Monday, April 23, 2018

Feds Say New Common Rule Will Reduce Burdens and Offer Guidance—But Not Yet

In a new notice of proposed rulemaking, published in the Federal Register on April 20, HHS and other Common Rule Agencies identify three provisions of the new Common Rule as “burden-reducing.” Among them is the redefinition of research to exclude historical research. Yet the notice gives institutions either three or nine months to implement the reforms.

[“Federal Policy for the Protection of Human Subjects: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period,” 83 Federal Register 17595 (April 20, 2018).

The “burden-reducing” label correctly implies that the corresponding provisions of the current Common Rule are unnecessarily burdensome. Yet rather than reducing the burdens immediately, the new NPRM gives institutions the choice of eliminating them in July 2018 or January 2019.

The notice presents this as a recognition of “entities’ possible inclinations to make all transitions at once.” To be sure, federal agencies seem to favor massive, comprehensive, and infrequent change to incremental improvement, but I wonder if research institutions feel the same. And it’s telling that the notice considers “entities” as the primary stakeholders in the decision. Recall that the 2011 ANPRM aimed at “Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” (Emphasis added.) The new notice does not speculate how investigators might feel about the pace of transition.

The notice also states,

We note that we intend to publish guidance on the carve-outs from the definition of research prior to July 2018, which may also impact an institution’s decision to elect to implement the three burden-reducing provisions or not.

In February 2007, OHRP promised such guidelines “by the end of the year.”

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