With the release of the meticulously-titled “Federal Policy for the Protection of Human Subjects: Six Month Delay of the General Compliance Date of Revisions While Allowing the Use of Three Burden-Reducing Provisions during the Delay Period”, a second delay to full implementation of the Common Rule became official. The agencies refer to the pending Common Rule changes as the “2018 Requirements,” but a consequence of this 142-page communique is that no part of the 2018 Requirements will be required in 2018. Most* provisions come into effect only in early 2019, and the sections slated for activation in 2018—the Three Burden-Reducing Provisions of the rule’s title—are optional until January 2019.
As a brief review, the Common Rule is a core set of rules governing how 17 federal agencies conduct research involving human subjects. The Common Rule applies to research grants that come from these agencies, so researchers and institutions—what this announcement describes as “regulated entities” and “the regulated community”—must follow whatever regulations are in effect. The goal of the Common Rule is to build strong, consistent protections for human participants in research, but until these revisions were announced in 2017 the Common Rule had not changed since its inception in 1991. The changes originally were scheduled for implementation in January 2018 (hence the term “2018 Requirements”), but two postponements have now pushed general implementation out by another year. The original Common Rule—also known now as the Pre-2018 Requirements—remains in place, other than the three new optional sections that will be available July 19.
The Three Burden-Reducing Provisions aim to streamline how regulated entities (and their IRBs) process, review, and approve human subject research. The drafters of the new rule believe that these three changes will be relatively easy to implement, bring significant savings in time and effort, and not weaken any human subject protections.
- A new definition of “research” can exclude from Common Rule jurisdiction a range of public health agency projects that do not need close IRB scrutiny.
- A change in continuing review requirements will relieve certain types of research (primarily research considered minimal risk) of a recurring review.
- No longer requiring a copy of a study’s grant documents can simplify the submission and review of research.
Possible Directions for Research
The new rule describes four general paths by which this time next year a Common Rule-guided research project could be following either the Pre-2018 Requirements or the 2018 Requirements. Along one path, research that is underway now or that begins any time before January 21, 2019 can follow the Pre-2018 Requirements from beginning to end. On a second path, any research that starts January 21, 2019 or after must follow the 2018 Requirements entirely. A third path allows research to follow the Pre-2018 Requirements until January 21, 2019, and then shift to the 2018 Requirements.
The fourth path involves the optional Three Burden-Reducing Provisions of the 2018 Requirements. Regulated entities can choose to adopt the three provisions on or after July 19, but that research must transition to all of the 2018 Requirements* in 2019. Between July 19, 2018 and January 21, 2019, regulated entities should determine for themselves which path seems the most effective. Two constants hold across all the possibilities, however: (1) most Pre-2018 Requirements remain in place until January 2019; and (2) after January 20, 2019, all research must follow the 2018 Requirements.
This second delay probably surprised no one. Even though many organizations were poised to implement the new Common Rule in January 2018 as originally mandated, none of the Common Rule signatories had issued policy guidance regarding the changes, and prominent voices in the research community had encouraged the agencies to hold off implementation. It will be interesting now to see who in the regulated community takes the various paths of Common Rule implementation in the months ahead.
*One section of the 2018 Requirements remains outside of these shifting deadlines. The requirement for cooperative research (also known as single IRB, or sIRB, review) has, since the 2017 introduction of the 2018 Requirements, been listed as being required in 2020. That has not changed.