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Answers to Questions Cover the Following Topics:
The NIGMS ESI MIRA is a grant to provide support for a program of research in an early stage investigator's (ESI) laboratory that falls within the mission of NIGMS. For the purposes of MIRA NOFOs, a research program is defined as a collection of scientific projects in an investigator’s lab that are related to the mission of NIGMS. The purpose is to increase funding stability while offering investigators the flexibility to follow important new research directions as opportunities arise; to more widely distribute funding among NIGMS investigators and increase the efficiency and efficacy of NIGMS funding; to reduce time spent writing, reviewing and managing multiple research grants and thus provide more time for research and mentoring junior scientists. The ESI-MIRA program does not require preliminary data, which should enable investigators to apply earlier in their independent careers and move into research areas that are distinct from those of prior mentors.
The three key differences are:
Any research area within the mission of NIGMS is eligible for support on a MIRA. Research areas supported by NIGMS are outlined on the NIGMS website. Some types of research (e.g., clinical studies or team science) may be better suited to other activity codes. We strongly encourage all applicants to discuss their planned proposal with NIGMS program staff well in advance of submission. Applications outside of the NIGMS mission will be returned to the applicant without review.
NIGMS supports basic research that increases our understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. The specific areas of research that fall into this general mission can be found at the NIGMS overview page and on the web pages of the NIGMS scientific divisions. In particular, note that NIGMS-supported research may utilize specific cells or organ systems if they serve as models for understanding general principles. Research whose overall goal is to gain knowledge about a specific organ or organ system, or the pathophysiology, treatment, or cure of a specific disease or condition will, in most cases, be more appropriate for another NIH Institute or Center and thus will not be suitable for this Notice of Funding Opportunity. For more information on your specific research program, contact a relevant program officer.
Yes. Clinical and translational research within the NIGMS mission may be supported through a MIRA. NIGMS supports research in specific areas that affect multiple organ systems; anesthesiology and peri-operative pain; sepsis; clinical pharmacology that is common to multiple drugs and treatments; trauma, burn injury, and wound healing (Division of Pharmacology, Physiology, and Biological Chemistry).
Pre-application discussion of clinical/translational research projects with an NIGMS program director who handles a portfolio related to your research. Such research can also be added after award of the MIRA, as a change in scope, provided NIH approval is obtained prior to initiating the studies.
MIRA is intended to enable consolidation of NIGMS support for multiple projects that may be disparate, so there is no obligation to develop a single unifying theme. 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.
Yes. Technology development can be included either as the sole focus of the application or integrated with addressing novel biological hypotheses. As always, we encourage applicants to discuss the planned proposal with NIGMS program staff well in advance of submission.
NIGMS staff will verify that the MIRA research effort requirement is met by using the Other Support documentation. A PD's/PI's effort on an award for which the purpose is education, training or enhancing workforce diversity, including R25s, will be excluded from the calculation of research effort. The sum of all research effort reported on the Other Support page inclusive of the effort to be committed to the MIRA will be used as the PD's/PI's total research effort level. A PD's/PI's effort on MIRA should be equal to or greater than 51% of the total research effort.
A MIRA PI must devote at least 51 percent of his or her total research effort to the MIRA. Research effort is calculated differently than professional effort in that research effort does not include effort expended toward teaching, administration and/or clinical duties. It should be reported as calendar months.
For example, if an investigator has two grants (including the MIRA) with 50 percent total effort between them, he or she must devote a minimum of 25.5 percent effort to the MIRA (50 percent total research effort x 51 percent MIRA effort requirement = 25.5 percent must be devoted to the MIRA), regardless of the amount of salary support requested. This would be equal to 3.06 calendar months of effort (25.5 percent x 12 calendar months = 3.06 months).
PIs must devote at least 51 percent of their total research effort, but a higher level of PI research effort is permitted. The total research effort should be calculated based on an investigator’s expected level of research effort should the MIRA application be funded.
Investigators cannot simultaneously hold another award that requires 50 percent or more research effort. NIGMS will not make a MIRA while such awards are active or pending. The pending applications must be withdrawn before the MIRA will be issued.
Salary may be requested based on the institutional base salary level for up to an amount commensurate with the number of calendar months of effort committed to the MIRA. A lower level of salary support may be requested; NIGMS does not consider there to be an obligatory relationship between percent of annual effort and percent of annual salary recovered from the grant as long as the salary requested is not in excess of the effort committed to the grant.
Yes. NIGMS strongly endorses collaborative research. However, the MIRA concept is based on the idea that NIGMS will provide support to individual investigators' research programs. Collaborators will work together because of their mutual interest in a problem, not through a subcontract. In cases where a collaborator’s efforts are well-justified, essential to the research program of the MIRA and cannot be supported by the collaborator, a consortium agreement may be included. Please note, however, that as stated in the PAR, applications involving a consortium/contractual arrangement are expected to be rare. If a consortium/contractual arrangement must be included, the application must also include a letter from the collaborating PD/PI indicating why they cannot participate in collaborative research with the PD/PI without support from the MIRA.
Yes. NIGMS supports international collaborative research efforts, and investigators are encouraged to pursue scientifically productive collaborations. In cases where a foreign collaborator's efforts are well-justified, represent a unique scientific opportunity, are essential to the research program of the MIRA and cannot be supported by the foreign collaborator, a consortium agreement with a foreign institution can be included. Please note, however, that as stated in the PAR, applications involving a consortium/contractual arrangement are expected to be rare. If a consortium/contractual arrangement must be included, the application must also include a letter from the subcontract PD/PI indicating why they cannot participate in collaborative research with the PD/PI without support from the MIRA. Please also note that foreign collaborations added after review require written approval by NIGMS staff.
As indicated in the NIH glossary, Co-Investigators are defined as collaborators and are considered equivalent to senior/key personnel. The Co-Investigator designation does not affect the PI's roles and responsibilities as specified in the NIH Grants Policy Statement, does not imply that there are multiple PIs, and does not confer any advantages or responsibilities on the individual in question beyond those of a collaborator or senior key person. Applicants should therefore consider whether designation as a collaborator might be sufficient. Applicants should also keep in mind that the MIRA concept is based on the idea that NIGMS will provide support to individual investigators’ research programs and that funding for collaborators of any kind is expected to be rare. Collaborators will work together because of their mutual interest in a problem. In rare cases where a collaborator's efforts are well-justified, essential to the research program of the MIRA and cannot be supported by the collaborator, a consortium agreement or request for salary support can be included. If a consortium/contractual arrangement or salary for a collaborator must be included, the application must also include a letter from the collaborator indicating why they cannot participate in collaborative research with the PD/PI without support from the MIRA. If the justification provided is deemed insufficient by review or by NIGMS leadership, the requested funds may be removed prior to award.
Yes, a MIRA investigator can collaborate with an intramural scientist, but no funds can be provided to the intramural laboratory from the MIRA. If involvement with an intramural lab is a substantial part of the investigator's research program, a MIRA may not be a suitable means of support.
This is considered on a case-by-case basis and requires the application of reasonable judgment by both the investigator and NIGMS staff. The extension of studies on a problem from one organism to another would be reasonable. Insights gained from studying one biological problem that extend the project into another within the mission of NIGMS would also be reasonable. When in doubt, you should discuss changes with the NIGMS program director. The flexibility to pursue new research directions does NOT mean a MIRA PI could submit an overlapping or even duplicate application to other NIH Institute(s)/Center(s), other federal agencies, or private foundations. Receiving funding on overlapping applications could lead to a budget reduction or termination of MIRA. Please contact your program officer for further discussions about these issues.
Any research in the PI's lab that falls within the NIGMS mission and does not introduce changes related to substantive grants policy issues would be considered within scope. Changing research direction within scope, i.e., within the NIGMS mission, does not require prior approval by NIGMS.
A MIRA may change in scope for reasons related to grants policy or for scientific reasons. Policy-related changes in scope would include the addition, or a change in the approved use, of human subjects, vertebrate animals, select agents or human embryonic stem cells. These changes require prior approval by NIGMS before the work is initiated. However, such changes in scope can be approved with appropriate documentation. On the other hand, work that migrates away from the NIGMS mission and into the mission of another NIH institute or center would be considered scientifically out of scope. The budget of MIRA grants that are determined to be out of scope scientifically may be reduced in non-competing years, or the award may be terminated. If you are unsure whether or not your new research direction is within the NIGMS mission, contact your NIGMS program director.
This decision is made by NIGMS program officials, division directors and NIGMS leadership. A preliminary determination may be made by contacting NIGMS staff. However, a final decision will only be made based on the submitted application itself.
This process should be completed within a few weeks after the receipt date. Investigators whose applications are returned without review will be notified ASAP.
MIRA-supported investigators will have the flexibility to pursue the science they want to do as it evolves, rather than being held to specific aims that they proposed before they received a grant. In this way, they will have greater flexibility to try ideas that might be considered high-risk. MIRA is expected to result in more stable funding of investigators, better continuity of effort and better ability to keep well-trained personnel in the laboratory. MIRA is also expected to broaden the distribution of funding among laboratories, enabling more of the nation's highly talented and promising investigators to participate.
Principal investigators who meet the following requirements are eligible to apply for PAR-23-145:
Research Area: Research areas supported by NIGMS are outlined on the NIGMS website. However, some types of research (e.g., clinical studies, technology development, or team science) might be better suited for more traditional grant mechanisms (e.g., R01, R21). Applicants are strongly encouraged to discuss their planned proposal with NIGMS program staff well in advance of submission, since applications outside of the NIGMS mission will be returned to the applicant without review.
ESI: NIH defines early stage investigators (ESIs) as new PIs who are within 10 years of having received their Ph.D. degree or completing medical residency (or the equivalent), and have not yet received R01-equivalent grant support (i.e., R01, R35, R37, DP1, DP2, U01 or SC1 grant awards). Your eRA Commons account indicates your ESI status and provides links to request extensions to your ESI status (found in the Education section of the PI's Personal Profile in eRA Commons), which are granted for a limited number of reasons - refer to NOT-OD-09-034 and NOT-OD-19-125 for more information.
The ESI status of the PD/PI(s) on a MIRA application will be determined at the time of submission. Applicants who receive funding as the PD/PI of an R01, RM1, SC1, DP1, DP2, or any other type of disqualifying award, including certain ones listed above, prior to issuance of the ESI MIRA, become ineligible to receive the award. Refer to NIH's Early Stage Investigator policies for information about what awards impact ESI status.
Independent Research Appointment: If your institution defines your position as one that permits you to submit an NIH grant application as an independent principal investigator of a research project grant, then you may apply. If you are not in an independent position, as is true for most postdoctoral fellows and many NIH Career Development "K" Awardees, then you may not apply. Eligibility is not related to academic rank (Assistant vs. Associate Professor) or to having a tenure-track position. Women and members of underrepresented groups who meet the other eligibility requirements are strongly encouraged to apply.
Eligible organization: Refer to the Section III. Eligibility Information of NOFO PAR-23-145.
K99 awardees who have not yet transitioned to an independent position may not apply. R00 awardees who have transitioned to an independent position may apply. If your K award is from another NIH institute (e.g., NHBLI, NINDS, NIDDK, NICHD), then there is a good chance that your area of interest is most closely aligned with the mission of that institute, rather than NIGMS.
If you currently hold a SCORE SC1 award (not applicable to SC2, SC3), then you are NOT eligible. NIGMS considers the SC1 to be a substantial form of support equivalent to an R01, so that you are no longer considered a new PI. See the SCORE Answers to Frequently Asked Questions.
If you currently hold an SC2 or SC3 award and are otherwise eligible, you may apply. If you are successful in receiving a MIRA, the SCORE award would be terminated or phased out.
If you are an IDeA junior investigator and are otherwise eligible, you may apply. The PI of an NIGMS IDeA grant is expected to be an established scientist and would not be eligible. If the junior investigator's support on the IDeA includes NIGMS-relevant specific aims, the NIGMS-related support will be terminated prior to the start of the MIRA. The award level of the IDeA grant is not reduced. However, the IDeA PI is informed what portion of the funds (all or partial) can no longer be made available to the junior investigator who will receive the MIRA.
You are eligible to apply if you have ESI status. If you receive a MIRA, the award may be adjusted to account for funds that you have already received for the AREA grant. This adjustment will apply to AREA grants that were awarded by NIGMS. However, if the PI has previously been supported by another institute of the NIH, the PI should be sure to check with an NIGMS program director to be sure the proposed work falls within the mission of NIGMS.
No, NIH intramural research scientists are not eligible to apply. A MIRA application can include a collaboration with an intramural scientist, but no MIRA funds can be provided to the intramural laboratory. A MIRA will not be converted to a cooperative agreement. Therefore, if involvement with an intramural lab is a substantial part of the investigator's research program, a MIRA may not be a suitable means of support.
Yes, a MIRA PD/PI may participate in a RM1 project as part of the PD's/PI's 51% total research effort. The MIRA PD/PI will not request or receive research funds from the RM1 while the PD's/PI's research program is supported by MIRA.
The MIRA PI can participate in other NIGMS large-scale research grants as a Core Leader if the purpose of the Core is solely to provide a service. The MIRA PI can participate in Center and other large scale research applications as an Other Significant Contributor (i.e., collaborator), but cannot receive any funds from the grant.
PD/PI may submit a research project grant application (i.e., R01) and an ESI MIRA application for the same council round. Submission of other research grant applications (e.g., R15, R16, R21) within NIGMS' mission is not allowed while an ESI MIRA application is pending review* at the same time, with the following exceptions:
The ESI status of the PD/PI(s) on a MIRA application will be determined at the time of submission. Applicants who receive funding as the PD/PI of an R01, RM1, SC1, DP1, DP2, or any other type of disqualifying award, including certain ones listed above, prior to issuance of the ESI MIRA become ineligible to receive the award. Refer to NIH's Early Stage Investigator policies for information about what awards impact ESI status.
Notes:*Applications are defined as 'pending review' until a summary statement is issued. ** 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. *** For the BTOD grants, the PD/PI must maintain 51% research effort toward their MIRA, and 3 person months' effort toward the BTOD. The BTOD award can only provide support in a MIRA PD/PI's laboratory for late-stage technology development and dissemination efforts.
MIRA PIs are not prevented from submitting applications to other NIH Institutes.
No. An investigator can only have one MIRA, which should be submitted by the institution where he or she primarily conducts his or her research program. Under rare circumstances, a subcontract might be permitted to support a part of the research program that is based at a different institution.
A PD/PI is expected to commit at least 51% of his/her total research effort to MIRA as originally reviewed and approved. Significant change of research environment will be evaluated by NIGMS staff on a case-by-case basis, and may lead to a reduction of budget level, reduction in duration of support, or termination of the MIRA award.
NIGMS supports basic research that increases our understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. The specific areas of research that fall into this general mission can be found at the NIGMS overview page and on the web pages of the NIGMS scientific Divisions. In particular, note that NIGMS-supported research may utilize specific cells or organ systems if they serve as models for understanding general principles. Research whose overall goal is to gain knowledge about a specific organ or organ system, or the pathophysiology, treatment, or cure of a specific disease or condition will, in most cases, be more appropriate for another NIH Institute or Center and thus will not be suitable for this Notice of Funding Opportunity.
Use the NIH RePORTER. You can search using keywords, or find similar applications funded by NIH and note the funding institute. The Matchmaker tab is particularly useful. You can enter your abstract and look for scientific matches. Finally, if you have submitted your proposed studies in an application to NIH before, and it was assigned any other institute, this decreases the likelihood that the research falls within the scientific mission of NIGMS. Finally, for more information on your specific research program, contact a relevant program officer.
The application will be returned without review. Note that NIGMS routinely returns applications that fall outside the NIGMS mission.
Yes. Extensions of ESI status are granted for a number of reasons, including family care responsibilities, extended periods of clinical training, extended periods of additional (non-degree) research training, disability or illness, active duty military service, federal loan clinical service requirements, and natural or other disasters. See New and Early Stage Investigator Policies.
No, you do not. You may have received support from other institutes previously (e.g., through R03 or R21 awards), but if you are otherwise eligible and the proposed work is within the mission of the NIGMS, you may apply. However, the fact that your previous work was supported by another part of NIH may be an indication that the work really is of interest to one of the other institutes.
No. This NOFO is intended to provide support for the NIGMS mission-related research program of a single independent investigator and multiple-PI applications are not allowed. While team science is an important component of the biomedical landscape, this MIRA PAR is focused on supporting the individual laboratories of newly independent investigators.
Revised applications may not be submitted in response to PAR-23-145. You may submit a NEW application on the same general topic as the one you submitted previously if you are still considered an ESI. The new application should make no reference to the previous application or its review. However, you may wish to change the application to address concerns raised during the previous review.
Yes. PAR-23-145 specifically states: "A PD/PI may submit an R01 application and a MIRA application within the same council round. If both applications are deemed meritorious enough for funding, NIGMS will only award one of the two grants and applicants will be required to withdraw the other." This means that ESI PIs may submit an R01 to the June 5, October 5, or February 5 deadlines in addition to submitting a MIRA in October and February.
No. As per PAR-23-145, submission of other research grant applications (e.g., R15, R16, R21) within NIGMS' mission is not allowed while an ESI MIRA application is pending review (summary statement is not released) and vice versa.
The only exception is an R01 in addition to the other mechanisms listed under Section I of the NOFO.
No. The NIH Common Fund DP2 Notice of Funding Opportunity states: "The NIH will not accept duplicate or highly overlapping applications under review at the same time."
Although there have been a variety of successful approaches to writing MIRA applications, in general we recommend that you think about how to cogently answer the following questions:
Because space is very limited, it is essential to keep the narrative at a high-level and focus on how the outcomes of the work will impact the field. Also, because a MIRA allows for changes in research direction, you do not need to propose in your application everything you think you might want to work on that is within NIGMS’ mission. It is probably a better strategy to focus on what you think is most important and then see how the work evolves if you are funded. We recommend against trying to cram all of the information you would usually have in one or more R01s into your MIRA application as that is usually not a successful approach. Reviewers are instructed to evaluate the applications from this broad perspective.
There is no limit on the number of applications that can be submitted by an institution, provided they are for support of the research programs of different eligible investigators.
It depends on the receipt date. NIGMS will not accept an ESI MIRA application while another one is pending review (summary statement is not released).
The summary statement for an ESI MIRA application submitted to the October receipt date (e.g., October 3, 2023) will not be released until March/April 2024 so submission of another ESI MIRA application to the February receipt date (e.g., February 1, 2024) is not allowed.
The summary statement for an ESI MIRA application submitted to the February receipt date (e.g., February 1, 2024) will be released in July 2024 so submission of a new ESI MIRA application to the October receipt date (e.g., October 3, 2024) is allowed if the PI remains eligible.
You may discuss your ideas with the program contacts named in PAR-23-145 or with the program officer who manages the portfolio of NIGMS applications and awards closest to your research. Portfolio descriptions can be found on the NIGMS website: Contacts by Research Area.
Specific aims are not allowed because a goal of MIRA is to move the scientific enterprise away from a focus on narrowly defined research projects with detailed specific aims and to refocus attention on the larger picture and potential overall impact of the research. If your institution's system for submitting a grant application gives you a warning and will not allow you to skip the specific aims page, enter the following text in the appropriate place: "Per the NOFO instructions, no specific aims are to be submitted."
Follow the instructions in the SF424 R&R application guide [PDF] as modified by the instructions in the NOFO. In brief, this means that the scientific content of the application will rely mainly on the abstract, public health relevance statement, facilities and other resources page, biosketch and the six-page research strategy, plus details on the involvement of human subjects and vertebrate animals as necessary. Applications must also provide data/resource sharing and key resource authentication plans. Avoid duplicating material covered in other sections. Do not include lists of publications, except as part of the biosketch, or references except as necessary in the Bibliography & References Cited section of the Other Project Information Form.
Because the goal of MIRA is to focus the investigator’s and reviewers’ attention on higher level questions about significance and impact of the research program, details in the research plan can be reduced. Furthermore, changes in the biographical sketch mean that much of the needed information about the recent past research contributions of the investigator can be presented there, rather than in the research plan.
Yes. As stated in PAR-23-145, all MIRA applications must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. Please follow instructions in the NOFO when preparing your PEDP. For additional help, refer to the NIH policy website for detailed information on strategies and examples and FAQs of a PEDP.
Yes. All MIRA applications must include a plan describing how key biological and/or chemical resources will be authenticated.
There is no change in the format/requirements for the Vertebrate Animals Section (VAS) of the MIRA application. MIRA applicants should follow current instructions on preparing the Vertebrate Animals section of the research plan [PDF, 6MB]. If you plan to use live vertebrate animals (including production of custom antibodies and animals obtained for their tissues), but do not yet have detailed plans, you must still include a Vertebrate Animals Section. You will need to answer "yes" to the question "Vertebrate animals, yes or no" in Item 2 of the Other Project Information component in your grant application package. Your application also covers all performance sites, including sub-award partners, collaborators, contractors and others involved in animal research. Even if the only animal work that will be done from your R35 application will be performed somewhere other than your institution (e.g., you plan to have an antibody made by an outside contractor) you must mark "yes" and follow the instructions for Vertebrate Animals in the SF424 Form Instructions and include a Vertebrate Animal Section (VAS, see Vertebrate Animal Worksheet).
NIH expects that sex as a biological variable will be factored into research designs, analyses and reporting in vertebrate animal and human studies. Strong justification from the scientific literature, preliminary data or other relevant considerations must be provided in the Research Strategy for applications proposing to study only one sex. If you have designed your studies and they will be discussed in your R35 application, you should provide this information in your VAS for points 1 to 3 (Description of Procedures, Justifications, and Minimization of Pain and Distress) so the study section can rate your VAS as acceptable or unacceptable.
If you plan to use animal studies in your MIRA application but have not defined your plans about the species, sex, protocols and procedures to minimize pain and distress, or other information required for submission for your institutional animal care and use committee (IACUC) approval and a completed VAS in your application, please indicate that animals will be used in your application on the appropriate pages of your application and include a VAS in your application with as much of the information that you can provide. But for those topics that you do not have definite information, indicate that animal studies will have a delayed onset.
At the appropriate time after review, you will be asked for your IACUC approval of your research protocols. If your plans remain uncertain, a restricted notice of grant award will be issued that bars the use of funds for vertebrate animal research until prior NIH approval is obtained.
Yes. Clinical and translational research within the NIGMS mission may be supported through a MIRA. Clinical research must be completely within the context of the NIGMS clinical areas (anesthesiology, clinical pharmacology, sepsis, injury and critical illness). Mechanistic clinical trials are permitted in MIRA when the mechanistic study is an essential part of the research program. 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. 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. Pre-application discussion of clinical/translational research projects with an NIGMS program director is encouraged.
There is no change in the format/requirements for the Protection of Human Subjects section in the MIRA application. MIRA applicants should use the PHS Human Subjects and Clinical Trials Information form. Please note that study records should be entered for delayed start human subjects studies, i.e. a study that can be described at the time of application but will not begin at the time of award. The delayed onset human subjects study section only applies to studies for which definite plans for human subjects involvement cannot be described at the time of application.
Yes, both delayed start and delayed-onset human subjects research are permitted in MIRA awards. MIRA awardees should submit a prior approval request to their program director to add human subjects research to their MIRA. Prior approval requests should contain IRB approval of the human subjects study as well as a complete PHS Human Subjects and Clinical Trials Information form.
MIRA awardees can submit a prior approval request to their program director to add human subjects research to their MIRA or to initiate "delayed onset" studies. Prior approval requests should contain IRB approval of the human subjects study as well as a complete PHS Human Subjects and Clinical Trials Information form.
All applications, regardless of the amount of direct costs requested for any one year, should address a resource sharing plan that describes plans to share resources generated as part of MIRA-supported research (e.g., Model Organism Sharing Policy, Research Tools Policy).
Yes, effective January 25, 2023, NIH implemented a new policy to promote the sharing of scientific data. A data management and sharing plan is required in MIRA applications. Include information on genomic data sharing (GDS) (https://sharing.nih.gov/genomic-data-sharing-policy) when applicable. Use "Other Plan(s)" attachment field on PHS 398 Research Plan Form to upload the data management and sharing plan.
Please refer to NIGMS Data Management and Sharing Plan for more information.
Only the items listed in NOT-OD-17-098, plus any additional items if specifically listed in the individual notice of funding opportunity as required or optional.
Yes. A letter of support should be included from the department chair, dean, or other academic unit leader that describes institutional commitment to the development of the investigator and any other pertinent information. This information could include start-up packages and other institutional research support, space available to the PD/PI, salary support commitment for the PD/PI, skills and career development opportunities for the PD/PI, mentoring during the promotion and tenure process, and career advancement prospects for non-tenure track applicants.
Letters from former mentors are not required, nor encouraged, except in the case of continuing collaborations.
Letters of support should also be included from collaborators (limited to 1 page each), whether or not they receive financial support from the MIRA. If support is requested, the collaborator’s letter of support should make his/her contributions to the program clear and detail the reasons he or she cannot participate in collaborative research with the PI without support from MIRA. They must not include attached Biographical Sketches and should not circumvent page limitations by including figures and data.
The letters of support must be included as an attachment to the PHS 398 Research Plan Form (Item 9 Letters of Support). See SF424 R&R application guide [PDF] section R.400.
The MIRA program wants to provide recognition during the review to PIs who have made significant contributions to the research community. These contributions are not limited to, but are exemplified by, the following examples:
The 51% research effort commitment letter from the institution must be submitted as part of the Just-in-Time information and not as part of the application. This letter from the institution's authorized organizational representative must state that the institution is aware of and accepts the condition that other NIGMS research awards must be relinquished as a condition of receiving a MIRA and that if chosen to receive an award, the PI will commit a minimum of 51 percent of his or her total research effort to MIRA activities.
Applications that miss the due date and time are subject to the NIH Policy on Late Application Submission.
Yes. You may request money for equipment in the first year and in any subsequent years with appropriate justification. This is not intended as a mechanism to support the purchase of "big-ticket" items that may be covered under instrument-specific funding opportunities. The maximum allowable MIRA budget is $275,000 direct costs per year including any equipment.
Yes, but such requests must be extremely well-justified. NIGMS continues to encourage collaborative and interdisciplinary research when it is appropriate, and individual MIRA grantees are free to collaborate with one another or with other investigators using funds from their individual grants to support their parts of the team's research. A letter from the collaborating PI should be included, making his/her contributions to the program clear and detailing the reasons he or she cannot participate in collaborative research with the PI without support from MIRA.
Key personnel should be limited to collaborators who will be supported by a consortium, if applicable, included in the MIRA application. Senior/key personnel must devote measurable effort to the project whether or not salaries or compensation are requested. "Zero percent" effort or "as needed" is not an acceptable level of involvement for those designated as senior/key personnel. Because the focus of a MIRA application is the research program of the principal investigator, the inclusion of many other senior key personnel and their biosketches may distract reviewers from the contributions of the PI.
In addition to the PI, biosketches of collaborators supported through a consortium, if applicable, are the only additional ones required. Because the focus of the MIRA application is the research program of the PI, the inclusion of other biosketches may distract reviewers from the contributions of the PI.
NIGMS hopes that the ESI MIRA mechanism will enhance investigators' ability to conduct ambitious and creative research; however, there is no special emphasis on conducting exceptionally risky or out-of-the-box studies. The Institute wants to support investigators who are working to answer important and interesting questions about biological systems that have relevance to human health.
No. Note that preliminary data are neither expected nor required, and PD/PIs may wish to indicate this prominently in the Research Strategy. In lieu of preliminary data from the 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. Reviewers will be asked to bear this in mind, as well as the career stage of the ESI applicants.
The reviewers will be asked to identify investigators with the potential to establish independent research programs that will make unique contributions to the investigator's area of science. Use the biosketch to emphasize your personal contributions to any publications resulting from work with former mentors. Evidence of independence may include preliminary data obtained since establishing an independent laboratory and publications separate from previous mentors, though these are not required and are not expected for those who apply shortly after achieving independence. The resources and environment section of the application should address laboratory space and equipment available to the investigator. A letter from a department chair or dean should attest to the commitment of the institution to the development of the PI, any specific commitments and plans for mentoring of the PI.
The names and email addresses of the scientific contacts are listed in Section VII of the NOFO. Once applications are received, they will be referred to the most relevant program official based on internal NIGMS referral procedures and guidelines. The program official assigned to your application should be visible to you in the eRA Commons by the time the application is reviewed, and the name and contact information for the program official should appear at the top of the summary statement.
The NIH policy on post-submission of grant application materials is applicable. Updates related to administrative changes and publication of articles up to 30 days before the study section meeting may be submitted to the study section SRO (scientific review officer). See Post-Submission Materials Policy FAQ.
Per NIH notice NOT-OD-12-141, videos will be accepted by the SRO managing the review. Contact the SRO for instructions.
The maximum allowable budget is $275,000 direct costs per year, excluding any subcontract indirect costs, for a total project period of 5 years.
No, an itemized budget request is not required and will not be accepted. Instead, provide a total budget request for each budget period as outlined in NOT-GM-24-031 and NOT-GM-24-042 and reiterated below.
Note: The budget instructions below have been updated to include instructions for the Data Management and Sharing Costs. Please see https://nigms.nih.gov/Research/Pages/data-management-and-sharing-plan.aspx for more information on the Data Management and Sharing policy.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
Itemized budget information is not required and will not be accepted. Instead, a total requested direct cost amount for each budget period, including requests for equipment purchase, is required. Applications may request up to $275,000 direct costs per year including equipment and consortium direct costs. It is expected that the annual Total Direct Costs in Section G will remain constant in all years.
All instructions in the SF424 (R&R) Application Guide must be followed except as detailed below. While a 10-year R&R Detailed Budget form is provided in the application package, applicants may not request more than 5 years of support.
In order to allow submission of a budget request without filling out detailed yearly budgets, some basic information must be completed in order for NIH to successfully process the budget form. For each budget period:
Note: This information has been updated to include instructions for the Data Management and Sharing Costs.
Justification for budget categories detailed below should be included in the budget justification. Additional information beyond these categories should not be provided.
Data Management and Sharing Costs: We expect that most NIGMS grantees will not have to significantly change their data management and sharing practices and thus additional costs will, in most cases, be modest. If you feel that complying with NIGMS' expectations for meeting the DMS policy will require significant additional expenditures, justification for these costs should be clearly labeled under "Data Management and Sharing Costs" and include the requested direct costs dollar amount. If no costs are requested for DMS, state "0" for the requested dollar amount in the budget justification. Include a brief justification of the activities proposed in the DMS Plan that will incur costs. Be sure to include a brief summary of type and amount of scientific data to be preserved and shared, the name of the established repository(ies) to be used, and general cost categories. The recommended length of the justification is no more than half a page. Follow instructions in the SF424 Application Guide for the Data Management and Sharing Justification, in Section L: Budget Justification.
Equipment: Justification for the need of equipment as well as equipment quote(s) may be included here.
Consortium/Contractual Arrangements are not anticipated in most cases and must be extremely 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. Provide the total consortium/subaward costs for each budget period listing the total direct costs and indirect (F&A) costs separately.
F&A base: Explain any exclusions applied to the F&A base calculation.
Yes, F&A costs should be applied as you normally would for an NIH research grant and requested in the application as per the instructions in the SF424 R&R application guide.
No, consortium costs are expected to be rare and must be extremely well justified. In the rare instance these costs are requested, the consortium/subaward direct costs (not including consortium F&A) should be included in the "Requested Direct Costs." in Section F. of the Budget Form. In the Budget Justification, provide an estimate of the total consortium/subaward costs (direct costs plus F&A costs) for each budget period, rounded to the nearest $1,000. Also, list the individuals and organizations with whom consortium/contractual arrangements have been made and indicate whether the collaborating institution is foreign or domestic.
If you receive funds as a project leader on an NIGMS multi-component grant (i.e., P01, P50, or RM1), your MIRA funding level will be adjusted to remove any overlap with the multi-component grant. You will be required to relinquish your funding from the multi-component grant at the end of its current competitive segment.
July 1 or December 1 are the anticipated start date for ESI MIRA.
No. An inflationary escalation is any direct cost category should not be included, regardless of whether the annual total direct costs remain constant. If such increases are included in the submitted budget, the increases are removed from requested funds and result in decreases in the total awarded budgets of the years where they were included
MIRA applications will be reviewed at the Center for Scientific Review. Below are the links to the current standing MIRA review panels.
In addition to the chartered MIRA study sections, Special Emphasis Panels can also be organized as needed.
Detailed experimental plans are not required for ESI MIRA applications and reviewers are instructed to pay attention to review criteria outlined in the Notice of Funding Opportunity. For example, reviewers consider the proposed research program, investigator qualifications, innovation, approach, and environment. In addition, the PI’s productivity and scientific impact relative to the applicant’s career stage, service to the scientific community, and Plan for Enhancing Diverse Perspectives are also considered. The discussion during the review meeting and written resume of it are expected to be brief when there is agreement among all reviewers about the merit of an application.
Applications are due in October and will be reviewed in February/March for consideration by the National Advisory General Medical Sciences Council in May, with an earliest possible award date of July. Applications received for the February receipt dates will be reviewed in June/July for consideration by the National Advisory General Medical Sciences Council in September, with the earliest possible awards beginning in December.
Yes. The Center for Scientific Review will ensure that reviewers have the relevant expertise to review the application, bearing in mind that a MIRA is intended to support a broad program of research and the breadth of research areas that are encompassed by the NIGMS mission. A MIRA application presents the big picture of a PI’s research program within the NIGMS mission rather than emphasizing technical details, therefore exact expertise in specific subfields is not required and should not be anticipated.
Instead, reviewers are expected to bring a broad perspective to evaluate the scientific questions being studied and the PI’s proposal for how to do so.
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 using the review criteria specified in PAR-23-145. Individual review criterion scores will not be assigned. This is intended to shift emphasis away from details of the application and the approach, and to emphasize the potential impact of the investigator's research program on the field. All applicants will receive a summary statement containing the reviewers' critiques, as well as a resume and summary of the discussion for those applications that are discussed.
Rosters will be available 15 days before the study section meeting.
Reviewers will be asked to consider whether the budget is fully justified and reasonable in relation to the proposed work. In answering this question, it is anticipated that reviewers will consider the resources at the laboratory's disposal, and likelihood of efficient use of funds in the future. Reviewers will not be asked to recommend specific changes to the detailed budget or budget amounts.
Yes. Appeals are allowed for PARs.
No, but if you are still eligible, you may submit a new application for a receipt date in the next fiscal year.
NIGMS has a long-established policy that requires additional scrutiny of grant applications from investigators whose overall research support would exceed $1,500,000 in total costs per year, inclusive of any award that might be made on the pending application. See the NAGMS Council Guidelines for Funding Decisions. In keeping with this policy, additional scrutiny will be given to MIRA applications from well-funded investigators. It is expected that a majority of applicants to the ESI MIRA program will have less than $1,500,000 per year in support (total costs).
The summary statements for MIRA applications will be made available to the National Advisory General Medical Sciences Council in the same way as for other applications.
MIRA grantees may apply for and receive research grants from other NIH institutes or centers or from other funding agencies. However, it is important to ensure the work supported by the MIRA is distinct from that supported by other sources or under review or funding consideration. A key test of scientific overlap is whether two grants would both be cited as having supported the same publication. If they would be, it is an indication that there may be scientific overlap between the two grants. NIGMS staff always evaluate the possibility of overlap with other active or pending grants prior to making an award. In addition, NIGMS staff look at the grants PIs cite on their papers at the time of each research performance progress report to check for possible scientific overlap between grants. They also evaluate the research the PI is currently conducting and compare this to the work being supported by the PI’s other research support. If it is determined that scientific overlap exists, the MIRA grant may be adjusted or terminated.
Note that early-stage investigators may apply for an ESI MIRA and an overlapping NIGMS R01 simultaneously, but only one of the applications could be funded.
Investigators with K awards from NIGMS will be required to relinquish the K award prior to the start date of the MIRA. 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.
NIGMS will notify applicants when to submit Just-in-Time information. This information will be requested for all applications under consideration for funding, but the request is not meant to imply anything about the probability of an award. Be sure that the Other Support information provides a complete and accurate accounting of the total costs (as outlined in NOT-OD-21-073) that support research in the investigator’s laboratory, as well as any pending applications. See the Other Support webpage for an example. Failure to follow the appropriate formats on or after January 25, 2022 may cause NIH to withdraw applications from or delay consideration of funding.
As stated in the section III, a letter from the institution's authorized organizational official is required verifying that the institution is aware of and accepts the condition that other NIGMS research awards must be relinquished as a condition of receiving a MIRA and providing a statement that if chosen to receive an award, the PI will commit a minimum of 51 percent of his or her total research effort to MIRA activities.
NIGMS staff will carefully consider the study section and advisory council recommendations, including the scores and language in the summary statement and the Just-in-Time information and recent history of other grant support, in making recommendations about whether to fund a grant and at what level. As with all funding decisions, NIGMS also considers the breadth and diversity of the institute's research portfolio.
Investigators who contact NIGMS staff will be given feedback in the usual way on their reviews and their prospects for receiving a MIRA. As always, NIGMS staff cannot make any definite statements until the plan to make an award is approved at an appropriate level. The Notice of Award is the only official notice of a government commitment to fund a MIRA.
Since both the DP2 and the ESI MIRA PAR are limited to ESI eligible investigators and both are considered to be R01 equivalent awards, you cannot receive both awards, regardless of whether or not they are both assigned to NIGMS.
If you receive an R01 award before the MIRA has been reviewed, the MIRA application will be inactivated and will not be reviewed. If the R01 award is received after the review, but before the MIRA is awarded, the MIRA will be inactivated, and no award will be made. If both applications are considered for award at nearly the same time, then NIGMS staff will make a case by case decision about whether to fund the MIRA, or to require withdrawal of the pending R01 application before an award is made.
Once the PI is notified by program staff that NIGMS intends to fund a MIRA and the approximate recommended funding level of the offered award, the PI should reply by email with his/her intention to accept the MIRA within one week. If the PI declines the planned award, the institution should withdraw the application immediately. If the MIRA is declined, the PI has the option to pursue other mechanisms to obtain NIGMS funding, but NIGMS will not assume any obligations as a result of this decision.
Applicants will not be informed that they will NOT receive an award, because an award may be made at a later date. In general, all NIH applications remain active until the automatic withdrawal date of March 31 of the fiscal year after submission. For example, grants submitted on October 3, 2020 (FY21) will be automatically withdrawn on March 31, 2022. In practice, it is expected that under this NOFO, all awards will have been made by the end of the fiscal year in which the application was submitted.
Yes. Automatic carry over authority will apply to MIRA. Standard NIH and NIGMS policies will apply.
If the MIRA application proposed to continue work on an NIGMS grant for which he or she is currently a co-investigator, the applicant's effort will be subsumed into the MIRA. When the MIRA is funded, NIGMS will inform the PI of the other grant that the MIRA PI can no longer receive funding as a co-investigator on the grant and that the PI may rebudget those funds in accordance with all relevant established policies. If after being awarded a MIRA, the MIRA PI wishes to be listed as an unpaid collaborator on another PI's NIGMS grant application, this is permitted, but the MIRA PI cannot request salary or receive funds in any form from another NIGMS award.
With acceptance of the MIRA, the special terms and conditions on the MIRA Notice of Award specify the existing NIGMS grants from which the MIRA PI can continue to receive funding. A MIRA PI, who is also a co-investigator, cannot receive funds from NIGMS grants not specified on the MIRA Notice of Award.
Non-affected grants include NIGMS grants that support research resources, training, workforce development or diversity building, clinical trials, SBIR/STTRs, conference grants, some cooperative agreements, and the portion of a multiple component grant that is strictly a core. Funds currently supporting these activities will not be included in the MIRA funding level.
Existing administrative supplements will not be taken into consideration while determining the MIRA award level.
It is very important for PIs to accurately attribute grant support on their publications. The terms and conditions of all NIH awards, including MIRAs, state that all research publications supported in whole or in part by NIH must include a specific acknowledgment of NIH grant support, such as: "Research reported in this publication was supported by [name of the Institute(s), Center, or other NIH offices] of the National Institutes of Health under award number [specific NIH grant number(s) in this format: R35 GM987654]."
(If you have more than one grant, only cite the grant(s) that supported the research described in the article.) In addition, prior to award of any NIH competing grant application, PIs are required to provide a complete list of all their active and pending other support and, in the subsequent annual progress reports, describe any changes in other support, including new funding received: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-114.html.
MIRAs will be eligible for Research Supplements to Promote Diversity in Health-Related Research, for Research Supplement to Promote Re-Entry into Biomedical and Behavioral Research Careers, and for Administrative Supplements for Equipment Purchases. Other supplements offered by NIGMS may also be made available to MIRA grantees, depending on the intention and constraints of the particular supplement program.
Once a MIRA has been issued, that grant cannot be converted to an R01 award. The terms and conditions of the MIRA will continue through the end of the project period unless the institution chooses to relinquish the grant early. At the end of the project period, the investigator will have the option to apply for continuation of the MIRA or to apply for a new R01 or other forms of NIGMS support.
Annual reports will be required using the Research Performance Progress Report (RPPR). The NOFO includes some additional instructions consistent with the broader goals of the research program supported by MIRA and the absence of detailed specific aims. Additional information is requested that relates any new program directions to the NIGMS research mission and defines the relationship of any new other support to the activities supported by MIRA. These reporting requirements are more specific for MIRA than for an R01 research project grant. See PAR-23-145: Item 4. Reporting under Section VI. Award Administration Information for more information.
Changes in other support must be reported in the RPPR. The relationship between other support and work supported by MIRA should be explained. NIGMS will assess whether there is sufficient scientific and budgetary overlap to warrant adjustment of the MIRA.
The requirement for at least 51 percent of total research effort must be met for the entire project period of MIRA. A PD/PI will not be permitted to reduce his/her effort level on MIRA to less than 51 percent of his/her total research effort.
Formally, the MIRA is awarded to the institution in support of a project, not to an individual person. The institution has the right to request prior approval by NIH for the replacement of the PI. However, given the very intimate association of the ideas, expertise and record of productivity of the specific investigator with the program of research described in the research plan of the MIRA application and the scientific merit of the application as determined during peer review, it is unlikely that NIGMS would approve a permanent change of PI. A temporary change may be allowed with prior approval under circumstances such as sabbatical leave, medical condition, disability or personal or family situations such as child or eldercare needs.
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. The situation will be evaluated on a case-by-case basis and the MIRA could be terminated if continued support is not warranted.
Standard NIH and NIGMS policies will apply.
Senior/key personnel named in the Notice of Award may be replaced or eliminated from the budget with NIH prior approval. Standard NIH and NIGMS policies apply. Refer to senior/key personnel named in the NoA and see Section 8.1.2.6 Changes in status of the PD/PI in the NIH Grants Policy Statement for full details.
Standard NIH and NIGMS policies will apply; NIGMS expects the PI to maintain a similar level of effort as in the funded application.
Senior/key personnel other than the PI may receive support from other awards, including other MIRA grants on which they are also not the PI. The PI of a MIRA will not be awarded other support from NIGMS, nor may a MIRA PI receive funds from the grants of another NIGMS investigator.
MIRAs are renewable through a competing application and peer review process.
Yes, MIRAs with modest budgets that have been very productive and score very well could receive budget increases. MIRA budgets will be set based on a number of factors. Scoring well on renewal will not by itself guarantee a budget increase.
Prior approval is needed for the following:
You will need to notify your NIGMS program officer and grants management specialist of any significant changes to your animal research. Addition of animal studies and/or initiation of "delayed onset" studies requires NIGMS and NIH Office of Laboratory Welfare (NIH OLAW) administrative review prior to the start of these animal studies if you will be using funds from your MIRA. Approval from your IACUC for any new animal studies that will be carried out or for any significant changes to your approved animal studies is also necessary. You will need to provide an updated VAS section and NIH OLAW will need to provide their written approval that you may proceed with your animal studies using your NIGMS MIRA funds including for the purchase of any animals. For details, please see NIH Notice NOT-OD-14-126.
If you conduct research involving animals on your MIRA without your IACUC approval, NIH may reduce the amount of your award or request return of funds, and you may not use any animal data obtained during this time for any activity related to the grant award.
MIRA awardees can submit a prior approval request in writing to their program officer to add human subjects research to their MIRA or to initiate "delayed onset" studies. Prior approval requests should contain a complete Protection of Human Subjects section as described in the current MIRA notice of funding opportunity.
MIRA awardees can submit a prior approval request in writing to their program director to add human subjects research to their MIRA or to initiate "delayed onset" studies. Prior approval requests should contain a complete Protection of Human Subjects section as described in the current MIRA notice of funding opportunity.
Your program officer's name will be on your summary statement and in the NIH Commons.
The requirement of MIRA 51% total research effort applies for the duration of the MIRA, even during a no-cost extension. However, for exceptional circumstances, written prior approval for the reduction in PI/PD effort below the MIRA 51% total research effort can be requested. The recipient is reminded that active awards must have a measurable level of effort. Written prior approval requests should be submitted at least 30 days before the effective date of the change. If the request is e-mailed, it must provide evidence of the AOR's approval; a cc to the AOR is not acceptable.
