National Academies Committee Calls for New Review of Human Subjects Research

By | June 30, 2016

On June 29, the National Academies of Science, Engineering, and Medicine released the final version of “Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century.” The Academies report calls for the creation of an independent national commission charged with fully examining the regulatory, legal, and ethical dimensions to research involving human subjects.

A similar expert panel helped draft the principles that guided the creation of the current Federal Policy for the Protection of Human Subjects also known as the “Common Rule.” The Academies report suggests that it is time to reexamine whether these principles are “still sufficient pillars upon which to build human research protection programs and regulations.”

To allow the commission the opportunity to do a complete evaluation of human research subject protections and to give stakeholders ample time for input, the report recommends that the Department of Health and Human Services withdraw the September 2015 Notice of Proposed Rulemaking to update the Common Rule.

The full report is part of ongoing efforts to broadly reduce regulatory burden on scientific researchers. It outlines a number of policy recommendations aimed at streamlining and harmonizing research regulations across the federal government. In its latest, finalized form, in addition to recommendations pertaining to human subjects, the document also includes sections on intellectual property, select agents/toxins and dual-use research of concern, and export controls. There is also an expanded section that outlines how the reports’ recommendations might be implemented in practice.