National Institute of General Medical Sciences (NIGMS), See Use the Budget Justification to provide the additional information requested in each budget category identified above only. Unique Entity Identifier and System for Award Management (SAM), See Part 1. To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project? MIRA at three years: maximizing NIGMS' research investment 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). Successful MIRA applications will be awarded in the fiscal year of Council review. PAR-19-367: Maximizing Investigators' Research Award (R35 - Clinical National Institute of General Medical Sciences (NIGMS) It is anticipated that this program will: Numbers from FY 2019 onward reflect NIHs updated definitions of ESI-eligible applications as delineated by the NGRI. Was this a temporary blip or does it mean that new R01s from EIs are less likely to be funded in the future? PAR-20-117: Maximizing Investigators Research Award (MIRA) for Early Transfer of a MIRA to a foreign institution will not be allowed. Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based). These EI MIRA renewal applications were exclusively from investigators whose first MIRA award was received in FY 2016 or FY 2017, when eligibility was restricted. 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. In Fiscal Year (FY) 2021, NIGMS received a congressional appropriation of $2,991,417,000. As NIGMS director, Jon oversees the Institutes research, training, and other programs. Agency Contacts of this FOA) before submitting a MIRA application. This includes any recent legislation and policy applicable to awards that is highlighted on this website. We also compared the MIRA success rates to those of ESI applicants for NIGMS R01s in fiscal years (FY) 2011-2015 . See Section III. Almost all investigators received an increase, with a median of 3% and the largest increases concentrated among those below the 20th percentile for prior funding. PAR-22-180: Maximizing Investigators' Research Award (R35 - Clinical Our recent post about MIRA renewals addresses some of the points you raise. Most increases over 10% were found among investigators below the 30th percentile of prior funding, and most cuts were among those above the 80th percentile. Will creative strategies be employed as needed and appropriate to address the research questions posed? If a pending MIRA application is unsuccessful, another new MIRA application(s) may be submitted as long as the PD/PI remains eligible. In the first section, we present award rates (the percentage of reviewed applications that receive funding), considering both programs overall and then FY 2021 renewal applications specifically. Increase the stability of funding for NIGMS-supported investigators, which could enhance their ability to take on ambitious scientific projects and approach problems more creatively; Increase flexibility for investigators to follow important new research directions within the NIGMS mission as opportunities arise, rather than being bound to specific aims proposed in advance of the studies; More widely distribute funding among the nation's highly talented and promising investigators to increase overall scientific productivity and the chances for important breakthroughs; Reduce the time spent by researchers writing and reviewing grant applications, allowing them to spend more time conducting research; Enable investigators to devote more time and energy to mentoring trainees in a more stable research environment. If the goals of the research are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day. All registrations must be completed prior to the application being submitted. Is there a plan to complete data analysis within the proposed period of the award? The number of funded ESIs has risen almost every year since FY 2013, with the slight decrease in the number of awards between FY 2017 and FY 2018. Section III. Contributions to portfolio breadth and diversity. Or was it 72% of all the submitted ex-ESI renewal applications were approved for funding? PD/PIs who are currently Early Stage Investigators (ESIs) should apply through the ESI MIRA FOA and should not apply through this FOA. The MIRA funding opportunity, which we examine in greater detail later in this post, has prompted an increase in the number of applications from ESIs. Distinct projects refer to funded core projects (e.g., R01GM999999) in a given fiscal year. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. The award rate for new (type 1; T1) EI R01s was 21% for 5 out of 6 years from FY 2015 to FY 2020 before falling to 17% in FY 2021. c) Under section D.2.c. Experimental details are not expected. Does the application adequately address the following, if applicable. Overview Information Participating Organization (s) National Institutes of Health ( NIH) Components of Participating Organizations National Institute of General Medical Sciences ( NIGMS) Funding Opportunity Title Maximizing Investigators' Research Award (MIRA) for Early Stage Investigators (R35 - Clinical Trial Optional) Activity Code For example, a research program that by its nature is not innovative may be essential to advance a field. Collaborative Program Grant for Multidisciplinary Teams (RM1) grants**; Biomedical Technology Development and Dissemination (RM1) grants***; Sepsis Human Biospecimen Collections (R21/R33) Phased Innovation Awards****; Grants supporting training, workforce development, or diversity building activities; INBRE (P20), COBRE (P20/P30), IDeA-CTRs (U54), SEPA, or NARCH; Investigators who receive support from NIGMS research grants of other investigators as collaborators and subcontractors on R01s will no longer be permitted to receive funds from those sources. Email: [email protected], Maqsood Wani, Ph.D. NIGMS Home | Contact Us | Your Privacy | Accessibility | Disclaimers | FOIA | HHS Vulnerability Disclosure, U.S. Department of Health and Human ServicesNational Institutes of Health: NIHTurning Discovery Into Health | USA.gov, National Institute of General Medical Sciences45 Center Drive MSC 6200 | Bethesda, MD 20892-6200. For assistance with application submission, contact the Application Submission Contacts in Section VII. Funding Distribution of NIGMS Competing R01 Applications by Percentile, FY 2021. ESI MIRA applications with overall impact scores between 10 and 50 were generally funded (solid green bars). For renewals of established investigator MIRAs, has the PD/PI maintained a productive research program with strong evidence of impactful contribution to the field and recognition of new opportunities and directions? An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The number of funded ESIs in FY 2021 who received MIRA grants was the largest to date and a notable increase over the number of investigators funded each year since the inception of the MIRA program. Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. Has the PD/PI demonstrated a record of accomplishments over the past five years that has advanced their field(s)? MIRA budgets for New Investigators will generally be $250,000 in annual direct costs. Most investigators receiving cuts were above the 80th percentile of prior funding, and none were ex-ESIs. Figure 2. Renewal rates and funding changes. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm. Also, because a MIRA is designed to provide support for a laboratory's research relevant to the mission of NIGMS, it is deemed to have overlap with most other research grant applications within the NIGMS mission. For renewals of previous ESI MIRAs, has the PD/PI established a research program with the potential for continued growth and enhanced scientific impact? Distinct features of MIRA include increased award length, stability, flexibility, and reduced administrative burden Established Investigator Award Rates. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed. Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review. 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? Publication plan that enumerates planned manuscripts and proposed lead authorship. All recipients of applicable NIH grants and cooperative agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at. Organizations are not eligible to apply. *** For the Biomedical Technology Development and Dissemination (BTDD) grants, the PD/PI must maintain 51% research effort toward their MIRA, and 3 person months' effort toward the BTDD. Inflation is now a looming problem in that average increases in grants do not come close to matching inflation, especially the double digits that many consumables are experiencing. Applicants must complete all required registrations before the application due date. Reviewers will consider each of the review criteria below in the determination of scientific merit but will not provide a separate score for individual criterion. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. Changes in success rates are a function of both changes in the number of competing applications and in the number of awards. Compared to EIs renewing their R01s, the EI MIRA program has had a higher award rate since its inception (Figure 1). 6. Im sure that they submit a new R01 to continue the research they were doing in the MIRA, but is there an opportunity for them to go back into the MIRA pool? 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. NIGMS will continue to monitor and report funding trends and will regularly update the community on activities within the Institutes portfolio. Optional: Accepting applications that either propose or do not propose clinical trial(s). 93.859 Funding Opportunity Purpose The Maximizing Investigators' Research Award (MIRA) is a grant to provide support for all of the research in an investigator's laboratory that falls within the mission of NIGMS. 1) and renewals of all active NIGMS MIRA grants. Thecumulative investigator rate is another measure of investigators success in receiving NIGMS funding. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. Current & Pending Support: This attachment is required. In comparison to R01 funding of NIGMS investigators, MIRA benefits include: MIRA may not be the best mechanism to support all kinds of research, even though the research may be within the NIGMS mission. See Section III.1 Eligible Individuals for more information about this requirement. All instructions in the SF424 (R&R) Application Guide must be followed except as detailed below. To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project? We noted earlier that the number of ESIs funded each year has been increasing over the past few years, especially the number of ESIs receiving MIRAs. If none of the above apply, state "Not Applicable.". Answers to Frequently Asked Questions About MIRA PAR-22-180 The goal of MIRA is to increase the efficiency of NIGMS funding by providing investigators with greater stability and flexibility, thereby enhancing scientific productivity and the chances for important breakthroughs. If the research is collaborative, do the investigators have complementary and integrated expertise? NIGMS Council Highlights MIRA Success and Efforts to Foster Inclusivity There are no notes pertaining to this field. The renewal (type 2; T2) EI R01 award rate ranged from 41% in FY 2016 to 51% in FY 2019, ending in FY 2021 at 45%. Contact Center Telephone: 800-518-4726 In FY 2021, NIGMS awarded R01-equivalent grants to 293 ESIs in total: 38 investigators received R01 awards, 234 investigators received R35 (MIRA) awards, and 21 investigators received NIH Directors New Innovator Awards (DP2s). Studies that propose clinical dissemination and implementation research, comparative effectiveness research, and/or pragmatic clinical trials are also not permitted. Table 1 shows summary highlights of these renewal award rate and budget change data. In this post, we first describe investigator-level trends for RPGs, then review the trends associated with competingRPGs, and lastly examine trends in the Institutes Maximizing Investigators Research Award (MIRA) program. Where necessary, PD/PIs and participants may be appropriately contacted after the completion of the grant period for updates on participants subsequent outcomes. The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA. These data align with the trends observed for funding in the MIRA program in previous years. 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. Recently issued trans-NIH policy notices may affect your application submission. 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. This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. The Maximizing Investigators' Research Award (MIRA) provides support for the program of research in an investigator's laboratory that is within the mission of NIGMS. Comment * document.getElementById("comment").setAttribute( "id", "a0d8191a340075faf90d7a1fb6b6ed6f" );document.getElementById("ff4f1eaaa7").setAttribute( "id", "comment" ); Sabrina is a program analyst in the NIGMS Division of Data Integration, Modeling, and Analytics. Department of Health and Human Services partners. The NIGMS R01 and R35 awardee counts (green squares, solid line; left axis) have increased over the past 6 years, resulting in a higher cumulative investigator rate (gray triangles, dotted line; right axis). This trend is in keeping with the budget principles for MIRA described in our FAQs. Is there a plan to update these numbers with the next years renewals and success rates? Part I. Overview Information contains information about Key Dates and times. These costs may be reimbursed only to the extent considered allowable pre-award costs. After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via theeRA Commons. Applications that fall outside of the NIGMS mission will be withdrawn prior to review. 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. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to: If this attachment is not included, the application will be considered incomplete and will not be reviewed. Paper applications will not be accepted. 1. A single NIGMS grant per PI to provide support for NIGMS-related research in an investigator's lab. NIGMS' Special Council Review policy for applications that result in over $1,500,000 annual total costs from all sources of research support being awarded to a PD/PI will apply to MIRAs. One aspect of the R01 ecosystem was that gaps in funding could be hedged against by multiple grants, or a wider number of applications under consideration during critical renewal periods. See your administrative office for instructions if you plan to use an institutional system-to-system solution. The representation of MIRA grants relative to R01 awards has steadily increased each year, and in FY 2021 MIRA represented 42% of the MIRA/R01 awards, an increase of 9 percentage points from the previous fiscal year. NIGMS staff will verify the MIRA research effort requirement is met by using the Other Support documentation and will exclude support for which the purpose is education, training or enhancing workforce diversity. ** MIRA applicants and recipients can participate as a PD/PI on a Collaborative Program Grant for Multidisciplinary Teams (RM1) as part of the 51% effort required by the MIRA but may not receive additional funds from this RM1. 22% is quite a difference. Is the process for obtaining informed consent or assent appropriate? Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. Letters of Support: Letters of support from collaborators should be limited to 1 page, may not include attached Biographical Sketches, and must not circumvent page limitations by including figures and data. MIRA Renewals: Award Rates and Budget Changes - NIGMS Feedback Loop Figure 3 shows that renewal award rates for ex-ESIs in FY 2021 were 33% for R01 renewals, 72% for MIRA renewals, and 49% for R01/MIRA conversions. Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity? When you say reviewed do you mean discussed (and received scores) or received applications (roughly)? Project Summary/Abstract: For this FOA, use the abstract to provide an overview of research in the laboratory, the goals for the next five years, and the overall vision of the research program. This difference was largest in the first 2 years of the program, which only accepted EI applications from NIGMS investigators holding either two NIGMS R01 grants or one R01 grant of more than $400,000 in annual direct costs. 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. Briefly indicate the overall goals of the projects and your responsibilities. 2. The first major wave of renewal applications from the broader EI MIRA program is anticipated in FY 2023. As outlined in the NIGMS strategic plan [PDF], one of the Institutes goals is for MIRAs to comprise at least 60% of the R01-equivalent pool by FY 2025. TheOER Glossaryand the SF424 (R&R) Application Guide provide details on these application types. FY 2021 Renewal Rates. In Figure 4, we illustrate R01 applications and award distributions across the percentile range for FY 2021. Other than years when equipment is requested, it is expected that the annual direct costs will remain constant in all years of an award period. Use the NIH ASSIST system to prepare, submit and track your application online. Research involving human subjects is permitted in the MIRA program. Between FY 2011 and FY 2015, ESI R01 awards had a median of $190,000 in annual direct costs, which was also the mode comprising 14% of these awards (the same modal value as for EIs). The recipient must also make semiannual disclosures regarding such proceedings. Another issue in the MIRA is if it is meant to lock early investigators in to dollar amounts that will increasingly not be able to support their groups. I noticed that the award rates for new R01s from established investigators (EIs) fell from 21% in 2017-20 to 17% in 2021 (Fig. Are the timeline and milestonesassociated with the Plan for Enhancing Diverse Perspectives well-developed and feasible? Applications may request a maximum project period of five years. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicants integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships. NIH RePORTer Success Rates Goals of the MIRA Program The intent is for the success rate of MIRA applications to be at least as good as the R01 success rate. Figure 5. Since gaps in funding, while perhaps temporary, almost always include loss of personnel and critical expertise, this is something that should be on radar at GM. As NIGMS director, Jon oversees the Institutes research, training, and other programs. Additional Information on Eligibility, Section I. Provide an estimate of total consortium/subaward costs (direct costs plus indirect [F&A] costs) for each budget period, rounded to the nearest $1,000. There are several options available to submit your application through Grants.gov to NIH and Please note: Comment moderation is enabled and may delay your comment. You must use one of these submission Figure 6 shows boxplots of FY 2021 R01 renewal award changes as a percentage of the prior award size by prior funding decile. Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice? Established Investigators Type 1 Award Size (Direct Costs), Pre-MIRA: FY 2011-2015Post-MIRA: FY 2018-2021. 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. In assessing the effectiveness of research project grant investments, NIGMS may use information from progress reports and public databases, PD/PIs, and from participants themselves. Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the Application and Funding Trends in Fiscal Year 2018 - NIGMS Feedback Median renewal budget changes were higher for ex-ESIs than EIs in all three cohorts (6.5% vs. 3.0% for R01 renewals, 8.3% vs. 3.0% for MIRA renewals, and 19.3% vs. 11.1% for R01/MIRA conversions). All applications, regardless of the amount of direct costs requested for any one year, should include both a Resource and a Data Sharing Plan. Components of Participating Organizations, Funding Opportunity Announcement (FOA) Number, Funds Available and Anticipated Number of Awards, Eligible Individuals (Program Director/Principal Investigator), SF424(R&R) Project/Performance Site Locations. Project-based opportunities to enhance the research environment to benefit early- and mid-career investigators.? Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. This initiative is not subject to intergovernmental review. Basically, Im trying out to see if PIs that chose not to submit a renewal are skewing that 72% number downward or not. To support the best science,NIGMSencourages inclusivity in research. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official. Funding Opportunity Description, Section IV. Do not include specific aims or use any similar designation in the abstract. RFA-GM-16-002: Maximizing Investigators' Research Award (R35) Not included are applications with overall impact scores greater than 60. Figure 6. List NIGMS grants first, followed by other NIH grants, followed by other sources of support. As this post illustrates, MIRA conversion and renewal rates are more favorable than comparable R01 renewals, and MIRA award sizes are larger than R01 awards.
