Ethical argument for establishing good manufacturing practice for phage therapy in the UK.

Antimicrobial resistance (AMR) poses an increasing threat to patient care and population health and there is a growing need for novel therapies to tackle AMR. Bacteriophage (phage) therapy is a re-emerging antimicrobial strategy with the potential to transform how bacterial infections are treated in patients and populations. Currently, in the UK, phages can be used as unlicensed medicinal products on a 'named-patient' basis.

Exploring the impact of e-learning modules and webinars on health professionals' understanding of the End of Life Choice Act 2019: a secondary analysis of Manatū Hauora - Ministry of Health workforce survey.

Aim: To explore the importance of health workforce training, particularly in newly regulated healthcare practices such as assisted dying (AD). This study aims to analyse the socio-demographic factors associated with health professionals' completion of the e-learning module and attendance at the two webinars provided by the New Zealand Ministry of Health - Manatū Hauora (MH) and whether completion of the e-learning module and webinars supported health professionals' understanding of the End of Life Choices Act 2019.

Method: Secondary analysis of the MH workforce surveys conducted in July 2021.

Respecting values and perspectives in biobanking and genetic research governance: Outcomes of a qualitative study in Bengaluru, India.

The promise of biobanking and genetic research (BGR) in the context of translational research towards improving public health and personalised medicine has been recognised in India. Worldwide experience has shown that incorporating stakeholders' expectations and values into the governance of BGR is essential to address ethical aspects of BGR.  This paper draws on engagement with various stakeholders in the South Indian city of Bengaluru to understand how incorporating people's values and beliefs can inform policy making decisions and strengthen BGR governance within India.

Health professionals' understanding and attitude towards the End of Life Choice Act 2019: a secondary analysis of Manatū Hauora - Ministry of Health workforce surveys.

Aim: To determine socio-demographic factors associated with health professionals' understanding of the End of Life Choice Act (the Act), support for assisted dying (AD), and willingness to provide AD in New Zealand.

Method: Secondary analysis of two Manatū Hauora - Ministry of Health workforce surveys conducted in February and July 2021.

Results: Our analysis showed (1) older health professionals (age>55) had a better overall understanding of the Act than their young colleagues (age⁢35), (2) female health professionals were less likely to support and be willing to provide AD, (3) Asian health professionals were less likely to support AD compared to their Pākehā/European counterparts, (4) nurses were more likely to support AD and be willing to provide AD when compared to medical practitioners, and (5) pharmacists were more willing to provide AD when compared to medical practitioners.

What constitutes equitable data sharing in global health research? A scoping review of the literature on low-income and middle-income country stakeholders' perspectives.

Introduction: Despite growing consensus on the need for equitable data sharing, there has been very limited discussion about what this should entail in practice. As a matter of procedural fairness and epistemic justice, the perspectives of low-income and middle-income country (LMIC) stakeholders must inform concepts of equitable health research data sharing. This paper investigates published perspectives in relation to how equitable data sharing in global health research should be understood.

Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam.

Background: The informed consent process in clinical trials has been extensively studied to inform the development processes which protect research participants and encourage their autonomy. However, ensuring a meaningful informed consent process is still of great concern in many research settings due to its complexity in practice and interwined socio-cultural factors.

Objectives: This study explored the practices and meaning of the informed consent process in two clinial trials conducted by Oxford University Clinical Research Unit in collaboration with the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam.

Equitable Design and Use of Digital Surveillance Technologies During COVID-19: Norms and Concerns.

Given the unprecedented scale of digital surveillance in the COVID-19 pandemic, designing and implementing digital technologies in ways that are equitable is critical now and in future epidemics and pandemics. Yet to date there has been very limited consideration about what is necessary to promote their equitable design and implementation. In this study, literature relating to the use of digital surveillance technologies during epidemics and pandemics was collected and thematically analyzed for ethical norms and concerns related to equity and social justice.

Towards a new model of global health justice: the case of COVID-19 vaccines.

This paper questions an exclusively state-centred framing of global health justice and proposes a multilateral alternative. Using the distribution of COVID-19 vaccines to illustrate, we bring to light a broad range of global actors up and down the chain of vaccine development who contribute to global vaccine inequities. Section 1 (Background) presents an overview of moments in which diverse global actors, each with their own priorities and aims, shaped subsequent vaccine distribution.

Equitable data sharing in epidemics and pandemics.

Background: Rapid data sharing can maximize the utility of data. In epidemics and pandemics like Zika, Ebola, and COVID-19, the case for such practices seems especially urgent and warranted. Yet rapidly sharing data widely has previously generated significant concerns related to equity.

Vaccine-enhanced disease: case studies and ethical implications for research and public health.

Vaccination is a cornerstone of global public health. Although licensed vaccines are generally extremely safe, both experimental and licensed vaccines are sometimes associated with rare serious adverse events. Vaccine-enhanced disease (VED) is a type of adverse event in which disease severity is increased when a person who has received the vaccine is later infected with the relevant pathogen.

Engaging publics in biobanking and genetic research governance - a literature review towards informing practice in India.

There is growing interest in advancing biobanking and genetic research in many countries, including India. Concurrently, more importance is being placed on participatory approaches involving the public and other stakeholders in addressing ethical issues and policymaking as part of a broader governance approach. We analyse the tools, purposes, outcomes and limitations of engaging people towards biobanking and genetic research governance that have been undertaken worldwide, and explore their relevance to India.

Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group.

This report of the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 outlines ethical standards for COVID-19 challenge studies. It includes eight Key Criteria related to scientific justification, risk-benefit assessment, consultation and engagement, co-ordination of research, site selection, participant selection, expert review, and informed consent. The document aims to provide comprehensive guidance to scientists, research ethics committees, funders, policymakers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining criteria that would need to be satisfied in order for such studies to be ethically acceptable.

The ethics of data sharing and biobanking in health research.

The importance of data sharing and biobanking are increasingly being recognised in global health research. Such practices are perceived to have the potential to promote science by maximising the utility of data and samples. However, they also raise ethical challenges which can be exacerbated by existing disparities in power, infrastructure and capacity.

SARS-CoV-2 challenge studies: ethics and risk minimisation.

COVID-19 poses an exceptional threat to global public health and well-being. Recognition of the need to develop effective vaccines at unprecedented speed has led to calls to accelerate research pathways ethically, including by conducting challenge studies (also known as controlled human infection studies (CHIs)) with SARS-CoV-2 (the virus which causes COVID-19). Such research is controversial, with concerns being raised about the social, legal, ethical and clinical implications of infecting healthy volunteers with SARS-CoV-2 for research purposes.

"Are we getting the biometric bioethics right?" - the use of biometrics within the healthcare system in Malawi.

Biometrics is the science of establishing the identity of an individual based on their physical attributes. Ethical concerns surrounding the appropriate use of biometrics have been raised, especially in resource-poor settings. A qualitative investigation was conducted to explore biometrics clients (= 14), implementers (= 12) and policy makers as well as bioethicists (= 4) perceptions of the ethical aspects of implementing biometrics within the healthcare system in Malawi.

Researcher and study participants' perspectives of consent in clinical studies in four referral hospitals in Vietnam.

Background: Within the research community, it is generally accepted that consent processes for research should be culturally appropriate and tailored to the context, yet researchers continue to grapple with what valid consent means within specific stakeholder groups. In this study, we explored the consent practices and attitudes regarding essential information required for the consent process within hospital-based trial communities from four referral hospitals in Vietnam.

Methods: We collected surveys from and conducted semi-structured interviews with study physicians, study nurses, ethics committee members, and study participants and family members regarding their experiences of participating in research, their perspectives toward research, and their views about various elements of the consent process.

How should assent to research be sought in low income settings? Perspectives from parents and children in Southern Malawi.

Background: Paediatric research in low-income countries is essential to tackle high childhood mortality. As with all research, consent is an essential part of ethical practice for paediatric studies. Ethics guidelines recommend that parents or another proxy provide legal consent for children to participate, but that children should be involved in the decision through providing assent.

Challenges arising when seeking broad consent for health research data sharing: a qualitative study of perspectives in Thailand.

Background: Research funders, regulatory agencies, and journals are increasingly expecting that individual-level data from health research will be shared. Broad consent to such sharing is considered appropriate, feasible and acceptable in low- and middle-income settings, but to date limited empirical research has been conducted to inform the design of such processes. We examined stakeholder perspectives about how best to seek broad consent to sharing data from the Mahidol Oxford Tropical Medicine Research Unit, which implemented a data sharing policy and broad consent to data sharing in January 2016.

Sharing Individual-Level Health Research Data: Experiences, Challenges and a Research Agenda.

Since January 2016, the Mahidol Oxford Tropical Medicine Research Unit (MORU) has trialled a data-sharing policy where requests to access research datasets are processed through a Data Access Committee. In this paper, we share our experiences establishing data management systems and data-sharing infrastructure including a data-sharing policy, data access committee and related procedures. We identified a number of practical and ethical challenges including requests for datasets collected without specific or broad consent to data sharing and requests from pharmaceutical companies for data to support drug registration applications.

'It is an entrustment': Broad consent for genomic research and biobanks in sub-Saharan Africa.

In recent years, there has been an increase in the establishment of biobanks for genetic and genomic studies around the globe. One example of this is the Human Heredity and Health in Africa Initiative (H3Africa), which has established biobanks in the sub-region to facilitate future indigenous genomic studies. The concept of 'broad consent' has been proposed as a mechanism to enable potential research participants in biobanks to give permission for their samples to be used in future research studies.

Negotiated learner modelling to maintain today's learner models.

Today's technology-enabled learning environments are becoming quite different from those of a few years ago, with the increased processing power as well as a wider range of educational tools. This situation produces more data, which can be fed back into the learning process. Open learner models have already been investigated as tools to promote metacognitive activities, in addition to their potential for maintaining the accuracy of learner models by allowing users to interact directly with them, providing further data for the learner model.

Research Stakeholders' Views on Benefits and Challenges for Public Health Research Data Sharing in Kenya: The Importance of Trust and Social Relations.

Background: There is increasing recognition of the importance of sharing research data within the international scientific community, but also of the ethical and social challenges this presents, particularly in the context of structural inequities and varied capacity in international research. Public involvement is essential to building locally responsive research policies, including on data sharing, but little research has involved stakeholders from low-to-middle income countries.

Methods: Between January and June 2014, a qualitative study was conducted in Kenya involving sixty stakeholders with varying experiences of research in a deliberative process to explore views on benefits and challenges in research data sharing.

Best Practices for Ethical Sharing of Individual-Level Health Research Data From Low- and Middle-Income Settings.

Sharing individual-level data from clinical and public health research is increasingly being seen as a core requirement for effective and efficient biomedical research. This article discusses the results of a systematic review and multisite qualitative study of key stakeholders' perspectives on best practices in ethical data sharing in low- and middle-income settings. Our research suggests that for data sharing to be effective and sustainable, multiple social and ethical requirements need to be met.