By Nir Eyal In many places around the world, declining levels of public trust in health officials, medical advice, and medical products are causing damages to personal and public health. For example, distrust is a major contributor to the low uptake of COVID-19 vaccination in many countries. Understandably, bioethicists seek to heed the potential of […]
Category: Research Ethics
When context calls: EFBRI – An Evolving Ethical Framework Informing Breastfeeding Research and Interventions
By Michaela Hefti and Rasita Vinay. Currently, there are no specific ethics guidelines informing biomedical research in breastfeeding and lactation – despite the potentially vulnerable populations involved. On 10 March 2022, EFBRI – An Evolving Ethical Framework Informing Breastfeeding Research and Interventions, was introduced via a LactaWebinar to address this gap and discuss the practical […]
Why we should not extend the 14-day rule
By Bruce P. Blackshaw In 1978, the first baby conceived by IVF was born in the UK, and public concern about how rapidly science was advancing resulted in a government inquiry being set up. It produced the Warnock Report, which recommended (amongst other things) that human embryos could be cultured in vitro for no longer […]
Finding meaning in loss: family experience of research on imminently dying patients in the intensive care unit
By Amanda van Beinum, Nicholas Murphy, Charles Weijer, and Jennifer Chandler “…this study […] it was a way of […] making him live on, in certain ways, or be able to say, ‘hey my dad did this’ you know, we did this, and maybe some good will come out of it…” Intensive care units can […]
Why we agreed to review the first COVID-19 human challenge study
By Simon E. Kolstoe, Tony Lockett and Hugh Davies Reliable information is essential for good decision making. This is particularly true when complex medical situations are combined with political and social ramifications, such as during the COVID-19 pandemic. The last two years have been revealing from the perspective of seeing how societies rely upon, but […]
What’s yours is ours: intellectual property protections for COVID-19 vaccines
By Nancy S. Jecker. The extraordinary circumstances of a global pandemic warrant waiving intellectual property protections for COVID-19 vaccines. The World Trade Organization (WTO) is currently considering such a move, which over 100 Nobel laureates and 75 former heads of state have backed, calling it a “vital and necessary step” that would “expand global manufacturing […]
The value of COVID challenge trials for diverse populations
By Nir Eyal and Tobias Gerhard Perhaps the strongest argument against COVID challenge trials posits that they must choose between the Scylla of insufficient safety for volunteers and the Charybdis of insufficient social value. In particular, challenge trials that exclude old or unhealthy participants for their own safety may involve surprisingly low risk, but they […]
Challenge studies for COVID-19: Now is still not the time
By Françoise Baylis and Landon J Getz Two challenge studies for COVID-19 involving the deliberate infection of healthy volunteers aged 18-30 are underway in the UK. Both studies involve the original strain of SARS-CoV-2 from Wuhan China, and not the recent variants of concern – commonly referred to as B.1.1.7, B.1.351 and P.1. These variants […]
COVID-19 human challenge volunteers are neither doing too little, nor helping too late
By Abie Rohrig and David Manheim The world’s first COVID-19 human challenge trial began in early March, with around a dozen healthy, consenting volunteers between the ages of 18-30 deliberately exposed to the virus at a quarantine facility in London. Getz and Baylis recently argued that the questionable harm-benefit ratio of COVID-19 challenge trials make them […]
Challenge studies for COVID-19: Now is not the time
By Landon J Getz and Francoise Baylis hVIVO, a for-profit clinical research organization in London, in collaboration with Imperial College London, has initiated a human challenge study in youth between the ages of 18 and 30 to determine the dose at which individuals become infected with SARS-CoV-2, the virus that causes COVID-19. The dose-ranging study, […]