A Conscious Decoupling of Effective and Compliance Dates

“We never expected perfection, we expected action.”

“Many institutions were prepared, after a frantic year of strategizing and interpreting what the changes meant and how to apply them. Our institution had spoken to researchers, who expected the change would occur on Jan. 19th. Now we have to say to them ‘maybe July 19, 2018.’ … Yes, I think guidances are a priority, but not at the expense of delaying the rule change again.”

The Department of Health and Human Services’ decision to put the brakes on a major overhaul to the human research protection regulations known as the Common Rule garnered about 60 or so comments in the past two months. (To be fair, not all 60 responses are relevant to the changes.)

For those of you just catching up, 1) seriously start reading my stuff, but 2) HHS starts working on the biggest Common Rule changes since 1991; 3) proposed rule comes out in 2015; 4) final rule comes out Jan. 19, 2017 with one-year effective and compliance date; 5) no guidances/further help on these changes issued in 2017; groups ask for delay in compliance date; 6) Jan. 17, 2018, rule is delayed for six months, until July 19; and 7) comments on delay due March 19.

And those who spent the last year working to comply with the revised Common Rule made clear they were not happy they spent the last year updating policies, electronic systems, training investigators, etc. on changes, just to be told it wasn’t happening—and they had two days to undo all their work.

Groups like the Council on Government Relations and university groups like the Association of American Medical Colleges, the Association of American Universities, and Association of Public & Land Grant Universities, are calling on the HHS to allow the effective date to go forward on July 19 but move the compliance date to January.

“Decoupling the effective and compliance dates would allow institutions to move forward where prepared to do so,” Lisa Nichols of COGR wrote.

Several more letters also supported this “decoupling” of the Common Rule dates.

The next thing to watch for is a new proposed rule on or before July 19, which may include some provisions of the revised Common Rule designed to reduce administrative burden.

You can see all the letters at Regulations.gov using the docket number HHS-OPHS-2017-0001-0052.

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