As the January 19 implementation date of the revised Common Rule approaches, the question remains as to whether or not implementation of the revised rule will be delayed — leaving many feeling uncertain.

There has been a degree of uncertainty about the implementation of the revised Common Rule ever since its release in January 2017, said Amy Dow, an attorney with Epstein, Becker & Green’s healthcare and life sciences practice.

Days after the final rule was adopted, it was subject to a regulatory freeze imposed by the new Trump administration. By last summer, research institutions and organizations “were growing weary” about the lack of information regarding the status of the January 19 implementation date, as well as the lack of guidance regarding many of the rule’s more complex provisions, Dow said.

Since then two proposed rules have appeared on the Office of Management and Budget (OMB) website. The first, posted in October, was a proposal for a one-year delay in the implementation date of the Common Rule revision while allowing the use of three burden-reducing provisions during the delay year. On January 4 another proposed rule appeared suggesting implementation of the complete rule could be delayed.

This has caused even more uncertainty within the regulated community, said David Borasky, vice president, IRB compliance, WIRB-Copernicus Group. “Even with these [two proposed rules] being posted to the OMB website, OHRP (Office for Human Research Protections) has been unwilling to bare any details regarding their approach to the rulemaking process. 

“And they haven’t definitely said whether the [rule] that came out last week supersedes the one that came out in October,” he noted. “So the regulated community is essentially operating in the dark.”

The result, according to Borasky and Dow, is that there are concerns about how prepared organizations and institutions are for the January 19 implementation date.

“Many of the final rule’s changes require the expenditure of significant resources for revisions of policies, procedures and documents, training and updates to information systems,” said Dow. “Research institutions may have been hesitant to expend already limited resources to make these changes in light of the uncertain status of the final rule’s provisions.”

Borasky suspects that the steps many organizations have taken to prepare for the implementation date have been “uneven” or taken longer than expected because they were hoping they would receive guidance on some of the new areas of regulation contained in the revised rule — several of which will impact clinical trial management.

“It bears repeating that the revised common rule only applies to research funded by a Common Rule agency, so the impact on industry-sponsored clinical research is really minimized,” Borasky pointed out. “That said, the provisions of the revised rule that will have the greatest immediate impact on the management of clinical trials are tied to its informed consent provisions.”

These include provisions such as the inclusion of key information in informed consent documents, described in the revised rule as a “concise and focused presentation of the key information that is most likely to assist a prospective subject of legally authorized representative in understanding the reasons why one might or might not want to participate in the research.”

 “This is a completely new area of regulation, so there is no precedent for it,” Borasky said. “And it is especially challenging because the requirement is very vague and it’s not clear what will be considered to be in compliance.”

Borasky pointed out that another provision that has caused some consternation is one requiring that consent forms for certain federally funded clinical trials be posted on a public website.

“It’s going to be established as a registry,” he said. “However, no information has been provided about this registry, so, in theory, there’s an aspect of the rule — if it goes into effect next week — that has no mechanism for complying with it. That’s certainly going to be a challenge.”

There’s also some confusion about another informed consent provision that could impact clinical trials, Borasky said. For studies on stored identifiable data or identifiable biospecimens, researchers will have the option to rely on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement. 

“For those sponsors or investigators that want to exercise this ‘broad consent’ option for certain kinds of research, it’s not entirely clear how it is intended to be operationalized,” he said.

All of this uncertainty is further complicated, Borasky pointed out, by the fact that the FDA won’t be harmonizing its regulations with those of the common rule agencies “for quite some time.”

“The 21St Century Cures Act calls for the harmonization of human subject protection regulations between the FDA and the common rule agencies,” but as Borasky pointed out, the FDA will have to go through its own, time-consuming, rulemaking process.

What would be the impact of an implementation delay?

A delay would definitely allow more time for agency guidance on implementing the changes required by the rule, Dow said. “And it will give affected research institutions the opportunity to make the necessary changes and educate their stakeholders to facilitate compliance.”

On the other hand, Borasky said an implementation delay would represent “wasted effort.”

“Every IRB I’m aware of has invested some effort in planning for these changes, and for many the investment has been significant,” he said. “It’s been a lot of effort preparing for a rule that we could learn won’t go into effect, and while that may bring relief to some, it will leave a number of us scratching our heads and wondering why we spent so much time, effort and money preparing for the implementation of this rule.”

“We have to be all in and assume that it will go into effect,” Borasky said. “For IRBs that means not waiting until the 18th to make sure everything is in place.”