The Reasonable Person Standard

by Jim Gearhart

What’s Happening With the Common Rule?

Important Update: Announced on Wednesday January 17, the “Delay of the Revisions to the Federal Policy for the Protection of Human Subjects” delays the effective and general compliance date of the revised Common Rule to July 19, 2018, six months after the original date of January 19, 2018. Research organizations should keep in mind that they will need to stay in compliance with the current regulations until the new Common Rule takes effect.


 

A year ago you may have thought, as I did, that the saga of revising the Common Rule was ending. Or, at least that we’d reached the beginning of the ending. The debates seemed over and the negotiations complete when the final changes appeared in the Federal Register on January 19, 2017. Only the details of implementation remained, the requirements of retooling systems for reviewing human subject research after decades of operation under the previous rules. The announcement named the changes Common Rule 2018, and decreed they (most of them) would become official in 12 months.

 

It Seems the Common Rule Changes May Not Become Official…Yet

News reports suggest a delay in implementation of the Common Rule.

The changes were published on January 19, 2017, one day before President Trump’s inauguration, after which the new administration announced a hold on implementing new regulations. Throughout the year, healthcare policy discussions and news coverage focused on the future of the Affordable Care Act, the nominations of new leadership, and high drug prices. No apparent progress was made on the Common Rule. Neither clarifying guidance nor agency-produced samples of new documents or official discussion about the new policies appeared. While numerous organizations outside the government (including Quorum and Kinetiq) offered comments and summaries about the changes, nothing came through official channels.

Twice in the past three months, government agencies have proposed delaying implementation of the Common Rule. In October, Health and Human Services (HHS) suggested waiting to implement most of the rule. The title of the request hinted that HHS wanted to move ahead with parts of the Common Rule, but no one has shared specifics publicly.

While that request remains pending, a similar request appeared in the government docket on January 4. Again, the content of the request is not yet publicly available, but the title—“Delay of the Revisions to the Federal Policy for the Protection of Human Subjects”—suggests that January 19, 2018, may come and go without full implementation.

A year ago we might have expected to spend the month of January launching new Common Rule practices. Now it looks like we’ll be waiting a little longer to see what will happen.

Despite this uncertainty, Quorum study submission processes will be ready for the Common Rule. We hope that every organization that worked toward compliance by the original deadline finds that the effort pays off.