Surprise! New Common Rule Now Under Review; Outcome Uncertain

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Institutions that waited nearly the entire Obama administration for a revised Common Rule governing human subjects research are going to have to continue being patient.

A final rule revamping 45 CFR Part 46, also known as the Common Rule, was issued on Jan. 19, the second-to-last day of President Obama’s term in office (RRC 2/17, p. 1). As published, the rule has the same effective date and implementation date (or compliance date), Jan. 19, 2018, one year from issuance, for most requirements.

Publication of the rule seemingly ended a protracted regulatory process that began in July 2011, when HHS and other agencies issued an advance notice of proposed rule making. The final rule contained a number of provisions that arguably could ease the load for investigators and institutional review boards (IRBs), such as changes to exempt categories and an allowance to stop reviewing some research.

But now the rule has gotten caught up in a “regulatory freeze” imposed by President Trump, and there is little information about its fate.

In the meantime, questions that the complicated Common Rule sparked have continued to grow, as a talk by an official with the Office for Human Research Protections (OHRP) at a recent meeting of the Federal Demonstration Partnership (FDP) showed. OHRP is the lead agency in the government charged with overseeing the conduct of human subjects research trials.

On the day he was inaugurated, President Trump signed an executive order implementing a hiring freeze, as well as a regulatory freeze delaying the effective date of regulations that have been published but not yet taken effect to no earlier than March 21, 2017, which was 60 days from the date of the order (RRC 2/3/17).

Agencies were also told to withdraw any regulations that had not yet been published and that, in the future, “for every one new regulation issued, at least two prior regulations [must] be identified for elimination.”

As explained in subsequent memorandums issued by the Office of Management and Budget (OMB), the purpose of the delay was to allow for “reviewing questions of fact, law, and policy ‘as permitted by applicable law.’”

The review is to identify costs in new or proposed regulations and to identify ways to offset them. Agencies were also instructed to “consider postponing the effective date beyond 60 days where appropriate.”

Even though the release date for the final Common Rule put it in the freeze/review period, the 2018 effective date was believed to mean it would likely be safe from any serious scrutiny. That argument was bolstered by the fact that the version that was ultimately released lacked many of the provisions the research community considered onerous. In addition, the Common Rule was not highlighted as a regulation that Congress wanted to repeal and, in its scaled-back final form, seemed palatable to the regulated community (RRC 2/17, p. 1).

Implementation Could Be Delayed

It came as a surprise, then, when OHRP officials in mid-May said that the administration was indeed reviewing the new Common Rule and that the implementation date could be delayed.

However, some of the statements were conflicting and left institutions without definitive answers on issues that go beyond just the implementation date.

Word of the review first came May 12 when BNA’s Life Sciences Law & Industry Report quoted Ivor Pritchard, senior advisor to OHRP Director Jerry Menikoff, who spoke at an industry meeting in Detroit. According to the report, Pritchard said OHRP was “basically in a holding pattern until they’ve had a chance to understand the provisions of the newly revised rule and recognize where there is latitude for new policy making.”

He was also quoted as saying administration officials have not yet “decided whether they want to go forward with the rule at all,” and that the implementation date could be delayed. 

The following day, Irene Stith-Coleman, OHRP director of the Division of Policy and Assurances, spoke at the FDP meeting and answered questions prompted by Pritchard’s comments after her formal presentation.

Stith-Coleman said OHRP is “operating under the assumption” that the 2018 date will hold “until we hear otherwise. And I can assure you, when we hear it, you’re gonna hear it,” she told the audience.

Asked when the review might be concluded, Stith-Coleman said, “I wish I had a crystal ball, but I don’t. I don’t know.” She added that OMB and HHS, as well as other agencies, might be involved in the review.

Confusion Among the Questions

One thing was clear without need of a crystal ball: audience members had many questions, some of which evidenced confusion. For example, one questioner noted that the final rule does away with the “box” on assurances that indicates institutions will voluntarily apply the Common Rule and/or its subparts to non-HHS funded research, which allows OHRP to have jurisdiction over compliance. He asked whether the absence of the box (or boxes; there are two) meant that the Common Rule automatically applied to non-HHS funded human subjects research. The opposite is true.

“Once the box disappears, OHRP will have no enforcement authority over non-HHS” supported or conducted human subjects research, Stith-Coleman said.

In response to another query, Stith-Coleman said OHRP would not have jurisdiction over exempt research unless it is of the type that is subject to limited IRB review. But she added that if research was wrongly declared exempt, OHRP could take an enforcement action.

One questioner wondered what an institution’s responsibilities are for oversight of expedited trials, given that the final rule doesn’t require continuing review. Should the institution require notification that a trial is over or require a final report, she asked.

Another area of concern expressed by an audience member is that the rule removes the requirement for IRBs to review grant applications, but this currently is a mandate from NIH. Still another person said he understood that some studies could undergo limited IRB review, but that there was no information as to what that entails.

Stith-Coleman said OHRP would provide compliance materials in the future.

“We are hoping to put out guidance on a number of provisions, certainly new provisions as well as update our existing guidances. So we will be busy, are busy,” she said.

Universities and other NIH grantees are also busy working toward implementation of the Common Rule’s single IRB requirement for multisite trials because, for them, the policy goes into effect in September (RRC 1/17, p. 3).

NIH decided to go ahead with this requirement while the revised Common Rule was still being drafted.

Awardees of funding from the other dozen or so agencies that also require adherence to the Common Rule will have until Jan. 19, 2020 or later, depending on the outcome of the administration’s review, to comply.

Link to Stith-Coleman’s slides: