Hot Topics: Health Regulation & Law
The Working Group on Compassionate Use and Preapproval Access (CUPA), a project of the NYU Grossman School of Medicine Division of Medical Ethics
The undersigned are members of a multidisciplinary group comprising bioethicists, clinicians, patient advocates, and representatives from industry and law who for the past seven years have been studying the ethical issues surrounding access to medical products before they have received regulatory approval.…Full Article
by Sweta Dubey MBBS & Siddhesh Zadey BSMS
For the first time in human history, over 3.9 billion people in about ninety countries around the world were contained in lockdowns as of the first week of April.…Full Article
by Daniel Du Pont, MD, MBE and Jill Baren, MD, MS, MBA, FACEP, FAAP
The novel coronavirus outbreak, like any pandemic, has brought with it many difficult choices.…Full Article
by Carlo Alfredo Clerici, MD, Tullio Proserpio, PhD, Costanza Raimondi, PhD candidate
The COVID pandemic has exposed us to our own fragility and has forced the entire world to confront a condition with no cure.…Full Article
by Joyeeta G Dastidar, MD
In New York City, the epicenter of the COVID-19 pandemic in the country with a quarter of the nation’s cases, hospitals prepared for ventilator shortages.
by Craig Klugman, Ph.D.
In a lawsuit this week, a judge in Cook County (IL) ruled against a suburban that wanted to force the county “to share the addresses of coronavirus patients”.…Full Article
by Craig Klugman, Ph.D.
… Full Article
We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Ventilators.
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
Patenting Foundational Technologies: Recent Developments in the CRISPR Patent Struggle
Clearing Muddy Waters: The Need to Reconceptualize Minor Increase over Minimal Risk in Pediatric Rare Disease Research
Can the Principles of Research Ethics Help Us Distribute Clinical Resources More Fairly?
Misrepresenting “Usual Care” in Research: An Ethical and Scientific Error
Operational Characteristics of Institutional Review Boards (IRBs) in the United States
Breaking a Vital Trust: Posting Photos of Patients on Facebook Among a Sample of Peruvian Medical Students
“Paid to Endure”: Paid Research Participation, Passivity, and the Goods of Work
The Continued Complexities of Paying Research Participants
The debate over plasma therapy continues on. Should its use become widespread? Although it has been authorized for use from the government, many hospitals grapple with this therapeutic due to need for further study.Full Article
The race for a COVID-19 vaccine has been on the forefront of many research pursuits, and bioethics is crucial when considering vaccine development and distribution. Clinical trials progressing through defined phases allow developers to gauge the effect of the vaccine in the larger population and study any effects of long-term utilization. Carl Zimmer of The New York Times provides a look at the early results from the “Sputnik V” vaccine in Russia.Full Article
Wisconsin’s Supreme Court has overturned the state’s “Safer at Home” orders and mandated that all future statewide restrictions to battle the coronavirus must be approved by the legislature’s rule-making committee before they could be implemented.Full Article
For years, California law required psychotherapists to report any patient who admitted developing, duplicating, printing or exchanging material depicting an obscene act involving a child. The therapists accepted that requirement. They regarded it as an obligation to report producers and distributors of child pornography. But when the Legislature amended the law in 2014 to reflect new technology, many therapists balked, complaining the new wording required them to inform on patients who posed no threat to others.Full Article
The new owner of a consumer DNA database that has powered a revolution in forensics vowed to resist attempts by police to circumvent the site’s privacy rules.Full Article
The use of a unique set of cells — human fetal tissue cells — has led to immense medical breakthroughs, but President Donald Trump, to the delight of many anti-abortion groups, has thwarted any such future scientific advances by placing an additional layer of scrutiny on National Institutes of Health (NIH) research proposals that would use these cells.Full Article
The French ban on direct-to-consumer genetic testing is part of the country’s bioethics laws, which legislators are supposed to revise every seven years. When those discussions got under way earlier this year, some geneticists expected the National Assembly to relax the rules about commercial DNA analysis. It didn’t.Full Article
Unwed pregnant women in China face a legal gray zone where they are unable to access public services for themselves and their children.Full Article
The state of California will pay $3.85 million to researchers at the University of California, Davis, to develop the nation’s first program to train health care professionals to help their patients reduce firearm-related injury and death, university officials announced Tuesday.Full Article