial communities from four referral hospitals in Vietnam. We collected surveys from and conducted semi-structured interviews with study physicians, study nurses, ethics committee members, and study participants and family members regarding their experiences of participating in research, their perspectives toward research, and their views about various elements of the consent process. In our findings, we describe three interrelated themes related to the consent process: words and regulation; reimbursement, suspicions, and joining; and responsibilities. In general, stakeholders had highly varied perspectives of nghiên cứu and researchers used varying levels of detail regarding all aspects of the study in the consent process to build trust with and/or promote potential research participants’ choices about taking part in research. Findings additionally highlight how researchers felt that offering financial reimbursements in a hospital setting, where payment for services was routine, would be unfamiliar to participants and could raise suspicions about the research. Participants, however, focused their discussions on reimbursement or alternative reasons for joining the study, such as health related benefits or altruism. Finally, participants often relied on their physician to help them decide about joining a study or not. Further research is needed to understand how researchers and participants make sense of and practice consent, and how that impacts participants’ decision-making about research participation. To promote valid consent within this context, it is important to engage with hospital-based trial communities as a whole. The data from this study will inform future research on consent, guide the revisions of consent related policies within our research sites and point to several larger issues surrounding researcher-participant expectations, communication, and trust.

In recent years, there has been an increase in the establishment of biobanks for genetic and genomic studies around the globe. One example of this is the Human Heredity and Health in Africa Initiative (H3Africa), which has established biobanks in the sub‐region to facilitate future indigenous genomic studies. The concept of ‘broad consent’ has been proposed as a mechanism to enable potential research participants in biobanks to give permission for their samples to be used in future research studies. However, questions remain about the acceptability of this model of consent. Drawing on findings from empirical research about the role of trust in decision‐making, we argue that an account of entrustment may be an appropriate way of addressing current challenges of seeking consent for biobank research in Africa. We propose a set of key points to consider that can support the proposed entrustment framework.

Background While community engagement is increasingly promoted in global health research to improve ethical research practice, it can sometimes coerce participation and thereby compromise ethical research. This paper seeks to discuss some of the ethical issues arising from community engagement in a low resource setting. Methods A qualitative study design focusing on the engagement activities of three biomedical research projects as ethnographic case studies was used to gain in-depth understanding of community engagement as experienced by multiple stakeholders in Malawi. Data was collected through participant observation, 43 In-depth interviews and 17 focus group discussions with community leaders, research staff, community members and research participants. Thematic analysis was used to analyse and interpret the findings. Results The results showed that structural coercion arose due to an interplay of factors pertaining to social-economic context, study design and power relations among research stakeholders. The involvement of community leaders, government stakeholders, and power inequalities among research stakeholders affected some participants’ ability to make autonomous decisions about research participation. These results have been presented under the themes of perception of research as development, research participants’ motivation to access individual benefits, the power of vernacular translations to influence research participation, and coercive power of leaders. Conclusion The study identified ethical issues in community engagement practices pertaining to structural coercion. We conclude that community engagement alone did not address underlying structural inequalities to ensure adequate protection of communities. These results raise important questions on how to balance between engaging communities to improve research participation and ensure that informed consent is voluntarily given.

COVID-19 poses an exceptional threat to global public health and well-being. Recognition of the need to develop effective vaccines at unprecedented speed has led to calls to accelerate research pathways ethically, including by conducting challenge studies ) with SARS-CoV-2. Such research is controversial, with concerns being raised about the social, legal, ethical and clinical implications of infecting healthy volunteers with SARS-CoV-2 for research purposes. Systematic risk evaluations are critical to inform assessments of the ethics of any proposed SARS-CoV-2 CHIs. Such evaluations will necessarily take place within a rapidly changing and at times contested epidemiological landscape, in which differing criteria for the ethical acceptability of research risks have been proposed. This paper critically reviews two such criteria and evaluates whether the use of effective treatment should be a necessary condition for the ethical acceptability of SARS-CoV-2 CHIs, and whether the choice of study sites should be influenced by COVID-19 incidence levels. The paper concludes that ethical evaluations of proposed SARS-CoV-2 CHIs should be informed by rigorous, consultative and holistic approaches to systematic risk assessment.

BackgroundHuman infection studies (HIS) are valuable in vaccine development. Deliberate infection, however, creates challenging questions, particularly in low and middle-income countries (LMICs) where HIS are new and ethical challenges may be heightened. Consultation with stakeholders is needed to support contextually appropriate and acceptable study design. We examined stakeholder perceptions about the acceptability and ethics of HIS in Malawi, to inform decisions about planned pneumococcal challenge research and wider understanding of HIS ethics in LMICs.MethodsWe conducted 6 deliberative focus groups and 15 follow-up interviews with research staff, medical students, and community representatives from rural and urban Blantyre. We also conducted 5 key informant interviews with clinicians, ethics committee members, and district health government officials.ResultsStakeholders perceived HIS research to have potential population health benefits, but they also had concerns, particularly related to the safety of volunteers and negative community reactions. Acceptability depended on a range of conditions related to procedures for voluntary and informed consent, inclusion criteria, medical care or support, compensation, regulation, and robust community engagement. These conditions largely mirror those in existing guidelines for HIS and biomedical research in LMICs. Stakeholder perceptions pointed to potential tensions, for example, balancing equity, safety, and relevance in inclusion criteria.ConclusionsOur findings suggest HIS research could be acceptable in Malawi, provided certain conditions are in place. Ongoing assessment of participant experiences and stakeholder perceptions will be required to strengthen HIS research during development and roll-out.

BackgroundLow literacy of study participants in Sub - Saharan Africa has been associated with poor comprehension during the consenting process in research participation. The concerns in comprehension are far greater when consenting to participate in genomic studies due to the complexity of the science involved. While efforts are made to explore possibilities of applying genomic technologies in diseases prevalent in Sub Saharan Africa, we ought to develop methods to improve participants’ comprehension for genomic studies. The purpose of this study was to understand different approaches that can be used to seek consent from individuals with low literacy in Sub-Saharan African countries in genomic research to improve comprehension.MethodsUsing qualitative study design, we conducted focus-group discussions, in-depth interviews and participant observations as data collection methods. This study was embedded in a hospital based genomic study on Sickle Cell Disease at Muhimbili National Hospital in Tanzania. Thematic content analysis was used to analyse the transcripts and field notes.ResultsFindings from this study show that literacy level has little influence on understanding the research details. According to the participants of this study, the methods used to provide information, the language, and time spent with the study participants were the key factors influencing understanding. The availability of group sessions held before individual consent to allow for a detailed questions and answers format was agreed to be the best method to facilitate the comprehension.ConclusionThe quality of the consenting process of participants will be influence by a number of factors. The type of research consented for, where the research will be implemented and who are the potential study participants are amongst the factors that need to be assessed during the consenting. Measures to improve participants’ comprehension need to be developed when consenting participants with low literacy level in genomic studies.

Patient and public involvement (PPI) has gained widespread support in health research and health policy circles, but there is little consensus on the precise meaning or justifications of PPI. We argue that an important step towards clarifying the meaning and justification for PPI is to split apart the familiar acronym and draw a distinction between patient and public involvement. Specifically, we argue that patient involvement should refer to the practice of involving individuals in health research or policy on the basis of their experience with a particular condition, while public involvement should refer to the practice of involving individuals in health policy or research based on their status as members of a relevant population. Analyzing cases from the UK, Australia, and the USA, we show how our proposed distinction can deliver much needed clarity to conversations on PPI, while guiding the development and evaluation of future PPI‐based policies.

Paediatric research in low-income countries is essential to tackle high childhood mortality. As with all research, consent is an essential part of ethical practice for paediatric studies. Ethics guidelines recommend that parents or another proxy provide legal consent for children to participate, but that children should be involved in the decision through providing assent. However, there remain uncertainties about how to judge when children are ready to give assent and about appropriate assent processes. Malawi does not yet have detailed guidelines on assent. Understanding perspectives among children and their parents can assist in developing contextually-appropriate assent guidance. Qualitative research was conducted with children and parents in three settings in Southern Malawi, to take account of any variations between socioeconomic and cultural contexts. In each setting, interviews were conducted with parents and their children who had participated in paediatric research to understand their experiences of assent and views on appropriate assent practice. Focus groups were also conducted with children and parents, to understand broader social perspectives. We found widespread support for involving children in decisions on research participation. Participants identified a range of factors that affect children’s capacity to give assent, including intellectual capacity, emotional development, life experience and cultural norms. Age was often mentioned as a consideration, but deemed an unreliable sole indicator of capacity to assent. In relation to appropriate assent processes, participants emphasised considerations such as supporting effective understanding and minimizing harms. Views on how to achieve these aims varied; for example, there were different ideas about the appropriate order in which to approach children and parents, and about whose decision to respect in the event of disagreement. Parents and children agreed about the value of involving children in decisions on research, and about the need to promote children’s decision-making capacity while respecting parents’ interests in children’s welfare. Developing practical guidance that meets these principles is challenging, particularly given the need for flexible approaches that suit different study types, children’s capacities and family environments. Further discussion within the Malawi research and ethics community will help develop contextually-appropriate guidelines.

BackgroundLiterature on issues relating to comprehension during the process of obtaining informed consent (IC) has largely focused on the challenges potential participants can face in understanding the IC documents, and the strategies used to enhance comprehension of those documents. In this review, we set out to describe the factors that have an impact on comprehension and the strategies used to enhance the IC process in sub-Saharan African countries.MethodsFrom November 2021 to January 2022, we conducted a literature search using a PRISMA tool. We searched electronic databases (PubMed, EMBASE, EBSCOHOST) to identify relevant peer reviewed studies. We then reviewed the references of these articles to find additional literature that might have been missed through the initial search. We were particularly interested in full text articles in English that focused on the IC process in SSA published between 2006 and 2020. We included systematic reviews, and studies from Western and Asian countries that included data about SSA. We excluded articles that focused on medical interventions and studies that did not require IC.ResultsOut of the 50 studies included most were multi-country (n = 13) followed by single country studies in South Africa (n = 12); Kenya, Tanzania, Uganda (n = 5) each; Gambia, Ghana and Nigeria (n = 2)each ; and one each for Botswana, Malawi, Mali, Mozambique. We identified three areas of focus: (1) socio-cultural factors affecting IC; (2) gaps in the ethical and legal frameworks guiding the IC process; and (3) strategies used to improve participants’ understanding of IC.ConclusionOur review showed wide recognition that the process of achieving IC in SSA is inherently challenging, and there are limitations in the strategies aimed at improving comprehension in IC. We suggest that there is a need for greater flexibility and negotiation with communities to ensure that the approach to IC is suited to the diverse socio-cultural contexts. We propose moving beyond the literal translations and technical language to understanding IC comprehension from the participants’ perspectives and the researchers’ views, while examining contextual factors that impact the IC process.

Background Achieving meaningful consent can be challenging, particularly in contexts of diminished literacy, yet is a vital part of participant protection in global health research. Method We explored the challenges and potential solutions of achieving meaningful consent through a qualitative study in a predominantly hill tribe ethnic minority population in northern Thailand, a culturally distinctive population with low literacy. Semi-structured interviews were conducted with 37 respondents who had participated in scrub typhus clinical research, their family members, researchers and other key informants. A thematic analysis was conducted. Results Our analysis identified four interrelated themes surrounding participants’ ability to give consent: varying degrees of research understanding, limitations of using informal translators, issues impacting decisions to join research, and voluntariness of consent. Suggestions for achieving more meaningful consent included the use of formal translators and community engagement with research populations. Conclusions Participant’s agency in decision making to join research should be supported, but research information needs to be communicated to potential participants in a way that they can understand. We found that improved understanding about the study and its potential benefits and harms goes beyond literacy or translation and requires attention to social and cultural factors.

Background Increase in global health research undertaken in resource poor settings in the last decade though a positive development has raised ethical concerns relating to potential for exploitation. Some of the suggested strategies to address these concerns include calls for providing universal standards of care, reasonable availability of proven interventions and more recently, promoting the overall social value of research especially in clinical research. Promoting the social value of research has been closely associated with providing fair benefits to various stakeholders involved in research. The debate over what constitutes fair benefits; whether those that addresses micro level issues of justice or those focusing on the key determinants of health at the macro level has continued. This debate has however not benefited from empirical work on what stakeholders consider fair benefits. This study explores practical experiences of stakeholders involved in global health research in Kenya, over what benefits are fair within a developing world context. Methods and results We conducted in-depth interviews with key informants drawn from within the broader health research system in Kenya including researchers from the mainstream health research institutions, networks and universities, teaching hospitals, policy makers, institutional review boards, civil society organisations and community representative groups. The range of benefits articulated by stakeholders addresses both micro and macro level concerns for justice by for instance, seeking to engage with interests of those facilitating research, and the broader systemic issues that make resource poor settings vulnerable to exploitation. We interpret these views to suggest a need for global health research to engage with current crises that face people in these settings as well as the broader systemic issues that produce them. Conclusion Global health research should provide benefits that address both the micro and macro level issues of justice in order to forestall exploitation. Embracing the two is however challenging in terms of how the various competing interests/needs should be balanced ethically, especially in the absence of structures to guide the process. This challenge should point to the need for greater dialogue to facilitate value clarification among stakeholders.