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Apr2018

Update: On June 18, HHS released a final rule confirming the delay of the general compliance date for the revised Common Rule until January 21, 2019. In addition to delaying the general compliance date, the rule also confirms the allowance of the three "burden-reducing provisions."

Keep up with the latest news and information at primr.org/CommonRule

On April 19, HHS and 16 other federal agencies released a new Notice of Proposed Rulemaking (NPRM) proposing to delay the general compliance date for the revised Federal Policy for the Protection of Human Subjects, or “Common Rule,” six more months to January 21, 2019. The NPRM also proposes to allow institutions to implement three “burden-reducing provisions” during the delay period, specifically:

  1. use of the revised definition of “research,” which deems four categories of activities as not research
  2. allowance for no annual continuing review for certain categories of research
  3. elimination of the requirement for IRB review of grant applications for research

The agencies are seeking public comment on these proposals. The comment period for this NPRM is short, just 30 days (ending May 20), presumably so that the rulemaking process can be completed before the July 19, 2018 effective and compliance date specified in the Interim Final Rule, which was published January 22, 2018 to delay the original effective and compliance date of January 19, 2018.

For those who have been following the rather tortured path of the revised Common Rule, this NPRM is the one that has been sitting with the Office of Management and Budget since October of 2017.

According to the notice, this NPRM is “intended to provide regulated entities additional time for the preparations necessary to implement the 2018 Requirements” and to allow time “for HHS and the other Common Rule agencies to develop implementation guidance.” The NPRM notes that the three burden-reducing provisions were chosen for early adoption because the agencies believe they could be implemented without “creating significant complexities,” unlike, say, adoption of the new exemption categories.

I provide a few more details below about the content of this NPRM, but before that, let’s consider, what this means for you. First, it means you have one more opportunity to comment on the revised Common Rule. In this case, HHS and its sister agencies are seeking comments on whether the additional six-month delay is a good idea, and on whether institutions should be permitted to implement the three burden-reducing provisions during the delay period (i.e.,from July 19, 2018 until the January 21, 2019 general compliance date).

It also means that, should this rule become final, institutions will need to continue to comply with all other requirements of the pre-2018 rule until January 21, 2019, at which point institutions would have to be compliant with all elements of the revised rule (other than the single IRB requirements, whose compliance date remains January 20, 2020).

Now, to get a little more into the weeds regarding the substance of the NPRM …To accommodate the proposed “flexibility” of having the option to implement the three burden-reducing provisions before the general compliance date, the NPRM redrafts the transition provisions in the revised rule text at §__.101(l)(2)(3) and (4). 

The NPRM clarifies that, as under the January 2017 final rule, studies initiated before the general compliance date would by default remain subject to the “pre-2018 Requirements” for the duration of the study, unless or until the institution decides to transition that study to the “2018 Requirements” (i.e., this version of the revised rule), and documents that decision and transition. Also as provided in the January 2017 rule, this proposed rule preserves the option of transitioning ongoing studies from compliance with pre-2018 Requirement to compliance with 2018 Requirements on or after the general compliance date. This new proposed rule, however, “proposes an additional flexibility for ongoing studies to transition to the 2018 Requirements if the decision to transition is documented prior to January 21, 2019. Between July 19, 2018 and January 21, 2019, institutions that elect to transition studies to the 2018 Requirements would, after the decision to transition has been made, be able to take advantage of the three burden-reducing 2018 requirements.”

In other words, for previously approved ongoing studies, the proposed rule makes three options available to institutions, beginning July 19, 2018:

  1. Continue to follow all pre-2018 Requirements for the duration of the study.
  2. Follow the pre-2018 Requirements, except for the three burden-reducing 2018 Requirements, until January 21, 2019, when all 2018 Requirements become applicable.
  3. Follow pre-2018 requirements until January 21, 2019, and at that point or some point after, choose to follow all of the 2018 Requirements for the duration of the study.

Thus the revised text of section §__.101 of the NPRM describes how the pre-2018 Requirements and the 2018 Requirements apply to research initiated during three time periods: prior to July 19, 2018, between July 19, 2018 and January 21, 2019, and on or after January 21, 2019.

The NPRM also provides “intended interpretations” of the three burden-reducing provisions, given that, during the transition period, some research may temporarily be subject to these three provisions of the revised rule, but not to other provisions they may make reference to. In other words, the NPRM explains how to “map” some of the references in the three burden-reducing provisions onto the pre-2018 Requirements that will otherwise still be in effect. If this sounds confusing, it is.

According to the NPRM, the agencies are also soliciting comments on the following:

  • The following three alternatives to the default proposal:
    • Delaying the effective date and general compliance date of the revised rule until January 21, 2019, without the option to implement any provisions during the delay period
    • Delaying the effective and general compliance date beyond January 21, 2019
    • No further delay, so that the rule goes into effect July 19, 2018
  • Their assumptions about how many regulated entities would have taken advantage of the expansion of exemption categories in the absence of additional guidance--guidance they suggest the additional six-month delay will allow them to develop.
  • Their assumptions about how many regulated entities will take advantage of the three burden-reducing provisions during the delay period

Finally, it’s worth noting that the NPRM says that it considered the alternative of allowing institutions to voluntarily comply with the revised rule beginning on July 19, 2018 and not requiring compliance until January 21, 2019 (an approach endorsed by AAMC, COGR and others over the last several months), but ultimately decided it would “result in confusion regarding implementation… that could be minimized with the issuance of guidance….” It goes on to indicate that the agencies are confident that approach proposed will allow them to issue guidance in time to ensure the regulated community can comply with the revised rule. Indeed, guidance about the “carve-outs” from the definition of research is promised by this July. Many in the community have been saying for months that guidance is critical to the successful implementation of the new rule on the part of the regulated community. It’s not clear to me, however, given history, that we should have confidence that guidance in forthcoming. The substance of the rule has been set for over a year now, and yet not a single piece of guidance has been released or published, despite SACHRP’s work.

So we continue to face uncertainty and the possibility of more waiting. I encourage you to share your thoughts with the regulatory agencies. And as always, PRIM&R is here to keep you up to date on the latest regulatory developments, so stay tuned to hear more about how PRIM&R will comment on the rule. And be sure to visit our Focus on the Revised Common Rule website for a comprehensive collection of information, resources, and tools to help you get ready for compliance with the revised rule.

Ed.: This post was originally published at 10:57 AM ET on April 19, 2018. It has since been updated to include additional information and analysis.

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