A clinical trial investigating COVID-19 antibodies conducted by the Changhua County Public Health Bureau and National Taiwan University in Taiwan violated the Human Subjects Research Act in that island nation. The head of the Department of Medical Affairs at the...
Ethics
More Reports Out of Russia of Unethical Practices Involving COVID-19 Vaccine Participation
Are Russian public sector workers getting coerced into participating in the Phase 3 Sputnik V COVID-19 vaccine trial in that country? If a recent Reuters report is correct, the answer is unfortunately affirmative. Although actual visits to clinical trial sites where...
Should Disgraced Researchers be Banned from Payments from Industry?
A critically important activity, clinical research struggles on the “trust front” as there is a growing perception among large segments of the public that bias and undue commercial influence hijack what is purported to be a science-based system. This unfortunate...
People’s Liberation Army Helped China Develop Ad5-nCoV COVID-19 Vaccine, While State-Owned SinoPharm’s Vaccine Moves Toward Approval
At present, there are eight COVID-19 vaccines nearing the end of final trials, and four of these are from China. China’s two leading candidates have been produced by the military and a state-owned enterprise, respectively. On September 11, Nature took a look at the...
US House of Representatives Seeks Answers About Transparency and Conflicts of Interest in Operation Warp Speed
On August 8, TrialSite News published an article outlining both ethical and transparency issues with Operation Warp Speed. Then, as reported by NBC News, on August 12 US House Democratic Representative James Clyburn of South Carolina sent a letter to HHS Secretary...
COVID-19 Trials in Egypt, Patient Accounts of IC Violations & the Need to Pass Modern Comprehensive Clinical Trials Legislation
Clinical trials targeting COVID-19 commenced in March of this year in Egypt, like many other nations. Thanks to evolving medical research infrastructure, particularly within the academic medical center complex, Egypt increasingly seeks a way to integrate into the...
Did SinoPharm use Executives & Scientists as Human Guinea Pigs in Pre-Clinical Research?
State-owned Sinopharm, one of the leading vaccine developers in the COVID-19 race, recently shared information that made it appeared to have used employees—including two executives—as research subjects even before the Chinese government approved testing on people....
Latvian-Based Meduza Accuses Russia of Unethical COVID-19 Vaccine Research
Latvian-based news site and aggregator, Meduza, is raising ethical concerns about COVID-19 vaccine research in Russia. The site says that issues include the fact that the state-owned Sberbank encouraged its workers to participate in vaccine trials. Also, at the...
UK Researchers Consider Human Challenge Trials to Accelerate COVID-19 Vaccine Studies
UK researchers are proposing what some would consider radical measures to accelerate the vaccine development schedule. Apparently, certain researchers posit that that vaccine volunteers should be infected with SARS-CoV-2, the virus behind the COVID-19 pandemic,...
Crowdsourced Research: Vulnerability, Autonomy and Exploitation
Patient recruitment challenges have plagued clinical research sponsors—from industry-backed to academia and government -funded, for decades. Only a small percentage of physicians and patients actually participate in clinical trials. Moreover, with greater numbers of...
Multi-Center Study Reveals that Many HIV Patients Willing to Put All on the Line for a Cure
A recent multi-center study reveals that people are willing to risk everything to contribute to a cure for HIV. In fact, the study uncovered that nearly 25% of people living with HIV were willing to risk near-certain death in a clinical trial if such a study would...
Many Insurance Policies Lack Clinical Trials Coverage: Should Research Sponsors Pay for it all?
Bioethicists are reminding sponsors and investigators that patients are due support for participating in clinical trials. After all, in many cases, a patient’s insurance policy may lack adequate coverage to participate in a study. Moreover, in most cases, these...
Ethics and Patient Care are Fundamental Values Underlying Great Clinical Programs
In 2004, Dan Markingson killed himself after participating in an antipsychotic drug study conducted by two University physicians, Dr. Stephen Olson, former head of the University’s psychiatry department, and Dr. Charles Schulz, former Department Chair and...
Are Illicitly Obtained Chinese Organs Impacting Western Clinical Research?
TrialSite News recently covered the ongoing suspicion that illicitly gotten organs from those persecuted in China could be impacting clinical research which would raise serious ethical questions driven by fundamental principles such as the Declaration of Helsinki. We...
Canada & Other Western Nations Complicit In Brutal Chinese Organ Trafficking Ecosystem?
A recent opinion piece in the Vancouver Sun was troublesome, to say the least. Chinese economic development has been, mildly put, incredible, and tremendous benefits go to the global economy. However, the unique configuration of centralized, state-sponsored planning...
University of Washington Marijuana Pregnancy Study Challenged on Ethical Questions
The University of Washington is reevaluating the ethics of an upcoming study of the effects of marijuana on unborn babies. It is the first such study that looks at babies whose mothers used marijuana during pregnancy, but no illicit drugs, alcohol or tobacco....
Trump Fetal Tissue Research Ban Update
Marie McCullough reports for the Philadelphia Inquirer that although the Trump Administration put a restriction on fetal tissue research, there are some loopholes. First, the policy doesn’t apply to those doing privately-funded fetal tissue research. Moreover, the...
UCSD Investigators Appear to Violate the Most Fundamental of Human Research Principles
Brad Racino and Jill Castellano writing for inewsource reports that "banished blood stool samples from San Diego veterans [were] used in research article, despite federal probe." Questionable research practices, including ethical issues—are raised by this Southern...
Adimab Challenges MIT Professor’s Research Integrity
Stat News recently covered a story concerning Ram Sasisekharan and concerns he used others’ body of work as his own underlying core research work product. He became known for his use of algorithms and other software models in the pursuit of new and better antibody...
NIH Suspended 7 Grants to Duke Over Patient Safety Concerns Last Year
What is going on with Duke? Last year the U.S. National Institutes of Health (NIH) suspended seven grants to Duke University following “allegations of research misconduct…and…potential issues concerning clinical research irregularities, now exposed due to a letter...