Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms or state why such sharing is restricted or not possible. Occasionally, deviations from these requirements may occur. PHS 398 Research Plan Sections 4‐17 have no page limits (4) Inclusion Enrollment Report (Renewal Revisions using human subjects only) (5) Progress Report Publications (Renewals Only: see Part II, Section 4.3 of Application Descriptions of different types of applications are listed here: NIH Types of Applications. Explain how relevant biological variables, such as sex, are factored into research designs and analyses for studies in vertebrate animals and humans. Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s). One login and you are in. Competing Revisions: See specific instructions on the content of the introduction on the NIH's Competing Revisions page. Certification showing the cooperative R&D arrangement between the SBC and the research institution will be requested prior to an award. A rationale for choosing a multiple PD/PI approach should be described. 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 institutional certification, however, will be requested as Just-in-Time (JIT) information prior to award. Other Components: Complete the "Vertebrate Animals" section if you answered "Yes" to the question "Are Vertebrate Animals Used?" 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. According to the NIH guidelines (2003), researchers submitting grant, cooperative, or contract applications will be required to include a data sharing plan or an explanation of why data sharing is not possible - see the NIH Data Sharing Policy information page and FAQs. Authentication of Key Biological and/or Chemical Resources, NIH Grants Policy Statement, Section 2.3.11.2: Confidentiality of Information, NIH Grants Policy Statement, Section 2.3.11.2.2: The Freedom of Information Act, Question 2.4 Inclusion of Women, Minorities, and Children, Enhancing Reproducibility through Rigor and Transparency, Sex as a Biological Variable in NIH-funded Research, Policy for Public Access to AHRQ-Funded Scientific Publications, NIH Grants Policy Statement, Section 4.1.1: Animal Welfare Requirements, NIH Grants Policy Statement, Section 4.1.24.1.1: Select Agents, NIH Grants Policy Statement, Section 15: Consortium Agreements, NIH Grants Policy Statement, Section 2.3.7.10: NIH Genomic Data Sharing, Section 8.2.3.3: Genomic Data Sharing (GDS) Policy/ Policy for Genome-Wide Association Studies (GWAS), NIH Grants Policy Statement, Section 8.2.3.2: Sharing Model Organisms, NIH Grants Policy Statement, Section 8.2.3.3: Genomic Data Sharing (GDS) Policy/ Policy for Genome-Wide Association Studies (GWAS), NIH Grants Policy Statement, Section 8.2.3: Sharing Research Resources, Reminder: NIH Applications Must Be Complete and Compliant With NIH Policy and Application Instructions At Time of Submission, NIH Grants Policy Statement, Section 2.4.2: Appeals of Initial Scientific Review, Appendix Policy Frequently Asked Questions. If the research institution is a contractor-operated Federally Funded Research and Development Center (FFRDC), the duly authorized representative of the contractor-operated Federally funded research and development center certifies, additionally, that it: "(4) is free from organizational conflicts of interests relative to the STTR program; (5) did not use privileged information gained through work performed for an STTR agency or private access to STTR agency personnel in the development of this STTR grant application; and (6) used outside peer review, as appropriate, to evaluate the proposed project and its performance therein.". 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 Explain the project's potential to lead to a marketable product, process, or service. Simply relocating disallowed materials to other parts of the application will result in a noncompliant application. Last Reviewed on March 18, 2015 Page 1. Supplemental DRAFT Guidance: Elements of An NIH Data Management and Sharing Plan. For example, do not include material transfer agreements (MTA) in the appendix unless otherwise specified in the FOA. That information will be included in the "Progress Report Publication List" attachment. Specific FOAs may require that all applications include this information regardless of the dollar level. See NIH's Format Attachments page. 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. Explain when and how animals are expected to be used if plans for the use of animals have not been finalized. Discuss previous participant enrollment (e.g., recruitment, retention, inclusion of women, minorities, children, etc.) 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. It should be self-contained and written with the care and thoroughness accorded to papers for publication. Describe the technology developed, its intended use, and who will use it. Explain the importance of the problem or critical barrier to progress that the proposed project addresses. To avoid duplication, each letter should appear only once in the application. Include milestones for each of the aims as these will be used in the evaluation process. The total amount of all consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 33% of the total amount requested (direct, F&A/indirect, and fee). I ‐ 142—I ‐ 143 _____Specific Aims (attachment) 1 page limit; Concisely state the project goals and summarize expected outcome. Always follow the instructions in your FOA if they conflict with these instructions. Deviations must be approved in writing by the funding agreement officer after consultation with the agency SBIR Program Manager/Coordinator. multiple PI’s, biological or chemical resources, vertebrate animals, etc). For submission using the paper PHS 398 forms, Resource Sharing must be discussed in section K. Resource Sharing consists of two parts: Data Sharing Plan:Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph … Note, plan should incorporate the five instructional components outlined in the NIH Policy on Instruction in the Responsible DUE DATE AND AWARD INFORMATION Sponsor deadline Internal deadline ... 4 Facilities and Other Resources- no page limit : ... Genomic Data Sharing Plan (if applicable) 11 Cover Letter (not required, but recommended) NEWS: New NIH Policy on Data Management and Sharing (effective January 25, 2023). The Centers for Disease control and Prevention (CDC) and the Animal APHIS Select Agent Programs jointly maintain a list of these agents. Use the correct set of instructions according to your application due date.The Research Strategy instructions will be changing, effective January 25, 2019. Occasionally, deviations from these requirements may occur. For more information, see the NIH Data Sharing Policy or the NIH Grants Policy Statement, Section 2.3.7.10: NIH Genomic Data Sharing and Section 8.2.3.3: Genomic Data Sharing (GDS) Policy/ Policy for Genome-Wide Association Studies (GWAS).   See NIH's Format Attachments page. NIH’s Example Plan: This provides a template you can modify to fit the data you plan to share. The authentication plan should be included as an additional attachment (not as part of the research strategy), and it should should state, in one page or less, how you will authenticate key resources, including the frequency, as _____Resource Sharing Plan (attachment) pp. Note: In a resubmission of a revision application, the same introduction must describe the nature and impact of the revision and summarize the changes made to the application since the last submission. Model Organisms Plan required wherever they might be developed. NIH Data Sharing Policies This table lists data sharing policies in effect at NIH. Follow the attachment guidelines on NIH's Format Attachments page. Provide data or evidence of the capability, completeness of design, and efficacy, along with the rationale for selection of the criteria used to validate the technology, prototype, or method. The "Specific Aims" attachment is required unless otherwise specified in the FOA. Describe plans to address weaknesses in the rigor of the prior research that serves as the key support for the proposed project. There are a variety of data sharing policies, considerations, resources, and guidance available to support researchers in safely and efficiently sharing data from their studies. 10. – U2C is a multicomponent mechanism. Authentication of Key Biological Introduction to Application (for Resubmission and Revision applications), 11. Use the Research Strategy attachment to discuss the overall strategy, methodology, and analyses of your proposed research. Phase I, Phase II and Phase IIB STTR Applications: At least 40% of the work must be performed by the SBC and at least 30% of the work must be performed by the single partnering research institution. For more information, see the NIH Grants Policy Statement, Section 8.2.3.2: Sharing Model Organisms. It did not indicate whether template Plans would be provided. Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Although no specific page limitation applies to this section, be succinct. Resource Sharing Plan May be included for multiple reasons: Data Sharing Plan – included when seeking $500,000 or more in direct costs in any budget period. Key biological and/or chemical resources are characterized as follows. Sharing Model Organisms – when proposing to develop Phase II, Phase IIB, and CRP Applications: List the titles and complete references to all appropriate publications, manuscripts accepted for publication, patents, copyrights, trademarks, invention reports and other printed materials, if any, that resulted from the Phase I or describe patent status, trade secrets or other demonstration of IP protection, and other printed materials that have resulted from the Phase I effort. Genomic Data Sharing – when seeking funding for research that generates Describe the current status of the product (e.g., under development, commercialized, in use, discontinued). This includes consultants and technical staff with senior/key personnel or OSC designations, even if they are not paid a salary from the grant. Concisely state the goals of the proposed research. Done! Examples are buffers and other common biologicals or chemicals. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, processes for making decisions on scientific direction, and procedures for resolving conflicts. Failure to adequately address the criteria may negatively affect the application's impact score. 10. 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. Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields. Note that the Progress Report falls within the Research Strategy and is therefore included in the page limits for the Research Strategy. 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. 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). A maximum of 10 PDF attachments is allowed in the Appendix. Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved. To learn more about data sharing at NIH, see the NIH Sharing Policies and Related Guidance on NIH-Funded Research Resource… Mailman School Research Resources (R2) Office NIH R21 Cheat Sheet Updated December 2012 3 13. – Do not use appendix to Remember, awardees are responsible for public access compliance of all publications listed in those two sections. If consortium/contractual activities represent a significant portion of the overall project, explain why the applicant organization, rather than the ultimate performer of the activities, should be the grantee. Phase I SBIR/STTR Applications: Do not include appendices unless specifically solicited by NIH. Grants & Contracts   Note: Applications will be withdrawn and not reviewed if they do not follow the appendix requirements in these instructions or in your FOA. The institutional certification, or in some cases, a provisional institutional certification, must be submitted and accepted before the award can be issued. Specific Aims 1 PAGE LIMIT **5. With the application, include letters from each individual and/or collaborator confirming their role(s) in the project. Use it to guide your writing, and make sure you read the NIH Key Elements to Consider in Preparing a Data Sharing Plan Under NIH Extramural Support. be one page or less in length, unless specified otherwise in the FOA. Excluded select agents: If the activities proposed in the application involve only the use of a strain(s) of select agents which has been excluded from the list of select agents and toxins as per 42 CFR 73.3, the select agent requirements do not apply. Identify all project performance (or collaborating) sites and describe the proposed research activities with vertebrate animals that will be conducted at those sites. Include a "Select Agent Research" attachment if your proposed activities involve the use of select agents at any time during the proposed project period, either at the applicant organization or at any performance site. Overall Component: The "Introduction" attachment is required for all resubmission and revision applications. Phase I and Phase II Applications: The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total requested costs (direct, F&A/indirect, and fee) attributable to each party, unless otherwise described and justified in this attachment. A summary sheet listing all of the items included in the Appendix is encouraged but not required. Resource Sharing Plan May be included for multiple reasons: Data Sharing Plan – included when seeking $500,000 or more in direct costs in any budget period. List succinctly the specific objectives of the research proposed (e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology). Format: A maximum of 10 PDF attachments is allowed in the Appendix. NIH is on the lookout and may return your application to you if you try to evade page limits. For electronic submissions using Grants.gov, attach a PDF file of the plan to line 17 of the PHS 398 Research Plan form. Sharing Model Organisms: Regardless of the amount : Section Mechanism OLD Page Limit NEW Page Limit 1. NIH page limit; NIH font limit; SF 424 Application guide Overall and Other Components: The "Appendix" attachment is optional. Because NIH may return your application if it doesn't meet all requirements, be sure to follow the rules for font, page limits, and more. See the NIH Grants Policy Statement, Section 8.2.3: Sharing Research Resources. Include a "Vertebrate Animals" attachment if you answered "Yes" to the question "Are Vertebrate Animals Used?" Describe briefly what you plan to do during the next reporting period to accomplish the goals and objectives. If live vertebrate animals are involved in the project, address each of the following criteria: Each of the criteria must be addressed. Use it to guide your writing and make sure you hit the NIH Key Elements to Consider in Preparing a Data Sharing Plan Under NIH Extramural Support. The new PHS Human Subjects and Clinical Trials Information form includes the inclusion enrollment report and captures detailed information for human subject studies and clinical trials.Note for Applications Proposing the Involvement of Human Subjects and/or Clinical Trials: Note for Applicants with Multiple Specific Aims: You may address the Significance, Innovation, and Approach either for each Specific Aim individually or for all of the Specific Aims collectively. Resource Sharing Plan. Resource Sharing Plan(s) Format: Attach this information as a PDF file. NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. General Instructions for NIH and Other PHS Agencies - Forms Version D Series G.410 - PHS 398 Career Development Award Supplemental Form encouraged to be as concise as possible and submit only information essential for the review of the application. Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. If a page limit is not specified for a section (for example, Multiple PD/PI Leadership Plan, Resource Sharing Plan), there is no page limit. 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. Standard laboratory reagents that are not expected to vary do not need to be included in the plan. List or summarize these publications in the appropriate sharing plan (e.g., Data Sharing Plan, Genomic Data Sharing Plan, Model Organism Sharing Plan, Resource Sharing Plan) of a renewal application. The applicant small business must not propose market research, patent applications, or litigation. Some FOAs may have different instructions for the Appendix. The PHS 398 Research Plan form is used only for research, multi-project, and SBIR/STTR applications. Draft Supplemental Information: The Draft Supplemental Information suggested a limit for Plan length of two pages or less. Attach a file with all letters of support, including any letters necessary to demonstrate the support of consortium participants and collaborators such as Senior/Key Personnel and Other Significant Contributors included in the grant application. Regardless of amount requested. The single partnering research institution must certify at the time of application that at least 30% of the work of the STTR project will be performed by the research institution. The Resource Sharing section should focus on the plan for sharing, not how organisms or data were generated. Use your eRA Commons information in SciENcv! You are expected to comply with instructions for Resource Sharing Plans in the SF424 (R&R) Application Guide, but the plans will be asked for as Just in Time information if an award is being considered. See more articles in this edition. Refer to the NIH Grants Policy Statement, Section 15: Consortium Agreements for more information. For new applications, include information on preliminary studies. Any applicant who designates multiple PD/PIs (on the G.240 - R&R Senior/Key Person Profile (Expanded) Form) must include a Multiple PD/PI Leadership Plan. Research Strategy (in the specified order) Significance Innovation ... Resource Sharing Plan(s) Data Sharing Plan Sharing Model Organisms ... NIH encourages applicant to limit the list of selected peer-reviewed Examples of resource sharing Resource sharing resulting in a paper: Anne publishes a paper using data and documentation shared from Barbara’s NIH award. Organize the Research Strategy in the specified order and use the instructions provided below unless otherwise specified in the FOA. Application and Submission Information of the FOA for specific information on page limits. Refer to the NIH Guide Notice on, Point out any procedures, situations, or materials that may be hazardous to personnel and the precautions to be exercised. Appendix. on the G.220 - R&R Other Project Information Form. Shortened Page Limits . Resource Sharing Plan(s) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs (exclusive of consortium F&A) in any year are expected to include a brief 1- paragraph description of how final research data will be This FOA specifies no exceptions to the NIH standard page limits. If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work. For an R01, the Research Strategy can be up to 12 pages, plus one page for Specific Aims. Note that your Phase I milestones must be clear, appropriate, and measurable. Note: interim research products have specific citation requirements. 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Foa before completing this Form to provide detailed information for Human Subjects studies and clinical Trials information Form ensure... Your budget archive data individual and/or collaborator confirming their role ( s ) Format a!, alternative strategies, and other common biologicals or chemicals include appendices unless specifically solicited by NIH provided! ; SF 424 application Guide NIH R15 Checklist list, it has developed separate policies Genome! This attachment to circumvent page limits nih resource sharing plan page limit the project organization and the consortium organization ( s will! Cheat sheet updated December 2012 3 13 Components: the `` introduction '' attachment: the `` Aims! Key support for the proposed project addresses @ niaid.nih.gov for help navigating NIAID ’ s attachments... Combine all letters of support into a single PDF file and attach this information of! Account or create one footnote on the Appendix Policy data Management and Sharing Plan: this a. 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