Sarah Edwards

Cluster randomized controlled trials (cluster RCTs) randomize whole clusters of individuals in testing two or more competing interventions. Here we will present the ethical problems raised by cluster RCTs concerning their effect on inequality. We argue that some inequalities generated by cluster RCTs are larger in scope than those generated from individual RCTs. We also argue that any cluster RCT-generated inequalities, which divide groups rather than individuals, are more problematic in type than the inequalities created in individual RCTs. These concerns should be taken into consideration when designing research at the cluster level, and those conducting the research should consider modified research design strategies in cases where they believe the risk of generating inequalities is large

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. Providing wider therapeutic access and coordinating observations and natural experiments, including service delivery by cluster (wedged cluster trials), may provide such a balance. However, there are important questions of fairness to resolve before any such research can proceed.

In this paper the need for valid evidence of the cost-effectiveness of treatments that have not been properly evaluated, yet are already available, albeit in short supply, are examined. Such treatments cannot be withdrawn, pending proper evaluation, nor can they be made more widely available until they have been shown to be cost-effective. As a solution to this impasse the argument put forward recently by Toroyan et al is discussed. They say that randomised controlled trials of such resources could be done but only if resources are randomly allocated independently of a research context. Relevant outcome data could then be collected for research, given this opportunity. We agree. We disagree with Toroyan et al on a number of points. First, they claim that no ethical issue relating to equipoise arises. We disagree and this disagreement depends on our showing that equipoise should be maintained in a relationship that they do not consider. Secondly, they say that consent to data collection is always needed. Again we disagree. Thirdly, they claim that the previous two issues are the only possible ethical issues that could arise. We argue, instead, that there is a further conflict of interests that has ethical import

Owing to unique features of their design, cluster randomized trials complicate the interpretation of standard ethics guidelines. The recently published Ottawa statement on the ethical design and conduct of cluster randomized trials provides researchers and research ethics committees with detailed guidance on the design, conduct, and review of cluster trials. The Ottawa statement sets out 15 recommendations, including guidance on the justification of study design, the need for research ethics committee review, the identification of research participants, obtaining informed consent, the role of gatekeepers in protecting cluster interests, the assessment of benefits and harms, and the protection of vulnerable participants.

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. However, the same cannot be said for implementing research in global health. In an effort to build on this work, the Pakistan Institute of Living and Learning and University College London in the UK sought to better understand differences in beliefs, values and norms of local communities in Pakistan. In particular, they have sought to help researchers from high income countries (HIC) understand how their values are perceived and understood by the local indigenous researchers in Pakistan. To achieve this end, a group discussion was organised with indigenous researchers at Pakistan Institute of Living and Learning. The discussion will ultimately help inform the development of a cultural protocol for researchers from HIC engaging with communities in LMIC. This discussion revealed five common themes; (1) religious principles and rules, (2) differing concepts of and moral emphasis on autonomy and privacy, (3) importance of respect and trust; (4) cultural differences (etiquette); (5) custom and tradition (gift giving and hospitality). Based on the above themes, we present a preliminary cultural analysis to raise awareness and to prepare researchers from HIC conducting cross cultural research in Pakistan. This is likely to be particularly relevant in collectivistic cultures where social interconnectedness, family and community is valued above individual autonomy and the self is not considered central to moral thinking. In certain cultures, HIC ideas of individual autonomy, the notion of informed consent may be regarded as a collective family decision. In addition, there may still be acceptance of traditional professional roles such as ‘doctor knows best’, while respect and privacy may have very different meanings.

Data is essential to governing those emerging matters of concern that confront the agrifood every day. But data is no neutral intermediary. It disrupts, exposes, and creates new social, economic, political, and environmental possibilities, whilst simultaneously hiding, excluding, and foreclosing others. Scholars have become attuned to both the constitutive role of data in creating everyday worlds, and the need to develop critical accounts of the materialities, spatialities and multiplicities of data relationships. Whereas this emerging work develops insight to the capacity for data topologies to reterritorialise the spatial performances of everyday life, it has largely reduced the associated temporal dimensions to matters of fact. The effect of these performances has been to naturalize the temporal quality of speed and elide the multiple temporalities required to enact contemporary data worlds. Applying the lenses of infrastructuring, performativity and ferality, this paper explores temporality and data in the everyday worlds produced through the New Zealand kiwifruit industry’s focus on dry matter. The paper argues that temporalities are deeply embedded in the kiwifruit industry’s data relations. We show that while temporal data relations are critical to the industry, we also highlight ways in which those relations introduce new, potentially destabilizing performances into kiwifruit relations.

This is the second in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. This paper examines the role of ethics committees in assessing the science of the research it reviews. While ethics committees are not specifically constituted to review the science of a project, they must nevertheless assess the social benefits of research and, in this context, have an important role in checking that the science has been properly peer-reviewed.

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. We argue that more discerning anthropological engagement as well as wider collaboration with other social scientists and those working in the humanities is urgently needed to improve the ethics of current biomedical and pharmaceutical research practice in Africa.

Early Childhood Curriculum addresses current approaches to curriculum for infants, toddlers and young children, ages birth to eight. It provides a comprehensive introduction to the curriculum issues that student teachers and emerging practitioners will face and equips them with the decision-making tools that will ultimately enhance and promote young children's learning. The text proposes a cultural historical framework to explore diverse approaches to early years education, drawing on research and examples of practice across a range of international contexts. It offers a clear focus on domain areas of the curriculum - the arts, health and wellbeing, literacy and language, science and maths, and information and communication technology - so that teachers are able to gain a breadth of understanding and effectively plan, design and implement curriculum strategy.