National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
R35 Outstanding Investigator Award
The Maximizing Investigators' Research Award (MIRA) provides support for individual investigators for research within the scientific mission of NIGMS via a single grant to achieve the following:
This NOFO invites applications from eligible NIGMS-funded investigators and from New Investigators proposing research that is aligned with NIGMS' scientific mission. The NOFO also allows renewal applications from all current MIRA grantees (including those previously funded as Early-Stage Investigators). Current Early-Stage Investigators (ESIs) should apply through the ESI MIRA NOFO, not this NOFO.
The National Institute of General Medical Sciences (NIGMS) supports basic research that increases our understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. NIGMS also supports research in specific clinical areas that affect multiple organ systems: anesthesiology and peri-operative pain; clinical pharmacology common to multiple drugs and treatments; and injury, critical illness, sepsis, and wound healing. NIGMS-funded scientists investigate how living systems work at a range of levels — from molecules and cells to tissues and organs — in research organisms, humans, and populations. Additionally, to ensure the vitality and continued productivity of the research enterprise, NIGMS provides leadership in supporting the training of future scientists and developing research capacity throughout the country.
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| January 27, 2026 | January 27, 2026 | Not Applicable | July 2026 | October 2026 | December 2026 |
| May 27, 2026 | May 27, 2026 | Not Applicable | November 2026 | January 2027 | April 2027 |
| January 27, 2027 | January 27, 2027 | Not Applicable | July 2027 | October 2027 | December 2027 |
| May 27, 2027 | May 27, 2027 | Not Applicable | November 2027 | January 2028 | April 2028 |
| January 27, 2028 | January 27, 2028 | Not Applicable | July 2028 | October 2028 | December 2028 |
| May 26, 2028 | May 26, 2028 | Not Applicable | November 2028 | January 2029 | April 2029 |
All applications are due by 5:00 PM local time of applicant organization.
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.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
To enhance grant funding efficiency and efficacy, the NIGMS established the Maximizing Investigators' Research Award (MIRA), a single grant that provides support for an investigator's NIGMS-aligned research program, encompassing all projects within their laboratory that align with the scientific mission of NIGMS.
It is anticipated that MIRA will achieve the following:
This NOFO invites new applications from eligible investigators as defined in the eligibility section (Section III. 1) and renewals from all current MIRA recipients. Early-Stage Investigators (ESIs) should apply through the ESI MIRA NOFO, not this NOFO.
The NIGMS MIRA differs from other institutes' R35 awards in that the MIRA is not a grant designed to only support a small number of investigators; instead, as described in the Institute's 2021-2025 strategic plan, MIRAs represent over 60% of NIGMS' R01-equivalent awards.
NIGMS will ensure a broad research portfolio, encompassing varied scientific disciplines, methodologies, geographic regions, institutions, and investigators. This approach maximizes the exploration of innovative ideas and enhances the potential for high impact scientific breakthroughs.
The NIGMS MIRA is intended to provide support for the NIGMS-mission aligned research program in an investigator’s laboratory. NIGMS supports basic research on biological processes as well as translational and clinical research in specific areas. In addition to investigating scientific questions, MIRA can support technology development and computational approaches, either as sole research program interests or as components of a broader research program. MIRA investigators have the flexibility to explore new ideas, techniques, and approaches, provided the research remains within the scientific mission of NIGMS. Research involving human subjects, vertebrate animals, stem cells, select agents, or foreign components requires prior approval by NIGMS staff per existing policies and procedures.
Compared to traditional R01 funding, the MIRA offers distinct advantages:
Although mutually beneficial collaborations are encouraged during the course of a MIRA, the MIRA is designed to support the NIGMS-aligned research of an independent investigator's laboratory. For research requiring financial support of collaborators and subcontractors, other funding mechanisms may be more appropriate.
Research involving human subjects is permitted in the MIRA program. Clinical research must be completely within the context of the research areas supported by NIGMS, which include several specific clinical areas: anesthesiology, perioperative pain, clinical pharmacology, sepsis, injury and critical illness, wound healing, innate immunity and inflammation. Clinical research that involves recruitment of human subjects at more than one site or the substantial financial support of multiple collaborators and subcontractors is not allowed, because these fixed commitments are not consistent with the highly flexible nature of the MIRA program. Mechanistic clinical trials are permitted in MIRA when the mechanistic study is an essential part of the research program. 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. Studies that propose clinical dissemination and implementation research, comparative effectiveness research, and/or pragmatic clinical trials are also not permitted.
Potential applicants are strongly encouraged to confer with the NIGMS program official managing their qualifying award(s) or relevant research portfolio(s), or for additional questions, the Scientific/Research Contacts listed in this NOFO (in Section VII. Agency Contacts) before submitting a MIRA application. NIGMS will not fund applications containing research projects that align with the missions of other NIH Institutes and Centers or federal agencies.
Overlap During Peer Review
Since a MIRA is designed to provide support for a PD's/PI's entire NIGMS-mission-aligned research program, it will overlap with most other NIGMS research grant applications. Therefore, a PD/PI may not have a MIRA application and another NIGMS research project grant application (e.g., R01, R15, R21, and R37) pending review at the same time. An application is pending review until its summary statement is issued. The following NIGMS applications are exempted from this policy:
Resolving Overlap with Other NIGMS Research Grants During the Award Process
A PD/PI awarded a MIRA must discontinue funding from other NIGMS research grants, except in specific situations as noted below. The following scenarios provide examples of how funding overlaps are addressed:
NIGMS will facilitate an orderly process to transition to MIRA funding when reductions in other commitments are required. Specific details will be provided by NIGMS staff on a case by case basis.
The MIRA budget will be determined by NIGMS staff, based upon the PD's/PI's prior NIGMS funding history, recommendations from the peer review group and the National Advisory General Medical Sciences Council, and the expected productivity and impact of the proposed research program. MIRA applications from PDs/PIs whose total research support from all sources exceeds $1,500,000 in annual total costs are subjected to NIGMS' Special Council Review policy.
A PD/PI with more than $400,000 in direct costs from NIGMS research grants will generally receive a MIRA budget that is approximately 12% lower than the PD's/PI's average NIGMS research funding levels over recent years (as determined by NIGMS staff). MIRA budgets for New Investigators will generally be $275,000 in annual direct costs.
Budgets for MIRA renewals are determined independently based on a variety of considerations, including peer review outcomes, the PD's/PI’s other support and commitments, NIGMS' scientific priorities, and available budget. Overall, most MIRA renewal budgets are expected to be comparable to prior funding periods, though some may increase or decrease. For more information, see this Feedback Loop Post.
Applying for Subsequent Awards after Receiving a MIRA
NIGMS will not accept assignment of an NIH Director's Transformative Research Award (TRA) R01 or NIH Director's Pioneer Award (DP1) application if the PD/PI has a MIRA, since by virtue of assignment to NIGMS, the proposed research falls within the mission of NIGMS and would by definition overlap with the MIRA.
Supplements to MIRAs:
MIRA grants are eligible for administrative supplements offered by NIGMS, depending on the specific supplement program's intent and constraints.
Renewals:
MIRA renewals are expected to have higher success rates compared to R01s due to the Institute's commitment to the program as well as the consolidation of separate research projects, which will result in fewer applications. If a MIRA renewal application is unsuccessful, the grant will terminate at the end of its approved project period. A resubmission (A1) application is not allowed; however, a PD/PI may submit a new MIRA application as long as they are eligible.
Any MIRA application submitted after a prior renewal's pending review must be a new application. However, if a renewal application is withdrawn prior to peer review, another renewal can be submitted in its place.
Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.
See Section VIII. Other Information for award authorities and regulations.
Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
The number of awards is contingent upon NIGMS appropriations and the submission of a sufficient number of meritorious applications.
Applications from investigators with existing NIGMS research grants may request up to $750,000 direct costs per year. Investigators should request well-justified costs that are aligned with their proposed research program, noting that efficient use of funds is an expectation of the MIRA program. Budget justification is considered during the review process and in making funding decisions. Generally, awards will be commensurate with the PD's/PI’s average total NIGMS research funding over the past few years.
For new applications from PDs/PIs previously funded through NIGMS R01-equivalents other than MIRAs, well-justified budget increases may be considered for PDs/PIs previously supported by budgets below $275,000 in annual direct costs, while modest reductions of approximately 12% on average, are expected for PDs/PIs with $400,000 or more in annual direct costs from NIGMS. The MIRA budget will typically be lower than an NIH Transformative Research Award and will be significantly reduced from an NIH Director's Pioneer Award (DP1).
MIRA budgets for New Investigators are typically set at $275,000 in annual direct costs, not including equipment.
For MIRA renewal applications, NIGMS expects that the award level may vary based on the justification and available funds. Meritorious renewal applications that are not prioritized for full funding may receive reduced budgets.
Equipment should be requested in Year 1 only. Unless equipment costs are requested, annual direct costs will remain constant throughout the award period.
Applications may request a maximum project period of five years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Higher Education Institutions - Includes all types
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.
Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Subject to the eligibility criteria below, any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with their organization to develop an application for support.
PDs/PIs whose only NIGMS research grant(s) is a multi-PD/PI grant(s) are not eligible to apply for a MIRA.
PDs/PIs with a funded NIGMS MIRA are eligible to submit a MIRA renewal application before the end of their eligibility time window. Successful renewal applications will generally be awarded in the fiscal year of Council review, with the current MIRA terminated upon the issuance of the MIRA renewal award. Resubmissions are not allowed. If a renewal MIRA application is unsuccessful, a new MIRA application may be submitted as long as the PD/PI remains eligible. The eligibility for investigators funded with a MIRA extends to the end of the second fiscal year following the one in which the funded MIRA was originally set to expire. For example, if the current MIRA expires in fiscal year 2025 (October 1, 2024 to September 30, 2025), a renewal MIRA application needs to be submitted before September 30, 2027.
PDs/PIs with at least one NIGMS single-PD/PI R01-equivalent award (defined here as R01, R37, DP1, DP2, and SC1) are eligible to submit a new MIRA application before the end of their eligibility time window. Successful MIRA applications will generally be awarded in the fiscal year of Council review. If a pending MIRA application is unsuccessful, a new MIRA application may be submitted as long as the PD/PI remains eligible. Resubmissions are not allowed. The eligibility for investigators funded with at least one single-PD/PI NIGMS R01 or equivalent award extends to the end of the fiscal year following the one in which the funded single-PD/PI R01 or equivalent award was originally set to expire. For example, if the qualifying R01-equivalent award ends in fiscal year 2025 (October 1, 2024 to September 30, 2025), a MIRA application needs to be submitted before September 30, 2026.
No-cost extensions (NCEs) cannot be used to extend the eligibility time window. NIGMS will consider requests to extend the eligibility time window to apply for a MIRA for life events (e.g., childbirth or adoption, military service, health-related issues, natural disasters) that impact research progress during the eligibility time window, as well as unanticipated administrative issues. Applicants seeking an extension of their eligibility status must contact a Scientific/Research Contact listed in this NOFO (in Section VII. Agency Contacts) at least 8 weeks before submitting the application.
New Investigators proposing NIGMS mission-aligned research programs are eligible to apply for a MIRA if the PD/PI is not a project leader on any NIH multi-component awards from NIH, except for Research Project Leaders and Pilot Project Leaders of COBRE, IDeA-CTR or NARCH awards. Potential applicants are strongly encouraged to contact NIGMS program staff to discuss the possible alignment of their proposed research program to the NIGMS mission before applying. Applications that fall outside the NIGMS scientific mission will be withdrawn prior to peer review.
ESIs should apply for a MIRA through the ESI MIRA NOFO, not this NOFO.
The PD/PI is required to devote at least 45% of their total research effort to the MIRA. Total research effort includes the PD's/PI's combined research effort across all institutions where they hold an appointment, expressed in person-months, and excludes time spent on teaching and on administration unrelated to the PD's/PI's research or clinical duties. NIGMS staff will verify compliance with the MIRA research effort requirement using the Just-in-Time (JIT) Other Support documentation.
All current NIGMS research grants except those listed in Section I will be terminated upon issuance of the MIRA grant. MIRA PDs/PIs receiving funds as Project Leaders on NIGMS multi-component grants (i.e., P50) or a Collaborative Program Grant for Multidisciplinary Teams (RM1) will have their MIRA budget adjusted to eliminate overlap, and they must discontinue their involvement in the multi-component grant at the end of its competitive segment.
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
Since a MIRA is designed to provide support for a PD's/PI's entire NIGMS-mission aligned research program, it will overlap with most other NIGMS research grant applications (e.g., R01, R15, and R21). Therefore, NIGMS will not accept a MIRA application from a PD/PI who is the PD/PI of another NIGMS research grant application pending review (as defined above), except as mentioned under Section I. Conversely, NIGMS will not accept any other applications from a PD/PI who has a MIRA application pending review, except as mentioned under Section I.
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
Project Summary/Abstract: The abstract should provide an overview of the research in the laboratory, goals for the next five years, and the overall vision of the research program. Specific aims or any similar designation, including “aims”, must not be included in the abstract as they are antithetical to MIRA's flexibility in allowing research to easily change directions. Doing so will lead to administrative withdrawal of the application prior to peer review.
All instructions in the How to Apply - Application Guide must be followed.
Biographical Sketches: A biosketch is required only for the PD/PI and, if included, for any collaborator(s) receiving financial support from the MIRA. As noted in the R&R Budget section below, consortia/subawards are not allowed.
Personal Statement: The Personal Statement should be tailored to the unique attributes and requirements of the MIRA, including descriptions of significant service to the scientific community that are beyond the mentoring and committee duties expected at the PD's/PI's institution.
Contributions to Science: This section should highlight contributions over the past five years. Since this NOFO targets PDs/PIs with funded NIGMS R35 or R01-equivalent awards or New Investigators seeking NIGMS funding, applicants should emphasize contributions within NIGMS' scientific mission, noting those supported by NIGMS whenever applicable. All sources of funding support, as acknowledged in publications, should be listed for each publication cited.
Applicants may include a link to their My Bibliography for a complete list of publications.
Figures or preliminary data must not be included in this section.
All instructions in the How to Apply - Application Guide must be followed.
Itemized budget information is not required. Instead, a total requested direct cost amount for each budget period, including requests for equipment, is required. Unless equipment is requested in Year 1, annual direct costs are expected to remain constant throughout the award period. Do not request equipment in years 2-5 and do not include expected inflationary adjustments in out years.
Consortia/subawards are not allowed and should not be included in the budget.
All instructions in the SF424 (R&R) Application Guide must be followed except as detailed below. While the application package includes a 10-year R&R Detailed Budget form, applicants may request no more than 5 years of support.
To submit a budget request without detailed yearly budgets, the following information must be completed. For each budget period:
Data Management and Sharing Costs: NIGMS expects that most grantees will incur minimal, if any, additional costs for data management and sharing, as significant changes to existing practices are not expected. The justification for Data Management and Sharing costs should be clearly labeled as “Data Management and Sharing Justification” and include any requested direct costs. If no costs are requested, state $0 for the requested amount. Follow the SF424 Application Guide instructions for the Data Management and Sharing Justification.
Budget Justification: The following budget categories must be justified, where applicable: equipment costs, data management and sharing costs, and any exclusions applied to the F&A base calculation. For MIRA renewal applications, justify any requested increase in funding compared to the previous project period. For new MIRA applications, justify any requested increase in support relative to the average NIGMS research support received over the previous three years. New Investigators should request a maximum of $275,000 in direct costs, excluding equipment costs.
The Budget Justification should include only the information requested for the budget categories listed above. Equipment quote(s), if applicable, may be included in this section.
All instructions in the How to Apply - Application Guide must be followed.
Do not complete the R&R Subaward form.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Specific Aims: This application must not include a Specific Aims attachment; inclusion of this page will lead to administrative withdrawal of the application prior to peer review.
Research Strategy: The Research Strategy must not contain specific aims or use any similar designation, including “aims.” Upload the Research Strategy as a single attachment. MIRA applications should not use the typical R01 application headings of Significance, Innovation, and Approach. This section should include the following information:
Keep in mind that although the proposed research direction(s) of the PD's/PI’s scientific program will be evaluated during review, the PD/PI will have the flexibility to pursue new opportunities or directions that arise within NIGMS's scientific mission over the course of the award period.
Since the MIRA enables consolidation of NIGMS funding support for potentially disparate projects, a single unifying theme is neither expected nor required. Applicants should justify the balance of effort and resources across activities, explaining how they are distinct or complementary.
The research strategy should address NIH policies on rigor and transparency in research (NOT-OD-18-228) and, if applicable, the consideration of sex as a biological variable (NOT-OD-15-102).
Progress Report Publication List: For MIRA renewal applications, follow the instructions in the SF424 Application Guide to prepare the progress report publication list. For each publication, list all funding sources acknowledged in the publication. If multiple funding sources are cited, clearly and concisely indicate which specific aspects of the work were supported by the MIRA.
Letters of Support: Letters of support from collaborators should be limited to one page, must not include attached Biographical Sketches, and must not circumvent page limitations by including figures and data. Letters of support from foreign collaborators may be subject to NOT-OD-25-098 and require a Foreign Justification.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - 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.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply - Application Guide must be followed.
Delayed Onset Study
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 How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
See Part 2. 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
Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.
Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. 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. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
Applicants are required to follow the instructions for post-submission materials, as described in the policy
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this NOFO, note the following:
The goal of the MIRA program is to provide support to individual investigators for research that is within the NIGMS scientific mission, and to provide PDs/PIs flexibility in pursuing their research goals, provided they remain in NIGMS's scientific mission. For this NOFO, applicants should provide an overview of their research program and the key questions or challenges they currently plan to address, along with a general description of possible strategies. Detailed experimental details are neither required nor expected. The MIRA is intended to consolidate support for projects that may address different research areas within the NIGMS's scientific mission, so there is no expectation or requirement for the PD/PI to propose a single unifying theme.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. 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.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project 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 project proposed).
Specific to this NOFO: Review criteria are not scored individually.
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. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a research that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
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? 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? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Specific to this NOFO:
Are the topics of the research program substantive and well-justified as areas for long-term pursuit? Does the proposed research program have an appropriate scope and level of ambition to meaningfully address the key questions or challenges posed?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? 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?
Specific to this NOFO:
Does the PD/PI demonstrate clear intellectual leadership of the proposed research program? Has the PD/PI provided evidence of creativity and adaptability, including the ability to identify new opportunities, explore new research directions, and adopt new systems or strategies, as appropriate for the proposed research program? Does the PD/PI have a strong record of conducting and reporting research that is rigorous, reproducible, transparent, and cost-effective? Has the PD/PI made meaningful contributions to the scientific community through service activities? Are the PD’s/PI's productivity and scientific impact appropriate for their level of funding and career stage?
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? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
In addition, for applications involving clinical trials
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?
Specific to this NOFO:
Is there evidence that the flexibility provided by the MIRA will enable the PD/PI to pursue innovative directions or approaches?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project 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, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
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? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? 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? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, sex, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Specific to this NOFO:
Does the PD/PI present a logical and well-articulated plan for sustained progress across the research program over the award period? Is there evidence that the research program is likely to evolve appropriately in response to findings and developments as the research progresses?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
As applicable for the research program 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.
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? 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?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
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. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
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.
For Resubmissions (as applicable), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals (as applicable), the committee will consider the progress made in the last funding period.
For renewals, the committee will consider the progress made in the last MIRA funding period. For renewals of previous ESI MIRAs, has the PD/PI established a research program with the potential for continued growth and enhanced scientific impact? 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?
For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project.
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.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
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.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be assigned to NIGMS and evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
During peer review, applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit will be discussed and assigned an overall impact score.
Following initial peer review, scored applications will receive a second level of review by the National Advisory General Medical Sciences Council. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO.
The following will be considered in making funding decisions:
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.
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 the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.
In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.
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.
ClinicalTrials.gov: If an award provides for one or more clinical trials. 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). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
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. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.
Applicants and recipients are strongly encouraged to refer to the NIH Director’s Statement of Priorities, entitled “Advancing NIH’s Mission Through a Unified Strategy.”
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).
Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.
Successful recipients under this NOFO agree that:
When recipients, subrecipients, or third-party entities have:
Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information.
Not Applicable
Consistent with the 2023 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. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.
a) Under Section B.1 What are the major goals of the project? 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. If the goals of the MIRA have changed, complete section B.1.a. Provide a rationale for the changes in the context of the originally proposed research program and give an explanation of how the research continues to fit within NIGMS mission interests.
b) Under Section B4, Opportunities for Training and Professional Development, indicate if individual development plans have been used for any graduate students and/or post-doctoral fellows supported by the award.
c) Under section D.2.c. Changes in Other Support, indicate if there have been changes in Other Support. In addition to the revised Other Support page, include an explanation of how changes in other support relate to the activities supported by the MIRA.
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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.
In carrying out stewardship of grant programs, NIGMS will periodically evaluate the MIRA program, employing the representative measures identified below. In assessing the effectiveness of research project grant investments, NIGMS may use information from progress reports and public databases, PDs/PIs, and from participants themselves. Where necessary, PDs/PIs and participants may be appropriately contacted after the completion of the grant period for updates on participant's subsequent outcomes. The overall evaluation of the program will be based on metrics that may include, but are not limited to, the following:
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk - Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues.
Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).
Email: NIGMS_EINIMIRA@nigms.nih.gov
Center for Scientific Review (CSR)
Email: NOFOReviewContact@csr.nih.gov
Email: MIRA-FINANCIAL@nigms.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.