Thursday, March 7, 2013

ANPRM Is Mostly Dead

The Chronicle of Higher Education reports that the regulatory reform process that began with the 2011 ANPRM "appears to be stuck, with little optimism for a way forward."

[Basken, Paul. “Federal Overhaul of Rules for Human Research Hits Impasse.” Chronicle of Higher Education, March 7, 2013, sec. Government. (paywall)]

The article explains,

After months of trying to reconcile the sometimes competing goals of making the rules both simpler and tougher, while engaging 17 different federal agencies affected by the Common Rule, participants are describing the process as stalemated.

"I think it's dead, pretty much," said E. Greg Koski, a former director of the human-research-protections office, reflecting assessments he's heard from key players in the process.

The office has a published timetable suggesting it will formally propose a new set of regulations next month. In a written statement, the current director of the Office for Human Research Protections, Jerry A. Menikoff, said he intended to keep trying.

"This is, of course, a complicated undertaking, as was stated from the outset, and it takes time," Dr. Menikoff said.

In other words, there's a big difference between mostly dead and all dead. Mostly dead is slightly alive.

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