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Summary
Concerns about the growth of research regulations and reporting requirements and their impact on scientific productivity and international competitiveness have prompted many reports and recommendations over the past two decades (1–6). In the United States, investigators spend a considerable portion of their time on federally funded research engaged in associated administrative tasks (7). This takes time and effort away from research and can serve as a disincentive to seek grants or enter the field. Congress aimed to increase the efficiency of the federal investment in research and development and to reduce administrative burden on federally funded scientists through provisions of the 21st Century Cures Act (Cures Act, 13 December 2016) and the American Innovation and Competitiveness Act (AICA, 7 January 2017) (8, 9). Addressing research regulatory burden in law and associated oversight may provide the relief that reports and recommendations alone have not generated. But more than a year and a half after enactment of these laws, under an administration that has eagerly expressed intent to reduce regulations and associated costs, we see limited progress, transparency, and engagement with the research institutions that accept federal awards. Here, we focus on U.S. efforts to address research regulatory reform and allow for more direct engagement by the stakeholder community in the regulatory process, similar to the efforts of other nations and the European Union (EU).
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