Selection of an application for award is not an authorization to begin performance. Application and Submission Information, Section V. Application Review Information, Section VI. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. Linkedin Should both applications be selected for funding, the PD/PI will be required to relinquish one of the awards. Are potential problems, alternative strategies, and benchmarks for success adequately presented? A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. 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. The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Maximizing Investigators Research Award for New and Early Maximizing Investigators' Research Award (MIRA) (R35) This includes any recent legislation and policy applicable to awards that is highlighted on this website. In addition, for applications involving clinical trials: If proposed, are the administrative, data coordinating, enrollment, and laboratory/testing centers, appropriate for the trial proposed? If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research. Increase flexibility for investigators to follow important new research directions as opportunities arise, rather than being bound to specific aims proposed in advance of the studies. Early Stage Investigators Extensions We understand that life happens. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov. See Notice Clinical trials that are designed to test safety and efficacy of interventions (Phase I, Phase II, Phase III) for the purpose of future clinical treatment and/or regulatory approval are not permitted in MIRA. An application does not need to be strong in all categories to be judged likely to have major scientific impact. WebNIH MIRA For Early Stage Investigators. Early-Stage Investigator Eligibility | National Institute of Enhance investigators ability to move into research areas that are distinct from those of their postdoctoral mentors, which could increases chances for new scientific discoveries; Increased stability of funding for NIGMS-supported ESIs, improved success rates, and more graduated, rather than all-or-none, funding decisions for MIRA renewals; Larger award amount than the current average NIGMS R01 award to ESIs, while the project period will be similar; More flexibility to pursue new ideas and opportunities as they arise during the course of research because the award is not tied to specific aims; A reduction in administrative burden associated with managing multiple grants; and. Applicants who receive R01, SC1, DP1, DP2, or any other type of disqualifying award prior to issuance of the ESI-MIRA become ineligible to receive the award. Has the investigator included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Other than years when equipment is requested, it is expected that the annual direct costs will remain constant in all years. NIGMS continues to encourage collaborative and interdisciplinary research when it is appropriate, and individual MIRA grantees are free to collaborate with one another or with other investigators using funds from their individual MIRA to support their contributions to the team's research. Zhongzhen Nie, Ph.D. Connect With Us: Maximizing Investigators Research Award (MIRA) for Early Stage Investigators (ESI) (R35 - Clinical Trial Optional) Activity Code R35 Outstanding If equipment is requested in Section C, do not add the equipment budget in Section F. If consortium/subaward costs are requested, the consortium/subaward direct costs (not including consortium F&A) should be included in the "Requested Direct Costs.". Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative, and relevant to the hypothesis being tested? If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. More Information About New and Early Stage Investigator MIRA The institution and PD/PI are aware of and accept that other NIGMS research awards, except as allowed in Section I, must be relinquished, and pending NIGMS research applications withdrawn, as a condition of receiving a MIRA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. As part of the scientific peer review, all applications: Cooperative Agreement Terms and Conditions of Award. Within the scope of the MIRA, investigators will have the freedom to explore new avenues of inquiry that arise during the course of their research, as long as they remain within the mission of NIGMS. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantees business official. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. An Early Stage Investigator (ESI) is a New Investigator who is within 10 years of completing the terminal research degree or within 10 years of completing Part I. Overview Information contains information about Key Dates and times. If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial? August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. Provide the total consortium/subaward costs for each budget period listing the total direct costs and indirect (F&A) costs separately. NIH MIRA Early Stage Investigator Award (2020) NSF CAREER Award (2019) Pharmaceutical Researchers and Manufacturers of America (PhRMA) Postdoctoral Fellowship in Pharmaceutics (2014) National Research Council (NRC) Postdoctoral Fellowship, National Institute of Standards and Technology (declined) 2012. Email:GrantsInfo@nih.gov(preferred method of contact) For this FOA: Are the theme and/or topics of the research program substantive and appropriate for long-term pursuit? 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. In another example, if an investigator spends 25 All instructions in the SF424 (R&R) Application Guide must be followed except as detailed below. Budget Justification: The following budget categories must be justified, where applicable: equipment and consortium/subaward costs. Telephone: 301-637-3015, Grants.gov Customer Support(Questions regarding Grants.gov registration and Workspace) For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. Assignment to a Scientific Review Group will be shown in the eRA Commons. See more tips for avoiding common errors. MIRA Welcome Letter MIRA for Established and New Investigators (EIs and NIs) See below Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity? Do not include the number of person months or direct costs. For this FOA: Is the logic of the approach compelling? In Section C: Enter budget request for equipment. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? In assessing the effectiveness of its research investments, NIH may request information from databases, PD/PIs, and from participants themselves. 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. This writing workshop supports early stage faculty interested in applying to the Maximizing Investigators Research Award (MIRA) Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. c) Under section D.2.c. Has the PD/PI presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? In lieu of preliminary data from the PI's independent lab, feasibility of the program may be demonstrated through literature citation, data from other sources, or data generated by the applicant as a graduate student or postdoctoral fellow. NIH defines an early stage investigator as one who is within 10 years of completing his/her terminal research degree (e.g., Ph.D.) or is within 10 years of Awardees must comply with any funding restrictions described in Section IV.5. The following will be considered in making funding decisions. PD/PIs who submitted a MIRA application in previous years and are still eligible for this FOA (i.e., retain their ESI status) are welcome to apply, but must submit a New application because Resubmission applications are not allowed. Components of Participating Organizations, Funding Opportunity Announcement (FOA) Number, Catalog of Federal Domestic Assistance (CFDA) Number(s), It is critical that applicants follow the instructions in the Research (R) Instructions in the, Optional: Accepting applications that either propose or do not propose clinical trial(s), Funds Available and Anticipated Number of Awards, Eligible Individuals (Program Director/Principal Investigator), All page limitations described in the SF424 Application Guide and the. Organizations are not eligible to apply. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. Web2019 ACS Infectious Diseases Young Investigator Award; 2017 NIH MIRA for Early Stage Investigators; 2011 Canadian Institutes of Health Research Postdoctoral Fellowship; 2008 Tri-Institutional Training Program in Chemical Biology Graduate Fellowship; Publications. PAR-20-117: Maximizing Investigators Research Award Project Summary/Abstract: Use the abstract to provide an overview of research in the laboratory, the goals for the next five years, and an overall vision of the research program. Jarrod French, PhD The Hormel Institute 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. Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? 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. See Notice NOT-OD-21-170, April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. WebNIGMS ESI MIRA is intended to provide support for research withinthe NIGMS missionin the laboratory of an Early Stage Investigator (ESI) NIGMS supports research on basic It is anticipated that this FOA will: October 2, 2020; October 4, 2021; October 3, 2022. For this FOA: Does the PD/PI have a consistent record of productivity and scientific impact commensurate with the applicant's current career stage? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy, or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors, or health care policy? Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation. A permanent change of PD/PI will not be allowed under the MIRA. Do not present or include figures or preliminary data. For this FOA, the instructions are hereby modified as follows: a) Under Section B.1 What are the major goals of the research? All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. MIRA provides support for research in an investigator's laboratory that falls within the mission of NIGMS. The ESI MIRA program encourages eligible applicants to submit an ESI MIRA application early in their independent research careers and to move into research areas that are distinct from those of their postdoctoral mentors. We have begun making grant awards resulting from responses to RFA-GM-16-003 (R35), Eligibility Information contains information about registration. Program Directors/Principal Investigators (PD(s)/PI(s)). A reduction in required application writing. NIH Relevance of the proposed research to NIGMS priorities. How will successful completion of the research change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? The goal of MIRA is to increase the efficiency and efficacy of NIGMS funding. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects. This section should contain the following information: 1) Background on the area(s) of research and key gaps in our understanding or important challenges to be addressed; 2) Recent Progress by the PD/PI, focusing on the past five years, to give context for the overview of future research. 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. NIGMS will assess the program's overall outcomes and gauge its effectiveness in increasing the efficiency and efficacy of NIGMS funding. Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? 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. Applications that are determined to be outside of the NIGMS mission will not be accepted for review. Facebook Glossary | BRAIN Initiative Note that preliminary data are neither expected nor required, and PD/PIs may wish to indicate this prominently in the Research Strategy. If the goals of the MIRA have changed, complete section B.1.a. Although the proposed direction of the PD/PI's scientific program will be considered in review, if new opportunities or directions arise during the course of the research, the PD/PI will have the flexibility to change course and pursue them. Rate at which NIGMS MIRA grantees elect to apply to renew their awards vs. re-enter the traditional system. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Reduce the time spent by researchers writing and reviewing grant applications, allowing them to spend more time conducting 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. Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? A detailed experimental plan should not be provided. Does the PD/PI have a strong potential to establish and sustain a successful independent program of research in his/her own laboratory?
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