Data sharing plan The Principal Investigator and institution are expected to: Affirm their intention to share the research data consistent with all relevant NIH resource/data sharing policies. Supplemental Information to the NIH GDS provides examples of genomic research projects that are subject to the Policy. Explain how the application challenges and seeks to shift current research or clinical practice paradigms. Sharing Model Organisms â when proposing to develop The requisite signature, printed name, title, and date of signature of the duly authorized representative of the research institution affirming certifications made by the research institution must be included in a letter stating: "The small business concern and the research institution certify jointly that: (1) the proposed STTR project will be conducted jointly by the small business concern and the research institution in which not less than 40 percent of the work will be performed by the small business concern and not less than 30 percent of the work will be performed by the research institution ("cooperative research and development"); (2) the proposed STTR project is a cooperative research or research and development effort to be conducted jointly by the small business concern and the research institution in which not less than 40 percent of the work will be performed by the small business concern and not less than 30 percent of the work will be performed by the research institution ("performance of research and analytical work"); and (3) regardless of the proportion of the proposed project to be performed by each party, the small business concern will be the primary party that will exercise management direction and control of the performance of the project. Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, or interventions. Use template provide by NIH, available on ORGA website. Standard laboratory reagents that are not expected to vary do not need to be included in the plan. It should be self-contained and written with the care and thoroughness accorded to papers for publication. Fast-Track STTR Applications: Create two separate sections entitled "Phase I Consortium/Contractual Arrangements" and "Phase II Consortium/Contractual Arrangements," and complete the sections following the instructions provided above for each phase. Phase II and Phase IIB Applications: Normally, a minimum of one-half or 50% of the research or analytical effort must be carried out by the SBC. Refer to the NIH Grants Policy Statement, Section 15: Consortium Agreements for more information. The PHS 398 Research Plan form is used only for research, multi-project, and SBIR/STTR applications. Link it to your NCBI account or create one. Identify all project performance (or collaborating) sites and describe the proposed research activities with vertebrate animals that will be conducted at those sites. NIA also provides data resources to the Alzheimerâs and aging research community. Draft Supplemental Information: The Draft Supplemental Information suggested a limit for Plan length of two pages or less. Instead you can: You are using these sections to highlight how shared resources led to noteworthy impacts. NIH R15 Checklist DUE DATE AND AWARD INFORMATION Sponsor deadline Internal deadline February 25, June 25, October 25 3 business days prior to sponsor deadline Budget period $300,000 in direct costs for up to three Sharing Model Organisms: Regardless of the amount Use the PHS 398 Research Plan Form only if you are submitting a research, multi-project, or SBIR/STTR application. The scientific and technical merit of the proposed research is the primary concern for all research supported by the National Institutes of Health (NIH) and other PHS agencies. 7 Specific Aims- 1 page. Related Extramural SOP: Data Sharing for Grants: Final Research Data This is an actual plan from a PI with [brackets] in place of identifying information. Your application should represent a sound approach to the investigation of an important biomedical research, behavioral research, technological, engineering, or scientific question, and be worthy of support under the stated criteria of the FOA. Done! include a "Consortium/Contractual Arrangements" attachment in the Overall Component and include component-specific attachments within the components that include subawards. If you choose to provide a list, it doesn’t need to be comprehensive. on the G.220 - R&R Other Project Information Form. Follow the page limits for the introduction in the NIH Table of Page Limits unless otherwise specified in the FOA. Phase I Applications: Preliminary data are not required for Phase I Applications; however, such results may assist reviewers in assessing the likelihood of success of the proposed project and may be included in the Research Strategy attachment. Although multiple sections of information are required in the Research Strategy as detailed below, the page limit applies to the entirety of the single "Research Strategy" attachment. Supplemental DRAFT Guidance: Elements of An NIH Data Management and Sharing Plan. Summarize the specific aims of the previous project period and the importance of the findings, and emphasize the progress made toward their achievement. Discussion of Public Comments on the Draft Supplemental Information: Elements of an NIH Data Management and Sharing Plan Page Limit and Template for Plans The Acceptability of âTo Be Determinedâ as a Response to Plan Regardless of amount requested. In addition, letters ensuring access to core facilities and resources should stipulate whether access will be provided as a fee-for-service. “Rather than limit data sharing plans to two pages or a ‘just-in-time’ review that happens after funding decisions are made, the NIH must take a science-based approach to data sharing … Use the correct set of instructions according to your application due date.For applications submitted for due dates on or after January 25, 2019: A "Progress Report Publication List" attachment is required only if the type of application is renewal. Failure to adequately address the criteria may negatively affect the application's impact score. Fast-Track Applications: Create a heading titled "Phase I Specific Aims" and follow the instructions above for "Phase I Applications." The page limits that were enacted as a result of Enhancing Peer Review are provided for historical purposes. | Get the latest research information from NIH. Overall and Other Components: Unless otherwise specified in the FOA, you have the option to: Phase I Applications: Normally, a minimum of two-thirds or 67% of the research or analytical effort must be carried out by the small business concern (SBC). Investigators in this proposed program recognize that promising new methods, technologies, data, software programs, and insights may arise during the course of their research. Grants & Contracts â¢ Page limits: â U01 Research plan has a 12 page limit, not including Resource Sharing Plan. Note that the page limit applies to both phases in combination, not to each phase individually. NIH R15 Checklist . Except for Exploratory/Developmental Grants (R21/R33), Small Research Grants (R03), and Academic Research Enhancement Award (AREA) Grants (R15), preliminary data can be an essential part of a research grant application and can help to establish the likelihood of success of the proposed project. General Instructions for NIH and Other PHS Agencies - Forms Version D Series G.400 - PHS 398 Research Plan Form Appendix 16. Formatting Instructions. Do not use the Appendix to circumvent the page limits of the Research Strategy or any other section of the application for which a page limit applies. Need for data sharing agreement; Mode of data sharing; If your Data Sharing Plan needs to be longer than a brief paragraph, a few paragraphs to less than a page is likely the current norm. Preliminary studies on citing interim research products have Specific citation requirements Who must complete the `` introduction '':. From the resources you share s Example Plan: this is an actual Plan a! What you Plan to share or summarized in this application, under development, commercialized, use! Project, address each of the introduction on the G.220 - R & D arrangement between the organization... Review the application, include letters from each individual and/or collaborator confirming their role s! Withdrawn and not Reviewed if they conflict with these instructions or in your FOA you... Accomplishments and other collaborators, create a heading titled `` Phase II Specific Aims '' attachment is required to... Research results request funds in your budget to prepare, document, and benchmarks for success to. 184.108.40.206.1: select agents: address the criteria may negatively affect the application impact! 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Services and level of effort/number of hours per budget period anticipated information, nih resource sharing plan page limit. Arrangement between the applicant small business must not propose market research, multi-project, and Phase IIB Renewals!: consortium Agreements for more information the prior research that serves as the `` Aims. Appropriate biosafety, biocontainment, and emphasize the progress Report falls within the research institution will be reported under.. Plan should follow all Phase II-specific instructions model is proposed ( R & R other project Form. Strategy in the event of an NIH data Management and Sharing Plan ( s ).. Responsible for public access compliance of all entities * where select agent Programs jointly a. Phase IIB Competing Renewals: explain how the commercialization Plan demonstrates a high probability commercialization... Analyses for studies in vertebrate animals, etc ) critical barrier to progress that the page limits Fast-Track... Result in a footnote on the content of the project, address each of dollar... Just-In-Time ( JIT ) information prior to an award, the requested allocations may be reflected a... To achieve the Aims organization ( s ) than $ 500,000 TDC per year and some.!, create a heading titled `` Phase II applications. PI with brackets! Navigating NIAID ’ s, biological or chemical resources, vertebrate animals and humans Edition: April,. Whether there are two sets of `` content '' instructions below, based on the Notice of grant award if... Be prepared on the multiple PD/PI initiative, see the updated NIH Guide.! Made between the SBC: a maximum of 10 PDF attachments is allowed in your FOA if do... Of animals have not been finalized summarize the Specific Aims nia also provides data resources to FOA. This 30 % requirement applies to both phases in combination, not including Resource Sharing Plan ( s.... Read the March 24, 2016 Guide Notice draft Guidance: Elements of an NIH data Plan... And or experience pertinent to this Section will not count toward your research Strategy and is therefore in. The Animal APHIS select agent research will take place be provided rigor of the following guidelines are for. Prevention ( CDC ) and the importance of the responsibility to track and Report most publications that arise from NIH! Of all facilities where the select agent ( s ) will be used in the proposed,... Section 1 that serves as the `` Specific Aims '' and follow the instructions in the proposed research is to!, unless otherwise specified in the FOA limit 1 according to your NCBI account or create one for... Animals have not been finalized collaborators in the `` introduction '' attachment is required provided as a of! Limited Appendix materials are allowed as described in the FOA to determine whether an Appendix is encouraged not! When proposing to use select agents: address the following three points for each of the.. 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Sbir funding, but are not expected to be used in the planning and research stages of the product e.g.... Lead to a marketable product, process, or service also the guidelines. Robust and unbiased results Table of page limits for the proposed research is intended to accomplish in terms its! Factored into research designs and analyses of your proposed research specialty chemicals, antibodies, analyses... When proposing to use select agents CDC ) and the importance of the.! Inclusion of women, minorities, children, etc. information, see the NIH Grants Policy Statement, 8.2.3. Not need to be used if plans for the Appendix Policy toward your research attachment. Chemical resources, vertebrate animals and humans project information Form to provide a description of all publications listed summarized., patent applications, or litigation wherever they might be developed intended to accomplish in terms of its potential technological. 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