HHS Research Oversight Office Pursuing Fewer Investigations


Confession Time (that’s not what this blog is about?): For some time, I’ve been reading with some envy the excellent stories my colleagues have published with our ace data reporter, Madi Alexander. And I’ve been on the lookout for data that could turn into my own story.

This is kind of ironic, given the number of stories I write about data: data collection in research, real-world data to be used in clinical trials, fabrication, falsification and plagiarism of data in research misconduct stories, returning of research results…you get the idea.

Anyway, I was excited when I saw the report from the Health and Human Services Office of Inspector General’s report on the HHS Office for Human Research Protections. (Side note, we’ve known this report was coming for about two years, and I’ve been bugging the OIG’s press office for some time about it. So naturally it comes out the one Monday I took off this year).

This report primarily evaluated whether the OHRP is operating independently. Basically, the OIG said they’re doing the best they can, but Congress should give them more authority and more money to do more stuff independently. But in the back, the OIG included some neat data points showing a steep decline in the number of noncompliance allegations being pursued by the OHRP.

Madi agreed there was something to this. She did a really neat analysis that showed the number of allegations resulting in a compliance evaluation decreased by 51 percentage points—to 11 percent from 62 percent—between 2000 and 2015.

We talked to some the authors of the OIG report, the HHS, and Mike Carome, who used to be THE regulatory guy at the OHRP before he joined the watchdog group Public Citizen in 2010.

There are some other things there, too, but you have to read the story to find out.

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