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by Jim Gearhart

5 NPRM Proposals You Won’t See in Common Rule 2018

After years of preparation and discussion, the Department of Health and Human Services published a new Common Rule. “Common Rule” is shorthand for “The Federal Policy for the Protection of Human Subjects,” which most federal agencies must follow when conducting research on people.

The new Common Rule started out as an Advanced Notice of Proposed Rulemaking in (ANPRM) in 2011, then became a Notice of Proposed Rulemaking (NPRM) in 2015. The NPRM went through some major changes before it appeared as the final rule on January 19 of this year—changes that came from extensive public comments and federal agencies’ reactions.

Three months after its publication, we’re now one-fourth of the way to the deadline for the Common Rule’s new policies to take effect (with one exception). It seems like a good moment to stop and recall: what were those big shifts between the NPRM and the final Common Rule?


Five Common Rule Proposals That Did Not Make the Cut

1. A New Definition for Human Subjects in Research

The final guidelines of Common Rule 2018 stepped back from the NPRM’s suggestion to redefine “human subject” in a much broader way. The NPRM proposed to equate research done on any donated biological sample or stored medical data as research performed on that person. The step aimed to apply human subject protections to rapidly changing areas of research, such as big data searches and genetic sequencing. It was an ambitious change, but the public comments against it dissuaded the policy drafters from keeping with it. For the most part, the current definition of “human subject research” will remain.

2. Broad Consent for Biospecimens

Without the redefinition of human subject research, another major component of the 2015 NPRM also became unnecessary: broad consent for using biospecimens in research. The NPRM’s definition of human subject research would have implied a need to gather consent for using or storing people’s biological specimens in innumerable situations. The NPRM pledged to ease the impact of the new definition by producing a standard consent form for all researchers use.

But the prospect of relying on an unseen document or tool to address unique study needs was not a welcome suggestion; many commenters objected to the unclear directions and the expected complications of implementing them. Now broad consent is an option that organizations still may choose to adopt.

3. Exclusions

The category of excluded research also fell victim to the non-change of the definition of human research. The NPRM had presented a new class of information-gathering actions that would, by definition, be excluded from the umbrella of research even though they might have applied to human subjects and so would have fallen outside the Common Rule. Essentially this was another way to lessen the impact of broadening the definition of human research.

4. Extended Scope of the Common Rule

The NPRM proposed extending the applicability of the Common Rule to any clinical trial conducted at an institution that receives federal support for human subject research. The final Common Rule dropped this suggestion and, in the opinion of at least one observer, could lessen the significance of an institution’s “checking the box” over how broadly to apply the Common Rule’s requirements.

5. Reliance on Tools and Guidance to be Released at Later Dates

I mentioned the much-promised broad consent form already, but the NPRM included ideas for other tools that were supposed to help in its implementation. These included: (1) new privacy standards for biospecimens and data; and (2) a tool to help researchers determine whether certain studies could be exempt from Common Rule oversight and IRB review. The NPRM promised to create these tools, but the final Common Rule removed the need for them.


So What Is Left in the Common Rule?

The research community is still poised to see significant changes in 2018. These articles and resources present good overviews about how the landscape could change by next January.


* The one exception to the 2018 effective date is the rule for cooperative IRB review, which has an extra two years before becoming official in 2020.


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