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Suggested Citation:"8 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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8

Introduction

As indicated in Part 1 of the committee’s report, Congress requested that the committee expedite its work and deliver a report at the end of September 2015. In meeting this request, the committee divided its work1 into two parts. Part 1 addressed a number of regulations governing research along the continuum from proposal submission to the final accounting and reporting of research results and upon which Congress might take immediate action. In addition, the committee offered a new regulatory framework for federally funded research.

In this, Part 2, the committee concludes its analysis of topics that adversely affect the nation’s ability to optimize its investment in academic research. This analysis includes a discussion of the implications of a recent Notice of Proposed Rulemaking (NPRM) that seeks to revise the Common Rule governing human subjects research. Because the proposed rule raises serious concerns and questions and has elicited powerful reactions from the research community, the public, and relevant federal agencies, the committee has focused particular attention on the NPRM and associated issues (see Chapter 9).

As it did with the first report, the committee gathered data, analyzed written materials, and invited presentations from experts and stakeholders to discuss additional issues of concern to the academic research community. A meeting was held at Rice University, in Houston, Texas, in late October 2015 to gather additional information on topics including human subjects research, technology transfer, select agents, and export controls. Further, the committee sought input on how best to operationalize the Research Policy Board recommended in Part 1. An additional data-gathering meeting was held in Washington, D.C. in January 2016. In addition, members of the committee briefed Senator Lamar Alexander, congressional staff, agency personnel, and other stakeholder groups on the findings and recommendations of Part 1 of its report (see Appendix I). These briefings were the source of useful and valuable input to the committee.

The additional input provided further evidence in support of the committee’s recommendations that the regulatory framework governing feder-

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1See pp. 22-23 for the charge to the committee.

Suggested Citation:"8 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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ally funded academic research should be critically reexamined and recalibrated and that a new mechanism be created to foster more effective cooperation between the federal government and research institutions in the conception, development, implementation, and harmonization of research policies.

In Part 2, the committee concludes its analysis and offers additional recommendations designed to optimize the nation’s investment in academic research. Chapter 9 addresses the Common Rule NPRM and the regulatory framework for human subjects research. The reporting of inventions derived from academic research is covered in Chapter 10. Research involving select agents and toxins is discussed in Chapter 11, and export controls are discussed in Chapter 12. In Chapter 13, the committee illustrates how future regulations might be developed as part of its proposed regulatory framework and elaborates on the roles that the proposed Research Policy Board, the White House Office of Science and Technology Policy, and the Office of Management and Budget might play.

Suggested Citation:"8 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
×
Page 151
Suggested Citation:"8 Introduction." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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Research universities are critical contributors to our national research enterprise. They are the principal source of a world-class labor force and fundamental discoveries that enhance our lives and the lives of others around the world. These institutions help to create an educated citizenry capable of making informed and crucial choices as participants in a democratic society. However many are concerned that the unintended cumulative effect of federal regulations undercuts the productivity of the research enterprise and diminishes the return on the federal investment in research.

Optimizing the Nation's Investment in Academic Research reviews the regulatory framework as it currently exists, considers specific regulations that have placed undue and often unanticipated burdens on the research enterprise, and reassesses the process by which these regulations are created, reviewed, and retired. This review is critical to strengthen the partnership between the federal government and research institutions, to maximize the creation of new knowledge and products, to provide for the effective training and education of the next generation of scholars and workers, and to optimize the return on the federal investment in research for the benefit of the American people.

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