Thursday, December 21, 2017

The black hole of accountability for cloud cuckoo-land medical research

If you're waiting for some agency to step and and investigate the secret offshore herpes experiments conducted by an unlicensed medical researcher at Southern Illinois University, think again. It's unlikely to happen. The FDA is not set up to investigate human subjects abuses and the agency that is -- the Office of Human Research Protection -- has pretty much given up. As Marisa Taylor at Kaiser Health News writes: 

The agency’s public assessments of research misconduct peaked in 2002, when it issued more than 100 “determination letters.”  That number has steadily declined. This year, it has issued one.

“A single letter in one year is extraordinary,” said Michael Carome, who was the agency’s associate director for regulatory affairs from 2002 to 2010. “OHRP’s compliance oversight activities are moribund.”

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