Vaccination is a highly effective public health strategy that provides protection to both individuals and communities from a range of infectious diseases. Governments monitor vaccination rates carefully, as widespread use of a vaccine within a population is required to extend protection to the general population through “herd immunity,” which is important for protecting infants who are not yet fully vaccinated and others who are unable to undergo vaccination for medical or other reasons. Australia is unique in employing financial incentives to (...) increase vaccination uptake, mainly in the form of various childcare payments and tax benefits linked to timely, age-appropriate vaccination. Despite relatively high compliance with the childhood vaccination schedule, however, the Australian government has determined that rates should be higher and has recently introduced policy that includes removing certain tax and childcare benefits for non-vaccinators and formally disallowing conscientious objection to vaccination. In addition, it has raised the possibility of banning unvaccinated children from childcare centres. This article examines the impact of coercive approaches to childhood vaccination and raises the question of the ethical justification of health policy initiatives based on coercion. We consider the current evidence regarding childhood vaccination in Australia, the small but real risks associated with vaccination, the ethical requirement for consent for medical procedures, and the potential social harms of targeting non-vaccinators. We conclude that the evidence does not support a move to an increasingly mandatory approach that could only be delivered through paternalistic, coercive clinical practices. (shrink)

In 2010, randomized controlled trials (RCTs) of two different biomedical strategies to prevent HIV infection had positive findings. However, despite ongoing very high levels of HIV infection in some countries and population groups, it has been made clear by regulatory authorities that the evidence remains insufficient to support either product being made available outside of research contexts in the developing world for at least two years. In addition, prevention trials in endemic areas will continue to test new interventions against placebo. (...) But the judgments of evidentiary standards are never value-neutral. Using the recent trials and their contexts as case studies, we examine the basis for these decisions, which will potentially delay access to scientific innovation to the people who are most urgently in need of it. (shrink)

BackgroundThe global interest in developing therapies for Ebola infection management and its prevention is laudable. However the plan to conduct an emergency immunization program specifically for healthcare workers using experimental vaccines raises some ethical concerns. This paper shares perspectives on these concerns and suggests how some of them may best be addressed.DiscussionThe recruitment of healthcare workers for Ebola vaccine research has challenges. It could result in coercion of initially dissenting healthcare workers to assist in the management of EVD infected persons (...) due to mistaken beliefs that the vaccine offers protection. It could also affect equity and justice. For example, where people who are not skilled health care professionals but who provide care to patients infected with Ebola are not prioritized for vaccination. The possibility of study participants contracting Ebola infection despite the use of experimental vaccine, and the standard of care they would receive, needs to be addressed clearly, transparently and formalized as part of the ethics review process. Future access to study products in view of current status of the TRIPS agreement needs to be addressed. Finally, broad stakeholder engagement at local, regional and international levels needs to be promoted using available communication channels to engage local, regional and international support. These same concerns are applicable for current and future epidemics.SummarySuccessful Ebola vaccine development research requires concerted efforts at public dialogue to address misconceptions, equity and justice in participant selection, and honest discussions about risks, benefits and future access. Public dialogue about Ebola vaccine research plans is crucial and should be conducted by trusted locals and negotiated between communities, researchers and ethics committees in research study sites. (shrink)

The successful demonstration that antiretroviral (ARV) drugs can be used in diverse ways to reduce HIV acquisition or transmission risks – either taken as pre-exposure prophylaxis (PrEP) by those who are uninfected or as early treatment for prevention (T4P) by those living with HIV – expands the armamentarium of existing HIV prevention tools. These findings have implications for the design of future HIV prevention research trials. With the advent of multiple effective HIV prevention tools, discussions about the ethics and the (...) feasibility of future HIV prevention trial designs have intensified. This article outlines arguments concerning the inclusion of newly established ARV-based HIV prevention interventions as standard of prevention in HIV prevention trials from multiple perspectives. Ultimately, there is a clear need to incorporate stakeholders in a robust discussion to determine the appropriate trial design for each study population. (shrink)

The principle of providing post-trial access for research participants to successful products of that research is widely accepted and has been enshrined in various declarations and guidelines. While recent ethical guidelines recognise that the responsibility to provide post-trial access extends to sponsors, regulators and government bodies as well as to researchers, it is the researchers who have the direct duty of care to participants. Researchers may thus need to act as advocates for trial participants, especially where government bodies, sponsors, and (...) regulatory bodies have complex interests vested in decisions about whether or not new interventions are made available, how, and to whom. This paper provides an empirical account of post-trial access in the context of HIV prevention research. It describes both access to the successful products of research and the provision antiretroviral drugs for trial participants who acquire HIV. First, we provide evidence that, in the current system, there is considerable variation in the duration and timeliness of access. We then argue that by analysing the difficulties faced by researchers to this point, and their efforts to meet this obligation, much can be learned about how to secure post-trial access in HIV biomedical preventions trials. While researchers alone have a limited obligation, their advocacy on behalf of trial participants may be necessary to call the other parties to account. (shrink)

Visual research methods like photography and digital storytelling are increasingly used in health and social sciences research as participatory approaches that benefit participants, researchers, and audiences. Visual methods involve a number of additional ethical considerations such as using identifiable content and ownership of creative outputs. As such, ethics committees should use different assessment frameworks to consider research protocols with visual methods. Here, we outline the limitations of ethics committees in assessing projects with a visual focus and highlight the sparse knowledge (...) on how researchers respond when they encounter ethical challenges in the practice of visual research. We propose a situated approach in relation to visual methodologies that encompasses a negotiated, flexible approach, given that ethical issues usually emerge in relation to the specific contexts of individual research projects. Drawing on available literature and two case studies, we identify and reflect on nuanced ethical implications in visual research, like tensions between aesthetics and research validity. The case studies highlight strategies developed in-situ to address the challenges two researchers encountered when using visual research methods, illustrating that some practice implications are not necessarily addressed using established ethical clearance procedures. A situated approach can ensure that visual research remains ethical, engaging, and rigorous. (shrink)

Visual research methods like photography and digital storytelling are increasingly used in health and social sciences research as participatory approaches that benefit participants, researchers, and audiences. Visual methods involve a number of additional ethical considerations such as using identifiable content and ownership of creative outputs. As such, ethics committees should use different assessment frameworks to consider research protocols with visual methods. Here, we outline the limitations of ethics committees in assessing projects with a visual focus and highlight the sparse knowledge (...) on how researchers respond when they encounter ethical challenges in the practice of visual research. We propose a situated approach in relation to visual methodologies that encompasses a negotiated, flexible approach, given that ethical issues usually emerge in relation to the specific contexts of individual research projects. Drawing on available literature and two case studies, we identify and reflect on nuanced ethical implications in visual research, like tensions between aesthetics and research validity. The case studies highlight strategies developed in-situ to address the challenges two researchers encountered when using visual research methods, illustrating that some practice implications are not necessarily addressed using established ethical clearance procedures. A situated approach can ensure that visual research remains ethical, engaging, and rigorous. (shrink)

Published data show that new HIV prevention strategies including treatment-as-prevention and pre-exposure prophylaxis (PrEP) using oral antiretroviral drugs (ARVs) are highly, but not completely, effective if regimens are taken as directed. Consequently, their implementation may challenge norms around HIV prevention. Specific concerns include the potential for ARV-based prevention to reframe responsibility, erode beneficial sexual norms and waste resources. This paper explores what rights claims uninfected people can make for access to ARVs for prevention, and whether moral claims justify the provision (...) of ARV therapy to those who do not yet clinically require treatment as a way of reducing HIV transmission risk. An ethical analysis was conducted of the two strategies, PrEP and treatment-as-prevention, using a public health stewardship model developed by the Nuffield Bioethics Council to consider and compare the application of PrEP and treatment-as-prevention strategies. We found that treating the person with HIV rather than the uninfected person offers advantages in settings where there are limited opportunities to access care. A treatment-as-prevention strategy that places all the emphasis upon the positive person's adherence however carries a disproportionate burden of responsibility. PrEP remains an important option for receptive partners who face increased biological vulnerability. We conclude that the use of ARV for prevention is ethically justified, despite imperfect global to drugs for those in clinical need. The determination of which ARV-based HIV prevention strategy is ethically preferable is complex and must take into account both public health and interpersonal considerations. (shrink)

In many countries around the world, people who inject drugs remain at high risk of HIV acquisition not because effective forms of prevention are unknown, nor because they find effective prevention undesirable, but because those in charge, mainly politicians but also bureaucrats, find evidence-based practice politically unacceptable. The evidence for preventive efficacy of harm reduction strategies, most prominently needle and syringe programmes but also treatment programmes such as opiate substitution, is irrefutable.1 However, political responses to drug use issues are varied (...) and complex, so the will to implement appropriate harm reduction programmes in the interests of public health remains lacking in too many jurisdictions. As a consequence, the discussion of how best, in the context of research, to reduce HIV incidence in populations of people who inject drugs but are not offered comprehensive access to known prevention strategies is—tragically—an important one. Dawson et al 2 focus on access to sterile injecting equipment and recognise that this should remain the ‘default’ standard of prevention for HIV prevention trials involving people for whom injecting drug use is the primary risk factor for HIV acquisition. ‘Standard of prevention’ means the background or minimal HIV risk reduction interventions offered to all participants in a trial, regardless of what other investigational interventions they are assigned to receive. The standard of prevention concept is grounded in the ethical principle of beneficence—that researchers and sponsors are obliged to maximise benefits and minimise risks to participants in research studies.3 …. (shrink)

Volume 20, Issue 10, October 2020, Page 47-49.

The American Journal of Bioethics, Volume 11, Issue 12, Page 48-50, December 2011.

In clinical research there is a tension between the role of a doctor, who must serve the best interests of the patient, and the role of the researcher, who must produce knowledge that may not have any immediate benefits for the research participant. This tension is exacerbated in HIV research in low and middle income countries, which frequently uncovers comorbidities other than the condition under study. Some bioethicists argue that as the goals of medicine and those of research are distinct, (...) it is a mistake for researchers to assume therapeutic responsibilities while engaging in research. Others propose that there is a duty of care, but disagree as to how this is limited and specified. In this qualitative study, principal investigators from HIV prevention trials discuss their experience of providing medical benefits to participants within the context of conducting research into HIV biomedical prevention technologies. They describe the limitations imposed at times by funders and at times by infrastructure constraints, and canvass the importance of ancillary care provision and capacity building in trial communities. The views of the principal investigators are compatible with the perspective that there is a duty of care, limited by the nature of the research, the depth of the relationship between research and participant, and the capacity of the research site. The therapeutic orientation in HIV prevention trial appears to be indivisible from competent research practise by making concrete and appropriate benefits available to trial participants and their communities that support rather than compete with local infrastructure. (shrink)

This article examines the relationship between bioethics and the therapeutic standards in HIV prevention research in the developing world, focusing on the closure of the pre-exposure prophylaxis (PrEP) trials in the early 2000s. I situate the PrEP trials in the historical context of the vertical transmission debates of the 1990s, where there was protracted debate over the use of placebos despite the existence of a proven intervention. I then discuss the dramatic improvement in the clinical management of HIV and the (...) treatment access movement, and consider how these contexts have influenced research practice. I argue that as HIV prevention trials oblige researchers to observe the rate at which vulnerable people under their care acquire HIV, there is an obligation to provide antiretroviral treatment to seroconverters and other health care benefits that fall within the scope of researchers' entrustment, both to avoid exploitation and to enact reciprocal justice. I argue against propositions that the obligations to provide specific benefits are vague, fall only upon researchers and sponsors, and create injustices by privileging the few over the many. Finally, I contend that the realisation of a broader standard of care in HIV prevention research broadens the role of research from being a simple tool to produce knowledge to a complex intervention that can play a part in the reduction of health disparities. (shrink)

There is increasing interest in the need to address the ethical dilemmas related to the engagement of adolescents in sexual and reproductive health research. Research projects, including those that address issues related to STIs and HIV, adverse pregnancy outcomes, violence, and mental health, must be designed and implemented to address the needs of adolescents. Decisions on when an individual has adequate capacity to give consent for research most commonly use age as a surrogate rather than directly assessing capacity to understand (...) the issues and make an informed decision on whether to participate in research or not. There is a perception that adolescents participating in research are more likely to be coerced and may therefore not fully comprehend the risk they may be taking when engaging in research. This paper examines the various ethical issues that may impact stakeholders' decision making when considering engaging adolescents in SRH research in Nigeria. It makes a case for lowering the age of consent for adolescents. While some experts believe it is possible to extrapolate relevant information from adult research, studies on ethical aspects of adolescents' participation in research are still needed, especially in the field of sexual and reproductive health where there are often differences in knowledge, attitudes and practices compared to adults. The particular challenges of applying the fundamental principles of research ethics to adolescent research, especially research about sex and sexuality, will only become clear if more studies are conducted. (shrink)

HIV prevention is a critical health issue in Nigeria; a country that has one of the worst HIV epidemic profiles in the world. With 270,000 new infections in 2012, Nigeria is a prime site for HIV prevention research. One effect of the HIV epidemic has been to revolutionalise ethical norms for the conduct of research: it is now considered unethical to design and implement HIV related studies without community engagement. Unfortunately, there is very little commensurate effort in building the capacity (...) of local persons to engage actively with researchers, and there is no existing platform to facilitate dialogue between researchers and communities engaged in research in Nigeria. In an effort to address this gap, we undertook a series of three community dialogues and two community-researcher interface meetings in Nigeria. This paper aims to give an empirical account of the dialogue from these community engagement processes and provide a resulting critique of the implementation of research ethics practices in Nigeria. It is anticipated that the outputs will: support researchers in designing community-based research protocols; inform ethics committees of key considerations during research protocol reviews from a community perspective; and inform policy makers and research sponsors about issues of primary concern to communities with respect to HIV research. (shrink)

In his article ‘The Ebola Clinical Trials: a precedent for research ethics in disasters’, Philippe Calain constructs a compelling case as to why and how experiences from the recent Ebola epidemic should be used to develop a framework for disaster research ethics. In particular, Calain proposes a useful model for assessing whether or not an unproven intervention could be suitable for human use in a disaster context, and makes a powerful argument against the separation of patient care from research goals. (...) In this commentary, I argue that the separation of patient care goals from research goals is also unhelpful in the context of other forms of participant disadvantage even when that disadvantage is less severe than an ongoing public health emergency. I contend that recognising that research in disadvantaged populations is an intervention that could and should aim to produce positive outcomes for participants, just as it should in disaster contexts, therefore seems a well-justified lesson that can be extrapolated from the experience of the Ebola epidemic. (shrink)

In July 2012, based on evidence from two major trials, the United States Food and Drug Administration approved the use of combined oral tenofovir/emtricitabine as pre-exposure prophylaxis for people at high risk of HIV acquisition. PrEP effectiveness is marred by poor adherence, however, even in trial populations, thus it is not a magic bullet for HIV prevention. It is, however, the most effective biomedical HIV prevention intervention available for people at high risk of HIV, particularly those who have receptive sex (...) and lack the power to negotiate condom use. Accordingly, there are compelling reasons to compare future experimental HIV prevention interventions against PrEP. The interests both of trial participants and of science are served by using PrEP as comparator: Not only would HIV incidence be reduced, but also the question of whether new interventions were superior to best proven interventions, in a given setting, would be answered comprehensively. (shrink)

The Oceania region is home to some of the world's most restrictive abortion laws, and there is evidence of Pacific Island women's reproductive oppression across several aspects of their reproductive lives, including in relation to contraceptive decision‐making, birthing, and fertility. In this paper we analyse documents from court cases in the Pacific Islands regarding the illegal procurement of abortion. We undertook inductive thematic analysis of documents from eighteen illegal abortion court cases from Pacific Island countries.Using the lens of reproductive justice, (...) we discuss the methods of abortion, the reported context of these abortions, and the ways in which these women and abortion were constructed in judges' summing up, judgements, or sentencing. Our analysis of these cases reveals layers of sexual and reproductive oppression experienced by these women that are related to colonialism, women's socioeconomic disadvantage, gendered violence, limited reproductive control, and the punitive consequences related to not performing gender appropriately. (shrink)

Dental caries is the main oral health challenge for children in Nigeria. Concern about its negative impact makes screening for caries in children an attractive public health strategy. The ability to detect the preclinical phase of caries, the availability of screening tools with high accuracy, and the possibility of treatment before onset of clinical symptoms with significant cost and health benefits, makes it appropriate for screening. However in Nigeria, the poor availability of highly specific and sensitive screening tools, poor access (...) to oral health care and concerns with pre-screening consent, raise the question of the appropriateness of conducting screening programmes for children. We argue that a number of structural challenges associated with poor uptake of oral health care services need to be addressed before screening for caries can be considered ethically appropriate. These include facilitating access of children to quality oral health care and a systematic national approach to oral health impl... (shrink)

The Oceania region is home to some of the world's most restrictive abortion laws, and there is evidence of Pacific Island women's reproductive oppression across several aspects of their reproductive lives, including in relation to contraceptive decision-making, birthing, and fertility. In this paper we analyse documents from court cases in the Pacific Islands regarding the illegal procurement of abortion. We undertook inductive thematic analysis of documents from eighteen illegal abortion court cases from Pacific Island countries.Using the lens of reproductive justice, (...) we discuss the methods of abortion, the reported context of these abortions, and the ways in which these women and abortion were constructed in judges' summing up, judgements, or sentencing. Our analysis of these cases reveals layers of sexual and reproductive oppression experienced by these women that are related to colonialism, women's socioeconomic disadvantage, gendered violence, limited reproductive control, and the punitive consequences related to not performing gender appropriately. (shrink)

Community engagement in research, including public health related research, is acknowledged as an ethical imperative. While medical care and public health action take priority over research during infectious disease outbreaks, research is still required in order to learn from epidemic responses. The World Health Organisation developed a guide for community engagement during infectious disease epidemics called the Good Participatory Practice for Trials of Emerging (and Re‐emerging) Pathogens that are Likely to Cause Severe Outbreaks in the Near Future and for which (...) Few or No Medical Counter‐Measures Exist (GPP‐EP). This paper identified priorities for community engagement for research conducted during infectious disease outbreaks drawing on discussions held with a purposive sample of bioethicists, social scientists, researchers, policy makers and laypersons who work with ethics committees in West Africa. These perspectives were considered in the light of the GPP‐EP, which adds further depth and dimension to discussions on community engagement frameworks. It concludes that there is no presumptive justification for the exclusion of communities in the design, implementation and monitoring of clinical trials conducted during an infectious disease outbreak. Engagement that facilitates collaboration rather than partnership between researchers and the community during epidemics is acceptable. (shrink)

ABSTRACT The aim of this study is to determine how stakeholder engagement can be adapted for the conduct of COVID‐19‐related clinical trials in sub‐Saharan Africa. Nine essential stakeholder engagement practices were reviewed: formative research; stakeholder engagement plan; communications and issues management plan; protocol development; informed consent process; standard of prevention for vaccine research and standard of care for treatment research; policies on trial‐related physical, psychological, financial, and/or social harms; trial accrual, follow‐up, exit trial closure and results dissemination; and post‐trial access (...) to trial products or procedures. The norms, values, and practices of collectivist societies in Sub‐Saharan Africa and the low research literacy pose challenges to the conduct of clinical trials. Civil‐society organizations, members of community advisory boards and ethics committees, young persons, COVID‐19 survivors, researchers, government, and the private sector are assets for the implementation and translation of COVID‐19 related clinical trials. Adapting ethics guidelines to the socio‐cultural context of the region can facilitate achieving the aim of stakeholder engagement. (shrink)

In their recent paper‘Undue inducement: a case study in CAPRISA 008’, Mngadi et al conclude that a participant in an HIV prevention study who deliberately concealed her pregnancy was not ‘unduly induced’ to participate by the offer of an experimental product. This paper argues that while the authors’ conclusion is sound, the framing of this case study is consistent with the preoccupation in research ethics with the concept of undue inducement, coupled with a highly risk-averse attitude to pregnancy. We suggest (...) that the critical research ethics question raised by Mngadi et al ’s case study is not ‘undue inducement’, but the exclusion of pregnant women from research studies where the risks are acceptable to the potential participant, and benefits likely. We also suggest that current regulatory paradigms regarding pregnancy are both overly paternalistic and value the fetus over the mother. In order to ensure timely provision of new HIV prevention agents, we argue that there is a need for expeditious testing of proven effective agents in pregnancy, with due consideration given to situations where preliminary efficacy data exist but fall short of licensure standards. This requires a paradigm shift from researchers, funders, regulators and ethical review bodies towards practices that critically examine the legitimacy of the exclusion of pregnant women on a study-by-study basis. (shrink)