As the federal government announced in June, three aspects of the revised Common Rule became available on July 19. These sections—collectively known as the three burden-reducing provisions—are an optional interim step toward full implementation of the revised Common Rule (slated for January 2019). Also on July 19, the Office of Human Research Protections (OHRP) in Health and Human Services (HHS) issued three guidance documents for the interim period, one for each new provision.
HHS and the other signatories to the Common Rule believe these three provisions will provide significant savings in time and resources, as well as prove relatively easy to adopt. The draft guidance documents from OHRP provide some particulars, and may help institutions and IRBs decide whether adopting the interim provisions makes sense for them. Two salient requirements also may guide an institution’s thinking:
- The three provisions are an all-or-nothing choice; either an institution adopts three or none (That choice can happen at the broad level of the institution, or for specific research projects).
- Any research that does utilize these three provisions now must adopt all revised Common Rule requirements in January 2019.
With those two requirements in mind, here is a quick look at OHRP’s three guidance documents about the Common Rule’s three burden-reducing provisions. (Check out our infographic, The Common Rule Implementation Pipeline, for a visual depiction of how adopting the revised Common Rule can work)
Burden-Reducing Provision #1:
Activities Deemed Not to be Research
The first provision refines the Common Rule’s definition of research, in effect reducing what projects might fall under the Common Rule and so reducing an IRB’s review burden. The new definition of research offers four particular areas where activities can be excluded from the Common Rule:
- Scholarly and journalistic activities
- Public health surveillance activities
- Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for criminal justice or investigative purposes
- Authorized operational activities for national security purposes
The July 19 guidance from OHRP addresses only the first area, “scholarly and journalistic activities.” The guidance notes that the criterion of “generalizable knowledge” is a key element in determining whether the Common Rule applies in a particular case. Generally speaking, if the information gathered focuses on implications for one person—such as interviews or surveys that focus on a historical figure’s influence—it is not Common Rule research. By contrast, if interviews and surveys seek to understand or explain a group of people—that is, to generalize it—then a very similar-appearing activity could need Common Rule-based oversight.
In this guidance, OHRP provided practical considerations for taking on the new definition of research early. In effect, this new definition essentially formalizes an interpretation that OHRP has held about Common Rule research for years, so formally adopting the new definition may not pose a significant step for many institutions.
Burden-Reducing Provision #2:
Eliminating Continuing Review for Some Kinds of Research
One of the most hailed time- and resource-saving aspects of the Common Rule revisions is the prospect of reducing how much research needs continuing review. As an interim measure, however, this provision may prove the most complicated of the three to implement. In January, this section of the revised Common Rule will relieve the continuing review requirement in three cases: (1) Research that qualifies for expedited review; (2) research that qualifies for “limited IRB review;” and (3) research that has reached a stage either of data analysis only or ongoing follow-up.
The interim regulations, however, allow for only the first and third category (See a copy of a table from OHRP’s July 19 guidance, “When Continuing Review Is Not Required During the 6-Month Delay Period of July 1, 2018 through January 20, 2019:2018 Requirements,” below). Presumably OHRP left the middle group out of the interim period because no specifics yet exist around limited IRB review.
Research Activities Generally Not Requiring Continuing Review
|Category of Activity||Regulatory|
|Research Eligible for Expedited|
Review in Accordance with 45 CFR
46.110 of the pre-2018
|Continuing review is eliminated for all studies that are eligible
for expedited review in accord with 45 CFR 46.110 of the pre-
2018 Requirements, unless an IRB determines otherwise.
|Research that has Progressed|
to a Certain Point
|Research that has progressed to the point that it involves only
one or both of the following, which are part of the IRB-approved
study: (a) Data analysis, including analysis of identifiable private
information or identifiable biospecimens, or (b) Accessing
follow-up clinical data from procedures that subjects would
undergo as part of clinical care.
Another complication is a change in qualifications for expedited review research. The criteria for expedited review research will change in January, but for now the current criteria remain in effect. This interim provision, then, needs interim guidance based on current rules, which will change in January. The practicalities of this shift may not be all that significant; again, the relative difficulty could depend on specifics at a particular research institution.
An additional shift will happen in January for documenting the need for continuing review. In January, IRBs or institutions will have to justify and document any decisions that insist on continuing review when the regulations do not mandate it. For now, though, even under the three burden-reducing provisions, such documentation is not necessary.
Clearly, adopting this provision now could be complicated, and the particulars might deter some institutions from moving forward before January. For those who do decide to adopt the interim measures, OHRP’s draft guidance on continuing review sets out the requirements, the transitions, and the proper references to use.
Burden-reducing Provision #3:
Elimination of the Requirement for the IRB to Review a Grant
While the second provision might be the most complicated to implement, the third, “Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements,” may be the easiest. It certainly is the easiest to describe: researchers no longer need to submit funding grants as part of an IRB review. The pre-2018 requirements of the Common Rule explicitly required that an IRB see the funding grant from a Common Rule signatory as part of a review. The 2018 Requirements eliminate this mandate with a straightforward language change: the rules now say “research project” instead of “grant,” giving institutions and IRBs greater flexibility in their requirements. The corresponding OHRP guidance is correspondingly brief—only a few paragraphs long. The gist is that no external rule requires IRBs to review grants. An institution or an IRB may decide to require grants as part of any review, but as of July 19, no one has to point to the Common Rule as the reason.
These three documents were the first formal guidance from OHRP about implementing the revised Common Rule, and hopefully more will come soon. The guidance, even as draft documents, should clarify for institutions the comparative burdens and benefits of taking on the interim measures of the Common Rule. During this interim period, Quorum will consider using the three burden-reducing provisions on a case-by-case basis to help clients achieve their research goals.