A Controversial Rewrite For Rules To Protect Humans In Experiments
By Rob Stein,
NPR
| 11. 25. 2015
Untitled Document
Throughout history, atrocities have been committed in the name of medical research.
Nazi doctors experimented on concentration camp prisoners. American doctors let poor black men with syphilis go untreated in the Tuskegee study. The list goes on.
To protect people participating in medical research, the federal government decades ago put in place strict rules on the conduct of human experiments.
Now the Department of Health and Human Services is proposing a major revision of these regulations, known collectively as the Common Rule. It's the first change proposed in nearly a quarter-century.
"We're in a very, very different world than when these regulations were first written," says Dr. Jerry Menikoff, who heads the HHS Office of Human Research Protections.
"The goal is to modernize the rules to make sure terrible things don't happen."
Many of the revisions are long overdue and would significantly improve oversight of scientific research, say researchers, bioethicists and officials who oversee human research studies.
But many of the updates are also triggering intense debate and criticism.
The new rules are too complex...
Related Articles
By Keith Casebonne and Jodi Beckstine [with CGS' Katie Hasson], Disability Deep Dive | 07.24.2025
In this episode of Disability Deep Dive, hosts Keith and Jodi explore the complex interplay between disability science, technology, and ethics with guest Katie Hasson, Associate Director at the Center for Genetics and Society. The conversation delves into...
By Angus Liu, Fierce Pharma | 07.22.2025
A brief skirmish between Sarepta Therapeutics and the FDA has ended before escalating into a full-on regulatory clash, as the company has bowed to the agency’s demand.
In a surprising reversal, Sarepta on Monday said it will pause all shipments...
By Lucy Tu, The Atlantic | 07.11.2025
Donald Trump—who is, by his own accounting, “the fertilization president” and “the father of IVF”—wants to help Americans reproduce. During his 2024 campaign, he promised that the government or insurance companies would cover the cost of in vitro fertilization. In...
By Jared Whitlock, Endpoints News | 07.15.2025
Patient groups face a harder and unpredictable path going state-by-state to boost screening for rare but treatable conditions after the Trump administration disbanded a federal advisory committee on newborn screening.
In April, the Advisory Committee on Heritable Disorders in Newborns...