Optimizing the Nation's Investment in Academic Research A New Regulatory Framework for the 21st Century (2016) / Chapter Skim
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1 Introduction
1 Introduction
Pages 19-32
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From page 19... ...
Concerns have been raised by numerous organizations 3 that federal regulations 4 1 The 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)
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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.
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CONGRESSIONAL CONCERN 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.
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Work with the stakeholders such as the Federal Demonstration Part nership to demonstrate methodologies for estimating the personnel time and costs of compliance for a subset of regulations and reporting requirements specific to research universities; 7. Develop a framework and supporting principles for the Federal regu lation of research universities in the 21st century, taking into account:
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The ad hoc committee, now named the Committee on Federal Regula tions 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, Educa tion, Labor and Pensions, asked the committee to deliver an expedited report by the end of summer 2015.
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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.
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, http://www.faseb.org/portals/2/pdfs/opa/ 6.7.13%20FASEB%20NSB%20Survey%20findings.pdf NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (Bethesda, MD: National Institutes of Health, Office of Biotechnology Activities, 2013) , http://osp.od.nih.gov/sites/default/files/Synthetic_FAQs_April_2013.pdf "Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards," Federal Register 78, no.
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13579, 2011 "Payroll Certifications: A Proposed Alternative to Effort Reporting," The Federal Demonstration Partnership, January 3, 2011, accessed August 24, 2015, http://sites.nationalacademies.org/cs/groups/pgasite/documents/webpage/ pga_055994.pdf Federation of American Societies for Experimental Biology (FASEB)
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(2000) Responsibilities of Institutions Regarding Investigator Financial Conflicts of In terest.
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15 CFR §§730-774 (2012) "Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards," Federal Register 78, no.
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(Bethesda, MD: National Institutes of Health, 2012) , http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-101.html "Office of Laboratory Animal Welfare: Obtaining Assurance," National Institutes of Health, Office of Extramural Research, 2015, http://grants.nih.gov/grants/olaw/obtain_assurance.htm National Science Foundation "Final Format: Research Performance Progress Report," The National Science Foundation, 2010, https://www.nsf.gov/bfa/dias/policy/rppr/format_ombostp.pdf Grant Policy Manual: Chapter V – Grantee Standards: 510 Conflict of Interest Policies (NSF 05-131)
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Requirements that result in the unnecessary loss of valuable research time must be addressed to fully realize returns on Federal investments in scientific research. A higher level of oversight and authority is necessary to effectively coordinate Federal research agency requirements, their implementation, and efforts to ensure compliance.
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Removal of unnec essary reporting burdens could free universities to further focus their resources on vital research and educational missions; to achieve this objective we need your help and engagement." Howard Shelanski, David Mader, and Anne Rung, "National Dialogue: Driving Efficiency for America's Colleges & Universities," The White House, August 14, 2015, https://www.whitehouse.gov/blog/2015/08/14/national-dialogue-driving-efficiency america%E2%80%99s-colleges-universities-0 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?
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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.
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