Congress and the Obama Administration still have time for a critical “course correction” by withdrawing the Notice of Proposed Rulemaking for the “Common Rule,” according to the final portion of a report issued by the National Academies of Sciences, Engineering, and Medicine on June 29. The chair of the committee that wrote the report, Larry Faulkner, president emeritus at the University of Texas, Austin, hopes the recommendations will inspire changes that will lead to “significantly greater value to the public from the nation’s investment in research.”
The dust is still settling on the announcement, and that makes it difficult to discern the impact of the new report at this stage, says David Borasky, MPH, CIP, vice president of quality management at Copernicus Group IRB. “The call for the establishment of a national commission” could be significant, he suggests.
In several places, the report focuses squarely on clinical trials, including tasking a proposed national, independent commission with addressing how the basic ethical principles governing human subjects research should be applied to unresolved questions and contexts. For example, when the unit of intervention is a cluster or group, or when comparing the effectiveness of clinical studies of different experimental interventions for a disorder to determine whether one approach may be preferable.
Part one of the National Academies study was released last September. The full study was sponsored by the U.S. Department of Education and the National Institutes of Health.
With an election looming and control of the U.S. Senate and House of Representatives seemingly up for grabs, it’s unclear how quickly these recommendations might or might not move forward.
To read a recent article on the Common Rule coauthored by Borasky for ACRP’s Clinical Researcher journal, please visit http://clinicalresearcher.acrpnet.org/content/30/1/14.