If the goals of the research are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? Are potential ethical issues adequately addressed? Such diversity will optimize returns on the Institute's investments by maximizing the ideas explored and the chances for important breakthroughs. Changes in Other Support, indicate if there have been changes in Other Support. Grants supporting resources for the research community (e.g., P30, R24); Biomedical Technology Development and Dissemination program RM1 grants; Grants supporting training, workforce development, or diversity building; INBRE (P20), COBRE (P20/P30), or IDeA-CTRs (U54); Public/State Controlled Institutions of Higher Education, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education), Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education), For-Profit Organizations (Other than Small Businesses), Indian/Native American Tribal Governments (Federally Recognized), Indian/Native American Tribal Governments (Other than Federally Recognized), Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations (other than Federally recognized tribal governments), Faith-based or Community-based Organizations. Maximizing Investigators Research Award for New and Early 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. As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items. The total research effort should be determined in person-months and should not include time expended toward teaching, administration not directly related to the PD's/PI's research, and/or clinical duties. In addition, for applications involving clinical trials: If proposed, are the administrative, data coordinating, enrollment, and laboratory/testing centers, appropriate for the trial proposed? The total research effort should include his/her combined research effort at all institutions where the PD/PI holds an appointment and should be expressed in person-months. Publication rate of NIGMS MIRA grantees vs. traditional NIGMS grantees. 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. UPDATE: The MIRA FOA for early stage investigators has been reissued. More Information About New and Early Stage Investigator MIRA Outcomes by Jake Basson, Jon Lorsch, and Peter Preusch 0 comments There has been ongoing Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission. 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. 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). For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. An NIGMS ESI MIRA is intended to provide support for research within the NIGMS mission in the laboratory of an early stage investigator (ESI). See Notice NOT-OD-21-170, April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. PAR-22-180: Maximizing Investigators' Research Award (R35 Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Other supplements offered by NIGMS may also be made available to MIRA grantees, depending on the intention and constraints of the particular supplement program. Is the proposed research program appropriate in scope and ambition to address the scientific questions posed? As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The MIRA grantees are 1.5 years younger on average than those MIRA applicants who did not receive an award (37.2 vs. 38.7 years, p<0.05), and about 2 years Is the projected timeline feasible and well justified? 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. Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? 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. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Are the plans to add or drop enrollment centers, as needed, appropriate? The goal of MIRA is to increase the efficiency and efficacy of NIGMS funding. 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. Budget Justification: The following budget categories must be justified, where applicable: equipment and consortium/subaward costs. 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. Enhance investigators' ability to move into research areas that are distinct from those of their postdoctoral mentors, which could lead to new scientific discoveries. Email:GrantsInfo@nih.gov(preferred method of contact) Research involving human subjects is permitted in the MIRA program. The PD/PI is required to devote at least 51% of his/her total research effort to this award. Use the Budget Justification to provide the additional information requested in each budget category identified above only. Selection of an application for award is not an authorization to begin performance. Applications will be assigned to NIGMS. 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. F&A base: Also use the Budget Justification to explain any exclusions applied to the F&A base calculation. Has the PD/PI presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? PAR-22-180 - Maximizing Investigators' Research Award (R35 - Clinical Trial Optional). Services, National Institutes of Health: The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organizations profile in the eRA Commons and for the System for Award Management. Email:support@grants.gov, Sailaja Koduri, Ph.D. 5. 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. Non-domestic (non-U.S.) components of U.S. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantees business official. Early Stage Investigator See Notice NOT-OD-19-137. Applications involving a consortium/contractual arrangement are expected to be rare. Citation rate of NIGMS MIRA grantees vs. traditional NIGMS grantees. An application does not need to be strong in all categories to be judged likely to have major scientific impact. Jessica L. Rouge. For this FOA, do not suggest a Scientific Review Group because applications will be reviewed by Special Emphasis Panels. 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. The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. A permanent change of PD/PI will not be allowed under the MIRA. ESI eligibility is determined at the time the application is submitted. MIRA Eligibility Flowchart for New and Early Stage 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 In Section F: Other Direct Costs add a line item titled Requested Direct Costs and provide the total request for that budget period (up to $250,000). This section should also address requirements related to sex as a biological variable as detailed in NOT-OD-15-102. Information regarding the disposition of applications is available in the NIH Grants Policy Statement. See below for MIRA for Early-Stage Investigators (ESIs). See Notice NOT-OD-22-018. Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. PAR-20-117: Maximizing Investigators Research Award YouTube. Authentication of Key Biological and/or Chemical Resources: For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources. 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. 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.