A recent meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) opened with the standard format of panel members going around the table, introducing themselves for the record. The elephant in the room needed no introduction.

“Interesting times,” committee chairman Stephen Rosenfeld, MD, MBA, said at the March 13 meeting. “I thought it was probably worth acknowledging things that are not explicitly on the agenda, but are probably in the background — the delay in implementation of the updated Common Rule. As you know, the interim and final rule effective date is now July, until we hear otherwise. There is the possibility that an NPRM [notice of proposed rulemaking] will delay the implementation further. That kind of colors all of the things we will talk about [at this meeting].”

Sitting at his side was Jerry Menikoff, MD, JD, director of the Department of Health and Human Services Office for Human Research Protections (HHS OHRP). “Sometimes things don’t work out exactly the way you want them to, but it is what it is,” he said.

Most of the requirements of the final rule were to become effective Jan. 19, 2018. However, HHS and a host of other federal agencies issued an 11th-hour “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

“The interim final rule is out. It spells out what the government is planning to do in terms of a notice of proposed rulemaking,” Menikoff said. “As far as where we are, that is still the government’s proposed intention. We certainly recognize the need to act expeditiously. It is very desirable that people get as much lead time as possible in order to plan for whatever the end result will be.”

With finalization of the revised Common Rule postponed, the conventional wisdom remains that IRBs should continue preparing to comply with the regulation as they await additional clarification and guidance. SACHRP hammered out some of those documents at the meeting, including a “Points for Consideration” document for exemptions to the new requirement to use a single IRB for multisite studies. (For more information, see related story in this issue.)

‘Incredibly Irresponsible’

Meanwhile, in comments received on the interim final rule, IRB members and others in in the human research protection community were not reticent in expressing opinions. Some saw the delay as a prudent measure that allowed much needed additional time; others as an unpleasant surprise that effectively penalized those that were ready to comply.

“The release of the interim rule in the final hours before implementation was incredibly irresponsible,” commented Megan Roth, PhD, director of research and sponsored programs and IRB chair at Abilene Christian University in Texas. “Those who had already implemented are now essentially having to undo all of the changes and preparations that were done, as well as retroactively re-review any studies that have been approved under the 2018 rules.”

With some skepticism, Roth cited the government’s reasoning in announcing the delay, that “allowing the regulation to become effective while further rulemaking for delay is ongoing would create confusion for, and impose unnecessary burdens on, the regulated community.”1

On the contrary, Roth argued, “the interim rule announcement in the final hours did effectively this because many institutions had already implemented or were in the final stages of implementation.”

The federal notice conceded that there may be some costs incurred by the action, and Roth provided details of same.

“There are extensive costs to this,” she wrote. “The man hours (and associated costs) that were required to update documents, update websites, reprogram submission portals, conduct training, announce changes to the institutional employees, etc., were effectively wasted.”

Further costs must be incurred to “revert websites back to their previous state, reprogram submission portals, [and] communicate to the institution that we are reverting back to the old rules,” Roth noted.

The announcement of the interim rule in the “twilight hours” of implementation created a hardship and caused “significant confusion for IRB reviewers and institutional researchers,” she concluded.

Conceding that many institutions desired a delay of the compliance date, “and this was supported across the board,” Roth said, “the responsible action would have been to uphold the previous language, which allowed institutions to move forward with implementation at any time while ensuring compliance by July.”

Retracting that allowance “has caused significant hardship and cost for institutions around the country. It has also caused significant confusion for the researchers affected,” Roth said.

Hurry Up and Wait

In some of the comments reviewed, this confusion translated to both demands for expediency and further delay to get everyone on the same page.

“While we understand the six-month delay allows additional time to issue guidance regarding interpretation and implementation of the more ambiguous aspects of the Revised Common Rule, we respectfully request that the effective date not be further delayed,” commented Helene Lake-Bullock, PhD, JD, director of research compliance subject rights at the University of Kentucky.

Prior to the “last-minute delay,” Bullock and colleagues drafted revised policies, programmed a new version of the electronic submission system, and conducted education on the impending regulatory change.

“If the federal agencies determine additional delay is necessary, we request delay of the compliance date only,” Lake-Bullock stated. “A July 2018 effective date allows prepared institutions to move forward with the new regulations while additional guidance is under development.”

Actual application of the rule will provide “real-world” experience, which could inform future guidance on the nuances of implementation, she said.

“After our efforts to alert and prepare our research community, postponing implementation again will be confusing for our researchers and damaging to the credibility of human research protections,” she commented.

Indeed, expressions of confusion came from such eminent research institutions as Stanford. A comment from the research office and IRB chairs asked, given the level of uncertainty and limited time, if a second interim final rule be issued. The OHRP notice indicates that the NPRM may further delay implementation of the 2018 Common Rule, but there is little information about whether additional changes could be coming, they said.

“Institutions remain in the same limbo experienced during the year leading up to the Jan. 19, 2018, compliance date,” Stanford IRB members commented. “The interim final rule has, unfortunately, provided no additional clarity, tools, guidance, templates, or other useful information to our institution in implementing the final rule. While we are not ungrateful for the extra time, the question remains, ‘For what and when do we start preparing?’”

Given this conundrum, Stanford IRB chairs proposed “separating the effective date from the compliance date.” They proposed an effective date of Jan. 19, 2019, with a compliance date of Jan. 19, 2020, for the revised Common Rule, and Jan. 19, 2022, for the cooperative research provision.

“This would give OHRP time to prepare and disseminate the promised guidance and templates needed to interpret the rule,” they said. “Otherwise, there will be negligible time to prepare to make the required changes, and scarce information on which to create policy. The research community must have certainty upon which to revise its compliance programs.”

Time and Clarity

Others also argued in favor of time and clarity, with the IRB chair at the University of Tennessee Health Sciences Center arguing that “we believe that a further delay beyond July 19, 2018, in the effective and compliance dates for the revised Common Rule is absolutely necessary.”

Terrence F. Ackerman, PhD, and colleagues cited two reasons for this imperative.

“First, there is a series of issues raised by the new rule that require OHRP to develop clarificatory guidance for use by IRBs,” he commented. “Second, there must be ample time allotted for IRBs to utilize the guidance to draft necessary materials prior to the effective and compliance dates for the new rule.”

Ackerman said, given the number of issues raised and the potential confusion, the effective date should not be made before OHRP issues guidance or before there is ample time for institutions to revise policies and procedures to reflect the guidance. For the latter, they suggested a minimum of six months to a year after guidance is issued.

As it currently stands, IRBs face a dilemma, he emphasized.

“For instance, when a continuation or revision is submitted, is it expected that we re-review the study and consent form according to the revised regulations, including the additional informed consent elements and new key information summary?” he commented. “If so, this would involve a substantial revision of the consent form for the study, thereby creating much additional work for investigators/research coordinators preparing submissions and additional review responsibilities for IRB staff.”

Faced with these complexities, IRBs might choose to use the old regulations for studies approved prior to the effective date of the new regulations, and the new regulations for studies approved on or after the effective date, he said.

“In that event, even more substantial administrative burdens will occur,” Ackerman said. “The essential problem is that IRBs will need to operate with ‘two sets’ of all materials relevant to the oversight of studies.”

These sets would include standard operating procedures, electronic submission forms, IRB training, policy and procedure guides, consent forms, and checklists.

“This dual system will engender numerous problems …. and will create human mistakes and confusion,” he said, recommending that, with some exceptions, the OHRP adopt the position that on the effective date of the new rule all studies must be reviewed according to the new regulations.

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.