Stuart Rennie

Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted with key stakeholders experienced in designing and conducting two selected CRTs in Malawi. The 18 interviewed stakeholders included investigators, clinicians, nurses, data management personnel and community workers who were invited to share their experiences related to implementation of CRTs. Data analysis revealed five major themes with ethical implications: (1) The moral obligation for health care providers to participate in health research and its compensation; (2) Suboptimal care services compromising the integrity of CRT; (3) Ensuring scientific validity and withholding care service; (4) Obtaining valid consent and permission for waiver of consent; and (5) Inadequate risk assessment for trial participation. Understanding key ethical issues posed by CRTs in Malawi could improve ethical review and research oversight of this particular study design.

BackgroundCurrent advances in biomedical research have introduced new ethical challenges in obtaining informed consent in low and middle-income settings. For example, there are controversies about the use of broad consent in the collection of biological samples for use in future biomedical research. However, few studies have explored preferred informed consent models for future use of biological samples in Malawi and South Africa. Therefore, we conducted an empirical study to understand preferred consent models among key stakeholders in biomedical studies that involve collection of biological samples in Malawi and South Africa. The main objective of the study was to explore views of key stakeholders on current policies on informed consent in Malawi and South Africa. MethodsThis was a qualitative study involving in-depth interviews and focus group discussions. Thirty-four in-depth interviews and 6 focus group discussions were conducted with REC members, Funders, Policymakers, CAB members and Research Participants in Malawi and South Africa to gather their views on models of informed consent. The study was conducted in Cape Town, South Africa, and Blantyre and Lilongwe in Malawi.ResultsMost key stakeholders preferred broad consent and tiered consent to specific consent. Some participants expressed a strong preference for specific consent to other models of informed consent in biomedical research. Few participants did not have any preference for a consent model, opting for any consent model which provides adequate information about the proposed research and what their national consent regulations require. Finally, very few participants preferred blanket consent to other informed consent models.ConclusionsThis study aimed to help fill the gap in the scientific literature on key stakeholder views on consent models for future use of biological samples in Malawi and South Africa. The findings of the study have provided some evidence that may support policies on permissible consent models for future use of biological samples in sub-Saharan Africa considering the differences in informed consent regulations and guidelines. Finally, the findings can inform ongoing discussions on permissible consent models to be used for future use of biological samples.

The use of targets to direct public health programmes, particularly in global initiatives, has become widely accepted and commonplace. This paper is an ethical analysis of the utilisation of targets in global public health using our fieldwork on and experiences with voluntary medical male circumcision initiatives in Kenya. Among the many countries involved in VMMC for HIV prevention, Kenya is considered a success story, its programmes having medically circumcised nearly 2 million men since 2007. We describe ethically problematic practices in Kenyan VMMC programmes revealed by our fieldwork, how the problems are related to the pursuit of targets and discuss possible approaches to their management. Although the establishment and pursuit of targets in public health can have many benefits, assessments of target-driven programmes tend to focus on quantifiable outcomes rather than the processes by which the outcomes are obtained. However, in order to speak more robustly about programmatic ‘success’, and to maintain community trust, it is vital to ethically evaluate how a public health initiative is actually implemented in the pursuit of its targets.

Traditional male circumcision is a deeply entrenched cultural practice in South Africa. In recent times, there have been increasing numbers of botched circumcisions by untrained and unscrupulous practitioners, leading to genital mutilation and often, the need for penile amputation. Hailed as a world’s first, a team of surgeons conducted the first successful penile transplant in Cape Town, South Africa in 2015. Despite the euphoria of this surgical victory, concerns about the use of this costly intervention in a context of severe resource constraints have been raised. In this paper, we explore some of the ethical implications of penile transplants as a clinical and public health response to the adverse consequences of traditional male circumcision. Given the current fiscal deficits in healthcare and public health sectors, how can one justify costly, high-technology interventions for conditions affecting a small section of the population? Since botched traditional male circumcisions are preventable, is a focus on penile transplantation as a form of treatment reasonable? Finally, do such interventions create undue expectations and false hope among a highly vulnerable and stigmatised group of young men? In this paper, we argue that given limited healthcare resources in South Africa and competing healthcare needs, prevention is a more appropriate response to botched traditional circumcisions than penile transplants.

HIV remission clinical researchers are increasingly seeking study participants who are diagnosed and treated during acute HIV infection—the brief period between infection and the point when the body creates detectable HIV antibodies. This earliest stage of infection is often marked by flu-like illness and may be an especially tumultuous period of confusion, guilt, anger, and uncertainty. Such experiences may present added ethical challenges for HIV research recruitment, participation, and retention. The purpose of this paper is to identify potential ethical challenges associated with involving acutely diagnosed people living with HIV in remission research and considerations for how to mitigate them. We identify three domains of potential ethical concern for clinicians, researchers, and ethics committee members to consider: 1) Recruitment and informed consent; (2) Transmission risks and partner protection; and (3) Ancillary and continuing care. We discuss each of these domains with the aim of inspiring further work to advance the ethical conduct of HIV remission research. For example, experiences of confusion and uncertainty regarding illness and diagnosis during acute HIV infection may complicate informed consent procedures in studies that seek to recruit directly after diagnosis. To address this, it may be appropriate to use staged re-consent procedures or comprehension assessment. Responsible conduct of research requires a broad understanding of acute HIV infection that encompasses its biomedical, psychological, social, and behavioral dimensions. We argue that the lived experience of acute HIV infection may introduce ethical concerns that researchers and reviewers should address during study design and ethical approval.

Ongoing global efforts to circumcise adolescent and adult males to reduce their risk of acquiring HIV constitute the largest public health prevention initiative, using surgical means, in human history. Voluntary medical male circumcision (VMMC) programs in Africa have significantly altered social norms related to male circumcision among previously non-circumcising groups and groups that have practiced traditional (non-medical) circumcision. One consequence of this change is the stigmatization of males who, for whatever reason, remain uncircumcised. This paper discusses the ethics of stigma with regard to uncircumcised adolescent males in global VMMC programs, particularly in certain recruitment, demand creation and social norm interventions. Grounded in our own experiences gained while conducting HIV-related ethics research with adolescents in Kenya, we argue that use of explicit or implicit stigma to increase the number of VMMC volunteers is unethical from a public health ethics perspective, particularly in campaigns that leverage social norms of masculinity. Ongoing global efforts to circumcise adolescent and adult males to reduce their risk of acquiring HIV constitute the largest public health prevention initiative, using surgical means, in human history. VMMC programs in Africa have significantly altered social norms related to male circumcision among previously non-circumcising groups and groups that have practiced traditional (non-medical) circumcision. One consequence of this change is the stigmatization of males who, for whatever reason, remain uncircumcised. This paper discusses the ethics of stigma with regard to uncircumcised adolescent males in global VMMC programs, particularly in certain recruitment, demand creation and social norm interventions. Grounded in our own experiences gained while conducting HIV-related ethics research with adolescents in Kenya, we argue that use of explicit or implicit stigma to increase the number of VMMC volunteers is unethical from a public health ethics perspective, particularly in campaigns that leverage social norms of masculinity.

Research ethics is predominantly taught and practiced in Anglophone countries, particularly those in North America and Western Europe. Initiatives to build research ethics capacity in developing countries must attempt to avoid imposing foreign frameworks and engage with ethical issues in research that are locally relevant. This article describes the process and outcomes of a capacity-building workshop that took place in Kinshasa, Democratic Republic of Congo in the summer of 2011. Although the workshop focused on a specific ethical theme – the responsibilities of researchers to provide health-related care to their research participants – we argue that the structure of the workshop offers a useful method for engaging with research ethics in general, and the theme of ancillary care encourages a broad perspective on research ethics that is highly pertinent in low-income countries. The workshop follows an interactive, locally driven model that could be fruitfully replicated in similar settings.

Compensation for research-related injuries (RRIs) remains a challenge in the current environment of global collaborative biomedical research as exemplified by the continued reluctance of the US government, a major player in international biomedical research, to enact regulation for mandatory compensation for RRIs. This stance is in stark contrast to the mandatory compensation policies adopted by other democracies like the European Union (EU) countries. These positions taken by the USA and the EU create a nexus of confusion when research is exported to low-income and middle-income countries which have no laws guiding compensation for RRIs. In this paper, we begin by exploring the background to policies concerning RRIs, how they reflect on the traditional dispute resolution mechanisms in African societies, and how this compares with the no-fault compensation model. We then explore the underlying African ethical framework of Ubuntu in the sub-Saharan region, guiding traditional practices of dispute resolution and compensation, and how this framework can help to form the moral justification for no-fault compensation as the preferred compensation model for RRIs for African countries. Finally, we call upon countries in the African Union (AU), to adopt a no-fault policy for compensation of RRIs, and enact it into a regulatory requirement for insurance-based no-fault compensation for biomedical research, which will then be enforced by member states of the AU.