HHS Proposes Common Rule Delay and Asks for Comment on Burden Reduction Provisions

April 23, 2018

HHS issued a proposed rule that would delay its revisions to the Common Rule for another six months and opened up discussion on the permitting of three burden-reducing provisions in the 2018 requirements for regulated entities.

The proposed rule, issued Friday, pushed back the revision implementation date, from July 19, 2018, to Jan. 21, 2019. The burden-reducing provisions up for discussion center on the 2018 requirements’ definition of “research,” which deems certain activities not to be research, the elimination of annual continuing review of certain categories of research, and the elimination of the requirement that institutional review boards review grant applications related to the research.

The proposed rule would offer organizations three options: to continue to follow the pre-2018 requirements for the study’s duration (the default option); to follow the pre-2018 requirements except for the three provisions until the 2018 requirements become applicable; or to follow the pre-2018 requirements until Jan. 21, 2019, and at some point afterward choose to follow all the 2018 requirements for the study’s duration.

David Borasky, vice president of Institutional Review Board (IRB) compliance at WIRB-Copernicus Group, noted that IRBs should be cautious in their considerations.

“If an IRB elects to start implementing these burden-reducing provisions to a study that is active right now, once the rest of the regulations go live in January 2019, you then have to comply with the rest of the new regulations,” he noted.

He also noted that the applicability of the rule would be limited to federally funded research not regulated by the FDA. The FDA is not allowing the three burden-reducing provisions.

But, he noted that some IRBs could decide that the burden reducing provisions are worth it.

“If you have a continuing review requirement and it’s eligible for that burden reducing measure, that’s great until next January, when you’d be required to apply every other aspect of the rule,” he said.

“For example, studies planning to recruit some subjects on or after Jan. 21, 2019 would have to meet the new requirements for obtaining the informed consent of those subjects,” it said. “In contrast, for studies whose remaining activities consist only of completing data analyses, the new requirements for informed consent generally would not be applicable.”

The proposed rule also seeks comments about an alternative decision to delay the effective and general compliance date until Jan. 21, 2019, without the option of implementing the provisions.

There has been a degree of uncertainty about the implementation of the revised Common Rule ever since its release in January 2017.

Days after the final rule was adopted, it was subject to a regulatory freeze imposed by the new Trump administration. Then in October, OMB posted a proposal for a one-year delay in the implementation date of the Common Rule revision while allowing the use of three unspecified burden-reducing provisions during the delay year. On January 4 of this year another proposed rule appeared suggesting implementation of the complete rule could be delayed.

Finally, the federal government pushed back its revisions to the Common Rule for an additional six months — making the announcement less than 36 hours before the changes were set to take effect Jan. 19 — and warned the public to expect additional delays down the line.

-By James Miessler