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<title>Resources For R21 Reviewers</title>
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<td class="title" align="center"><br />QUICK REVIEW GUIDE<br />R21 EXPLORATORY/DEVELOPMENTAL GRANTS<br /><br /></td>
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<td><span class="bodytext">PURPOSE: The National Library of Medicine (NLM) supports the use of the National Institutes of Health (NIH) Exploratory/Developmental Research Grant Award (R21) mechanism for exploratory/developmental research projects in biomedical informatics, biotechnology information, and health sciences library and information science. The R21 is intended to encourage exploratory and developmental research projects by providing support for the early and conceptual stages of these projects.<br /><br />SCOPE: The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models or applications that could have major impact on a field of biomedical, behavioral, or clinical research. Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.<br /><br />MECHANISM OF SUPPORT: This PA uses the NIH R21 mechanism. The applicant may request a project period of up to two years with a combined budget for direct costs of up $275,000 for the two year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 may be requested in any single year. Exploratory/developmental grant support is for new projects only; competing continuation applications will not be accepted.<br /><br />Application Instructions: Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 15 pages. No preliminary data are required. Use the instructions for the appendix detailed in the PHS 398 except that no more than 5 manuscripts, previously accepted for publication, may be included.<br /><br />ELIGIBLE APPLICANTS: For-profit or non-profit organizations; Public or private institutions, such as universities, colleges, hospitals, and laboratories; Units of state and local government; Eligible agencies of the Federal government; Domestic or foreign. Both new and experienced investigators may apply.<br /><br />NIH REVIEW APPROACH The R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools or technologies that have significant potential. An exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly,</span>
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<ul>
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<li><span class="bodytext">Reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding.</span></li>
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<li>Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications including supportive preliminary data.</li>
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<li>Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.</li>
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<li>Preliminary data specific to the proposed project are not expected, but data demonstrating feasibility are desirable. Novel and creative approaches are essential. Formative evaluation is acceptable.</li>
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<li>The R21 exploratory/developmental mechanism of grant support is intended to enable an investigator to explore the feasibility of an innovative research question or approach. Such work is not necessarily hypothesis-driven.</li>
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</ul>
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NIH REVIEW CRITERIA
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<ul>
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<li>Significance. Is the research likely to provide a foundation for a new research area or have potential for wide applicability? Does this represent a groundbreaking, precedent-setting research topic that clearly requires additional preliminary data for its potential to be assessed?</li>
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<li>Approach. Are the approaches and methods adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For technology development projects, are the milestones sufficiently specific and quantitative to guide both the research and subsequent evaluation of success or failure of the proposed concept?</li>
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<li>Innovation. Does the applicant propose new approaches or explore new approaches or are extant informatics approaches or concepts applied to disaster management in novel ways?</li>
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<li>Investigators. Are the PI and key personnel appropriately trained in their disciplines and capable of conducting the proposed research?</li>
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<li>Environment. Does the scientific and technological environment in which the work will be done contribute to the probability of success? Does the proposed research take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of other support that will contribute to the success of the research?</li>
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</ul>
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NLM REVIEW CRITERIA: The relevance of the proposed work to the expressed NLM interests should be described. The significance, importance, or potential impact of proposed research should be clearly discussed, and the procedures, data analyses, and expected conclusions should be well described. Applications should include the following elements:
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<ul>
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<li>Does the proposed research represent a change in research focus or a new research direction for the laboratory that requires feasibility pilot studies, or is the proposed research the logical continuation of ongoing research efforts?</li>
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<li>In the case of research that is hypothesis-driven, will the successful outcome of the proposed studies likely generate sufficient data to pursue follow-up studies and lead to a full-scale research grant application?</li>
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<li>In the case of proposed research that is either technology-driven or design- driven, will the project generate a body of data, a technological advance or product that will be useful to the disaster management community?</li>
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<li>How will the successful completion of the proposed studies impact the concepts, methods, or technologies that drive the field?</li>
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</ul>
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<p class=”margin-top-5”><small>Last Reviewed: November 25, 2022</small></p>
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