Dual-use research and research using enhanced pathogens in high-income countries: whose business?

U.S. regulation of dual-use research of concern and of research with enhanced pathogens of pandemic potential may alter soon.

Future pandemics and the urge to 'do something'.

Research with enhanced potential pandemic pathogens (ePPP) makes pathogens substantially more lethal, communicable, immunosuppressive or otherwise capable of triggering a pandemic. We briefly relay an existing argument that the benefits of ePPP research do not outweigh its risks and then consider why proponents of these arguments continue to confidently endorse them. We argue that these endorsements may well be the product of common cognitive biases-in which case they would provide no challenge to the argument against ePPP research.

When offering a patient beneficial treatment undermines public health.

Sometimes, offering someone beneficial care is likely to thwart the similar or more serious medical needs of more people. For example, when acute shortage is strongly predicted to persist, providing the long period on scarce intensive care that a certain COVID-19 patient needs is sometimes projected to block several future COVID-19 patients from receiving the shorter periods on intensive care that they will need. Expected utility is typically higher if the former is denied intensive care.

COP27: The Prospects and Challenges for the Middle East and North Africa (MENA).

In line with the global trend, the Middle East and North Africa (MENA) region has been growing vulnerable to the direct and indirect health effects of climate change including death tolls due to climatological disasters and diseases sensitive to climate change since the industrial revolution. Regarding the limited capacity of MENA countries to adapt and respond to these effects, and also after relative failures of the previous negotiation in Glasgow, in the upcoming COP27 in Egypt, the heads of the region's parties are determined to take advantage of the opportunity to host MENA to mitigate and prevent the worst effects of climate change. This would be achieved through mobilizing international partners to support climate resilience, a major economic transformation, and put health policy and management in a strategic position to contribute to thinking and action on these pressing matters, at least to avoid or minimize the future adverse consequences.

Ethical and legal race-responsive vaccine allocation.

In many countries, the COVID-19 pandemic varied starkly between different racial and ethnic groups. Before vaccines were approved, some considered assigning priority access to worse-hit racial groups. That debate can inform rationing in future pandemics and in some of the many areas outside COVID-19 that admit of racial health disparities.

Characterizing altruistic motivation in potential volunteers for SARS-CoV-2 challenge trials.

In human challenge trials (HCTs), volunteers are deliberately infected with an infectious agent. Such trials can be used to accelerate vaccine development and answer important scientific questions. Starting early in the COVID-19 pandemic, ethical concerns were raised about using HCTs to accelerate development and approval of a vaccine.

Mass drug administration of azithromycin: an analysis.

Background: WHO recommends mass drug administration (MDA) of the antibiotic azithromycin for children aged 1-11 months in areas with high rates of infant and child mortality. Notwithstanding the substantial potential benefits of lowering childhood mortality, MDA raises understandable concerns about exacerbating antibiotic resistance.

Objectives: In this study, we aimed to evaluate the use of MDA using both quantitative and ethical considerations.

The ethical case for placebo control in HIV-cure-related studies with ART interruption.

Many studies that seek to cure HIV must ask participants to interrupt their antiretroviral treatment. In such circumstances, is it permissible to include a placebo group in the study? We explain why doing so is a scientific and an ethical necessity, and more benign than imagined.

Consent Requirements for Testing Health Policies: An Intercontinental Comparison of Expert Opinions.

Individual informed consent is a central requirement for clinical research on human subjects, yet whether and how consent requirements should apply to health policy experiments (HPEs) remains unclear. HPEs test and evaluate public health policies prior to implementation. We interviewed 58 health experts in Tanzania, Bangladesh and Germany on informed consent requirements for HPEs.

A new day for human challenge trials?

Two years into the coronavirus disease 2019 (COVID-19) pandemic and following several hot debates, the world's first COVID-19 human challenge trial has recently been published by Killingley et al. We review its findings and explain why this particular juncture in time makes additional challenge trials for COVID-19 and for other diseases justified and important.

Coronavirus Disease 2019 (COVID-19) Vaccine Prioritization in Low- and Middle-Income Countries May Justifiably Depart From High-Income Countries' Age Priorities.

In high-income countries that were first to roll out coronavirus disease 2019 (COVID-19) vaccines, older adults have thus far usually been prioritized for these vaccines over younger adults. Age-based priority primarily resulted from interpreting evidence available at the time, which indicated that vaccinating the elderly first would minimize COVID-19 deaths and hospitalizations. The World Health Organization counsels a similar approach for all countries.

Research ethics and public trust in vaccines: the case of COVID-19 challenge trials.

Despite their clearly demonstrated safety and effectiveness, approved vaccines against COVID-19 are commonly mistrusted. Nations should find and implement effective ways to boost vaccine confidence. But the implications for ethical vaccine development are less straightforward than some have assumed.

Pandemic vaccine testing: Combining conventional and challenge studies.

Early into COVID, human challenge trials were considered, but usually as alternatives to conventional randomized controlled trials. Instead, assessment of authorized COVID vaccines, of further COVID vaccines, and of vaccines against future pandemics should combine both designs, in five different ways, including a wholly novel one that we elaborate, Viz., combining data from both designs to answer a single question.

"The research assistants kept coming to follow me up; I counted myself as a lucky person": Social support arising from a longitudinal HIV cohort study in Uganda.

Background: Participation in longitudinal research studies in resource-limited settings often involves frequent interactions with study staff and other participants, as well as receipt of incentives and transportation reimbursements. Social support-receipt of material and emotional resources from one's social network-has been linked to antiretroviral adherence in sub-Saharan Africa. The extent to which social support arises from study participation, its range and depth, and its implications for observational study conduct, have not been extensively described.

"Thought provoking", "interactive", and "more like a peer talk": Testing the deliberative interview style in Germany.

Proponents of the newly-developed "deliberative interview" argue that examining complex issues requires more dynamic and engaging interview exchanges. Unlike traditional qualitative interviews, deliberative interviewing champions opinion sharing, active debates and similar speaking times by both sides throughout the interview. Drawing on 20 interviews with health experts in Germany, we examined the process and outcome of deliberative versus conventional interviews on the topic of informed consent.

The Ethics of Human Challenge Trials Using Emerging Severe Acute Respiratory Syndrome 2 Variants.

The world's first coronavirus disease 2019 human challenge trial using the D614G strain of severe acute respiratory syndrome 2 (SARS-CoV-2) is underway in the United Kingdom. The Wellcome Trust is funding challenge stock preparation of the Beta and Delta variant for a follow-up human challenge trial, and researchers at hVIVO are considering conducting these trials. However, little has been written thus far about the ethical justifiability of human challenge trials with SARS-CoV-2 variants of concern.

Do coronavirus vaccine challenge trials have a distinctive generalisability problem?

Notwithstanding the success of conventional field trials for vaccines against COVID-19, human challenge trials (HCTs) that could obtain more information about these and about other vaccines and further strategies against it are about to start in the UK. One critique of COVID-19 HCTs is their distinct paucity of information on crucial population groups. For safety reasons, these HCTs will exclude candidate participants of advanced age or with comorbidities that worsen COVID-19, yet a vaccine should (perhaps especially) protect such populations.