Optimizing the Nation's Investment in Academic Research A New Regulatory Framework for the 21st Century (2016) / Chapter Skim
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7 A New Regulatory Framework for the Nation's Investment in Academic Research
7 A New Regulatory Framework for the Nation's Investment in Academic Research
Pages 135-150
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From page 135... ...
Despite the achievement of these extraordinary benefits, the partnership has come under stress from increasingly numerous and complex federal regulations and reporting requirements. While began as a means of exercising responsible oversight, regulations and reporting requirements have grown such that they now 135
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It is time for a reaffirmation of the partnership and the development of a sensible regulatory framework adapted to the current needs of research enterprise. OVERARCHING FINDINGS As noted throughout this report, the research performed at research institutions by individual investigators and research teams, selected on the basis of scientific merit and capability, fuels economic growth, strengthens national security, enhances the overall health, education, and well-being of U.S.
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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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Over the course of the committee's deliberations, it became evident that to achieve a more efficient and effective research enterprise -- one that maximizes the social benefits resulting from deployment of its intellectual capital and public and private investment of funds -- it is essential to establish a much more focused, integrated, and forward-looking framework for managing the research partnership. The committee recognizes, as have others, "the importance of ensuring that policies have strong empirical foundations, both through careful analysis in advance and through retrospective review of what works and what does not." 3 In this report, the committee aims to articulate a framework that can meet the complexity and scale of 21st-century issues and that can adapt to the 3 Cass Sunstein, Simpler: The Future of Government (New York, NY: Simon & Schuster, 2013)
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This research partnership, involving the mutual investment of talent and resources, has for the past seven decades produced the world's most successful national research enterprise, an enterprise that has been and continues to be widely emulated around the world. Historically, this system was based primarily on investigator-initiated project proposals, which, if deemed meritorious by anonymous peer review, were funded by grants to the successful investigators' institutions to be used for research by the applicants.
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Although it was once sufficient for an institution to provide a few assurances regarding its conformity with applicable federal rules, now there is a need for a sophisticated infrastructure of compliance systems and safeguards to ensure the protection of human subjects, the humane care and use of animals, the appropriate use of taxpayer funds, the management of the potential for financial conflicts of interest, the safe storage and handling of potentially hazardous materials, and the appropriate recognition and management of biosafety and national security concerns. Today, government and academic research institutions expend substantial resources on the implementation of these requirements, on information systems for tracking transactions to effectively manage and report on these matters, and on training for faculty and staff to fulfill these requirements.
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Another goal of the new framework is the routine exchange of information regarding safeguards, financial transactions, reports of inventions, and other matters in federal-wide standard systems such as e-commerce solutions to facilitate standard investigatorand project-specific exchanges of applications, biosketches, and progress reports. A successful framework must ensure that investigators can conduct research in an environment that aims to ensure safety, efficiency, and integrity while facilitating scientific progress and the optimal use of researchers' time.
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The RPB will provide research institutions a formal mechanism by which they can participate in the development of new regulations, the harmonization of existing regulations, review of the effectiveness and efficiency of the existing regulatory burden, and proposals for modification of existing regulations to minimize their tion, addressed the interfaces and linkages among federal, state, and local government; (b) the Small Business Regulatory Enforcement Fairness Act (SBREFA)
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These two officials should, in turn, have the obligation to report annually and jointly to Congress on regulatory issues affecting the research partnership and suggested steps to create a more effective regulatory environment. The proposed new entity, the RPB, bridges the governmental organizations (shown in blue)
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It should be cognizant of trends af fecting the overall regulatory load, and it should anticipate future regu latory challenges, especially those emerging from new science, such as synthetic biology, gene editing, and autonomous technology. It should organize expert project teams, as needed, to develop timely analysis on matters under consideration.
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Associate Director, Academic Research Enterprise, OSTP While the RPB, as conceived, would fulfill the need for an active forum bridging the public-sector and private-sector partners, there remains a need for a federal officer with a focus on the healthy functioning of the governmentacademic research partnership. The mission for the proposed OSTP Associate Director, Academic Research Enterprise, should be: To coordinate the federal research policy and regulatory process and to routinely integrate and organize input in a broadly representative fashion among federal research agencies, the RPB, and other representatives of in stitutions of higher education and their representative associations.
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Federal research agencies could, however, provide the necessary funding for this OSTP Associate Director position. Principles to Guide the Regulatory Framework Finally, the committee offers the following principles to consistently guide the recalibration and future development of federal research regulations: 1.
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work in partnership with OMB-OIRA to manage the overall regulatory burden; and (d) jointly, with the Administrator of OIRA, issue an annual report to Congress on regulatory issues and ac tions affecting the research partnership.
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148 Optimizing the Nation's Investment in Academic Research 7.2. Specifically, the committee recommends that participants in the government-academic research partnership adopt the above set of operational principles as a part of the new regulatory framework for federally funded academic research.
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Part 2
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