Considerations for prioritising clinical research using bacteriophage.

Antimicrobial resistance (AMR) poses a significant global health threat, as it contributes to prolonged illness, higher mortality rates and increased healthcare costs. As traditional antibiotics become less effective, treatments such as bacteriophage therapy offer potential solutions. The question remains, however, on how to set research priorities in the face of a growing number of antibiotic-resistant pathogens, some common and/or dangerous.

An examination of the relationship between risk perceptions, cultural-religious beliefs and coping during COVID-19 pandemic control in South Asian countries: a systematic review.

Background: Covid 19 was declared as a public health emergency by the World Health Organisation (WHO) due to its rapid spread and catastrophic effects on health. It affected around 119 M people with mortality rate of 0.27% worldwide, including South-Asians.

Is equipoise a useful concept to justify randomised controlled trials in the cultural context of Pakistan? A survey of clinicians in relation to a trial of talking therapy for young people who self-harm.

Background: Clinical equipoise, also defined as the uncertainty principle, is considered essential when recruiting subjects to a clinical trial. However, equipoise is threatened when clinicians are influenced by their own preferences. Little research has investigated equipoise in the context of trial recruitment.

Perceived coercion, perceived pressures and procedural justice arising from global lockdowns during the COVID-19 pandemic: A scoping review.

This aim of this scoping review is to map what is known about perceived coercion, perceived pressures and procedural justice within the context of the general population's experience of 'lockdowns' imposed by governments worldwide in response to the increased transmission of COVID-19. Arksey & O'Malley's (2005) framework for conducting scoping reviews was chosen. A sensitive search strategy was devised and conducted using PubMed, Scopus, and Web of Science using the following search terms: (adherence OR acceptance OR agreement OR trust OR distrust OR compliance OR willing*) OR (perceived coerc* OR percept* coerc* OR pressure OR force OR influence OR control OR threat OR justice) AND (lockdown) AND (COVID OR SARS-CoV-2 OR COVID-19).

An ethics of anthropology-informed community engagement with COVID-19 clinical trials in Africa.

The COVID-19 pandemic has reinforced the critical role of ethics and community engagement in designing and conducting clinical research during infectious disease outbreaks where no vaccine or treatment already exists. In reviewing current practices across Africa, we distinguish between three distinct roles for community engagement in clinical research that are often conflated: 1) the importance of community engagement for identifying and honouring cultural sensitivities; 2) the importance of recognising the socio-political context in which the research is proposed; and 3) the importance of understanding what is in the interest of communities recruited to research according to their own views and values. By making these distinctions, we show that current practice of clinical research could draw on anthropology in ways which are sometimes unnecessary to solicit local cultural values, overlook the importance of socio-political contexts and wider societal structures within which it works, potentially serving to reinforce unjust political or social regimes, and threaten to cast doubt on the trustworthiness of the research.

Recognising values and engaging communities across cultures: towards developing a cultural protocol for researchers.

Efforts to build research capacity and capability in low and middle income countries (LMIC) has progressed over the last three decades, yet it confronts many challenges including issues with communicating or even negotiating across different cultures. Implementing global research requires a broader understanding of community engagement and participatory research approaches. There is a considerable amount of guidance available on community engagement in clinical trials, especially for studies for HIV/AIDS, even culturally specific codes for recruiting vulnerable populations such as the San or Maori people.

Non-inferiority versus superiority trial design for new antibiotics in an era of high antimicrobial resistance: the case for post-marketing, adaptive randomised controlled trials.

Antimicrobial resistance is one of the most important threats to global health security. A range of Gram-negative bacteria associated with high morbidity and mortality are now resistant to almost all available antibiotics. In this context of urgency to develop novel drugs, new antibiotics for multidrug-resistant Gram-negative bacteria (namely, ceftazidime-avibactam, plazomicin, and meropenem-vaborbactam) have been approved by regulatory authorities based on non-inferiority trials that provided no direct evidence of their efficacy against multidrug-resistant bacteria such as Enterobacteriaceae spp, Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Burkholderia cepacia, and Acinetobacter baumannii.

A Radical Approach to Ebola: Saving Humans and Other Animals.

As the usual regulatory framework did not fit well during the last Ebola outbreak, innovative thinking still needed. In the absence of an outbreak, randomised controlled trials of clinical efficacy in humans cannot be done, while during an outbreak such trials will continue to face significant practical, philosophical, and ethical challenges. This article argues that researchers should also test the safety and effectiveness of novel vaccines in wild apes by employing a pluralistic approach to evidence.

How informed is declared altruism in clinical trials? A qualitative interview study of patient decision-making about the QUEST trials (Quality of Life after Mastectomy and Breast Reconstruction).

Background: Randomised controlled trials (RCTs) often fail to recruit sufficient participants, despite altruism being cited as their motivation. Previous investigations of factors influencing participation decisions have been methodologically limited. This study evaluated how women weigh up different motivations after initially expressing altruism, and explored their understanding of a trial and its alternatives.

Reconstructing communities in cluster trials?

Background: There is growing interest in the ethics of cluster trials, but no literature on the uncertainties in defining communities in relation to the scientific notion of the cluster in collaborative biomedical research.

Methods: The views of participants in a community-based cluster randomised trial (CRT) in Mumbai, India, were solicited regarding their understanding and views on community. We conducted two focus group discussions with local residents and 20 semi-structured interviews with different respondent groups.

A systematic review of factors affecting children's right to health in cluster randomized trials in Kenya.

Following the South African case, Treatment Action Campaign and Others v Minister of Health and Others, the use of 'pilot' studies to investigate interventions already proven efficacious, offered free of charge to government, but confined by the government to a small part of the population, may violate children's right to health, and the negative duty on governments not to prevent access to treatment. The applicants challenged a government decision to offer Nevirapine in a few pilot sites when evidence showed Nevirapine significantly reduced HIV transmission rates and despite donor offers of a free supply. The government refused to expand access, arguing they needed to collect more information, and citing concerns about long-term hazards, side effects, resistance and inadequate infrastructure.

Ethics of clinical science in a public health emergency: drug discovery at the bedside.

Clinical research under the usual regulatory constraints may be difficult or even impossible in a public health emergency. Regulators must seek to strike a good balance in granting as wide therapeutic access to new drugs as possible at the same time as gathering sound evidence of safety and effectiveness. To inform current policy, I reexamine the philosophical rationale for restricting new medicines to clinical trials, at any stage and for any population of patients (which resides in the precautionary principle), to show that its objective to protect public health, now or in the future, could soon be defeated in a pandemic.

A qualitative investigation of selecting surrogate decision-makers.

Background: Empirical studies of surrogate decision-making tend to assume that surrogates should make only a 'substituted judgement'--that is, judge what the patient would want if they were mentally competent.

Objectives: To explore what people want in a surrogate decision-maker whom they themselves select and to test the assumption that people want their chosen surrogate to make only a substituted judgement.

Methods: 30 undergraduate students were recruited.

Assessing the remedy: the case for contracts in clinical trials.

Current orthodoxy in research ethics assumes that subjects of clinical trials reserve rights to withdraw at any time and without giving any reason. This view sees the right to withdraw as a simple extension of the right to refuse to participate all together. In this paper, however, I suggest that subjects should assume some responsibilities for the internal validity of the trial at consent and that these responsibilities should be captured by contract.

Hard paternalism, fairness and clinical research: why not?

Jansen and Wall suggest a new way of defending hard paternalism in clinical research. They argue that non-therapeutic research exposing people to more than minimal risk should be banned on egalitarian grounds: in preventing poor decision-makers from making bad decisions, we will promote equality of welfare. We argue that their proposal is flawed for four reasons.

Student projects in medicine: a lesson in science and ethics.

Regulation of biomedical research is the subject of considerable debate in the bioethics and health policy worlds. The ethics and governance of medical student projects is becoming an increasingly important topic in its own right, especially in the U.K.