FDA Just Quietly Gutted Protections for Human Subjects in Research

Late last year, the U.S. Food and Drug Administration quietly introduced a regulation that may be one of the most important shifts in how nonprofit and for-profit U.S. institutions, both at home and abroad, conduct future medical and public health research

Newsweek reported:

It represents an erosion of personal medical choice and threatens to undermine the public’s trust in scientific investigations in biomedicine.

A bedrock of ethical research design is the universal requirement of informed consent for any medical procedure, treatment, or intervention.

Researchers must provide information to possible participants, without pressure or coercion, to decide whether the risks are worth the potential benefit of an intervention.

The FDA’s exceptions, until recently, are historically reserved for people who are incapacitated or for urgent, life-threatening emergencies.

These measures have generally been strengthened since the Nuremberg Trials, formally adopted across the U.S. government through the institutional review board (IRB) system.

An IRB is a committee of specialists and administrators at each institution that oversees research design and assures the protection of research subjects.

At its core, the new FDA rule change allows any IRB to broadly assume the FDA’s own exemption power, dubiously granted under the 21st Century Cures Act of 2016, to grant exemptions to informed consent requirements based on “minimal risk”.

Based on vague guidelines, it effectively gives thousands of IRB committees the unilateral ability to determine that researchers need not obtain true informed consent from research participants.

AI Trains on Kids’ Photos Even When Parents Use Strict Privacy Settings

Ars Technica reported:

Human Rights Watch (HRW) continues to reveal how photos of real children casually posted online years ago are being used to train AI models powering image generators — even when platforms prohibit scraping and families use strict privacy settings.

Last month, HRW researcher Hye Jung Han found 170 photos of Brazilian kids that were linked in LAION-5B, a popular AI dataset built from Common Crawl snapshots of the public web.

Now, she has released a second report, flagging 190 photos of children from all of Australia’s states and territories, including indigenous children who may be particularly vulnerable to harms.

These photos are linked in the dataset “without the knowledge or consent of the children or their families.” They span the entirety of childhood, making it possible for AI image generators to generate realistic deep fakes of real Australian children, Han’s report said.

Perhaps even more concerning, the URLs in the dataset sometimes reveal identifying information about children, including their names and locations where photos were shot, making it easy to track down children whose images might not otherwise be discoverable online.

That puts children in danger of privacy and safety risks, Han said, and some parents thinking they’ve protected their kids’ privacy online may not realize that these risks exist.

Dark Side of ‘the Next AI Trade’: Seizing Private Property for Transmission Lines

ZeroHedge reported:

There’s a dark side to ‘The Next AI Trade‘ — at least for some landowners. Powering up America and upgrading power grids for artificial intelligence data centers, onshoring trends, and the electrification of the economy will require thousands of miles of new transmission lines nationwide.

Existing lines will be upgraded, but new lines will also be needed, resulting in the seizure of private property via eminent domain.

According to Fox 45 Baltimore, the Maryland Piedmont Reliability Project (MPRP) is a new plan to build a 70-mile 500,000-volt transmission line across three counties: Frederick, Baltimore, and Carroll. The line will connect a substation in southern Frederick County and supply the area with additional load capacity to handle surging power demand from AI data centers.

MPRP’s website explains that the new transmission lines will require the acquisition of private property through the use of an eminent domain, or government-mandated seizure to complete the construction.

It’s becoming clear that the dark side of powering up America for AI data centers will be land grabs by the government through eminent domain.

Businesses Are Harvesting Our Biometric Data. The Public Needs Assurances on Security

The Conversation reported:

Biometrics are unique physical or behavioral traits and are part of our everyday lives. Among these, facial recognition is the most common.

Facial recognition technology stems from a branch of AI called computer vision and is akin to giving sight to computers. The technology scans images or videos from devices including CCTV cameras and picks out faces.

The system typically identifies and maps 68 specific points known as facial landmarks. These create a digital fingerprint of your face, enabling the system to recognise you in real time.

From supermarkets to car parks and railway stations, CCTV cameras are everywhere, silently doing their job. But what exactly is their job now?

Businesses may justify collecting biometric data, but with power comes responsibility and the use of facial recognition raises significant transparency, ethical and privacy concerns.

Students Scoff at a School Cellphone Ban. Until They Really Begin to Think About It

Los Angeles Times reported:

The Board of Education’s 5-2 decision to ban cellphones by January 2025 aims to change the behavior of a generation of students and will be one of the most consequential and closely watched shifts in schooling since students were forced to go to class online — many by phone — more than four years ago at the onset of the pandemic.

Details, such as how the rule will be enforced and where the phones will be stored during the schoolday, will be worked out in the coming months. But the goals are clear.

School leaders say they want to combat classroom distractions that are impeding learning and to reduce the dangers of social media addiction.

At this point, the leaders say, a strict phone ban is the only way to get students to talk to one another and their teachers and come to value face-to-face conversations over digital connections.

Los Angeles will join a growing movement in K-12 education to ban phones and has won the support of Gov. Gavin Newsom, who has endorsed a bill to make such a rule to go statewide.

Last year, Florida passed a policy to bar student cellphones from all K-12 classrooms. A similar law will go into effect in Indiana next year. In Ohio, new legislation will force schools to devise policies to “minimize students’ use” of cellphones.

New York City, the nation’s largest school district, is poised to introduce a student cellphone ban this month that’s similar to the one in Los Angeles, after dropping a prior ban in 2015.

EU Commission Urges Digital ID, E-Health Records, and Touts ‘Anti-Disinformation’ Efforts in Digital Decade Report

Reclaim the Net reported:

Earlier this week the EU Commission (EC) published its second report on what it calls “the state of the digital decade,” urging member countries to step up the push to increase access and incentivize the use of digital ID and electronic health records.

At the same time, the bloc is satisfied with how the crackdown on “disinformation,” “online harms,” and the like is progressing.

While the report is generally upbeat on the uptake of digital ID (eID schemes) and the use of e-Health records, its authors point out that there are “still significant differences among countries” in terms of eID adoption.

To remedy member countries falling short on these issues, it is recommended that they push for increased access to eID and e-Health records in order to meet the objectives set for 2030.

Anthony Blinken Reveals Government’s AI Plan to Censor Free Speech

Technocracy News reported:

U.S. Secretary of State Anthony Blinken admitted last week that the State Department is preparing to use artificial intelligence to “combat disinformation,” amidst a massive government-wide AI rollout that will involve the cooperation of Big Tech and other private-sector partners.

At a speaking engagement streamed last week with the State Department’s chief data and AI officer, Matthew Graviss, Blinken gushed about the “extraordinary potential” and “extraordinary benefit” AI has on our society, and “how AI could be used to accelerate the Sustainable Development Goals which are, for the most part, stalled.”

He was referring to the United Nations Agenda 2030 Sustainable Development goals, which represent a globalist blueprint for a one-world totalitarian system.

New Cyberattack Targets iPhone Apple IDs. Here’s How to Protect Your Data

CBS News reported:

A new cyberattack is targeting iPhone users, with criminals attempting to obtain individuals’ Apple IDs in a “phishing” campaign, security software company Symantec said in an alert Monday.

Cyber criminals are sending text messages to iPhone users in the U.S. that appear to be from Apple, but are in fact an attempt at stealing victims’ personal credentials.

See more here childrenshealthdefense

Header image: Sarah Silbiger / Getty Images

Bold emphasis added

Please Donate Below To Support Our Ongoing Work To Defend The Scientific Method

PRINCIPIA SCIENTIFIC INTERNATIONAL, legally registered in the UK as a company incorporated for charitable purposes. Head Office: 27 Old Gloucester Street, London WC1N 3AX. 

 

Trackback from your site.

Leave a comment

Save my name, email, and website in this browser for the next time I comment.
Share via