Optimizing the Nation's Investment in Academic Research A New Regulatory Framework for the 21st Century (2016) / Chapter Skim
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Overarching Summary
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Through teaching, mentoring, research, and scholarship, research institutions train each succeeding generation of researchers, scholars, and leaders and thereby are uniquely responsible for both the creation and the transmission of new knowledge. The result of this unique government–academic research partnership is a system of education, mentorship, and discovery that is renowned internationally, consistently attracts the best talent from around the world, and serves as a model for other nations determined to advance their leadership in science and engineering in pursuit of economic and social progress and prosperity.
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Within this new time frame, the committee reviewed extensive background materials and held four meetings and one regional workshop at the University of California, San Francisco, to hear from various stakeholders, including federal research and regulatory agencies, inspectors general, research administrators, accrediting bodies, higher education groups, and principal investigators. In 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.
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that seeks to revise the Common Rule governing human subjects research. The committee had made initial comments on human subjects research regulations in its September 2015 report (see Chapter 5)
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From stakeholders at every level and perspective, the committee heard how increasing federal regulations hinder the out put of the remarkable research enterprise that arose from the govern ment-academic 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 and re invigorated to best serve the nation in the 21st century are the objectives of this report.
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6. Academic research institutions often receive research funding from multiple federal agencies, but approaches to similar shared goals and requirements (formats of grant proposals and biosketches, animal care, financial conflicts of interest, etc.)
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Recognizing the importance of regulation to the overall health of the research enterprise, the recommendations and framework are intended to achieve a more sensible regulatory structure that harmonizes and streamlines, where appropriate, federal regulations and policies addressing the same concerns and eliminates regulations that no longer benefit the nation's investment in research. The goal of the framework is not to increase bureaucracy but rather to make the federal regulatory regime simpler and more effective for all those involved in the partnership.
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5. Direct federal agencies following the Common Rule to require, for multi site research studies, that a single institutional review board (IRB)
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11. In concert with the White House OMB, affirm that research institutions may take advantage of the flexibility provided by the Uniform Guidance 8 for the documentation of personnel expenses (Recommendation 6.2)
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Permit, as an immediate, interim measure, research institutions to use subrecipients' publicly available Single Audit Reports to verify that subrecipients have not been otherwise debarred or suspended with re spect to the receipt of federal funds. For those with a clean Single Audit Report, the prime institution should be allowed to rely on the Single Audit Act oversight process as an alternative to conducting a review of the adequacy of the subrecipient's institutional systems and business practices (Recommendation 4.6)
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The commission should make rec ommendations to the President, Congress, and relevant federal agencies regarding how the basic ethical principles governing human subjects research should be applied to unresolved human research questions and novel human research contexts. The commission should have two broad charges: Recommend to the President and Congress ethically sound regulato ry approaches for unresolved questions in human subjects research; and 10 This criterion should be added as an additional item in Methods of Procurement to be Followed, 2 CFR § 200.320(f)
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. 11 The proposed Research Policy Board could take a leadership role in discussions about which agency should have responsibility for the regulation of the microbes and toxins on the select agents and toxins list.
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Processes that are redundant to the institutional animal care and use committee approval process, such as the Vertebrate Animal section of Public Health Service grant applications and the Department of De fense central administrative protocol review, should be eliminated (Recommendation 5.8)
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This can only be achieved if universities foster a culture of integrity among academic leaders, faculty, postdoctoral trainees, students, and staff, and institutional administrators, and mete out appropriate sanctions in instances where behavior deviates from the ethical and professional norms of the institution and of the academic research community. Universities that deviate from or fail to enforce the norms of behavior should be sanctioned.
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. Specifically, the committee recommends that participants in the government– academic research partnership adopt a set of operational principles as a part of the new regulatory framework for federally funded academic research: 1.
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Targeted revisions to regulations affecting research institutions, combined with a new framework of structures and principles to coordinate and nurture the government–academic research partnership, will serve the nation as it confronts the scientific and technological challenges of the 21st century.
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Part 1
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