US toughens rules for clinical-trial transparency
By Sara Reardon,
Nature News
| 09. 16. 2016
The disappointing results of clinical trials will no longer be able to languish unpublished, thanks to rules released on 16 September by the US Department of Health and Human Services (HHS) and the US National Institutes of Health (NIH).
The long-awaited changes to the HHS clinical-trial disclosure laws requires, for the first time, that researchers report the design and results of all clinical trials and empowers the government to enforce penalties for those that do not comply. The NIH rules apply only to work done through agency grants, and include stricter reporting requirements for phase I trials. If institutions don’t follow the rules, the NIH could withdraw their funding.
“I think a lot of major universities just miss the point that if you do an experiment on a person and get consent, you really have the obligation to make the results known,” says Robert Califf, head of the US Food and Drug Administration (FDA). “This is fundamentally an ethical issue.”
Both sets of rules are intended to crack down on the large number of clinical trials that are conducted but...
Related Articles
By Megan Mineiro and Caroline Kitchener, The New York Times | 10.05.2025
Kathleen Whipple and her husband had dreamed of a big family, but struggled to conceive.
Upon his return from an overseas deployment with the Navy, the couple learned from a fertility doctor that her husband’s sperm count was half of...
By Alondra Nelson, Science | 09.11.2025
In the United States, the summer of 2025 will be remembered as artificial intelligence’s (AI’s) cruel summer—a season when the unheeded risks and dangers of AI became undeniably clear. Recent months have made visible the stakes of the unchecked use...
By Emma McDonald Kennedy
| 09.25.2025
In the leadup to the 2024 election, Donald Trump repeatedly promised to make IVF more accessible. He made the commitment central to his campaign, even referring to himself as the “father of IVF.” In his first month in office, Trump issued an executive order promising to expand IVF access. The order set a 90-day deadline for policy recommendations for “lowering costs and reducing barriers to IVF,” although it didn’t make any substantive reproductive healthcare policy changes.
The response to the...
By Johana Bhuiyan, The Guardian | 09.23.2025
In March 2021, a 25-year-old US citizen was traveling through Chicago’s Midway airport when they were stopped by US border patrol agents. Though charged with no crime, the 25-year-old was subjected to a cheek swab to collect their DNA, which...