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Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases? argues that while lessons from Operation Warp Speed may benefit patients facing serious non-pandemic diseases, there are also cautionary lessons to be learned from relaxation of FDA standards, October 2021 |
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Virginia Brown’s commentary, Centering Social Justice for Covid-19 Resources and Research, recommends the incorporation of a community-based participatory research framework into research to address fair distributions of burdens and benefits, September 2021 |
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How Patient Data Underpin COVID-19 Research addresses the benefits and ethical concerns associated with collecting and using massive amounts of data in COVID-19 research, and how such research revealed problems with data sets (e.g., fragmentation of records, bias) and lessons for future research, September 2021 |
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François Bompart provides an Ethical Rationale for Better Coordination of Clinical Research on COVID-19, May 28, 2020 |
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Conducting Research in the COVID-19 Pandemic: Ethics in an Emergency, an archived webinar from the Consortium on Law and Values in Health, Environment & the Life Sciences, University of Minnesota, March 3, 2021; conference/webinar website here |
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The Hastings Center has collected articles from the medical and bioethics literatures regarding COVID-19 vaccine and treatment research |
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Where Is America’s Groundbreaking Covid-19 Research? In this New York Times opinion piece, Penn bioethicists Ezekiel J. Emanuel, Cathy Zhang, and Amaya Diana identify 6 lessons from the British COVID-19 research effort which could improve the US effort, September 1, 2020 |
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How the World Missed COVID-19’s Silent Spread reports how journals’ publication practices, as well as the effects of competition between laboratories and even countries, shaped understanding of virus transmission, The New York Times, June 28, 2020 |
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The Pandemic Claims New Victims: Prestigious Medical Journals, June 15, 2020 New York Times front-page report on the retraction of two studies inadequately vetted by The Lancet and NEJM and the challenges for peer review of detecting fraudulent studies, especially in the face of the pandemic’s pressure |
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‘It’s Just Everywhere Already’: How Delays in Testing Set Back the U.S. Coronavirus Response reports the effect of federal and state authorities not permitting the repurposing of samples from the Seattle flu study to test for the presence of coronavirus, March 10, 2020 |
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In her NEJM letter, Early Detection of Covid-19 through a Citywide Pandemic Surveillance Platform, and related supplement, Helen Chu et al. explain how the Seattle flu study was employed to test for coronavirus and report results under a public health surveillance exemption, May 1, 2020 |
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Against pandemic research exceptionalism, by Center faculty member Alex John London from CMU and Jonathan Kimmelman, who argue that rigorous standards for scientific research should not be abandoned in COVID-19 clinical research, April 23, 2020 Three related articles by Alex John London:
Also see Placebo use in vaccine trials: Recommendations of a WHO expert panel, 2014, to which he contributed |
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Companies researching COVID-19 interventions are considering allocation issues regarding the products they are seeking to produce; for example, Johnson & Johnson has issued an Ethical Framework for Decision-Making During the COVID-19 Pandemic |
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The Inflated Promise of Genomic Medicine, by Eric Parens, argues that COVID-19 “has laid bare the need to reconsider the hope and money we invest in genetics research,” June 1, 2020 |
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The Danger of Rushing Through Clinical Trials During the Coronavirus Pandemic—an interview in The New Yorker with Peter B. Bach, who runs the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, and who cautions against relaxing rigorous standards for conducting clinical trials in the search for COVID-19 treatments, May 14, 2020 |
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Clinical Trials vs. Right to Try: Ethical Use of Chloroquine for Covid-19—Robert Veatch argues that “whether hydroxychloroquine is beneficial or harmful depends not only on the results of trials, but also on the unique value systems of individual patients,” April 29, 2020 |
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Ethical Responsibility in Publishing Research Results on Covid-19 Treatments—a brief commentary by Michael Erdek on the risks and ethics of premature publication, April 30, 2020 |
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Ethics and Evidence in the Search for a Vaccine and Treatments for Covid-19—placing the push to relax scientific standards in the historical context, this brief Hastings Center review recommends against acceding to this pressure, April 15, 2020 |
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UPMC led global trial fast tracks testing of hydroxychloroquine, other COVID-19 therapies—in this April 9, 2020 news report, Derek Angus, Professor and Chair of Department of Critical Care Medicine at Pitt and UPMC, explains an adaptive clinical trial model that relies on reinforcement learning (a type of artificial intelligence) to identify an evidence-backed therapy for COVID-19 more rapidly than can be achieved through traditional clinical trial approaches |
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Compassionate Use of Remdesivir for Patients with Severe Covid-19—reporting on a Gilead Sciences funded study of 53 patients, with 36 showing “clinical improvement,” following compassionate use of Remdesivir |
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FDA Expedites Treatment of Seriously Ill COVID-19 Patients with Experimental Plasma, an NPR news report that includes brief discussion of research risks, March 24, 2020 |
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Treating COVID-19—Off-Label Drug Use, Compassionate Use, and Randomized Clinical Trials During Pandemics—Arguing for the importance of RCTs with appropriate control groups, the author states: “The administration of any unproven drug as a “last resort” wrongly assumes that benefit will be more likely than harm. However, when a drug with unknown clinical effects is given to patients who have severe illness from a new disease (like COVID-19), there is no way to know whether the patients had benefited or were harmed if they were not compared to a concurrent control group. A common interpretation of off-label use and compassionate use of drugs is that is that if the patient died, they died from the disease, but if the patient survived, they survived because of the given drug. This is not true” |
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Ethics Committee Reviews of Applications for Research Studies at 1 Hospital in China During the 2019 Novel Coronavirus Epidemic—Based on an analysis of protocols reviewed by the Ethics Committee of the Henan Provincial People’s Hospital during the COVID-19 epidemic, the authors conclude that “the high frequency of issues with the research proposals and informed consent forms reflect that during an outbreak, researchers may use experimental drugs on affected patients, relax inclusion and exclusion criteria, and fail to offer reasonable compensation or to inform vulnerable patients of trial risks. Because the climate of fear may induce patients to agree to participate in research, the ethics committee paid special attention to such issues” |
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Infectious Disease Research and Dual-Use Risk, a brief overview of the dual-use research concern that research on infectious agents, their prevention, and their treatment can be diverted and “weaponized” |