Has the PD/PI presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? WebNIH MIRA For Early Stage Investigators. Is there evidence that the research program will evolve appropriately as the work is performed? All instructions in the SF424 (R&R) Application Guide must be followed except as detailed below. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIHs electronic system for grants administration. Funding Restrictions. Letters of support from collaborators must be limited to 2 pages, must not include attached Biographical Sketches, and should not circumvent page limitations by includingfigures and data. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. Paper applications will not be accepted. WebDr. Investigators with K awards from another NIH institute may receive an NIGMS MIRA but will be required to adjust their person-months effort on those awards to be smaller than the person-months effort committed to MIRA. Is there a logical plan for sustained progress across a research program for the five-year award period? Note that preliminary data are neither expected nor required, and PD/PIs may wish to indicate this prominently in the Research Strategy. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Eligibility to apply for this FOA is limited to NIH defined Early Stage Investigators. It looks like your browser does not have JavaScript enabled. Entering $0 does not imply that the PD/PI will not receive any salary or fringe benefit support from the grant. These costs may be reimbursed only to the extent considered allowable pre-award costs. Note that the goals of the program of research supported by the MIRA are broader than the specific aims of a single project and should be appropriately described. Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applications that are determined to be outside of the NIGMS mission will not be accepted for review. Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? An ESI, or Early Stage Investigator, is a Program Director / Principal Investigator (PD/PI) who has completed their terminal research degree or end of post Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. For this FOA: Are the theme and/or topics of the research program substantive and appropriate for long-term pursuit? Awardees must comply with any funding restrictions described in Section IV.5. A permanent change of PD/PI will not be allowed under the MIRA. The PD/PI of a MIRA cannot receive funds from other NIGMS grants (e.g., as a sub-project leader or as the recipient of a sub-contract), excepting those listed in, NIGMS will not consider funding future individual PD/PI or multiple PD/PI research grants from a MIRA investigator during the MIRA funded project period, except for applications included under the list of exempted awards in. See Section III.1 Eligible Individuals for more information about this requirement. See Part 1. Funding Opportunity Description, Section IV. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75. Do not repeat material adequately covered in the Biosketch. If the program is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed? May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score. Has the PD/PI shown evidence of being creative and adaptable, able to recognize new opportunities and to explore new areas of scientific inquiry, and openness to the use of new systems and strategies, as appropriate for the proposed research program? List the individuals/organizations with whom consortium or contractual arrangements have been made and indicate whether the collaborating institution is foreign or domestic. A reduction in required application writing. A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. What do I need to know to start the process? Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score. Because the MIRA is intended to support a significant and ambitious program of research, the PD/PI is required to devote at least 51% of his/her total research effort to this award. Supporting fundamental research by funding individual projects has a number of consequences that could reduce the efficiency and effectiveness of the biomedical research enterprise in the U.S. To address these issues and increase the efficiency and efficacy of grant funding, the NIGMS Maximizing Investigators' Research Award (MIRA) is a single grant to provide support for the NIGMS-relevant program of research in an investigator's laboratory. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS). This writing workshop supports early stage faculty interested in applying to the Maximizing Investigators Research Award (MIRA) Need help determining whether you are doing a clinical trial? eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threatensubmission by the due date, and post-submission issues). Do not present or include figures or preliminary data. Applicants should directly address the rationale, underlying the balance of effort and the resources dedicated to each activity, and how the activities are distinct or complementary. National Institute of General Medical Sciences (NIGMS) NOT-OD-19-125 Notice of System Change and Procedure for Requesting an Extension to Early Stage Investigator (ESI) Status, July 26, 2019- Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. In order to allow submission of a budget request without filling out detailed yearly budgets, some basic information must be completed for NIH to successfully process the budget form. Itemized budget information is not required and will not be accepted. Does the application propose to use existing available resources, as applicable? Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects. c) Under section D.2.c. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system. 5. Helping investigators transition to This would be equal to 3.06 calendar months of effort (25.5 percent x 12 calendar months = 3.06 months). In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. Transfer of a MIRA to a foreign institution will not be allowed. Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Applications will be assigned to NIGMS. Work involving the addition of human subjects, clinical trials, vertebrate animals, stem cells, select agents, or a new foreign component would require prior approval by NIGMS staff according to existing policies and procedures. In assessing the effectiveness of its research investments, NIH may request information from databases, PD/PIs, and from participants themselves. Investigators who receive funds as project leaders on NIGMS multi-component grants (i.e., P01, P50 or RM1) will have their MIRA award level adjusted to remove any overlap between their MIRA and their multi-component grant. This should be a description of the key questions or challenges the PD/PI plans to address and the general strategies that might be used to approach them. Applications will compete for available funds with all other recommended applications. Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed. ESI eligibility is determined at the time the application is submitted. Changes in Other Support, indicate if there have been changes in Other Support. See Notice NOT-GM-21-002. PHS Human Subjects and Clinical Trials Information. 3) Overview of Future Research Plans. Part I. Overview Information contains information about Key Dates and times. Non-domestic (non-U.S.) components of U.S. Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? A researcher funded by a MIRA will not subsequently be awarded any other sources of NIGMS funding, with the following exceptions: NIGMS will not accept applications from MIRA grantees for awards not on the above list that would begin prior to the end date of the MIRA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory General Medical Sciences Council. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Research Support: List ongoing and completed research projects with funding sources from the past three years, and briefly indicate the overall goals of the projects and your responsibilities. If the program involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed? In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. Eligibility Information contains information about registration. Is the process for obtaining informed consent or assent appropriate? Clinical research that involves recruitment of human subjects at more than one site, or the substantial financial support of multiple collaborators and subcontractors, is not allowed, because these fixed commitments are not consistent with the highly flexible nature of the MIRA program. Institutions will be required to relinquish their interests in current NIGMS-funded research grants and withdraw pending applications where the applicant is listed as the PD/PI or multi-PD/PI. All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. In comparison to R01 funding of NIGMS ESI investigators, Maximizing Investigators Research Award for Early Stage Investigators (ESI MIRA) benefits include: In developing MIRA, NIGMS is committed to maintaining support for at least the current total number of NIGMS-funded early stage investigators and their associated programs of research. Section A: Senior/Key Persons provide an entry for the PD/PI, including the appropriate level of effort, and enter $0 for Requested Salary and $0 for Fringe Benefits. 4/28/2023 11:58 AM, Maximizing Investigators' Research Award (MIRA) (R35), MIRA Eligibility for Administrative Supplements, MIRA Current and Pending Support Model Attachment (Required), Eligibility: NIH Definitions of Early Stage Investigators and Related Policies and Procedures, Biophysics, Biomedical Technology, and Computational Biosciences, Genetics and Molecular, Cellular, and Developmental Biology, Pharmacology, Physiology, and Biological Chemistry, Training, Workforce Development, and Diversity, FAQs About Noncompliance and Withdrawal of Applications, Native American Research Centers for Health (NARCH), Science Education Partnership Awards (SEPA), Parent Announcements for Investigator-Initiated Applications, Research With Activities Related to Diversity (ReWARD), Maximizing Investigators' Research Awards (MIRA), Instrumentation Grant Program for Resource-Limited Institutions (RLI-S10), Multidisciplinary Teams/Collaborative Research, Grant Application and Post-Award Information, Talking to NIH Staff About Your Application and Grant, Research Using Human Subjects or Specimens, Chemistry, Biochemistry, and Pharmacology, Webinars for the NIGMS Training Community, Grant Writing Webinar Series for Institutions Building Research and Research Training Capacity, Budget, Financial Management, and Congressional Material, Data Integration, Modeling, and Analytics, U.S. Department of Health and Human Given that the MIRA is meant to provide support for a research program within the NIGMS mission in a PDs/PIs laboratory, and may include multiple projects on disparate topics, there is no obligation for the PD/PI to present a single unifying theme. In addition, for applications involving clinical trials: If proposed, are the administrative, data coordinating, enrollment, and laboratory/testing centers, appropriate for the trial proposed? NIH considers requests for extensions of ESI eligibility from researchers who have lapses in If the goals of the research are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? Is there a plan to complete data analysis within the proposed period of the award? Personal Statement: Use the Personal Statement to address MIRA-specific elements of the Investigator Review Criterion. Applications that are incomplete or non-compliant, or that do not fall within the NIGMS mission, will not be reviewed. Supplements to MIRAs: MIRAs will be eligible for Research Supplements to Promote Diversity in Health-Related Research, for Research Supplement to Promote Re-Entry into Biomedical and Behavioral Research Careers, and for Administrative Supplements for Equipment Purchases. NIGMS will assess the program's overall outcomes and gauge its effectiveness in increasing the efficiency and efficacy of NIGMS funding. Do they have appropriate expertise in study coordination, data management, and statistics? If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Enable investigators to devote more time and energy to mentoring trainees in a more stable research environment. October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. We have begun making grant awards resulting from responses to RFA-GM-16-003 (R35), Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Such diversity will optimize returns on the Institute's investments by maximizing the ideas explored and the chances for important breakthroughs. For this FOA: Is the logic of the approach compelling? Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. Reviewers will consider each of the review criteria below in the determination of scientific merit, however, individual review criterion scores will not be assigned. November 24, 2020 - Notice of Special Interest (NOSI): Synthetic Biology for Biomedical Applications. Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)? Linkedin Agency Contacts of this FOA) before submitting an ESI MIRA application that includes clinical research. For the purpose of this FOA, a program of research is a collection of projects in the investigator's lab that are relevant to the mission of NIGMS. Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. Telephone: 301-637-3015, Grants.gov Customer Support(Questions regarding Grants.gov registration and Workspace) The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission. Information regarding the disposition of applications is available in the NIH Grants Policy Statement. The research strategy should address the requirements of the NIH policy on rigor in research as detailed in NOT-OD-18-228. The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. Is the overall strategy well-reasoned and appropriate to accomplish the overall goals of the research program? See Notice NOT-OD-22-018. Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Additional information may be found in the SF424 (R&R) Application Guide. Is s/he clearly the intellectual driver of the proposed research program? Resubmissions: Investigators who applied in response to RFA-GM-16-003, RFA-GM-17-004, or PAR-17-190 are welcome to apply provided they are still eligible (retain their ESI status), but the application must be written as a New submission without reference to the previous application or review or an Introduction to Application. In addition, for applications involving clinical trials: Does the application adequately address the following, if applicable. Obtaining an eRA Commons account can take up to 2 weeks. Does the PD/PI show promise as a mentor of undergraduate and graduate students, and postdoctoral associates, and the potential to establish a record of professional service? An Early Stage Investigator (ESI) is a Program Director/Principal Investigator (PD/PI) who meets the following qualifications: Completed terminal research degree or end of post-graduate clinical training, whichever date is This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. National Institute of General Medical Sciences (NIGMS), See See below for MIRA for Early-Stage Investigators (ESIs). Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. Amit Joshi awarded NIH MIRA By Brad Binder August 24, 2022 Dr. Amit Joshi was awarded a NIH R35 MIRA (Maximizing Investigators Research Award) ESI (Early-Stage Investigator) for his project, Mechanisms of organelle biogenesis at the endoplasmic reticulum subdomains.
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