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 Standard laboratory reagents that are not expected to vary do not need to be included in the plan. Competing Revisions: See specific instructions on the content of the introduction on the NIH's Competing Revisions page. Overall and Other Components: The "Appendix" attachment is optional. Describe the biocontainment resources available at all performance sites. GENERAL APPLICATION GUIDE FOR NIH AND OTHER PHS AGENCIES, 1. Read all the instructions in the FOA before completing this form to ensure that your application meets all IC-specific criteria. Resource Sharing Plan. Follow the attachment guidelines on NIH's Format Attachments page. For more information, see the. 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 … If applicable to the proposed science, briefly describe methods to ensure the identity and validity of key biological and/or chemical resources used in the proposed studies. An "Introduction to Application" attachment is required only if the type of application is resubmission or revision or if the FOA specifies that one is needed. NIH R15 Checklist . If you choose to provide a list, it doesn’t need to be comprehensive. Appendix Follow all instructions in the Outline a plan to make research findings available to qualified â¦ The Centers for Disease control and Prevention (CDC) and the Animal APHIS Select Agent Programs jointly maintain a list of these agents. Concisely state the goals of the proposed research. The PHS Human Subjects and Clinical Trials Information form will capture detailed study information, including eligibility criteria; inclusion of women, minorities, and children; protection and monitoring plans; and statistical design and power. NIH maintains a list of such journals. Overall and Other Components: Unless specific instructions are provided in the FOA, applicants have the option of including the "Letters of Support" attachment in the Overall Component, Other Components, or both. NIH Data Sharing Policies This table lists data sharing policies in effect at NIH. 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. NIA also provides data resources to the Alzheimerâs and aging research community. Attach this information as a PDF file. Blank data collection forms, blank survey forms, and blank questionnaire forms - or screenshots thereof, Failure of reviewers to address non-required appendix materials in their reviews is not an acceptable basis for an appeal of initial peer review. 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. You are allowed to cite interim research products. Provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for each of the following: If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of their authors, indicate "PMC Journal - In Process." (In general, NIH policy is that for each section of the research plan for a "U" award, applicants may submit additional information: 1 page for each 6 page section, 2 for each section up to a page limit of 12 pages, and for each 30 Grants & Contracts Authentication of Key Biological and/or Chemical Resources, NIH Grants Policy Statement, Section 220.127.116.11: Confidentiality of Information, NIH Grants Policy Statement, Section 18.104.22.168.2: 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 22.214.171.124.1: Select Agents, NIH Grants Policy Statement, Section 15: Consortium Agreements, NIH Grants Policy Statement, Section 126.96.36.199: NIH Genomic Data Sharing, Section 188.8.131.52: Genomic Data Sharing (GDS) Policy/ Policy for Genome-Wide Association Studies (GWAS), NIH Grants Policy Statement, Section 184.108.40.206: Sharing Model Organisms, NIH Grants Policy Statement, Section 220.127.116.11: 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. Include milestones for each of the aims as these will be used in the evaluation process. Resource Sharing Plan(s) 22. Model Organisms Plan required wherever they might be developed. Note on GDS: For proposed studies generating human genomic data under the scope of the GDS Policy, an institutional certification may be submitted at the time of application submission, but it is not required at that time. Describe plans to address weaknesses in the rigor of the prior research that serves as the key support for the proposed project. 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 (attachment) pp. 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. When resources have been developed with NIH funds and the associated research 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). – U2C is a multicomponent mechanism. The University of Delaware is committed to the open and timely dissemination of research outcomes. This form includes fields to upload several attachments, including the Specific Aims and Research Strategy. III. For renewal/revision applications, provide a Progress Report. Phase II, CRP, Fast-Track, and Phase IIB Competing Renewals: Explain how the commercialization plan demonstrates a high probability of commercialization. include a "Consortium/Contractual Arrangements" attachment in the Overall Component and include component-specific attachments within the components that include subawards. Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields. 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. Letters are not required for personnel (such as research assistants) not contributing in a substantive, measurable way to the scientific development or execution of the project. 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 shared, or explain why data-sharing is not possible. Note: The signature of the authorized organization representative in G.200 - SF 424 (R&R), Authorized Representative signifies that the applicant and all proposed consortium participants understand and agree to the following statement: The appropriate programmatic and administrative personnel of each organization involved in this grant application are aware of the agency's consortium agreement policy and are prepared to establish the necessary inter-organizational agreement(s) consistent with that policy. This includes consultants and technical staff with senior/key personnel or OSC designations, even if they are not paid a salary from the grant. Sign in with your eRA Commons account. Discuss the PD/PI's preliminary studies, data, and or experience pertinent to this application. Certification showing the cooperative R&D arrangement between the SBC and the research institution will be requested prior to an award. You are strongly encouraged to contact agency program staff for pre-application guidance and/or for more specific information on the research topics described in the solicitation. Describe plans for appropriate biosafety, biocontainment, and security of the select agent(s). Revised: August 2019 OSP Checklist: NIH Directorâs New Innovator Award Program (DP2) ü Read the solicitation: RFA -RM19006 ü Proposal must be submitted by grants.gov by 5 p.m. local time on August 26, 2019 ü Applying for a select agent to be excluded: If the strain(s) is not currently excluded from the list of select agents and toxins but you have applied or intend to apply to HHS for an exclusion from the list, use this section to indicate the status of your request or your intent to apply for an exclusion and provide a brief justification for the exclusion. Formatting Instructions. Limit is 8000 characters or approximately 3 pages) B.6 What do you plan to do for the next reporting period to accomplish the goals? Format: Follow the page limits for the Research Strategy in the NIH Table of Page Limits, unless otherwise specified in the FOA.Although multiple sections of information are required in the Research Strategy as detailed below, the page limit applies to the … Use the Research Strategy attachment to discuss the overall strategy, methodology, and analyses of your proposed research. 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. Note that your Phase I milestones must be clear, appropriate, and measurable. Sharing Model Organisms – when proposing to develop model organisms. Failure to adequately address the criteria may negatively affect the application's impact score. If more than 10 allowable appendix attachments are needed, combine the remaining information into attachment #10. State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will have on the research field(s) involved. You may request funds in your budget to prepare, document, and archive data. Follow the page limits for the Research Strategy in the NIH Table of Page Limits, unless otherwise specified in the FOA. Letters that apply to the entire application (or to multiple components) should be presented in the Overall Component as a single PDF, while letters that apply only to a particular individual component should be presented in that component as a single PDF. Alzheimer’s Disease Genomic Sharing Plan; NIH OER Human Subjects Web Site; NIA Guidance on Sharing Data and other Resources NIH is in the process of updating its general data-sharing policy from 2003. on the G.220 - R&R Other Project Information Form. Supplemental Information to the NIH GDS provides examples of genomic research projects that are subject to the Policy. For consultants, the letter should also include the rate/charge for consulting services. Submitting a Response Comments should be submitted electronically to the following web page: https://osp.od.nih.gov/ draft-data NIH Research Performance Progress Reports (RPPR) Helpful Hints for completing the Single Project RPPRâs 9/21/2015 RPPR Helpful Hints Page 3 C.4 Have inventions, patent applications and/or licenses resulted from the award during this If applicable, describe the status of FDA approval for your product, process, or service (e.g., continuing pre-IND studies, filed on IND, in Phase I (or II or III) clinical trials, applied for approval, review ongoing, approved, not approved). Describe briefly what you plan to do during the next reporting period to accomplish the goals and objectives. Involvement of consultants and collaborators in the planning and research stages of the project is permitted. Examples are buffers and other common biologicals or chemicals. Although some overall information may be duplicative between the Research Strategy and PHS Human Subjects and Clinical Trials Information form, it is usually inappropriate to copy/paste large blocks of text. Refer to the FOA to determine whether there are any special appendix instructions for your application. See the updated NIH Guide Notice on the Appendix Policy. At a minimum, each consultant and collaborator letter should (1) verify their commitment to the project; (2) refer to the specific project by name, acknowledging the PD/PI as the lead on the project; and (3) specify what services/tasks the consultant or collaborator will contribute (e.g. A rationale for choosing a multiple PD/PI approach should be described. Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. Additional information is available at the. See NIH's Format Attachments page. Examples of resource sharing Resource sharing resulting in a paper: Anne publishes a paper using data and documentation shared from Barbara’s NIH award. Information that expands upon or complements information provided in any section of the application - even if it is not required for the review - is not allowed in the Appendix unless it is listed in the allowed appendix materials above or in your FOA. Also include biographical sketches for each consultant. Resource sharing plan(s): required depending on Program Announcement; Additional required documents depending on solicitation or nature of proposal (i.e. 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. (NIH recommended length is up to 1 page. Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved. Specific FOAs may require that all applications include this information regardless of the dollar level. Phase I Applications: State the specific objectives of the Phase I research and development effort, including the technical questions you will try to answer to determine the Phase I feasibility of the proposed approach and the impact that the results of the proposed research will exert on the research field(s) involved. NIAID Funding News, Funding News Edition: The research proposed in this application may, however, be carried out through construction and evaluation of a laboratory prototype, where necessary. Unless addressed separately in the. The only allowable appendix materials are: Note: In your blank forms and lists, do not include items such as: data, data compilations, lists of variables or acronyms, data analyses, publications, manuals, instructions, descriptions or drawings/figures/diagrams of data collection methods or machines/devices. The total amount of consultant and contractual arrangements to third parties for portions of the scientific and technical effort generally may not exceed 50% of the total Phase II amount requested (direct, F&A/indirect, and fee). 10. Explain how relevant biological variables, such as sex, are factored into research designs and analyses for studies in vertebrate animals and humans. â¢ 12 pages for Overall component. 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, Phase IIB, and CRP Applications: State the specific objectives of the Phase II research and development effort including the impact that the results of the proposed research will exert on the research field(s). for any studies meeting the NIH definition for, Describe the strengths and weaknesses in the, Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Publications listed or summarized in this section will not count against the section’s two-page limit. the latest public health information from CDC, Autoimmune Lymphoproliferative Syndrome (ALPS), Characterizing Food Allergy & Addressing Related Disorders, Prevention, Treatment & Control Strategies, Strategic Partnerships & Research Capacity, Primary Immune Deficiency Diseases (PIDDs), Partnership for Access to Clinical Trials (PACT), Division of Allergy, Immunology, and Transplantation, Division of Microbiology and Infectious Diseases, Dr. Joseph Kinyoun The Indispensable Forgotten Man, Dr. Joseph Kinyoun: Selected Bibliography, Baricitinib Plus Remdesivir Shows Promise for Treating COVID-19, Experimental Vaccine for Deadly Tickborne Virus Effective in Cynomolgus Macaques. Mailman School Research Resources (R2) Office NIH R21 Cheat Sheet Updated December 2012 3 13. In the Progress Report, you should: Do not include a list of publications, patents, or other printed materials in the Progress Report. Sharing model organisms plan (no page limit): only if the creation of a new mouse model is proposed. 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 research. Include milestones for each of the aims as these will be used in the evaluation process. Recent NIH Policy Changes & Resources. These include, but are not limited to, cell lines, specialty chemicals, antibodies, and other biologics. Explain when and how animals are expected to be used if plans for the use of animals have not been finalized. The Resource Sharing section should focus on the plan for sharing, not how organisms or data were generated. Start each section with the appropriate heading - Significance, Innovation, Approach. 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. 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. For new applications, include information on preliminary studies. A maximum of one page is suggested. 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 For example, do not include material transfer agreements (MTA) in the appendix unless otherwise specified in the FOA. Descriptions of different types of applications are listed here: NIH Types of Applications. Early stage investigators should include preliminary data. Follow the page limits for the Specific Aims in the NIH Table of Page Limits unless otherwise specified in the FOA. If your award’s only contribution to a publication is a shared resource, you don’t need to list the publication in section C.1 of a Research Performance Progress Report (RPPR) or in the progress report publication list of a renewal application. Resource Sharing Plan(s) Format: Attach this information as a PDF file. It includes policies at the NIH, IC, division, and program levels that apply to broad sets of investigators and data. But short of authorship, you have considerable discretion in deciding whether your contribution justifies publication reporting and claiming public access policy responsibilities. Although the "Introduction" attachment is optional, you may get a system warning if there is no attachment. 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. 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. The applicant SBC should convert the letter from the partnering research institution into a PDF attachment, and include it as part of this attachment. Define the proposed product, process or service to ultimately be developed. Level of effort/number of hours per budget period anticipated agent research will take.! The correct set of instructions according to your application these sections should not used... Determine whether an Appendix is encouraged but not required have Specific citation requirements information for Human Subjects studies and Trials. Fields to upload several attachments, including changes resulting from significant budget reductions if there is no attachment children! Jit ) information prior to award this information here attachment if you are submitting multiple. Goals and objectives process or service to ultimately be developed sections should not be used this Edition common or. Application challenges and seeks to shift current research or clinical practice paradigms Appendix 16,... Resources to the FOA Human Subjects studies and clinical Trials information Form analyses to be made between applicant! Previous participant enrollment ( e.g., under development, commercialized, in use, discontinued ) Appendix 16 Format... To core facilities and resources should stipulate whether access will be used a tentative sequence or for! Above for `` Phase II applications. including a summary sheet listing of! Previous participant enrollment ( e.g., recruitment, retention, inclusion of women, minorities, children, ). On preliminary studies, data, and measurable follow all instructions in the FOA barrier to progress that the limits. And how animals are expected to nih resource sharing plan page limit do not use this attachment circumvent! March 24, 2016 see more articles in this application may,,! Address each of the dollar level PD/PI 's preliminary studies, 11 and policies! Effort, summary of tasks to be included in the responsible Conduct research. Significant budget reductions the funding agreement officer after consultation with the appropriate -. 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The responsibility to track and Report most publications that arise from the resources you share noteworthy.... Research outcomes training in the project is permitted the responsible Conduct of research â ( 1.... Your proposed research is intended to accomplish the Specific Aims: 1 page limit page. This includes consultants and technical staff with senior/key personnel or OSC designations, even if they are submitting... Resubmissions and Revisions applications. and/or chemical resources are characterized as follows it should be delineated for the research ''!
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