Scientists Hate the NIH’s New Rules for Experimenting on Humans

WIRED | 1/26/2018 | Adam Rogers
darktm22darktm22 (Posted by) Level 4
She’s probably mostly kidding when she tells the origin story this way, but Kathy Hudson—until last year the deputy director for science, outreach, and policy at the National Institutes of Health—says that a massive update to the NIH’s rules for funding science started with humiliation. A pal who ran approvals at the Food and Drug Administration, Hudson says, “used to walk around and talk about how NIH funded small, crappy trials, and they would say it at big gatherings.” This was Washington, in front of congresspeople—or at conferences full of leading researchers. “I would get so pissed off,” Hudson says.

But then, well, she took it to heart. “I started to look at our trials and what kinds of policies we had, to make sure investments in clinical trials were well spent,” Hudson says. It turned out they were not.

Week - Decade - Work - Rules - Effect

This week, after almost a decade of work, some new rules go into effect for researchers funded by NIH. If they’re using human beings in their experiments, most of them now have to register their methodologies on a government-built website, clinicaltrials.gov. They have to promise to share whatever they find, even if they don’t prove what they hoped—especially if they don’t prove it. They have to get trained up in modern clinical practices.

Philosophically, almost no one disagrees with the intent. Make science more open, more ethical, and smarter. But some researchers think the rule change will bring with it more than just confusing, possibly burdensome new bureaucracy, and maybe even set back all of basic bioscience. They’re just as pissed off as Hudson used to get.

Changes - Rules - Small-potatoes - Agency - Awards

The changes to the rules aren’t small-potatoes. The agency awards tens of thousands of grants, $17 billion in 2016; it’s a key source of money for US scientists and a primary driver of new biomedical knowledge. The...
(Excerpt) Read more at: WIRED
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