Engage research institutions on research regulatory reform

Editor’s Note: Full implementation of the Data Access Act and the Data Quality Act would resolve the science transparency and quality concerns of all stakeholders. See, American Association for the Advancement of Science-Federal Focus Symposium on Data AccessCRE’s Emphasis on Data Access and Data Quality is Rooted in the Paperwork Reduction Act Amendments of 1995, and Update on the CRE Position on the EPA Silent Science Initiative. With respect to making US regulatory science processes to those in the EU, please see  The US Data Access Act is No Match to its Counterpart in the UK.


Lisa Nichols, Council on Governmental Relations, Washington, DC
David Wynes, Emory University, Atlanta, GA

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 (16). 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) (89). 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).


Subregulatory Burden

Although not addressed in the Cures Act or the AICA, another area that could be taken up is the issue of subregulatory burden. Although guidance can be welcome and critical, providing necessary details for implementation while maintaining a level of flexibility, agency requirements based on policies, procedures, award terms, and other materials can also substantially increase administrative burden. These measures, which, unlike regulations, generally do not undergo review by OIRA, have proliferated and can effectively serve as regulation, in many cases without input from the research community or adequate analyses of outcomes, such as costs, impact, and scientific implications. The OMB’s 2007 Agency Good Guidance Practices bulletin sought to curb these practices, yet they persist. An example of this is the NIH Office of Laboratory Animal Welfare’s interpretation of “should” statements as “must” statements in the Guide for the Care and Use of Laboratory Animals (15). Review of subregulations by the RPB and interagency working group and a restatement of the OMB bulletin would be helpful. This could be accompanied by a request for comment seeking feedback on burdensome federal guidance.

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