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Trump administration delays human research protection rule to 2019

The Trump administration has delayed by six months implementing a revised set of policies governing the protections for Americans participating in government-funded research known as the Common Rule.

The rule, initially written in 1991, affects research supported by the U.S. Department of Health and Human Services and 15 other federal agencies, including the departments of Defense and Energy and the National Aeronautics and Space Administration.

The initial revisions to the Common Rule were unveiled Jan. 18, 2017 — two days before then-President Barack Obama left office. They were officially published in the Federal Register on Jan. 19, 2017.

But shortly after he was sworn in on Jan. 20, 2017, President Donald Trump issued an executive memorandum freezing all pending regulations and rules.

This past January, the new administration issued an interim rule delaying the Obama administration's revised Common Rule until July 19 — a date that has now been delayed to Jan. 21, 2019, according to an early notice posted June 18 in the Federal Register, which is set to officially be published June 19.

The Trump administration dubbed its revisions, plus the technical amendments it made in January, the 2018 requirements.

Delay anticipated

The latest delay was anticipated after the administration in April issued a notice of proposed rulemaking and asked for the public to weigh in on whether another six months was needed before the latest version took effect.

The Trump administration also proposed and sought comments on whether to allow regulated entities to implement certain burden-reducing provisions of the 2018 requirements in specified circumstances during the continued delay period. The administration said it adopted those proposals as part of its now final, but delayed, rule.

For now, the agencies are required, with an exception, to continue to comply with the requirements of the pre-2018 version of Common Rule until Jan. 21, 2019.

That one exception 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: the revised definition of "research," which deems certain activities not to be work covered by the Common Rule; the elimination of the requirement for annual continuing review with respect to certain categories of research; and the end of the requirement that institutional review boards evaluate grant applications or other funding proposals related to the research.

The administration said any institutions that take advantage of those three measures — which must be implemented during the delay period and be for studies initiated before Jan. 21, 2019, that are expected to transition to compliance with the revised Common Rule — must comply with all other pre-2018 requirements during the delay period.

Appropriate balance

"We believe this rule strikes an appropriate balance of permitting voluntary early adoption of provisions that reduce burdens without creating significant complexities," the administration said.

It noted that an institution's decision about whether to transition a study to the 2018 requirements might vary depending on the nature and progress of the research, including any elements that may need to be conducted on or after Jan. 21, 2019.

For example, the administration said, studies planning to recruit some volunteers on or after Jan. 21, 2019, would have to meet the new requirements for obtaining the informed consent of those participants. In contrast, for studies in which the remaining activities consist only of completing data analyses, the new requirements for informed consent generally would not be applicable.

Institutions that take advantage of that flexibility may, as a matter of policy, adopt a more stringent standard, like those set under the pre-2018 requirements, for any or all of the circumstances addressed by these three provisions, the administration added.

Comments

The administration received 62 public comments on its January interim rule and another 73 on its April notice, though not all that input was related to the Common Rule.

From those comments "several common themes emerged," including the need for a delay of the compliance date, though there was limited support to extend the timeline beyond January 2019.

There was also support for prompt guidelines to be issued — something the administration said it was working on developing.

The comments also called for institutions to be permitted to voluntarily implement the 2018 requirements in their entirety at any time after July 19.

The administration acknowledged that it was criticized in the comments for waiting until two days before the Obama-era rule was to take effect in January before issuing the initial delay, creating "chaos and confusion in the regulated community."

"This rollout created administrative burdens for institutions, as many had changed IT systems, training programs and other operational tasks and then had to hastily undo these changes," the administration said.

Single review board

One of the changes the Obama administration had proposed in its revised rule was to have a single institutional review board, or IRB, rather than multiple reviews, oversee cooperative research studies involving more than one institution, with that change implemented by January 2020.

While the Trump administration noted that it did not solicit input on the single IRB requirement for cooperative research, it said it received several comments, with some arguing that the costs of implementing that measure had been underestimated and others seeking a longer timeline for putting that process in place.

The Trump administration said it agreed with its predecessor that the January 2020 timeline was sufficient. It also said that none of the comments provided data about the costs to implement the single IRB.