And Then There Was One

From Health Care Blog

By Jeannie Baumann | December 6, 2017

It’s like they knew it was coming.

Part of my job is to look for all the research-related, noncompliance findings issued by various oversight agencies in the federal government. By the end of November, the Health and Human Services Office for Human Research Protections hadn’t posted any determination letters on its website in 2017. Zero determination letters in a single calendar year would be highly unusual indeed, but that’s what it looked like OHRP was on track to do.

To figure out why, I talked with a bunch of attorneys and other research compliance experts who have been working on these issues for a while. They have me some great answers as to why there were zero determination letters from OHRP.

So naturally, the very next day, OHRP posted its first determination letter.

It turns out there are actually 16 open noncompliance cases that are coming down the pike, an HHS spokesperson told me. And to be fair, OHRP is coming off a massive overhaul of the regulations it administers—an effort that basically dominated at least the last six years of work at the OHRP.

“It’s not like they’re twiddling their thumbs,” the spokesperson said.

There are a whole bunch of other possible reasons why the public-facing enforcement front has dwindled, which you can read about in my full story here.

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