CoViD-19: Time to rethink the RCT and consider more efficient and ethical approaches to clinical knowledge acquisition

By Michael Keane. A recent, much publicized, randomized controlled trial (RCT) demonstrated that the corticosteroid, dexamethasone, reduced mortality from CoViD-19. This was hailed as a practice-changing breakthrough. The authors announced that “RECOVERY is a large, pragmatic, randomized, controlled adaptive platform trial designed to provide rapid and robust assessment of the impact of readily available potential […]

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Clamping down on unethical research: time for a moratorium on publishing Chinese transplant research

By Wendy A Rogers, Angela Ballantyne, Wendy C Higgins, Wendy Lipworth. Our paper in JME investigates the pros and cons of publishing and/or retracting unethical biomedical research. We focus on Chinese transplant research using organs procured from non-consenting executed prisoners. However, this is not the only topic currently raising questions about the justifiability of publishing […]

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Can research participants break from the chain of traditional data sharing consent?

By Vasiliki Rahimzadeh In their recent article, Mann et al. propose to share biomedical research data more widely, securely and efficiently using blockchain technologies. Used to power cryptocurrencies such as Bitcoin, blockchain and the wider group of distributed ledger technologies provide new ways of exchanging data, including sensitive data such as health data, in that […]

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How should the risks of infecting research participants with SARS-CoV-2 be assessed?

By Susan Bull, Euzebiusz Jamrozik, Ariella Binik, Michael Parker Vaccine development processes typically take ten to twenty years. The exceptional pace of COVID-19 vaccine research has resulted in early human trials being commenced with vaccine candidates. Calls have been made to conduct controlled human infection studies (CHIs), also known as challenge studies, with SARS-CoV-2 to […]

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Ethical oversight during COVID-19: rewriting the norms of research ethics review?

By Anna Chiumento and Lucy Frith One consequence of physical distancing in response to the COVID-19 pandemic has been the rapid suspension or adaptation of ongoing research activity.  This presents an opportunity for the research ethics community and researchers to promote ethical oversight that integrates the situated and informed judgement of researchers, rebalancing away from […]

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Is Research Ethics Committee review of most clinical trials fundamentally broken?

By Mark Yarborough Imagine that you suffered from a fatal neurodegenerative disorder like Alzheimers or ALS, or that you had a serious chronic condition like hypertension or heart disease. Imagine further that you were asked to participate in a clinical trial related to your disease. Finally, imagine that the person recruiting you into the trial […]

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We need a framework for the ethics of secondary epidemic vaccine trials

By Joshua Teperowski Monrad Introduction In the 21st century, few medical innovations have been as intensely anticipated as an effective vaccine for COVID-19. The pipeline of candidates now includes more than a hundred potential products, as governments, pharmaceutical companies, and researchers engage in an unprecedented effort to combat the worst pandemic of a century. This […]

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Experiment on identical siblings separated at birth: Ethical implications for researchers, universities and archives today

 By Adam Kelmenson, MS & Robert Klitzman, MD   The 2018 film Three Identical Strangers brought wide media and public attention to a previously little-known 1960’s psychological study.  The researchers had secretly separated several sets of twins and one set of triplets into adoptive families, and then studied them for decades without disclosing to the […]

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What happens when a healthcare institution becomes a research subject?

By Jan Piasecki and Vilius Dranseika. Consider a hospital manager who works in a large hospital employing hundreds of medical professionals and receiving thousands of patients every day. When she is approached by a group of researchers, she faces a difficult decision. On the one hand, she and the staff of her hospital are committed […]

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Allocating scarce biospecimens

By Leah Pierson, Sophia Gibert, and Joseph Millum Clinical researchers frequently collect samples of blood, skin, and other bodily tissues from their patient-participants and have samples left over when their research is complete. These biospecimens are often in high demand from other scientists who want them for their own research. How should such collections of […]

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