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  1. COVID-19 Human Challenge Trials – What Research Ethics Committees Need to Consider.Lisa Tambornino & Dirk Lanzerath - 2020 - Research Ethics 16 (3-4):1-11.
    To reduce the global burden of the COVID-19 pandemic, there is an urgent need to develop a safe vaccine. Vaccine development usually takes many years as it goes through several different phases. To hasten COVID-19 vaccine development, it has been suggested that the final stage could be replaced with a human challenge trial. Volunteers would be intentionally infected with SARS-CoV-2 to see how the vaccine candidate works. To intentionally infect a healthy human being with a potentially deadly virus is contrary (...)
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  • Challenges to Biobanking in LMICs During COVID-19: Time to Reconceptualise Research Ethics Guidance for Pandemics and Public Health Emergencies?Shenuka Singh, Rosemary Jean Cadigan & Keymanthri Moodley - 2022 - Journal of Medical Ethics 48 (7):466-471.
    Biobanking can promote valuable health research that may lead to significant societal benefits. However, collecting, storing and sharing human samples and data for research purposes present numerous ethical challenges. These challenges are exacerbated when the biobanking efforts aim to facilitate research on public health emergencies and include the sharing of samples and data between low/middle-income countries and high-income countries. In this article, we explore ethical challenges for COVID-19 biobanking, offering examples from two past infectious disease outbreaks in LMICs where biobanking (...)
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  • Ethics of Digital Contact Tracing Wearables.G. Owen Schaefer & Angela Ballantyne - 2022 - Journal of Medical Ethics 48 (9):611-615.
    The success of digital COVID-19 contact tracing requires a strategy that successfully addresses the digital divide—inequitable access to technology such as smartphones. Lack of access both undermines the degree of social benefit achieved by the use of tracing apps, and exacerbates existing social and health inequities because those who lack access are likely to already be disadvantaged. Recently, Singapore has introduced portable tracing wearables to address the equity gap and promote public health. We argue that governments have an ethical obligation (...)
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  • Equipoise, Standard of Care, and Consent: Responding to the Authorisation of New COVID-19 Treatments in Randomised Controlled Trials.Soren Holm, Jonathan Lewis & Rafael Dal-Ré - 2022 - Journal of Medical Ethics:1-6.
    In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of Molnupiravir, a novel antiviral medicine aimed (...)
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  • Controlled Human Infection with SARS-CoV-2 to Study COVID-19 Vaccines and Treatments: Bioethics in Utopia.Søren Holm - 2020 - Journal of Medical Ethics 46 (9):569-573.
    A number of papers have appeared recently arguing for the conclusion that it is ethically acceptable to infect healthy volunteers with severe acute respiratory syndrome coronavirus 2 as part of research projects aimed at developing COVID-19 vaccines or treatments. This position has also been endorsed in a statement by a working group for the WHO. The papers generally argue that controlled human infection is ethically acceptable if the risks to participants are low and therefore acceptable, the scientific quality of the (...)
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  • Pandemic Vaccine Trials: Expedite, but Don’T Rush.Angus Dawson - 2020 - Research Ethics 16 (3-4):1-12.
    It has been proposed that the urgency of having a vaccine as a response to SARS-CoV-2 is so great, given the potential health, economic and social benefits that we should override the established s...
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  • Pandemic Ethics and Status Quo Risk.Richard Yetter Chappell - 2022 - Public Health Ethics 15 (1):64-73.
    Conservative assumptions in medical ethics risk immense harms during a pandemic. Public health institutions and public discourse alike have repeatedly privileged inaction over aggressive medical interventions to address the pandemic, perversely increasing population-wide risks while claiming to be guided by ‘caution’. This puzzling disconnect between rhetoric and reality is suggestive of an underlying philosophical confusion. In this paper, I argue that we have been misled by status quo bias—exaggerating the moral significance of the risks inherent in medical interventions, while systematically (...)
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  • Ethical Research in the COVID-19 Era Demands Care, Solidarity and Trustworthiness.Kate Chatfield & Doris Schroeder - 2020 - Research Ethics 16 (3-4):1-4.
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  • COVID-19 Vaccines: A Look at the Ethics of the Clinical Research Involving Children.Laura Cabiedes-Miragaya & Inés Galende-Domínguez - 2022 - Journal of Medical Ethics 48 (10):666-671.
    Currently, millions of minors are being inoculated against SARS-CoV-2 in many countries in the world. Ethical concerns about clinical research involving children have barely been addressed in the literature, despite the fact that the paediatric population is particularly vulnerable within this context. Children should be included in the research plans for COVID-19 vaccines. Nevertheless, it is necessary to critically assess to what extent clinical trials are being conducted according to methodological and ethical criteria that allow us to conclude that the (...)
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  • Exploring the Ethics of Tuberculosis Human Challenge Models.Abie Rohrig, Josh Morrison, Jonathan Pugh, Julian Savulescu & Helen McShane - manuscript
    TB human challenge studies could accelerate TB vaccine development by reducing uncertainty in early-stage vaccine testing, selecting promising vaccine candidates for large-scale field trials, and identifying an immune correlate of protection. However, ethical concerns regarding the exposure of trial participants and bystanders to significant risk have been a limiting factor for TB human challenge models. We analyze the expected social value and risks of different types of TB human challenge models, and conclude that given the massive public health burden of (...)
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