By Gary Evans, Medical Writer

With finalization of the revised Common Rule postponed for at least six months — and possibly one year — IRBs should continue preparing to comply with the regulation as they await additional clarification and guidance, advises David Borasky, MPH, CIP, vice president of compliance at the WIRB-Copernicus Group in Durham, NC.

Most of the requirements of the final rule published last year were to become effective Jan. 19, 2018. However, the Department of Health and Human Services (HHS) and a host of other federal agencies recently issued a stopgap “interim final rule” that moved the effective date to July 19, 2018. That six-month delay is likely to extend to a full year because the federal agencies “are developing a notice of proposed rulemaking in order to fully engage regulated entities and the public … until Jan. 21, 2019,” the federal notice states.1

“They go on to say the additional time provided will allow sufficient time for the notice and comment rulemaking process to be completed,” Borasky says. “It sounds like their intent is to have a one-year delay.”

The situation may become clearer after an expected update and discussion at the March 13-14 meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), he says. Borasky is co-chair of SACHRP’s Subpart A Subcommittee, which advises the HHS Office for Human Research Protections (OHRP).

“My hope is that, going forward, there is a bit more transparency around the rulemaking process and we aren’t sort of hanging on until the final hours to find out if something is going to go forward or not,” Borasky says. “But clearly, they are telegraphing the idea that they are really thinking of a one-year delay, not a six-month delay.”

IRB Advisor asked Borasky some additional questions about this development in the following interview, which has been edited for length and clarity.

IRB Advisor: Can you comment on why you think it was necessary to delay the rule?

Borasky: In depends on your perspective. We [at WIRB-Copernicus] were prepared to implement the rule as written on the implementation date. It terms of why [the delay] was necessary, I look at the Good Cause section on that interim final rule. It is noted that representatives of the regulated community and HHS’s own advisory committee — SACHRP — have requested a delay in implementation of the 2018 requirements. They cite the final rule’s complexity and the lack of guidance and the need to revamp processes, procedures, and systems. To some extent, that is true.

There has been absolutely no guidance out of OHRP. I think SACHRP, in part, recommended the delay because there are a number of things in the new rule that would benefit from having guidance from the regulators in terms of what constitutes compliance. That simply is not in place yet.

IRB Advisor: You note that SACHRP has provided comments to OHRP on a few different aspects of the rule.

Borasky: None of those recommendations have yet been issued as guidance, or even as draft guidance, out of OHRP. I think the regulators, to their credit, understand that there are some aspects of the rule that are certainly new, and perhaps a bit nuanced and complex, and that the regulated community would be well served to have some guidance on how to implement those. What is unfortunate is that they had a whole year to prepare that guidance or instruction and didn’t take advantage of it. [They] waited until the 11th hour to issue that delay. That part of it is a bit disappointing. If they knew that the delay was going to be necessary for those reasons, it is a little frustrating that they waited so long to formally announce it.

IRB Advisor: In the interim, what do you recommend IRBs focus on in terms of compliance and preparedness?

Borasky: Hopefully, most IRBs have initiated some level of preparations because we found out so late that there would be a delay. It would have been a gamble that ultimately paid off — but a gamble nonetheless — to have not started any level of preparation to the new rule prior to its delay being announced. Assuming that most IRBs have started to take some level of action in terms of preparing for the final rule, presumably what is lacking is to complete those preparations.

Obviously, the one thing that could impact how IRBs implement the rule would be having OHRP or other Common Rule agencies provide guidance on what compliance means for this rule. SACHRP has made recommendations in the areas of broad consent, behavioral interventions, and the transition provisions for moving on to the new rule. But those only exist as SACHRP recommendations. OHRP has not pointed at those and said, “That’s exactly what we are thinking.” I know some members of the IRB community look at SACHRP as a resource, but it’s impossible to say to what extent their recommendations will be adopted by OHRP.

In the absence of any guidance, I think IRBs should stay on the course of preparing. There certainly are aspects of the rule that are not all that hard to decipher; for example, implementing a change in continuing review requirements for expedited research. You don’t need a whole lot of guidance to explain what that means. The required elements of informed consent, with the exception of the key information provision, are relatively straightforward. So, I think [IRBs should continue] preparing their systems and consent templates or other tools that they have. Stay on that path.

IRB Advisor: Given the current antiregulatory political climate, there has been some suggestion that the Common Rule may not be finalized for an indefinite period, going beyond this extension.

Borasky: I have heard some of those same concerns, and certainly the regulators did themselves no favors by not publishing the final rule until the last day of the previous administration. It seems that a number of people believe that this delay was announced so close to the implementation date due to the transition to the new administration. But nobody has said that definitively — that’s just speculation. From the aspect of the administration having concerns about it, my opinion is that the new rule reduces regulatory burden. That certainly seems to be in the spirit of the current administration’s approach. It had the endorsement of most of the Common Rule agencies. It is addressing issues that are important to the NIH, which has already announced similar policies like its single IRB, which are in harmony with the final rule. To me, that points to the rule being implemented at some point.

REFERENCE

1. 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.