Is the Common Rule on the ‘Wright’ Path?


What a difference a month can make, especially for new acting Health and Human Services Secretary Don Wright.

“We will ask HHS leadership,” Wright wrote as part of a response letter to the watchdog agency for his department in reference to a report on whistle-blower protections.

• Aug. 28: Wright submits his letter. (Here’s our story on it.)

• Sept. 29: The White House designates him as acting HHS secretary to replace Tom Price, who resigned over his use of private jets with taxpayer dollars.

Over the course of a single lunar cycle, Wright went from asking that guy to being that guy. This, of course, has huge implications for Medicare- and Medicaid-related things, for which you should follow my colleagues Sara Hansard, Alex Ruoff, Victoria Pelham and others about.

His appointment could also potentially be good news for research. As the acting assistant secretary of health, Wright oversaw the HHS offices in human research protections and research integrity. He was also the acting research integrity director at one point.

This experience in research oversight could be handy as the status of the Common Rule remains on hold. These are the regulations designed to protect people from experiencing undue harm in research by making sure, in part, they are aware of what’s going on before any testing on them begins. They also underwent a massive revision, which took more than five years to accomplish and marked the first-ever update to the Common Rule in three decades.

The Obama administration dropped that new rule on its last day in office, and initially thought institutions would have a year to get up to speed. But the Trump administration almost immediately issued a regulatory freeze on all midnight rules—this one is about as midnight as you can get.

The final rule removed most of the controversial stuff, so there isn’t necessarily an issue with the content of the rule. Meanwhile, months have gone by, nothing else has happened, and the rule is supposed to go into effect in a little more than three months, on Jan. 19, 2018. It’s still under a review by administration officials within the department.

What does this mean for the regulated community? I have a feeling this will be coming up at the final meeting of the year for the HHS Secretary Advisory’s Committee on Human Research Protections. It is most definitely coming up in San Antonio in early November when Public Responsibility in Medicine & Research takes its annual conference there.

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