The evolution of public health ethics frameworks: systematic review of moral values and norms in public health policy.

Given the evolution of the public health (PH) and the changes from the phenomenon of globalization, this area has encountered new ethical challenges. In order to find a coherent approach to address ethical issues in PH policy, this study aimed to identify the evolution of public health ethics (PHE) frameworks and the main moral values and norms in PH practice and policy. According to the research questions, a systematic search of the literature, in English, with no time limit was performed using the main keywords in databases Web of Science (ISI) and PubMed. Finally, the full text of 56 papers was analyzed. Most of the frameworks have common underpinning assumptions and beliefs, and the need to balance PH moral obligation to prevent harm and health promotion with respect for individual autonomy has been specified. As such, a clear shift from liberal values in biomedical ethics is seen toward the community's collective values in PHE. The main moral norms in PH practice and policy included protecting the population against harm and improving PH benefits, utility and evidenced-based effectiveness, distributive justice and fairness, respect for all, privacy and confidentiality, solidarity, social responsibility, community empowerment and participation, transparency, accountability and trust. Systematic review of PHE frameworks indicates utilization of the aforementioned moral norms through an practical framework as an ethical guide for action in the PH policy. The validity of this process requires a systematic approach including procedural conditions.

What is a good health check? An interview study of health check providers' views and practices.

BACKGROUND: Health checks identify (risk factors for) disease in people without symptoms. They may be offered by the government through population screenings and by other providers to individual users as 'personal health checks'. Health check providers' perspective of 'good' health checks may further the debate on the ethical evaluation and possible regulation of these personal health checks. METHODS: In 2015, we interviewed twenty Dutch health check providers on criteria for 'good' health checks, and the role these criteria play in their practices. RESULTS: Providers unanimously formulate a number of minimal criteria: Checks must focus on (risk factors for) treatable/preventable disease; Tests must be reliable and clinically valid; Participation must be informed and voluntary; Checks should provide more benefits than harms; Governmental screenings should be cost-effective. Aspirational criteria mentioned were: Follow-up care should be provided; Providers should be skilled and experienced professionals that put the benefit of (potential) users first; Providers should take time and attention. Some criteria were contested: People should be free to test on any (risk factor for) disease; Health checks should only be performed in people at high risk for disease that are likely to implement health advice; Follow up care of privately funded tests should not drain on collective resources. Providers do not always fulfil their own criteria. Their reasons reveal conflicts between criteria, conflicts between criteria and other ethical values, and point to components in the (Dutch) organisation of health care that hinder an ethical provision of health checks. Moreover, providers consider informed consent a criterion that is hard to establish in practice. CONCLUSIONS: According to providers, personal health checks should meet the same criteria as population screenings, with the exception of cost-effectiveness. Providers do not always fulfil their own criteria. Results indicate that in thinking about the ethics of health checks potential conflicts between criteria and underlying values should be explicated, guidance in weighing of criteria should be provided and the larger context should be taken into account: other actors than providers need to take up responsibility, and ideally benefits and harms of health checks should be weighed against other measures targeting (risk factors for) disease.

Social values and the corruption argument against financial incentives for healthy behaviour.

Financial incentives may provide a way of reducing the burden of chronic diseases by motivating people to adopt healthy behaviours. While it is still uncertain how effective such incentives could be for promoting health, some argue that, even if effective, there are ethical objections that preclude their use. One such argument is made by Michael Sandel, who suggests that monetary transactions can have a corrupting effect on the norms and values that ordinarily regulate exchange and behaviour in previously non-monetised contexts. In this paper, I outline Sandel's corruption argument and consider its validity in the context of health incentives. I distinguish between two forms of corruption that are implied by Sandel's argument: efficiency corruption and value corruption While Sandel's thought-provoking discussion provides a valuable contribution to debates about health policies generally and health incentives specifically, I suggest the force of his criticism of health incentives is limited: further empirical evidence and theoretical reasoning are required to support the suggestion that health incentives are an inappropriate tool for promoting health. While I do not find Sandel's corruption argument compelling, this only constitutes a partial defence of health incentives, since other criticisms relating to their use may prove more successful.

Looking for Trouble: Preventive Genomic Sequencing in the General Population and the Role of Patient Choice.

Advances in genomics have led to calls for developing population-based preventive genomic sequencing (PGS) programs with the goal of identifying genetic health risks in adults without known risk factors. One critical issue for minimizing the harms and maximizing the benefits of PGS is determining the kind and degree of control individuals should have over the generation, use, and handling of their genomic information. In this article we examine whether PGS programs should offer individuals the opportunity to selectively opt out of the sequencing or analysis of specific genomic conditions (the menu approach) or whether PGS should be implemented using an all-or-nothing panel approach. We conclude that any responsible scale-up of PGS will require a menu approach that may seem impractical to some, but that draws its justification from a rich mix of normative, legal, and practical considerations.

Ethical challenges posed by the Ebola virus epidemic in West Africa.

This paper examines how people in West Africa are reacting to the Ebola virus disease, an epidemic presently prevalent in the region. Certain lifestyle changes are suggested. Additionally, the heart of the paper focuses on the request by governments to be allowed access to experimental drugs, such as Zmapp and TKM-Ebola, for their infected populations. The author argues that granting such a request would circumvent research ethics procedures, which could potentially constitute significant risk to users of the drugs. The Pfizer Kano meningitis trial of 1996 is cited as an example to buttress how unapproved drugs could prove fatal.

Ethical issues in cardiovascular risk management: Patients need nurses' support.

Involving patients in decisions on primary prevention can be questioned from an ethical perspective, due to a tension between health promotion activities and patient autonomy. A nurse-led intervention for prevention of cardiovascular diseases, including counselling (risk communication, and elements of shared decision-making and motivational interviewing) and supportive tools such as a decision aid, was implemented in primary care. The aim of this study was to evaluate the nurse-led intervention from an ethical perspective by exploring in detail the experiences of patients with the intervention, and their views on the role of both the nurse and patient. The study had a qualitative design. 18 patients who had received the intervention participated. Data were gathered by in-depth interviews. The interviews were analysed using directed content analysis. The findings revealed that patients perceived the consultations not as an infringement on their autonomy, but as supportive to risk reduction efforts they tried but found hard to realise. They specifically emphasised the role of the nurse, and appreciated the nurse's realistic advice, encouragement, and help in understanding. Patients' views on and experiences with risk management are in line with notions of relational autonomy, caring cooperation and communicative action found in the literature. We conclude that patients define the relationship with the nurse as shared work in the process of developing a healthier lifestyle.

Separate goals, converging priorities: on the ethics of treatment as prevention.

Recent evidence confirming that the administration of antiretroviral drugs (ARVs) to HIV-infected persons may effectively reduce their risk of transmission has revived the discussion about priority setting in the fight against HIV/AIDS. The fact that the very same drugs can be used both for treatment purposes and for preventive purposes (Treatment as Prevention) has been seen as paradigm-shifting and taken to spark a new controversy: In a context of scarce resources, should the allocation of ARVs be prioritized based on the goal of providing treatment, or on the goal of preventing the spread of the HIV epidemic? Contributions to this discussion tend to assume that treatment and prevention constitute two divergent goals that entail conflicting priorities. We challenge that assumption on the basis of both conceptual and empirical examination. We argue that, as far as the provision of ARVs to HIV-infected persons is concerned, the goals of treatment and prevention do not entail conflicting priorities; to the contrary, they dictate converging strategies for the optimal allocation of ARVs. In light of the current evidence, the concept of Treatment as Prevention can indeed be seen as paradigm-shifting, yet in a novel way: Rather than extending the tension between the goals of treatment and prevention to the level of drug-allocation, it dissolves this tension by providing a rationale for a unified strategy for allocating ARVs.

From modeling to morals: imagining the future of HIV PREP in Lesotho.

Amidst growing global endorsements of new biomedical HIV prevention strategies, ARV-based pre-exposure prophylaxis (ARV PrEP) has garnered considerable attention as a potentially promising prevention strategy. Though it may offer more effective protection for certain at-risk groups than conventional prevention strategies (such as sexual partner reduction, condom use, and prevention of mother-to-child transmission), PrEP is more costly. PrEP requires more ongoing contact between individuals and providers, and a level of surveillance from the health system that is not necessary with other preventive measures. In this sense, it represents a new bio-technology for HIV prevention that poses particular challenges for worldwide implementation, given developing countries' struggling health systems and incomplete HIV treatment programs. Since the emergence of PrEP has stimulated ethical discussions premised on incomplete knowledge of efficacy and implementation, this paper explores the ethical parameters of a likely scenario for PrEP usage in a single, resource-poor country. We first develop a plausible model for PrEP deployment and utilization based on current PrEP research, while carefully considering the reigning institutional values of feasibility and effectiveness in global health approaches. Drawing on ethnographic research of HIV treatment and prevention approaches in Lesotho, we address ethical questions arising from this scenario of PrEP delivery. Lesotho presents a compelling and emblematic case study of PrEP's potential successes and pitfalls in a developing country, given the country's high HIV prevalence, struggles to achieve universal access to HIV treatment regimes, continued existence of stigma around the epidemic, and difficulties in addressing persistent social inequalities that fuel infections.

Ethical use of antiretroviral resources for HIV prevention in resource poor settings.

The effectiveness of antiretroviral regimes (ARVs) to reduce risk of HIV transmission from mother to child and as post-exposure prophylaxis has been known for almost two decades. Recent research indicates ARVs can also reduce the risk of HIV transmission via sexual intercourse in two other ways. With pre-exposure prophylaxis (PrEP), ARVs are used to reduce risk of HIV acquisition among persons who are HIV negative and significantly exposed to the virus. With treatment as prevention (TasP), ARVs are used to reduce risk of HIV transmission from persons who are already HIV positive. The development of these new prevention strategies raises a rationing problem: given the chronic shortage of ARVs for HIV-infected persons in need of treatment, is it ethically justified to allocate ARVs for PrEP and/or TasP? This article examines the intuitively appealing view that allocation of ARVs for treatment should be the highest priority, the use of ARVs for TasP should be a secondary priority, and that utilizing ARVs for PrEP would be unethical. I will argue that selective, evidence-based allocation of ARVs for prevention in certain cases could be ethically justified even when there is insufficient anti-retroviral access for all those needing it for treatment.

Ethical considerations in determining standard of prevention packages for HIV prevention trials: examining PrEP.

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.

Ethics of ARV based prevention: treatment-as-prevention and PrEP.

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.

Preexposure prophylaxis for adolescents and young adults at risk for HIV infection: is an ounce of prevention worth a pound of cure?

An alarming proportion of incident human immunodeficiency virus (HIV) infections worldwide occur in youth. In the United States, 69% of all new infections among youth occurred in young men who have sex with men (YMSM). Recent studies show the promise of preexposure prophylaxis (PrEP) for preventing HIV infection, but research efforts suffer from disproportionately low representation of the youth who are most at risk. Youth-focused research is critical and should include behavioral, community, and biomedical interventions to create a comprehensive HIV prevention package. The many ethical, legal, and regulatory considerations in conducting HIV research among, and in providing care services to, youth must be addressed so that those at high risk and most likely to benefit can have unfettered access to safe and effective health-promoting interventions. YMSM and minority youth are at substantial HIV risk and urgently need effective HIV prevention tools for which the short and long-term benefits and risks have been carefully considered.

How good is "good enough"? The case for varying standards of evidence according to need for new interventions in HIV prevention.

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.