Is the PD/PI clearly the intellectual driver of the proposed research program? Is the overall strategy well-reasoned and appropriate to accomplish the overall goals of the research program? Other Attachments: The application must include the following attachment. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. If equipment is requested in Section C, do not add the equipment budget in Section F. If subaward/consortium costs are requested, the subaward/consortium direct costs (not including consortium F&A) should be included in the "Requested Direct Costs. Applications that do not comply with these instructions may be delayed or not accepted for review. ESI MIRA award rates were 29% for the first 2 years (FY 2016-2017) and then increased to 42% from FY 2019 to FY 2021. 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. The NIGMS MIRA differs from other institutes' R35 awards in that MIRA is not a grant designed to support a small number of investigators; instead, the Institute intends to have at least 60% of the R01-equivalent pool eventually be MIRAs as stated in the Institute's strategic plan. Applications from investigators who are not eligible to receive the award will be administratively withdrawn without review. ESI eligibility is determined at the time the application is submitted. Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? 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 NIH Grants Policy Statement. Figure 7 shows the impact scores of ESI MIRA applications for FY 2021 to FY 2022. The chart below illustrates the published paylines for the NIH institutes most awarded to UTMB investigators: Larger award amount than the current average NIGMS R01 award to ESIs. The PD/PI is required to devote at least 51% of their total research effort to this award. If the goals of the MIRA have changed, complete section B.1.a. Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)? All applications are due by 5:00 PM local time of applicant organization. Reviewers should evaluate the likelihood that the proposed research will launch and sustain a successful independent research program. Investigators and teams composed of researchers at different career stages. The purpose of the NHLBI R35 Program is to promote scientific productivity and innovation by providing long-term support and increased flexibility to experienced Principal Investigators (PIs) who meet the eligibility requirements of the RFAs and whose outstanding record of research demonstrate their ability to make major contributions to heart, . Characteristics of the applicant and awardee pool for the program, such as: Number of ESI PD/PIs who apply for MIRA instead of R01s, Geographic distribution of Investigator demographics. Provide complete justification using the Budget Justification. Additionally, NIGMS will not accept assignment of an NIH Directors Transformative Research Award (TRA) R01 or NIH Directors Pioneer Award (DP1) application if the PD/PI has a MIRA. Recently issued trans-NIH policy notices may affect your application submission. 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. 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 (R35 - Clinical Trial Optional) Activity Code R35 Outstanding Investigator Award Should both applications score well enough for funding consideration, you will be required to withdraw one. Do not include the number of person months or direct costs. Only those application types listed here are allowed for this NOFO. Use the NIH ASSIST system to prepare, submit and track your application online. In carrying out stewardship of grant programs, NIGMS will periodically evaluate the MIRA program, employing the representative measures identified below. Note that preliminary data are neither expected nor required, and PDs/PIs may wish to indicate this prominently in the Research Strategy. All ESI MIRA applicants with unfunded applications scoring below 20 received a comparable research project grant (RPG), such as a DP2 or R01, instead of a MIRA. Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide. The recipient must also make semiannual disclosures regarding such proceedings. TheOER Glossaryand the SF424 (R&R) Application Guide provide details on these application types. The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO. NIH Institutes Post New Paylines (effective December 2019) Conformance to the requirements in the Application Guide is required and strictly enforced. The curves are smoothed by including applications and awards with impact scores within 2 points of the value displayed, creating a rolling average for the fraction of funded applications. Notices of Special Interest associated with this funding opportunity. For further information on the PEDP, please see https://braininitiative.nih.gov/about/pedp-key-elements-and-examples. All recipients of applicable NIH grants and cooperative agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. . All instructions in the SF424 (R&R) Application Guide must be followed. In Section A: Senior/Key Person, provide an entry for the PD/PI, including the appropriate level of effort, and enter $0 for Requested Salary and $0 for Fringe Benefits. Transfer of a MIRA to a foreign institution will not be allowed. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. 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. 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? Age difference in FY16 between ESI MIRA and ESI R01 not statistically significant (p=0.16) ESI MIRA Round 2 is significantly younger than ESI R01 FY17 (p<0.001) Combined, ESI MIRA cohort is 1.2 years younger than ESI R01 cohort (p<0.001) No applications were reviewed from Alaska, Hawaii, or Puerto Rico. Enable investigators to apply earlier in their independent research careers, allowing them to secure grant funding that will launch and sustain productive research careers. See the Office of Extramural Researchs comprehensive blog post for more information about overall impact scores and percentiles. Are the PD/PI, collaborators, and other researchers well suited to the program? Applicants are expected to provide an overview of the research program/scientific questions they plan to address and a general description of possible strategies; experimental details are not expected. The program will also help distribute funding more widely among the nation's highly talented and promising investigators. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Award Rates: MIRA and R01 Renewals in FY 2021 This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. Scores by year - Returns a score for each year per contact and s coring formula (if the contact's score is > 0 for that year). Other Information for award authorities and regulations. Is the rationale for the approach compelling? Posted Date May 24, 2022 . Non-domestic (non-U.S.) components of U.S. In lieu of preliminary data from the PD/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. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). 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. For this NOFO, eligibility is limited to NIH-definedEarly Stage Investigators. The focus should be on the importance of the questions or challenges. Use an institutional system-to-system (S2S) solution to prepare and submit your application Scientific and technical merit of the proposed research program as determined by scientific peer review. By virtue of assignment to NIGMS, the proposed research falls within the mission of NIGMS and would overlap with the MIRA. Is there evidence that the research program will evolve appropriately as the work is performed? PD/PIs who are currently Early Stage Investigators (ESIs) should apply through the ESI MIRA FOA and should not apply through this FOA. In Section C: Equipment Description, enter budget request for equipment. 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? To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project? Funded applications are designated with solid bars, while unfunded applications are designated with striped bars. PDF Final Report Endline Impact Evaluation - The International Agency for Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. 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. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. MIRA Review 23 Special Emphasis Panels organized by NIGMS Broad expertise and perspective No separate criterion scores Focus: Sustainability of the research program, track-record of the PI, and impact of PI on the scientific community Shock Society 6.8.2020 Research Strategy: 6 pages, significant scientific All budget information should be provided on the R&R Budget form for Budget Type Project.. With awardees from the ESI MIRA program now coming in for renewals of their first grants alongside EI MIRA renewals, those on their first renewals will be clustered together in review and scored relative to others at a similar career stage. PDs/PIs who submitted a MIRA application in previous years and are still eligible for this NOFO (i.e., retain their ESI status) are welcome to apply, but must submit a New application because Resubmission applications are not allowed. Funding Restrictions. In case of changes in employment of the PD/PI (e.g., accepting an appointment at another institution, while retaining an appointment at the institution which received the MIRA award), the PD/PI is required to maintain their commitment to MIRA as originally reviewed and approved. Mechanistic clinical trials are permitted in MIRA when the mechanistic study is an essential part of the research program. All PD(s)/PI(s) must have an eRA Commons account. In another example, if an investigator spends 25 percent of his/her time on research, he/she must devote at least 12.75 percent effort to MIRA (25 percent research effort x 51 percent MIRA effort requirement = 12.75 percent effort to the MIRA). Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301. Content and Form of Application Submission. Is the process for obtaining informed consent or assent appropriate? For assistance with application submission, contact the Application Submission Contacts in Section VII. Notice of Funding Opportunity Description, Section IV. Contact Center Telephone: 800-518-4726 Include a link to your My Bibliography complete list of publications and be sure the data are complete and up to date. Tag: Funding Outcomes - National Institutes of Health ESI R01 award rates have fallen from 25% to 17% between FY 2015 and FY 2021. Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified? Additional information may be found in the SF424 (R&R) Application Guide. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html. 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. Both these measures are variations of "average citations received per article . Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? 2. Optional: Accepting applications that either propose or do not propose clinical trial(s). Is the projected timeline feasible and well justified? List the individuals/organizations with whom consortium or contractual arrangements have been made and indicate whether the collaborating institution is foreign or domestic. 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 preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? Webinar and Other Resources for New MIRA ESI Funding Opportunity, Maximizing Investigators Research Award (MIRA), review differences in R01-equivalent applications by career stage, U.S. Department of Health and Human Services, National Institutes of Health: NIHTurning Discovery Into Health. 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. Publication plan that enumerates planned manuscripts and proposed lead authorship. Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. All ESI MIRA applicants with unfunded applications scoring below 20 received a comparable research project grant (RPG), such as a DP2 or R01, instead of a MIRA. 2313). Plan for Enhancing Diverse Perspectives (PEDP) (1-page maximum): All applications must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. As noted on the FAQs page, the time period for determining ESI status begins after completing one's post-graduate clinical training. Are potential ethical issues adequately addressed? To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project? Enable investigators to devote more time and energy to mentoring trainees in a more stable research environment. To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project? For the purpose of this NOFO, a program of research is a collection of projects in the investigator's lab that are relevant to the mission of NIGMS. Webinar and Other Resources for New MIRA ESI Funding Opportunity 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. This would be equal to 3.06 calendar months of effort (25.5 percent x 12 calendar months = 3.06 months). To easily access these queries, do the following: Go to RiSE > Intelligent Query Architect. Only a single overall impact score will be voted, no separate criterion scores. c) Under section D.2.c. Telephone: 301-637-3015, Grants.gov Customer Support(Questions regarding Grants.gov registration and Workspace) Scoring - iMIS Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds. For Budget Type select Project. A separate budget form for any Subaward/Consortium is not required for this NOFO. Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based). It is critical that applicants follow the instructions in the Research (R) Instructions in theSF424 (R&R) Application Guideexcept where instructed in this notice of funding opportunity to do otherwise. A PD/PI may submit an R01 application and a MIRA application within the same council round. 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. Funded applications are designated with solid bars, while unfunded applications are designated with striped bars. Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s). Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the research program to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the program proposed). Participation of individuals from diverse backgrounds, including groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce (see. Tips to esi related to provide their reviews and awards. See Section VIII. PAR-17-190: Maximizing Investigators' Research Award for Early Stage When involving human subjects research, clinical research, and/or NIH-definedclinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: 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. All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. . Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75and 2 CFR Part 200 Award Term and Conditionfor Recipient Integrity and Performance Matters. Applications that are incomplete or non-compliant, or that do not fall within the NIGMS mission, will not be reviewed. The number of funded ESI MIRAs in FY 2022 was the largest to date, and more than four times larger than in the program's first year. Reduce the time spent by researchers writing and reviewing grant applications, allowing them to spend more time conducting research.