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