Hot Topics: Clinical Trials & Studies
Brian M. Cummings, MD and John J. Paris, SJ, PhD
In The New York Times, almost overlooked amidst multiple articles on Covid-19 published that day, we found a challenging essay by Max Fisher entitled, “Europe’s Vaccine Ethics Call: Do No Harm and Let More Die”? …Full Article
by Berklee Robins, MD, MA & Ashley Sweet, MD, MBE
Vaccines are approved when it is clear that the benefits to the individual and society outweigh the potential risks and side effects of vaccination.…Full Article
This editorial appears in the September issue of the American Journal of Bioethics
by David Magnus, PhD
This issue features a set of articles addressing allocation issues for drugs for COVID-19 that have not been approved by the FDA but are available through either Emergency Use Authorization or Expanded Access Programs (EAP).…
by Kiarash Aramesh M.D., Ph.D.
The COVID-19 pandemic has been accompanied by a surge of pseudoscientific claims, sometimes made or supported by political powers.…Full Article
by Jamie Webb MA, MSci
‘An experimental vaccine against the coronavirus showed encouraging results in very early testing, triggering hoped-for immune responses in eight healthy, middle-aged volunteers, its maker announced Monday.’…Full Article
by Jing Wan,Yuqiong Huang, Amaneh Abdel Hafez Aljaafreh, Dandan Dong, Yali Cong , Jun Lin, Hongxiang Chen
COVID-19 is an emerging infectious disease that is extremely contagious and can cause serious consequences and even death.
by Keisha Ray, Ph.D.
I take the drug hydroxychloroquine, brand name Plaquenil, for an autoimmune disease. Hydroxychloroquine was once used to treat malaria and is now commonly used to treat a range of inflammatory disorders like lupus and rheumatoid arthritis.…Full Article
by Craig Klugman, Ph.D.
In a news item reported in Rolling Stone, NPR, and The Houston Chronicle, the medical director of a coastal Texas nursing home used his political connections to get enough hydroxychloroquine to begin his own “observational” trials—minus a control group, minus informed consent, minus informing anyone.…Full Article
by Ariadne A. Nichol, B.A.
Development of experimental vaccines to combat the COVID-19 pandemic has been rapidly progressing. In the United States, several Phase I clinical trial participants already received an injection of mRNA-1273, the experimental vaccine developed by the National Institutes of Health (NIH) and a biotechnology firm called Moderna.…Full Article
by Craig Klugman, Ph.D.
On March 31, the U.S. Department of Justice put in an order for $60,000 worth of hydroxychloroquine, a drug that Trump has been pushing as a treatment for COVID-19 (to clarify, it is unproven and has never worked on any other coronavirus).…Full Article
Self-Defeating Codes of Medical Ethics and How to Fix Them: Failures in COVID-19 Response and Beyond
Don’t Blame Hippocrates for Low Enrollment in Clinical Trials
Ethically Allocating COVID-19 Drugs Via Pre-approval Access and Emergency Use Authorization
The Limits of Individualism: Potential Societal Harms from the EAP for Convalescent Plasma
Partnering With Patients to Bridge Gaps in Consent for Acute Care Research
Patient’s Perspectives of Experimental HCV-Positive to HCV-Negative Renal Transplantation: Report from a Single Site
Misrepresenting “Usual Care” in Research: An Ethical and Scientific Error
Ethics and Collateral Findings in Pragmatic Clinical Trials
Where do we go from here in fighting COVID-19? “Now, researchers are racing to develop the next generation of COVID-19 vaccines, utilizing a variety of innovative technologies to produce more convenient and more potent options.”Full Article
As states begin to vaccinate more people, “everyone needs to grapple with questions of equity — how to improve vaccine access for all Americans, especially for groups historically made most vulnerable to severe illness.”Full Article
“From academic research centers to intensive care units (ICUs) to scientific journals to government agencies, scientists fighting the pandemic say they are hitting a wall, 15 months after the first report of a cluster of cases introduced the virus “Full Article
Can we work faster to make vaccines? How can we get vaccines distributed across the world? What are the ethical challenges of vaccine distribution? All these questions need to be considered for what it takes to vaccinate the world against COVID-19.Full Article
“The goal is to gain important insights into early human development….. But the research, which was published in two separate papers Wednesday in the journal Nature Portfolio, raises sensitive moral and ethical concerns.”Full Article
Mass vaccination reveals barriers to vaccine equity that exist in society. “Vaccine navigators have a role in improving vaccine equity: the challenge of responding to underlying inequalities that create barriers to health and health care.”Full Article
Autonomy, a bioethics principle. How does autonomy look in the context of genomic data sharing? “A panel of researchers in Africa says that [little data control] can fuel distrust between researchers and participants, and needs to change.”Full Article
What will be the possibilities once we know the full human genome? “Challenging as it has been to build, a single end-to-end genome offers researchers limited value without other genomes from diverse individuals against which to compare it.”Full Article
Vaccination is hard. “It’s a debate that gets at fundamental questions about individual liberty, bodily autonomy, and communal obligation.” Check out this interview with Keisha Ray, a bioethicist speaking on the obligations for the COVID vaccine.Full Article
A vaccine surge is coming, but also poses many questions to solve. How can we ensure doses are going to those in need? With growing doses available, many factors need to be considered.Full Article