Research universities1 are critical contributors to our national research enterprise.2 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. Through teaching, mentoring, research, and scholarship, research universities train each succeeding generation of investigators, scholars, and leaders and thereby are uniquely responsible for both the creation and transmission of new knowledge.
For over half a century, the American people have seen fundamental research as a national imperative. They have contributed, through the allocation of federal funds, to a unique government-academic research partnership that fosters innovative research at universities. The result of this partnership is a system of internationally renowned institutions that is focused on higher education and discovery that consistently attracts the best talent from around the world and serves as a model for other nations determined to advance their leadership and contributions in science, health care, technology, and engineering.
1The terms research universities and research institutions, used interchangeably throughout this report, encompass not only research universities but also other entities such as teaching hospitals (e.g., Massachusetts General Hospital) and academic research institutes (e.g., The Scripps Research Institute) conducting federally funded research.
2The national research enterprise comprises the federal government, national laboratories, universities, and industry. Within this enterprise the federal government provides funds to universities to conduct the majority of U.S. basic research. Christine M. Matthews, Federal Support for Academic Research (CRS Report No. R41895) (Washington, DC: Congressional Research Service, 2012), 7, https://www.fas.org/sgp/crs/misc/R41895.pdf.
3Federation of American Societies for Experimental Biologists, Findings of the FASEB Survey on Administrative Burden (2013), http://www.faseb.org/portals/2/pdfs/opa/6.7.13%20FASEB%20NSB%20Survey%20findings.pdf.
Robert S. Decker, Leslie Wimsatt, Andrea G. Trice, and Joseph A. Konstan, A Profile of Federal–Grant Administrative Burden Among Federal Demonstration Partnership Faculty:
and reporting requirements have led to an environment wherein an increasing percentage of scientists’ time is spent complying with regulations, rather than on the conduct of research, the education of students, and the pursuit of scholarship. The result is that the federal investment in research is no longer delivering the optimal return on the nation’s investment.
From its inception, the partnership between the federal government and research universities has appropriately included federal oversight of research. Research must be conducted with integrity, and the expenditure of taxpayer funds makes full accounting and transparency compulsory. Further, as some research carries significant risk, careful oversight is necessary to ensure the safety of human research participants, the appropriate care of research animals, and the protection of the public. Developed effectively, regulations provide a framework for the conduct of research that embodies the shared values of the federal government, research institutions, and the public. Unfortunately, federal regulations and reporting requirements have grown to such an extent that they also encumber the research enterprise, hamper innovation, divert time and expertise from research to administrative matters, and discourage the next generation of investigators.
The increase in federal regulations is well recognized and has many sources. In part, it may be due to the momentum and inertia of a regulatory process that provides little opportunity to review, evaluate, and eliminate unneeded regulations. This is a concern far beyond the research enterprise, as is manifested by decades of initiatives to reduce paperwork and streamline regulation across the federal system.5 A growing public interest in reducing the cost of government and in increas-
A Report of the Faculty Standing Committee of the Federal Demonstration Partnership (2007), http://www.iscintelligence.com/archivos_subidos/usfacultyburden_5.pdf.
National Science Foundation, Reducing Investigators’ Administrative Workload for Federally Funded Research (NSB-14-18) (Arlington, VA, 2014), http://nsf.gov/pubs/2014/nsb1418/nsb1418.pdf.
Mo Brooks (Congressman, Chairman, Subcommittee on Research and Science Education). Letter to Gene Dodaro (Comptroller General of the United States, U.S. Government Accountability Office, Washington, DC) October 13, 2012, https://science.house.gov/sites/republicans.science.house.gov/files/documents/Letters/100312_brooks_GAO.pdf.
4Throughout this report, the term regulation is used not only to encompass laws but also the “general and permanent rules published in the Federal Register by the executive departments and agencies of the federal government” [“About the CFR,” National Archives, accessed September 9, 2015, http://www.archives.gov/federal-register/cfr/about.html], agency policies and policy guidance (including answers to FAQs), and executive actions.
5See, e.g., Exec. Order No. 12,291, 46 FR 13193, 3 CFR (1981), Federal Regulatory Review aimed “to reduce the burdens of existing and future regulations, increase agency accountability for regulatory actions, provide for presidential oversight of the regulatory process, minimize duplication and conflict of regulations, and insure well-reasoned regulations,” February 17, 1981; Exec. Order No. 12,866, 58 FR 51735 (1993) Regulatory
ing accountability has simultaneously led to increased budgetary vigilance and auditing across the federal government. In the particular case of scientific research, the increase in regulation stems, in part, from specific research concerns. Public perception of the risks of some research procedures, materials, or outcomes motivates the accretion of regulations. Episodic investigator misconduct, sometimes associated with investigator or institutional conflicts of interest6—and the real and perceived failure of some research institutions to prevent, investigate, or respond sufficiently—have also led to new regulations.
It is appropriate to review the regulatory framework as it currently exists, to consider specific regulations that have placed undue and often unanticipated burdens on the research enterprise, and to reassess 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.
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, Congress has commissioned a number of reports to examine the federal regulation of higher education. In the fall of 2013, for example, Senators Lamar Alexander, Barbara Mikulski, Michael Bennet, and Richard Burr tasked higher education leaders to examine the federal regulation of higher education. That task force, co-chaired by William Kirwan, chancellor of the University System of Maryland, and Nicholas Zeppos, chancellor of Vanderbilt University, focused on those regulations promulgated and enforced by the U.S. Department of Education (DoED). The task force developed “recommendations for consolidating, streamlining, and eliminating redundant and burdensome Federal regulations and reporting affecting institutions of higher education.” Its report, Recalibrating Regulation of Colleges and Universities, was published by the American Council on Education in February 2015 and addresses DoED regulations. The report provides a valuable complement to the current report.
Planning and Review, September 30, 1993; Exec. Order No. 13,563, 76 FR 3821 (2011) Improving Regulation and Regulatory Review, January 18, 2011; Exec. Order No. 13,579, 76 FR 41587 (2011) Regulation and Independent Regulatory Agencies, July 11, 2011; and Exec. Order No. 13,610, 77 FR 28469 (2012) Executive Order 13610, Identifying and Reducing Regulatory Burdens, May 10, 2012.
6For the purposes of this report, the phrase conflicts of interest generally refers to financial conflicts of interest.
CHARGE TO THE COMMITTEE
In January 2014, Congress called upon the National Academy of Sciences to examine the regulations and policies of all federal agencies that support basic and applied research at universities. In response to this call, in late 2014 the National Academies of Sciences, Engineering, and Medicine appointed an ad hoc committee under the auspices of the Committee on Science, Technology, and Law and the Board on Higher Education and Workforce. The committee’s charge is set forth below.
The committee will:
conduct a study of Federal regulations and reporting requirements with specific attention to those directed at research universities. In conducting its analyses, the committee will be aware of: (a) the context and intended benefits and circumstances under which a particular regulation was issued and may have evolved, and (b) whether those contexts or circumstances still remain of public concern. The committee will develop a new framework for Federal regulation of research universities in the 21st century that addresses the needs of Congress, Federal agencies, and the broader public while advancing to the maximum extent feasible the missions of research universities.
Specifically, the committee will:
- Identify by research agency and statutory authority the Federal regulations with significant impact, and the reporting requirements with which research universities must comply;
- Work with research universities and associations to gather and review information on personnel time and costs of compliance with Federal regulations and reporting requirements;
- Work with research universities and associations to gather and review information on methodologies for most efficiently and effectively estimating time, costs, and resulting benefits;
- Work with federal research agencies to identify regulations and requirements with significant impact that the committee should review;
- Work with professional staff of congressional committees with jurisdictional responsibility for regulatory oversight and research funding;
- Work with the stakeholders such as the Federal Demonstration Partnership to demonstrate methodologies for estimating the personnel time and costs of compliance for a subset of regulations and reporting requirements specific to research universities;
- Develop a framework and supporting principles for the Federal regulation of research universities in the 21st century, taking into account:
(a) the purposes, costs, benefits, and reporting requirements of regulation, (b) the processes used to promulgate regulations and reporting requirements, (c) the roles of Congress, Offices of Inspectors General and Federal agencies, including the Office of Science and Technology Policy and the Office of Management and Budget, and (d) the missions of research universities;
- Recommend steps needed to implement the framework;
- Assess how a subset of regulations and reporting requirements fit within the framework, and offer suggestions for evaluating those regulations and reporting requirements that are outdated or redundant, or where compliance burdens have become disproportionate with expected benefits; and
- Identify regulations and reporting requirements that will require additional analysis in order to assess their fit with the framework and to develop improved approaches.
The ad hoc committee, now named the Committee on Federal Regulations and Reporting Requirements: A New Framework for Research Universities in the 21st Century, was to conduct its work over an 18-month period. However, 3 months after the committee was convened, Senator Lamar Alexander, Chair, Senate Committee on Health, Education, Labor and Pensions, asked the committee to deliver an expedited report by the end of summer 2015. As he explained in his remarks at the committee’s July 2015 meeting, Senator Alexander believed that fall 2015 presented a unique opportunity to reconsider, in a bipartisan manner, the regulatory environment governing federally funded research, as Congress would be considering several legislative actions involving higher education, research policy, and medical innovation where it would be appropriate to make changes to the current regulatory structure. “Here’s what I suggest you do. Make an interim report in September to Congress, especially the Senate, on the specific recommendations that you would like us to put into law, or make changes to existing regulations that would simplify and reduce the cost of federal regulations on university-based research.”7
Within this new time frame, the committee reviewed extensive background materials and held four meetings and a regional workshop at the University of California, San Francisco to hear from stakeholders. The committee sought input from a number of individuals and organizations (see Acknowledgments, p. xi)
7Senator Lamar Alexander, before the committee, July 22, 2015, Washington, D.C. See Jeffrey Mervis, “Senator Offers Tantalizing Prospect of Regulatory Relief for Biomedical Researchers,” ScienceInsider, (2015), DOI: 10.1126/science.aac8892.
deeply engaged in the issues addressed in this report. In addition, the committee reviewed numerous background papers and studies (see Box 1-1), including many that documented: (1) the reasons for and growth in regulations governing research at academic institutions; (2) the increased time that scientists devote to administrative activities; (3) the erosion of the robustness of the research enterprise; and (4) recommendations put forth over past decades to address these problems.
The committee considered regulations along the continuum of research from proposal preparation and the conduct of research through to the final accounting of research funds. It identified important areas for improvement along three main tracks: (1) regulations governing research project management; (2) regulations governing the conduct of research; and (3) regulations governing research financial accounting (see Box 1-2). As it is impossible for the committee to consider all regulations and related policy and guidance associated with these tracks, the committee elected to direct detailed attention to those issues repeatedly identified in presentations to the committee and in past reports as encumbering the research enterprise. Throughout its review and deliberations, the committee remained mindful of both the history of the U.S. research enterprise and the current fast-paced, hypercompetitive global research environment in which the enterprise now operates.
Over the course of its study, the committee discovered, as have others, little rigorous analysis or supporting data precisely quantifying the total burden and cost to investigators and research institutions of complying with federal regulations specific to the conduct of federally funded research. Many of the reports available are surveys of faculty and administrators who may have biases.8 The committee, however, identified numerous reports from outside the academic research community (e.g., from the President’s Council of Advisors on Science and Technology, Congress, the White House, and the National Science Board) that expressed interest in rethinking government policies in light of concerns that regulations were directing investigator time away from research to the detriment of the nation’s investment (see Box 1-3).
8The Federal Demonstration Partnership has issued two reports: Robert Decker, Leslie Wimsatt, Andrea Trice, and Joseph Konstan, A Profile of Federal-Grant Administrative Burden Among Federal Demonstration Partnership Faculty, (Washington, DC: Federal Demonstration Partnership, 2007) and Sandra Schneider, Kristen Ness, Sara Rockwell, Kelly Shaver, and Randy Brutkiewicz, 2012 Faculty Workload Survey: Research Report, (Washington, DC: Federal Demonstration Partnership, 2014), indicating that faculty conducting federally funded research spend 42 percent of their time on “pre and post-award administrative activities” and “meeting requirements” rather than conducting active research. These reports represent an important effort to collect data on this issue. Work that identifies appropriate methodologies and study design for data collections of this type should proceed.
The committee had difficulty finding data calculating the opportunity costs associated with diverting time, expertise, resources, and potential away from the conduct of basic and applied research to meet regulatory demands. Noting the lack of empirical data, former Office of Information and Regulatory Affairs administrator Cass Sunstein identifies several questions that need to be asked: “What do we actually know about the likely effects of proposed rules? What would be the human consequences? What are the costs and benefits? How can government avoid reliance on guesses and hunches? What do we know about what existing rules are actually doing for—or to—the American people? How can we make things simpler? … We have started to incorporate the resulting findings [of economic and social science], and we need to do far more.”9
The committee found that prior recommendations by others, though grounded in reality and practicality, had gained little traction. From stakeholders at every level and perspective, the committee heard how increasing regulations hinder the output of the remarkable research enterprise that arose from the government-academic research partnership. Describing how and why this growth of regulations occurred, why a course correction is needed, and how the government-academic research partnership can be recalibrated to best serve the nation in the 21st century are the objectives of this report.
9Cass Sunstein, Simpler: The Future of Government (New York, NY: Simon & Schuster, 2013), p. 5.
Following the release of this expedited report, the committee will continue its assessment, seek additional data regarding the effects of regulations on the conduct of research, hold additional meetings (including a regional meeting at Rice University) and issue in spring 2016 an addendum report addressing any outstanding items from its charge not captured in the current report and address other regulations (e.g., export controls and dual-use research of concern), that it has been unable to address comprehensively under the expedited time line.
ORGANIZATION OF PART 1 OF THIS REPORT
To enable full consideration of the impact of federal regulations on the research enterprise, Chapter 2 describes the previously strong government-academic research partnership and the developing erosion of that relationship as reflected in the growth of the regulatory regime. Chapter 3 provides an overview of the process for securing a federal research grant. Drawing on presentations to the committee, numerous prior reports and studies, and committee analysis, Chapters 4, 5, and 6 examine significant regulations and policies that are interfering with the effectiveness of the decades-old research partnership and offer detailed findings and recommendations to rationalize them. Chapter 7 provides the committee’s overarching findings and offers a framework for a national strategy to renew the partnership between the government and academic research institutions for the 21st century.