PMC:7454258 / 178294-207806 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/7454258","sourcedb":"PMC","sourceid":"7454258","source_url":"https://www.ncbi.nlm.nih.gov/pmc/7454258","text":"Identified NIH strategies for strengthening national nutrition research\nAs the nation's largest funder of research, NIH is one essential (although not exclusive) home for increased authority, coordination, and funding for nutrition science (110). Any new NIH strategy must leverage and amplify, not replace or compete with, existing extramural and intramural nutrition research efforts across the 27 current NIH institutes, centers, or offices or with existing nutrition research across other federal departments and agencies. Key identified strategies are summarized in Table 4 and reviewed below.\n\nNew National Institute of Nutrition\nA new NIH National Institute of Nutrition (NIN) would be additive to the 27 current institutes and centers leading research within NIH (Supplemental Figure 8). NIN would be a crucial new asset for NIH to accomplish its mission “to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability” (321). NIN would be tasked with leading innovative, cross-cutting, and foundational research on nutrition and health, including intramural and extramural programs and training and outreach activities. Under the leadership of the NIN Director, NIN would help guide strategic planning, coordination, and review of nutrition research across NIH and with other federal departments and agencies. This would increase harmonization, collaboration, and leveraging of all nutrition-related research programs across NIH institutes, centers and offices. NIN priority areas and funding should be coordinated with, additive to, and synergistic with existing NIH nutrition research efforts, such as within NIDDK, NHLBI, and NCI, among others, as well as with USDA, CDC, FDA, DoD, VHA, and NASA, among others. Rather than “silo-ing” nutrition research, NIN would help craft strategies and focus areas that span across, support, and/or are not covered by specific interest areas of other federal nutrition research efforts. A new NIH National Advisory Council on Nutrition Research—comprising research experts, health professionals, and community members—would advise the HHS Secretary, NIH Director, and NIN Director on matters related to the NIN's mission.\nTABLE 4 Key strategies within the NIH for strengthening and accelerating national nutrition research1\nOption Description Advantages Disadvantages Paths forward\nNew National Institute of Nutrition (NIN)2 Leads research, coordination, training, outreach on foundational and cross-cutting topics in nutrition and health\nAdditive focus areas and funding to existing NIH and other federal nutrition research efforts\nHarmonizes and leverages other nutrition and related research at NIH and other agencies and departments\nStrong partner to inform, collaborate on, and help address joint research needs of other departments and agencies, e.g., USDA, FDA, CDC, DoD, VA, USAID, and CMS\nPromotes and supports training of a diverse 21st century nutrition research workforce\nGuides and supports training of health care professionals for clinical care and basic and translational science in nutrition\nTranslates and disseminates sound nutrition science findings to the public\nFosters innovative external collaborations and partnerships Strong leadership, robust infrastructure, and investment\nCan better address nutrition science that is cross-cutting rather than disease specific\nIncludes extramural and intramural research, training, and outreach activities\nA long-term structure, leading to unanticipated positive returns, outlasting shorter-term options, and evolving appropriately with changing science and needs of the US population\nMeaningful external advisory mechanism to solicit diverse relevant insights and input\nStrong return on investment, in line with or exceeding other NIH research investments Requires new, additive appropriations to prevent reductions in any ongoing NIH or other federal nutrition research\nCould increase silo-ing of nutrition research\nWould need to navigate potentially entrenched cultures and perspectives around NIN nutrition research\nWithout new appropriations, could increase competition for resources Congress establishes a new NIN by statute, with dedicated appropriations and updating the current cap on the number of NIH institutes and centers\nCongressional inquiry and/or appropriations could explore the current status of federal nutrition research and potential options including an NIN\nNew NIH Office for Nutrition Research Restores the NIDDK Office of Nutrition Research back into the NIH Office of the Director (within the Division of Program Coordination, Planning, and Strategic Initiatives)\nModeled after the NIH Office of Disease Prevention (ODP), Office of Dietary Supplements (ODS), or Office of Behavioral and Social Sciences Research (OBSSR)\nWould lead efforts to build and coordinate new collaborative relationships and synergies within NIH, with other federal agencies and departments, and with external stakeholders including public-private partnerships to drive nutrition research and innovation\nPlan and coordinate trans-NIH nutrition research initiatives\nLead cooperative efforts to identify and stimulate priority areas of science, provide guidance on rigorous methodology, offer trainings, and increase the impact, visibility, and dissemination of findings\nDirector of the NIH Office of Nutrition Research would also serve as the Associate Director of Nutrition Research Legislation is not required\nElevates the leadership, staffing, resources, and capacities of this important area within and outside NIH\nReestablishes close communication and coordination with the NIH Director and the other divisions and offices within the NIH Office of the Director\nIncreases capacity and expertise for dissemination of sound nutrition science\nCan engage strong external advisory mechanisms\nSome dedicated funding to stimulate research across NIH\nNot viewed as serving only one institute\nAbility to transition to an NIH center and/or institute over time Size and resources of such an office remain relatively limited for substantially needed strategic planning, cross-governmental collaboration, public communication, assistance with the DGAs, DRIs, and national monitoring and surveillance, food and nutrition regulatory activities, and external partnerships\nInsufficient independent funding to stimulate major extramural or intramural research\nInadequate authority and resources to support new national training of scientists and health care professionals\nBudgets, staff sizes, and influence can vary widely between offices and fluctuate over time NIH Director has discretion to restore this office into the NIH Office of the Director\nCongress can authorize (ideally with new appropriations) the creation of this office within the NIH Office of the Director\nNew Trans-NIH Initiative(s) in Nutrition Research An initiative across multiple NIH institutes and centers around a specific focused priority research topic\nModeled after several examples such as the BRAIN Initiative, “All of Us” Research Program, or the NIH Human Microbiome Project\nCan be supported by dedicated staff within NIH and other federal working groups\nDedicated funding to support intramural and extramural research, training, and technology development\nCan help create new or enhanced public–private partnerships Legislation is not required\nHelps galvanize NIH around a key topic\nOften preceded by a comprehensive and separately useful review of relevant leadership, staffing, funding, external advisory mechanisms, and collaborative approaches available across NIH\nBrings new strategic planning, workgroups, funding opportunities, training, and technology development\nValuable when combined with other NIH options, above Only covers one focused topic, while needs and opportunities across nutrition research are broad and complex\nUnlikely to provide the sustained leadership, coordination, and resources to grasp the critical science gaps and opportunities\nGenerally time-limited and not sustained Can be established by the NIH Office of the Director with support from the NIH Common Fund\nCan be established by Congressional authorization and appropriations\n1 These strategies include key organizational structures successfully used within NIH (322). Importantly, these different options are not mutually exclusive, but can be implemented in combination to create synergies and leverage complementary strengths. CMS, Centers for Medicare and Medicaid Services; DGAs, Dietary Guidelines for Americans; DoD, Department of Defense; USAID, US Agency for International Development; VA, Department of Veterans Affairs.\n2 A new NIH National Center for Nutrition Research (NCNR) could also be proposed, broadly similar to the proposed NIN but on a smaller scale—for example, modeled after the path of the Office of Research on Minority Health (ORMH) within the NIH Office of the Director (Public Law 103–43) that led to the National Center on Minority Health and Health Disparities (NCMHD) (Public Law 106–525) that led to the National Institute on Minority Health and Health Disparities (NIMHD) (Public Law 111–148) (see Supplemental Text 3). NIN would expand the knowledge base of research on diet-related illnesses and their intersections with other fields through strategic planning, coordination, and evaluation of NIH nutrition research and through conduct and support of research in nutrition science and related areas. Relevant cross-cutting areas of focus could include many priority areas from genetic, molecular, and biological science to clinical, behavioral, and translational research, as well as research on health systems, workforce development, and health equity (Table 2). NIN's efforts would support, expand, and amplify key science relevant to other NIH institutes, centers, and offices, such as on nutrition and diabetes, obesity, cardiovascular disease, cancer, brain health, minority health and disparities, child health, and more. Within NIH, NIN would represent a natural authority and partner to support and coordinate cross-cutting intramural research that complements existing nutrition research portfolios across NIH. NIN would also promote and support the training of a diverse 21st century nutrition science workforce, including in cross-disciplinary priority areas like quantitative methods, personalization, and technology. Given NIH's roles in supporting training of health care professionals, NIN would also guide and support innovative programs to build a cadre of well-trained health professionals for both clinical care and basic and translational science in nutrition (269, 323).\nNIN would provide required leadership, staff, expertise, and resources to build meaningful partnerships on nutrition-related activities and research priorities of other federal departments and agencies, in particular USDA as well as FDA, CDC, DoD, VA, USAID, and CMS, among others. For example, this role could include development of joint requests with USDA for applications investigating the interlinkages between food, nutrition, health, and agricultural practices. NIN would support the efforts of HHS ODPHP in the USDA–HHS partnership to review evidence and, importantly, address new scientific needs for the DGAs. NIN would similarly support collaborative new science to inform the DRIs, FDA food safety and regulatory activities, USDA nutrition assistance programs, CDC surveillance and public health activities, USAID priorities, and DoD and VA research needs for US active-duty forces (including enhanced human performance and military readiness), military families, and veterans. NIN would inform and support CMS and CMMI efforts, such as “Food is Medicine” interventions to reduce diet-related illness and associated health care costs (268, 324, 325). Such joint initiatives will have the greatest impact if nutrition research at these other departments and agencies were simultaneously strengthened with new investments. NIN would also lead and have the required staff capacity to engage meaningfully in public–private partnerships and with nonprofit organizations and international entities such as the WHO and World Bank.\n\nAdvantages\nNIN would add strong authority, infrastructure, investment, and external advisory mechanisms for nutrition research to the nation's largest funder of science. NIN would require a Federal Advisory Committee (Council) and would have a budget and funding authority. NIN would allow NIH to better address nutrition science that is cross-cutting rather than disease-specific, both across institutes, centers, and offices within NIH and with other federal departments and agencies. For example, the NIN would be instrumental in implementing and achieving the goals of the new 2020–2030 Strategic Plan for NIH Nutrition Research (129). As a long-term structure, NIN's activities and benefits would provide both expected and unexpected returns over many decades, outlasting shorter-term options such as cross-agency initiatives and changing priorities of individual administrations, and evolving appropriately with changes in science, food systems, nutritional needs, and disease conditions of the US public. A new institute could help maintain the strength of NIH focus on laboratory and clinical research in nutrition while, at the same time, facilitating expansion to research efforts to other translational priorities across NIH and across other federal departments and agencies. As has been seen with NIH research overall, NIN's coordinated leadership, structure, and capacity would likely provide a strong ROI to the US economy. The combination of NIN plus a new cross-governmental approach (Table 3) would provide a powerful strategy to address the scope and scale of the challenges and opportunities we face as a nation.\n\nDisadvantages\nThe addition of a new institute would require legislative action to increase the current limit of 27 NIH institutes and centers (Public Law 109–482) and provide additive new appropriations to prevent reductions in any ongoing NIH or other federal nutrition research. NIN could increase silo-ing of nutrition research or divestment in nutrition research from other parts of NIH, which has historically been and should remain a component of almost all NIH institutes, offices, and centers. Even with a remit to coordinate and complement existing efforts, a new institute would need to navigate potentially entrenched cultures and perspectives around the “home” of certain areas of research. Congressional appropriations for expanded nutrition research funding within and outside NIH would be needed to prevent increased competition for resources.\n\nPath forward\nCongress can authorize the establishment of NIN, updating the cap (Public Law 109–482) on the total number of NIH institutes and centers and providing new, additive appropriations to NIH. As an intermediary step, Congress could submit an inquiry to appropriate federal departments and agencies, host hearings, as well as appropriate funds, to explore the current status of federal nutrition research and potential options including the NIN.\n\nNew National Center for Nutrition Research\nAs a smaller model than a new institute, a new NIH National Center for Nutrition Research (NCNR) could be created, representing a 28th institute or center at NIH that would be broadly similar to a new NIN, although with less stature, staff, and funding (Supplemental Text 3). The NCNR could aim to accomplish many of the same goals as an NIN, on a lesser scale. Advantages, disadvantages, and the path forward for NCNR are likewise similar, on a reduced scale, to NIN. Long term, the NCNR could further evolve into an institute, as has happened to other centers at NIH. However, if a research area is of sufficient national priority that it may transition into an institute within a decade or less, then starting as a center can be inefficient, compared with directly creating an institute. For example, both the National Institute of Minority Health and Health Disparities (NIMHD) and National Institute of Nursing Research (NINR) were founded as centers but transitioned into institutes within ≤10 y (Public Laws 111–148, 99–158, 103–43).\n\nNew NIH ONR within the NIH Office of the Director\nThis option would return ONR to the NIH Office of the Director (Supplemental Figure 9) (326), the central entity for setting NIH policy and planning and for managing and coordinating NIH programs and activities (327). Multiple offices and divisions within the NIH Office of the Director function together to identify opportunities and needs across the agency (328). The NIH ONR can be modeled after other Congressionally mandated offices within the NIH Office of the Director (see “Path forward” below). Each of these lead and coordinate trans-NIH efforts, guided by an Office director, dedicated expert staff (ranging from 15 to 30 full-time employees), and specific budgetary resources. Like the NIH Office of Disease Prevention Director who also serves as the Associate Director for Prevention (Public Law 99–158), the Director of the NIH ONR would also serve as the Associate Director for Nutrition Research.\nThe NIH ONR would lead efforts to build and coordinate new collaborative relationships and synergies within the NIH, with other federal departments and agencies, and with external stakeholders including public–private partnerships to drive nutrition research and innovation. The NIH ONR would lead cooperative efforts to identify and stimulate priority areas of science, provide guidance on rigorous methodology, offer trainings, and increase the impact, visibility, and dissemination of findings. The new office would plan and coordinate relevant trans-NIH initiatives (see below), such as supported by the NIH Common Fund, a “venture” fund within the NIH Office of the Director, which aims to propel high-risk, high-reward research to speed scientific discovery and translation to improve health at a faster pace (329). The new office would develop approaches and resources to support analyses and reporting of nutrition research portfolios across NIH.\n\nAdvantages\nRestoring the ONR into the NIH Office of the Director would elevate the leadership, staffing, resources, and capacities of this important area within and outside NIH. This structure would reestablish close communication and coordination with the NIH Director, other divisions and offices within the NIH Office of the Director, and the nutrition activities across all the NIH institutes and centers. This is particularly important for identification and prioritization of concrete, timely research focus areas, given the breadth of areas and topics touched by nutrition. This office would have some dedicated funds to help stimulate priority research across NIH and encourage NIH institutes, centers, and other offices to direct or pool their funds toward common priority areas and would not be dependent on or viewed as serving any single institute. This office could help stimulate new, flexible appropriations for the NIH Office of the Director to focus broadly on nutrition priority areas, outside the Common Fund per se.\nIn addition to research strategy and harmonization, the new office director and staff (including communications specialists, present in other similar NIH Office of the Director Offices) would increase capacity and expertise for dissemination of nutrition science to the public and other stakeholders. This office could engage strong external advisory mechanisms, strengthening input from other federal departments and agencies, academic institutions, advocacy groups, state and local governments, and community members. Based on Congressional prioritization of new national research areas, such an office can transition into a center (e.g., National Center for Complementary and Integrative Health; Public Laws 103–42, 105–277, 113–235) or an institute (e.g., NINR, Public Law 103–43; NIMHD, Public Laws 103–43, 106–525, 111–148).\n\nDisadvantages\nThe size and resources of such an office would remain limited to coordinating and developing nutrition strategy across all NIH institutes, centers, and offices, inform and collaborate with other federal departments and agencies engaged in nutrition-relevant research and programming, assist with communication to the public, work with ODPHP in the USDA–HHS partnership to develop the DGAs, and meaningfully engage in public–private or other external partnerships. Such an office does not generally have sufficient independent funding to promote major extramural or intramural science. Such an office does not have sufficient authority or resources to support national training of new scientists and health care professionals in nutrition. An office's budget, staff size, and influence can vary widely across offices and over time depending on other NIH priorities.\n\nPath forward\nThe NIH Director has discretion to restore this office into the NIH Office of the Director. Congress can also pass legislation to create a new Office of Nutrition Research within the NIH Office of the Director, similar to other Congressionally mandated offices such as the NIH Office of AIDS Research (Public Law 103–43), Office of Research on Women's Health (Public Law 103–340), Office of Behavioral and Social Sciences Research (330) (Public Law 103–43), Office of Disease Prevention (331) (Public Law 99–158), and Office of Dietary Supplements (332) (Public Law 103–417).\n\nNew trans-NIH initiative(s) in nutrition research\nTrans-NIH initiatives are efforts to promote collaborative research across NIH in a particular area of science. These initiatives can originate from the NIH Director; NIH institutes, centers, or offices; or Congress. Some of these initiatives engage with external stakeholders such as businesses and nonprofit foundations. The funding, leadership, and structures for trans-NIH initiatives tend to vary. Generally, trans-NIH programs utilize the same mechanisms of grant funding that NIH currently offers: research grants (R series), career development awards (K series), research training and fellowships (T \u0026 F series), program project/center grants (P series), and resource grants (various series) (333). NIH currently supports a variety of broad-reaching programs that are trans-NIH in nature; examples include Biomedical Information Science and Technology Institute (BISTI), NIH Blueprint for Neuroscience Research, Research Supplements to Promote Diversity in Health-Related Research, Administrative Supplements to Existing NIH Grants and Cooperative Agreements, New and Early Stage Investigators Policies, Genome-Wide Association Studies, NIH Common Fund, NIH Basic Behavioral and Social Science Research Opportunity Network (OppNet), Presidential Early Career Award for Scientists and Engineers, Stem Cell Information (PECASE), and the Trans-NIH Countermeasures Against Chemical Threats (CounterACT) program (333).\nThe NIH Common Fund has emerged as one approach to support trans-NIH programs and uses the same mechanisms of support. The NIH Common Fund is a specific component of the NIH budget and is managed by the Office of Strategic Coordination/Division of Program Coordination, Planning, and Strategic Coordination/Office of the NIH Director (329). Common Fund programs are short-term (usually ∼5 y), goal-driven strategic investments that are “intended to change paradigms, develop innovative tools and technologies, and/or provide fundamental foundations for research that can be used by the broad biomedical research community” (329). Then, an NIH institute, center, or office or multiple institutes, centers, and offices must continue the support of these time-limited programs.\nAs one example, the NIH Human Microbiome Project was a trans-NIH initiative supported by the NIH Common Fund from 2007 to 2016 (334). This project aimed to expand science on the microbiome. Initially funded as an initiative of the NIH Roadmap for Biomedical Research, the NIH Human Microbiome Project was originally established as a 5-y project with a budget of $150 million (335). The project began with a “jumpstart” phase in 2007 and a set of grants was funded in mid-2009 and additional demonstration project grants were awarded. These activities were supported by a Data Analysis and Coordination Center and a set of additional grants was awarded for developing new technologies, new software tools, and studying the ethical, legal, and social implications of this work. The grantees worked together in a highly cooperative consortium. Ultimately, this 10-y $215 million project spanned \u003e20 of the NIH institutes, centers, and offices and resulted in a \u003e40-fold increase in nonproject investment in microbiome research (336). That is, individual or multiple institutes, centers, and offices used program announcements or request for applications. Some of these funding mechanisms were supported by the Common Fund and others were additional commitments by the participating NIH institutes, centers, and offices from their own budgets. The Trans-NIH Microbiome Working Group established in 2012 provided a forum for coordinating NIH extramural research activities related to the human microbiome and continues to coordinate this work after the NIH Human Microbiome Project was completed. Notably, the NIH Human Microbiome Project identified several potential priority areas around food and the microbiome, but these topics have not yet been systematically pursued.\nThe Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative is an example of a trans-NIH initiative (337), supported by staff within NIH and across federal working groups and providing funding for intramural and extramural research, training, and technology development. Between 2013 and 2019, this initiative supported \u003e700 research projects totaling ∼$1.3 billion through support across the NIH, including appropriations through the 21st Century Cures Act (Public Law 114–255) (337). The BRAIN initiative is managed by 10 NIH institutes and centers, with coordination at multiple levels. Extramural program staff and institute and center directors meet regularly to integrate strategic planning, management, and a BRAIN Multi-Council Working Group and Neuroethics Working Group provide further input on a variety of issues.\nAnother trans-NIH example is the All of US Research Program (Public Law 115–31), directly supported through annual appropriations from Congress ($1.5 billion over 10 y) (Public Law 115–31). This initiative, supported and overseen by NIH, arose from recommendations by the NIH's Precision Medicine Initiative Working Group of the Advisory Committee to the Director (338). The program staff are based in the NIH Office of the Director, with a Trans-NIH Liaisons Coordinating Team made up of scientific leaders from across NIH and has an external advisory panel.\nA potential trans-NIH program in Precision Nutrition is being considered as an NIH Common Fund program for fiscal year 2021 (131, 339), and the NIH Director included Precision Nutrition in the NIH's congressional budget justification for fiscal year 2021 (131). A new Program Director in the NIDDK ONR was hired in 2020 to lead this initiative.\n\nAdvantages\nLegislation is not required. A trans-NIH initiative can help galvanize NIH to develop a coordinated approach to a specific topic on nutrition and human health (e.g., see Table 2). Such an effort would generally be preceded by a careful—and separately useful—review of relevant NIH leadership, staffing, funding, external advisory mechanisms, and collaborative approaches available. A trans-NIH initiative brings new strategic planning, working groups, funding opportunities, training, and technology development. A trans-NIH initiative is complementary to other NIH and cross-governmental strategies to strengthen federal nutrition research. Such initiatives can also help build new or enhanced public–private partnerships.\n\nDisadvantages\nThe needs and opportunities across nutrition research are broad and complex, and a new trans-NIH initiative would cover 1 focused topic, such as, if funded, precision nutrition. Addressing the science gaps and opportunities for nutrition—a leading cause of disease in the US—will require greater and more sustained authority, coordination, resources, and collaboration than provided by a single initiative, especially one only limited to precision nutrition. Trans-NIH initiatives are generally time-limited, difficult to sustain, and not easily communicated to a broad range of external stakeholders. The long-term success of such initiatives can be dependent on a single leading NIH institute, center, and/or office to commit to carry that area of work forward after the initial investments.\n\nPath forward\nThe NIH Director could propose new trans-NIH budget initiatives for Congress to review; as noted earlier, Precision Nutrition is proposed in NIH's congressional budget justification for fiscal year 2021 (131). Congress could authorize and appropriate funds for this proposed initiative or put forth support for another or additional trans-NIH initiative(s) focused on ≥1 areas of nutrition research. NIH institutes, centers, and offices can develop and collectively support trans-NIH initiatives. 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