In This Issue

So When Will the Revised Common Rule Be Published?

That is the million-dollar question.

By Sangeeta Panicker, PhD

And the answer to that question is, your guess is as good as mine.

To recap the sequence of events – back in July 2011, the Department of Health and Human Services (DHHS) issued an Advance Notice of Proposed Rulemaking seeking input on how the Common Rule (45 CFR 46, Subpart A) should be revised to make it more effective. Some 1,100 comments and four years later, in September 2015, presumably based on comments received, a Notice of Proposed Rulemaking (NPRM) regarding proposed revisions to federal regulations for the protection of human research participants was published for public comments. The DHHS Office for Human Research Protections (OHRP), received nearly 2,200 comments, before the comment period ended in early January 2016.

Other events might impact if and when a revised rule is issued

Since the end of the comment period, at various public fora, OHRP officials indicated that the final rule was expected to be published no later than September 2016. However - 

In late June 2016 - based on the recommendations of a Congressionally mandated report drafted by a committee of The Academies, in late June, Rep. Daniel Lipinski, D-Ill., introduced legislation entitled “University Regulation Streamlining and Harmonization Act of 2016.” (PDF, 267KB) The legislation calls for the establishment of a research policy board to review current and proposed federal regulations as well as major policies and guidance governing the conduct of scientific research.

In late July 2016 - The Academies’ report was released to the public. It included an extensive review and analysis of the NPRM and concluded that the inadequacies of the NPRM “signal a pressing need for a comprehensive review of the nation’s ethical, legal, regulatory, and institutional frameworks for protecting human research subjects” (p. 168). Given that there is no entity currently that can undertake such an effort, the report recommended that the President rescind the NPRM, and that Congress establish a national commission, which should be charged with “examining and updating as necessary the ethical, legal, and institutional frameworks governing human subjects research” (p. 168) and making recommendations “regarding how the basic ethical principles governing human subjects research should be applied to unresolved human research questions and novel human research contexts” (p. 168).

In late September 2016 - the House Committee on Science, Space, and Technology, Subcommittee on Research and Technology held a hearing titled “Academic Research Regulatory Relief: A Review of New Recommendations” during which the chair of The Academies’ committee testified (PDF, 429KB) and reiterated the recommendations put forth in the report, including the rescinding of the NPRM.

In early October 2016 - an OHRP spokesperson was quoted in the media as saying that a final rule is expected to be issued before the end of the year.

So, when?

Let the guessing game begin.