From the Director: OHRP releases three draft guidance documents related to the revised Common Rule

Elisa Hurley

On July 20, the Office for Human Research Protections (OHRP) published three new draft guidance documents related to the three “burden-reducing provisions” institutions can take advantage of during the “delay period” before the general compliance date of the revised Common Rule. [Update] On July 25, OHRP issued a Federal Register Notice and the community and public has until August 24, 2018 to comment.

In this post, I’ll begin with some general considerations institutions should be aware of when thinking about taking advantage of these transition provisions, and then give a brief summary of the guidance documents.

For any study that is ongoing prior to January 21, 2019, the default is to apply the old Common Rule (also known as the pre-2018 Requirements). However, as of July 19, 2018, institutions can choose to implement (only) the following three provisions of the revised Common Rule (or 2018 Requirements):

  • Use of the revised definition of “research,” which deems four categories of activities not to be research (scholarly and journalistic activities; public health surveillance activities; collection of information and biospecimens for a criminal justice agency or criminal investigatory purposes; and operational activities in support of national security or intelligence missions);
  • The allowance for no annual continuing review of certain categories of research; and
  • The elimination of the requirement that institutional review boards (IRBs) review grant applications or other funding proposals related to the research.

Institutions have the option of implementing these provisions for any existing study or study that commences at any time during the delay period, namely, the six months from July 19, 2018 until January 21, 2019, when the full set of provisions of the revised Common Rule (excepting the single IRB provision) go into effect.

There are several things institutions should be aware of when thinking about whether to transition to use of these provisions at some point during the delay period. The first is that, as the regulations are written, decisions about transitioning are to be made on a study-by-study basis. Institutions can, therefore, look at their portfolio of research protocols and decide, on a study-by-study basis, which protocols might be beneficial to transition. Those decisions need to be documented and dated. The second important thing to note is that the three provisions come as a regulatory package—in choosing to implement one, an institution is choosing to implement them all (though of course they may not all be relevant to a particular study). The third important point is that a decision to implement these provisions for an ongoing study, or set of studies, during the delay period commits the institution to transitioning that study, or set of studies, to compliance with all requirements of the revised Common Rule come January 21, 2019. In other words, the decision to take advantage of these provisions sometime in the next six months is a decision to transition the study in question to the revised Common Rule.

With that in mind, let’s look more closely at the three draft guidance documents.

The first draft guidance, Scholarly and Journalistic Activities Deemed not to be Research: 2018 Requirements, specifically addresses the first category of activity deemed by the revised Common Rule not to be research and therefore not to fall within the scope of the regulations: scholarly and journalistic activities, such as biography, oral history, journalism, and historical scholarship. As the draft guidance states, this category of activities was explicitly carved out from the definition of research in the revised rule to resolve ongoing uncertainty in the community about whether they require regulatory review. The draft guidance clarifies that the objective of activities in this category is “to provide an accurate and evidence-based portrayal” of specific individuals, and not to develop generalized knowledge.” If, however, the activity in question involved collecting and using information about a specific individual for the purposes of drawing general conclusions about the group or population of which the person is a part, then the activity would be considered research for the purposes of the regulations.

The draft guidance also makes clear that determinations about whether an activity is research should be made by looking at the specific activities in question, rather than by looking at the academic discipline in which that activity is situated. For instance, anthropology and sociology may sometimes make use of activities that focus inquiry specifically on individuals being observed or studied; but, they often collect information from individuals in order to understand the larger culture of which those individuals are a part. The first activity would not be considered research, while the second likely would.

The second draft guidance is titled, When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements. This guidance focuses on the two circumstances in which continuing review of research is not required during the six-month delay period:

  1. Research eligible for expedited review in accordance with the old Common Rule (pre-2018 requirements)
  2. Research that has progressed to the point that it only involves data analysis and/or accessing follow-up data from procedures that subjects would undergo as part of clinical care

Between now and January 21, 2019, then, an institution could decide that for studies that meet one of these requirements, it is no longer going to conduct continuing review. The guidance clarifies that for research not subject to continuing review, the revised Common Rule does not “require investigators to provide annual confirmation to the IRB that such research is ongoing or that no changes have been made.” Thus for research that transitions to comply with the revised rule and no longer requires continuing review, institutions have the flexibility to determine how they want to maintain oversight of that research; the regulations do not preclude institutions, though, from conducting or internally requiring reviews not required by the regulations.

It’s important to note that this guidance only applies during the six-month delay period. The revised Common Rule includes a requirement that, if an IRB determines that continuing review of a research study is required, even though the regulations do not require it, the IRB must document why it thinks continuing review is necessary. The draft guidance clarifies that this documentation requirement does not apply during the delay period. Furthermore, the guidance notes that on January 21, 2019, the circumstance under which continuing review is not required will change. For one thing, the provisions around expedited review at 45 CFR 46.110 will change in January. For another, research that undergoes limited IRB review—a new type of review introduced by the revised Rule—will also not require continuing review.

The third guidance is titled, Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements. This guidance focuses on the elimination in the revised Common Rule of the pre-2018 Requirement that an institution with an approved Federalwide Assurance must certify to HHS that each grant application or funding proposal submitted to an HHS entity has been reviewed and approved by the IRB. As the guidance states, “experience suggests that review and approval of the application or proposal is not a productive use of IRB time.” Furthermore, eliminating this requirement is not expected to have a detrimental impact on human subject projections, according to the guidance, because for all HHS funded studies, the research protocol will still be subject to the requirement for IRB review and approval for the purposes of certification.

We’d love to hear from you about how you’re approaching the next six months and the transition to the revised Common Rule. Are you planning to take advantage of the burden-reducing provisions during this delay period? Are these guidance documents helpful to you in making these decisions? What kinds of considerations are factoring into your institutions’ decisions?

For more information, tools, and resources on the revised Common Rule, and to share your own resources with the research oversight community, visit our Focus on the Revised Common Rule website.