By Gary Evans, Medical Writer

The revised Common Rule has been issued in final form,1 with IRBs allowed to use three “burden-reducing” provisions to prepare for a Jan. 21, 2019, compliance date.

This follows the publication of an interim final rule2 and delay announcement on Jan. 17, 2018, which was then followed by request for comment on April 20.3

“The one exception to this general rule is that institutions will be permitted (but not required) to implement, for certain research, three burden-reducing provisions of the 2018 requirements during the delay period (July 19, 2018, through Jan. 20, 2019),” the final rule states. “Institutions taking advantage of the three burden-reducing provisions must comply with all other pre-2018 requirements during the delay period.”

Moreover, the burden-reducing provisions can only be implemented during the delay period with respect to studies initiated prior to Jan. 21, 2019, that will “transition to compliance” with the revised Common Rule.

The burden-reducing provisions include:

• a revised definition of “research,” which deems certain activities not to be research covered by the Common Rule;

• elimination of the requirement for annual continuing review with respect to certain categories of research;

• elimination of the requirement that IRBs review grant applications or other funding proposals related to the research.

Given the thicket of regulatory action and delay, IRB Advisor spoke to David Borasky, MPH, CIP, vice president of IRB compliance at the WIRB-Copernicus Group in Cary, NC.

IRB Advisor: Can you put this issuance of a Final Rule with an effective date of Jan. 21, 2019, in context with the other actions and previous iterations in this process?

Borasky: Six months ago or so, we were waiting for the final rule to go into effect with a Jan. 19, 2018, implementation date. Then within days of the go-live date they issued the first six-month extension. There was a delay until at least July, and then they mentioned the fact that they anticipated an additional delay. People were relieved to know the status, and then during the additional delay the big hope was if it was going to further delayed that they wouldn’t wait until the last minute again.

I think in general, the IRB community — whether they wanted the additional delay or not — was happy to know the status fairly early. Since April we have known the status of the delay. It is delayed until January 2019, except for these three burden-reducing provisions.

IRB Advisor: What are the benefits of these provisions?

Borasky: They are sort of a mixed bag. The first was a change to the definition to research. Really, the definition in the new rule is more exclusionary. It is taking things out of the realm of research, like journalistic and scholarly activities, and public health surveillance. I think many IRBs already had cut down the scope [of these], but there was concern from some researchers that their IRBs were engaged in mission creep. I think the regulators purposely called this out as things to get out of there.

I suspect, and this is just my opinion, that they made that one of the burden-reducing provisions because it is pretty easy to implement without much additional guidance. It is what it is. There should be no question that public health surveillance is not research. That was sort of a no-brainer, and a nod to a lot of the nonmedical community who were seeking some relief under the new rule.

IRB Advisor: What about the provision dropping the review of grant applications?

Borasky: That was just sort of a nuisance thing that had crept into requirements for IRBs, probably back in the late 1990s or around 2000. OHRP had made it clear that they expected IRBs to be looking at grant applications, primarily from NIH, to make sure that there was concordance between what the awardees said they were doing in their grant, and what they told the IRB they were doing.

In reality, I am not aware of any time that an IRB found a complete discrepancy between the two, so most IRBs viewed it as a nuisance requirement that we did because we knew there was an expectation to do it. So I think having that go away is also a nice thing.

IRB Advisor: What about dropping the annual continuing review with respect to certain categories of research?

Borasky: This one is the most interesting. I would say that is the biggest immediate change that we could make. We have the ability now to not do continuing review for certain activities. I think institutions will be eager to start doing that, taking things off the plate of their IRB administration.

Probably the biggest one is that under the new rule, studies that start off as expedited review don’t have to come back for continuing review. There are also some specific carveouts in the rule itself.

IRB Advisor: Is there any downside to IRBs adopting these burden-reducing provisions?

Borasky: The questions I have been getting are whether institutions and IRBs should implement these burden-reducing provisions. The hiccup in it is if you decide to do that with a protocol now, then in January you have to apply the rest of the new rule to any protocol you approved using the burden-reducing provisions. For example, if you had a grant come in and you wanted to approve it without reviewing the grant application, then by January — when the rest of the rule goes into effect — you have to build in all of the new consent form requirements and required elements of consent.

I know there is some chatter among my colleagues on IRBs about whether they want to do that. If they do implement now, should they go ahead and implement everything they can implement now? Because that would save you approving something now in August 2018, and then coming back in January and making the researchers make changes to conform to the rest of the rule.

IRB Advisor: You note that at some point the FDA will have to harmonize its requirements with those in the Common Rule.

Borasky: The thing to remember in the regulated community is that until the FDA is clear about where they can harmonize, these new burden-reducing provisions to exempt something from continuing review — those are not allowed by the FDA regulations at this time. So if you had an FDA-regulated study, you couldn’t start using the continuing review provision because that is inconsistent with the FDA regulations — at least until the FDA comes out with a statement about how they are going to harmonize. It is a little bit of a wrinkle that gives some people pause.

I think it is going to be institution by institution. Part of it will depend on an institution’s research portfolio. We receive a lot of FDA-regulated studies, so we are careful about not implementing something that currently does not meet FDA regulatory requirements.

If I was at an institution that had largely NIH-funded studies, it would make a lot of sense to just start applying these things now. It will be interesting to see the uptake of these burden-reducing provisions.

IRB Advisor: There has been a lot of activity and uncertainty. Do you expect this to be the final iteration of the Common Rule going forward?

Borasky: I think the OHRP has been pretty clear. I would never say never, but what we are going to see next January is the implementation of the final rule as it is written now — as it would have gone into effect this past January. I don’t anticipate any more tinkering with the rule itself or any more extensions.

In reading the preamble to this additional delay, I was personally curious to see how they responded to comments. Nearly half of the people that submitted comments really just said, “You should implement the whole rule now.” I think people are tired of waiting and are ready to go — or as ready as they are going to be. This additional six months does allow OHRP to write guidance and probably for the FDA to figure out where will be their pain points in trying to harmonize with this.

IRB Advisor: OHRP has been criticized for a lack of implementation guidelines. Is that situation changing?

Borasky: OHRP has been pretty clear in some of their public comments that they are working on guidance. They know the areas that probably will require the most guidance because there are new aspects of these new regulations that are whole-cloth new. There is nothing about them related to the old regulations — categories of exemptions and so forth. They are working on those.

REFERENCES

1. HHS, et al. 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. June 19, 2018. Available at: https://bit.ly/2tjNBM6.

2. HHS, et al. 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. April 20, 2018. Available at: https://bit.ly/2HbOlfZ.

3. HHS, et al. Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects. Fed Reg 83 FR 2885: Jan. 22, 2018. Available at: http://bit.ly/2C50tbp.