From: Wired

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

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.

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, 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.

Read the whole story: Wired


I am 85 years of age and have been doing research and serving on review committees since I was in my late 20’s. I have been funded through NIH and NSF and the current issue regarding the stress on “clinical trials” reminds me of the stark difference in the understanding of scientific development in those two agencies. Some accurate understanding of the normal function of a system must precede the development of principled treatments of that system when it does not function normally. That is Science 101, and those making regulations to control research funded by NIH appear to have skipped that course.

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