Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. 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. 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 Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. Do not present or include figures or preliminary data. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. 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. Maximizing Investigators Research Award for New and Early 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. More widely distribute funding among the nation's highly talented and promising investigators to increase overall scientific productivity and the chances for important breakthroughs. Provide the Budget Period Start Date and End Date. Maximizing Investigators Research Award (MIRA) for Early Stage Investigators (ESI) (R35 - Clinical Trial Optional) Activity Code R35 Outstanding September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. The Concept to Clinic: Commercializing Innovation Education Program is designed to help current BRAIN-funded investigators from a research institution or early-stage start-up better understand how to take their innovative technology and apply it to an unmet market need. For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center? For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section. 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. Services, National Institutes of Health: All instructions in the SF424 (R&R) Application Guide must be followed. In addition, for applications involving clinical trials: Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by clinical and/or preclinical studies or information in the literature or knowledge of biological mechanisms? Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Because the MIRA is expected to provide support for the research program of an independent investigators laboratory, PDs/PIs may find other grant programs better suited to research requiring financial support of collaborators and subcontractors. 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. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. Eligibility to apply for this FOA is limited to NIH defined Early Stage Investigators. PAR-22-180 - Maximizing Investigators' Research Award (R35 - Clinical Trial Optional). Information regarding the disposition of applications is available in the NIH Grants Policy Statement. Additional information may be found in the SF424 (R&R) Application Guide. Applications from investigators who are not eligible to receive the award will be administratively withdrawn without review. Part I. Overview Information contains information about Key Dates and times. Trending Young in New and Early Stage Investigator MIRA Applicants must complete all required registrations before the application due date. How will successful completion of the research change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? List the individuals/organizations with whom consortium or contractual arrangements have been made and indicate whether the collaborating institution is foreign or domestic. More Information About New and Early Stage Investigator MIRA Outcomes by Jake Basson, Jon Lorsch, and Peter Preusch 0 comments There has been ongoing A proposed Clinical Trial application may include study designs, methods, and interventions that are not by themselves innovative but address important questions or unmet needs. WebDr. Letters from former mentors are not required, nor encouraged, except in the case of continuing collaborations. First MIRA Awards to New and Early Stage Investigators Applications involving a consortium/contractual arrangement are expected to be rare. WebEarly Stage Investigator (ESI) A Program Director / Principal Investigator (PD/PI) who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously competed successfully as PD/PI for a substantial NIH independent research award. Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? 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. Early Stage Investigator Is there a plan to complete data analysis within the proposed period of the award? Maximizing Investigators Research Award for New and Early Is the process for obtaining informed consent or assent appropriate? Glossary | BRAIN Initiative Does the application propose to use existing available resources, as applicable? The NIH BRAIN Initiative is providing National Institute of General Medical Sciences (NIGMS) For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding? Selection of an application for award is not an authorization to begin performance. We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. November 24, 2020 - Notice of Special Interest (NOSI): Synthetic Biology for Biomedical Applications. Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53. When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. 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 Preliminary data are neither required nor expected, but if provided will be evaluated during the review process. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). Subscriptions 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. See the NIH Grants Policy Statement for additional information on this reporting requirement. Provide complete justification using the Budget Justification. 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. Enable investigators to apply earlier in their independent research careers, allowing them to secure grant funding that will launch and sustain successful research careers. NIH Application and Submission Information, Section V. Application Review Information, Section VI. All budget information should be provided on the R&R Budget form. Preliminary dataare not required and justification for the proposed work may be provided through literature citations, data from other sources, or data generated by the applicant as a graduate student or postdoctoral fellow. July 1, 2020 - Notice of Pre-Application Webinar for PAR-20-017. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission. 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? Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). Other than years when equipment is requested, it is expected that the annual direct costs will remain constant in all years. 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.