NIH’s New Rules Governing Human Research Go Into Effect

More than 3,500 scientists had signed an open letter to NIH Director Francis Collins opposing the rules change.

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NIH Director Francis CollinsWIKIMEDIA, ERNESTO DEL AGUILA III

Today (January 25), the National Institutes of Health (NIH) adopted new, stricter rules governing research involving humans, and implemented new requirements for researchers studying human behavior. The policy affects funding applications submitted from today onward for investigations that would have previously been considered basic research. They will now be considered clinical trials.

“A lot of research that most of us have never thought of as being clinical trials is going to suddenly to fall under that rubric,” Ellen Wright Clayton, a bioethicist and law professor, tells The Washington Post. Her own studies, which examine how testing patients’ DNA for indications of future health problems can affect doctors’ or patients’ behavior, had been considered basic research under the old rules. “It has to do with health, ...

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