Answers to Frequently Asked Questions About MIRA PAR-22-180

Answers to Questions Cover the Following Topics:

MIRA Program Description

What is the NIGMS MIRA program and what is its purpose?

  • A single NIGMS grant per PI to support the NIGMS-related research in an investigator’s lab. Distinct features of MIRA include increased award length, stability, flexibility, and reduced administrative burden
  • PI relinquishes other NIGMS support with some exceptions, e.g., resource, training, small business grants
  • Award levels determined based on your current NIGMS support
  • Plan for renewals – lower application numbers, higher success rates, flexible funding levels with the possibility of budget increases

What distinguishes MIRA from traditional NIH programs?

The three key differences are:

  1. The scope of the research supported by the MIRA, which encompasses the broad program of the investigator's laboratory that is within the mission of NIGMS, in contrast to a narrowly focused project(s).
  2. The flexibility that program-level support provides to the investigators, allowing them to pursue new research directions as opportunities arise. This flexibility is reflected in the form of the MIRA application, which shifts emphasis away from specific aims and details of proposed experiments and toward the importance of the overall research questions. The review process and review criteria emphasize the potential impact of the work over details of the approach.
  3. The possibility of funding a renewal application that is deemed meritorious but not as strong as would have been expected, based on the previous budget or other factors, for the full 5 years but at a lower level, allowing the PI’s research program to continue, albeit at a reduced scale.

How much time/effort must recipients devote to MIRA? How many calendar months?

MIRA provides support for a major research effort in the investigator's laboratory, leading to a requirement that he or she must devote at least 51 percent of their total research effort to the MIRA. Research effort per this FOA is calculated differently than professional effort in that research effort does not include effort expended toward teaching, administration not directly related to the PD's/PI's research, and/or clinical duties and needs to be expressed in person-months.

For example, if an investigator has two awards (including the MIRA) with 50 percent total effort between them, the investigator must devote a minimum of 25.5 percent effort to MIRA (50 percent 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). In another example, if an investigator spends 25 percent of the PI’s time on awards, the PI must devote at least 12.75 percent effort to MIRA (25 percent research effort x 51 percent MIRA effort requirement = 12.75 percent effort to the MIRA). This is equal to 1.53 calendar months (12.75 percent x 12 calendar months = 1.53 calendar months).

PIs must devote at least 51 percent of their research effort, but a higher level of PI research effort may be requested, if well justified. 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 research effort (such as an R35 from another institute of the NIH or a DP1 Pioneer Award). NIGMS will not award a MIRA while such awards are active or applications for any such awards are pending. The pending applications must be withdrawn before the MIRA will be issued.

How will NIGMS staff members verify if a PD’s/PI’s effort requirement is met?

NIGMS staff will verify that the MIRA research effort requirement is met by using the Other Support documentation. For this FOA, 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.

NOTE: If an application was submitted under a previous MIRA FOA, the PD’s/PI’s total research effort is inclusive of awards for which the purpose is education, training or enhancing workforce diversity, including R25s.

How much salary can be charged to MIRA?

Salary may be charged 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 charged; NIGMS does not consider there to be an obligatory relationship between percent of annual effort and percent of annual salary recovered from the grant.

What scientific areas of research are appropriate for support by MIRA?

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. Potential applicants are strongly encouraged to confer with the program official managing their qualifying award(s) or relevant research portfolio(s) before submitting a MIRA application.

Can technology development be included or is the award only for hypothesis-driven research?

Yes. Technology development can be an essential part of any research program and hypothesis-driven science is only one way of approaching a research problem. However, a program aimed almost exclusively at technology development may be more appropriately supported by other mechanisms.

Can a MIRA support clinical/translational research?

Yes. Clinical and translational research within the NIGMS mission may be supported through a MIRA. Pre-application discussion of clinical/translational research projects with an NIGMS program director managing the qualifying award is encouraged. 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.

Can I continue to work with my current collaborators?

Yes. NIGMS strongly encourages collaborative research. However, the MIRA concept is based on the idea that NIGMS will provide support to an individual investigator's research program. 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 can be included.

Can I collaborate with an NIH intramural scientist?

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.

Can I work with foreign collaborators?

Yes. NIGMS supports international collaborative research efforts, and investigators are encouraged to pursue scientifically productive collaborations. In rare 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.

Can you clarify how much flexibility is meant by "flexibility to pursue new research directions"?

This needs to be considered on a case-by-case basis and requires the application of reasonable judgment by both investigators and NIGMS staff. The extension of studies on a problem from one organism to another would be very reasonable. Extending a project into another within the mission of NIGMS would also be reasonable. When in doubt, you should discuss proposed changes with the appropriate 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.

What would be considered within or outside the scope of a MIRA?

Potential indicators of changes in scope 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 appropriate documentation and prior approval by NIGMS before the work is initiated. Work that migrates fully into the mission of another NIH institute or center would be considered out of scope, and it would be appropriate for this work to transition out of MIRA to grants supported by the relevant NIH institute or center.

Can a PI apply for a MIRA and NIGMS R01, R15, or R21 grants concurrently?

On submission of a MIRA application, the PI cannot submit another research grant including R01, R15 or R21 to NIGMS until the MIRA application has been reviewed and a summary statement issued. Please refer to PAR 22-180 for applications that are allowed pending review at the same time as your MIRA application.

What other NIGMS funding opportunities can a MIRA PI apply for?

These applications are explicitly allowed:

  • Grants supporting resources for the research community;
  • Collaborative Program Grant for Multidisciplinary Teams (RM1) grants;
  • Biomedical Technology Development and Dissemination (RM1) grants;
  • Sepsis Human Biospecimen Collections (R21/R33) Phased Innovation Awards*;*;
  • Contracts;
  • Grants supporting training, workforce development, or diversity building activities;
  • Grants supporting multi-site clinical research, both clinical trials and observational studies, with costs for patient recruitment, protocol-related expenses, and/or community resource activities (e.g., specimen banking, dissemination);
  • INBRE (P20), COBRE (P20/P30) or IDeA-CTRs (U54), SEPA, or NARCH;
  • SBIR/STTR grants;
  • Conference grants;
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 Biomedical Technology Development and Dissemination (BTDD) grants, the PD/PI must maintain 51% research effort toward their MIRA, and 3 person months' effort toward the BTDD. The BTDD award can only provide support in a MIRA PD/PI's laboratory for late-stage technology development and dissemination efforts.

**** For the Sepsis Human Biospecimen Collections (R21/R33) Phased Innovation Awards, if a New Investigator is issued the R33 portion of the phased award prior to the MIRA, they are no longer eligible as a New Investigator to receive the MIRA

Research Supplements to Promote Diversity in Health-Related Research, and certain types of administrative supplements, including equipment supplements that may be offered by NIGMS through FOAs in the NIH Guide.

MIRA PIs are not prevented from submitting applications to other NIH Institutes.

How can I decide if MIRA is right for my circumstances?

Decide whether a single NIGMS program, with a budgetary constraint on well-funded labs, is worth the advantages provided by the MIRA program. The advantages include 5 years of funding, more scientific flexibility, greater funding stability and reduced administrative burden.

Why does NIGMS think that this initiative will enhance the quality of science generated by its community of grantees?

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.

Can the topic of a MIRA be multiple distinct research directions?

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.

Eligibility Information

What NIGMS grants are qualifying awards for a MIRA application?

Investigators who are currently funded with at least one single-PI R01-equivalent award (defined here as R01, R35, R37, DP1, DP2, SC1, or NRNM U01) from NIGMS are eligible to apply for a MIRA.

What if I don’t have an active NIGMS grant?

New Investigators (those who have not competed successfully for a substantial, independent NIH research award) working in the mission areas of NIGMS will be eligible to apply for a MIRA if they have not received substantial funding as a subproject leader on a multi-component NIH award, except for project leaders and pilot project leaders on NIGMS COBRE, NIGMS IDeA-CTR or NIGMS NARCH awards who are eligible to apply for a MIRA. Potential applicants are strongly encouraged to contact NIGMS program staff to discuss the relevance of their research program to the NIGMS mission before submitting a MIRA application. Applications that fall outside of the NIGMS mission will be withdrawn prior to review.

PD/PIs who are currently Early Stage Investigators (ESIs) should apply through the ESI MIRA FOA and should not apply through PAR 22-180.

What is the time window for submission of a new MIRA application?

A new MIRA application can be submitted at any time prior to the original project end date, but no later than the end of the fiscal year following the one in which the qualifying award was originally set to expire , regardless of the status and duration of a no-cost extension. For example, if the qualifying R01-equivalent award ends in fiscal year 2022 (October 1, 2021 to September 30, 2022), a MIRA application needs to be submitted before September 30, 2023.

Can I renew my MIRA?

Yes, NIGMS encourages PDs/PIs who are currently funded with an NIGMS MIRA to renew their MIRAs, including both established investigator MIRAs and ex-early-stage investigator (ESI) MIRAs. Information on MIRA renewal success rate and budget increases can be found in this NIGMS Feedback Loop post.

What is the time window for submission of a renewal MIRA application?

A renewal MIRA application should be submitted no later than 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 2022 (October 1, 2021 to September 30, 2022), a renewal MIRA application needs to be submitted before September 30, 2024. NIGMS will not accept applications from MIRA grantees for awards that would begin prior to the end date of the current MIRA, with the exceptions listed in the FOA.

Why do MIRA renewal applications have a longer time window for eligibility?

As a MIRA is to support a PD’s/PI’s research program within NIGMS’ scientific mission, it will be the only qualifying award for the PD/PI. In contrast, a PD/PI may have two R01s as qualifying awards and thus could have multiple opportunities to submit a new MIRA application.

Will early submissions be allowed?

NIGMS will not accept applications from MIRA grantees for awards that would begin prior to the end date of the current MIRA, with the exceptions listed in the FOA.

Suppose my MIRA application does not score well enough to be funded. May I reapply for a MIRA next year?

A PD/PI may submit another MIRA application as long as the PD/PI is eligible. Note that each application will be considered as a new application, not as a resubmission.

Does the eligibility time window include grants in no-cost extension status?

The original project expiration date of the qualifying award will be the sole determinant. Please see the previous questions about the time windows for new and renewal applications. The qualifying award could be in no-cost extension when a new or renewal MIRA application is submitted.

Can I submit a R01 application before my MIRA is due for renewal?

Because MIRA supports the research program of a PD/PI, NIGMS will not accept a R01 application with a project start date before the end date of the MIRA. MIRA Renewals have a high success rate. Unless your research program has changed significantly and MIRA is no longer optimal for supporting your lab, renewing MIRA would be a better option in most cases.

Can I be a PI on a new MPI R01 application before my MIRA is due for renewal?

NIGMS expects MIRA PDs/PIs to collaborate with other investigators using funds from their MIRA awards. NIGMS will not accept MPI R01 applications with MIRA awardees listed as one of the PDs/PIs unless the requested start date is after the MIRA project end date and the MIRA PD/PI does not have a MIRA application pending review.

Can I be a PI or a project lead on a NIGMS Collaborative Program Grant for Multidisciplinary Teams or other multiple component project?

Yes, a MIRA PD/PI may participate in a RM1 project as part of the PD’s/PI’s 51% 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.

If an investigator has two or more R01-equivalent grants, do they all have to meet the eligibility requirements for applying for the MIRA?

No, an investigator needs only one eligible R01-equivalent award in a given fiscal year to be eligible to apply for the MIRA.

If I am the PI on one or two multi-PI R01s, am I eligible to apply?

No. Eligibility is restricted to PDs/PIs with at least one NIGMS single-PI R01-equivalent award.

Are individuals at all stages of their careers eligible?

Investigators with a qualifying NIGMS award are eligible to apply for a MIRA in the time window defined in the FOA. New Investigators (those who have not competed successfully for a substantial, independent NIH research award) working in the mission areas of NIGMS are eligible as described in the eligibility section. Early state investigators working in the NIGMS mission areas should apply for a MIRA only through the MIRA FOA for ESIs.

May two or more scientists apply as a team for an NIGMS MIRA?

No. This FOA is intended to provide support for the NIGMS mission-related research program of a single independent investigator.

Are scientists in the NIH intramural research program eligible to apply?

No, NIH intramural research program scientists are not eligible to apply. A MIRA application can include a collaboration with an intramural scientist, but no funds can be provided to the intramural laboratory via MIRA. A MIRA will not be converted to a cooperative agreement. Therefore, if the intramural researcher would have primary responsibility for a significant component of a MIRA program, a MIRA may not be a suitable means of support.

Can I apply for a MIRA if I have grants from other NIH Institute(s)/Center(s) in addition to my qualifying awards from NIGMS?

Yes. Investigators may have support from other NIH components or from other sources. However, that support in itself does not confer eligibility to apply for a MIRA. Investigators are eligible if they meet the eligibility requirement as defined in the FOA (PAR 22-180) and are able to commit 51 percent of their total research effort to the MIRA.

Can I combine all my NIH grants into a MIRA?

Research supported by non-NIGMS sources may not be included in the base of the MIRA budget, and NIGMS funds will not be awarded to support the non-NIGMS research. Please note that, consistent with NIGMS' policy on Support of Research in Well-Funded Laboratories, if your laboratory receives a large amount of research support from non-NIGMS sources such that your total funding is in excess of $1,500,000 annual total costs, your application will receive additional scrutiny by the NIGMS Advisory Council and, if awarded, your MIRA budget may be reduced.

Can I submit an application for the continuation of my current NIGMS grant support and apply for MIRA at the same time?

No. NIGMS will not accept a new or renewal R01 application from a PD/PI until after the summary statement of a pending MIRA application is released. NIGMS will not accept a MIRA application from a PD/PI until after the summary statement of a pending R01 application is released.

Are Howard Hughes Medical Institute investigators eligible to apply for MIRA? What about individuals with other types of substantial, unrestricted laboratory grant support?

Yes. HHMI investigators are eligible to apply for MIRA. The relationship between the work supported by HHMI and the work to be supported by NIGMS must be carefully explained but need not be separated into different projects and different specific aims. However, study sections, the National Advisory General Medical Sciences Council, and NIGMS staff will take total support, including PI salary support by HHMI, into account when considering the appropriate budget level of a MIRA. Investigators with other types of substantial, unrestricted laboratory support will be similarly considered on a case-by-case basis.

If I have an appointment at more than one institution, can I apply for a separate MIRA through each institution?

No. An investigator can only have one MIRA, which should be submitted by the institution where the PI primarily conducts their 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.

Can I keep my MIRA if I obtain a second appointment at another domestic or foreign institution?

A PD/PI is expected to commit at least 51% of their 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 termination of the MIRA award.

Can I request an extension of my eligibility status?

You may request to extend your eligibility to apply for a MIRA for reasons including medical issues, disability, family care responsibilities, extended periods of clinical training, natural disasters, and active-duty military service. Please submit your request at mira2019research@nigms.nih.gov. Your request will be determined by NIGMS staff on a case-by-case basis.

Application and Submission Information

Is there a limit on the number of applications that can be submitted by a PI? By an institution?

An investigator may be the PI on only one application for a MIRA in any one review cycle. 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 independent eligible investigators.

Can I get advice on my ideas for submission of a MIRA application?

You may discuss your ideas with the program officer who administers your current NIGMS applications and awards. New Investigators are strongly encouraged to contact the program officer who manages scientific portfolios relevant to what you propose to study in your MIRA application.

What became of the specific aims section of the grant application?

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 FOA instructions, no specific aims are to be submitted."

How should I prepare the Current and Pending Support attachment?

Provide information on current and pending research support at the time of application as instructed in PAR 22-180, which is different than the Other Support reported as part of your Just-in-Time information. Be sure to distinguish the direct costs per year that support research in the investigator's laboratory from support that goes to other investigators. See the MIRA webpage for an example.

Why is the research strategy section only six pages?

Because the goal of MIRA is to focus the investigator's and reviewers' attention on the higher level questions about significance and impact of the research program, details in the research plan can be reduced. Furthermore, changes in the biosketch 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.

Do I need to include a Plan for Enhancing Diverse Perspective (PEDP)?

Yes. As stated in PAR 22-180, 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 FOA when preparing your PEDP. For additional help, refer to the NIH BRAIN Initiative website for detailed information on the key elements and examples and FAQs of a PEDP.

Can a MIRA support human subjects and clinical/translational research?

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.

How do I prepare the Protection of Human Subjects section?

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.

Is delayed-onset human subjects research permitted in a MIRA?

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.

What approvals are required to add human subject studies to my MIRA project or to initiate "delayed onset" human subject studies?

MIRA awardees can submit a prior approval request via their AOR to the assigned NIGMS Grants Management Specialist 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.

What may I include in the appendix?

Please follow instructions in this Guide Notice when preparing your appendix materials. Do not use the appendix to circumvent the page limits.

When should the institutional letter of support be submitted?

The institutional letter of support should be submitted as part of the Just-in-Time information. 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 their total research effort to MIRA activities.

What is the policy on acceptance of late applications?

Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Can I include a collaborator?

Financial support for a collaborator is not anticipated in most cases of MIRA, and such requests must be extremely well-justified. One approved request is for the MIRA PI to continue working with a longtime collaborator in order to gain access to the collaborator’s collection of cells from human subjects with mitochondrial disorders, which is not available anywhere else in the world.

Should I submit letters of support?

A letter of support should be included from a collaborator who will receive financial support from the MIRA, which is not anticipated in most cases. Other letters of support are not encouraged. A MIRA PI will have the flexibility in future research directions and may or may not require any specific support.

Can you provide examples of "contributions to the research community"?

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:

  • Providing a research resource that is widely used, e.g., maintaining a research organism database.
  • Running an effective program that gives high school or undergraduate students from diverse backgrounds experience and mentoring in biomedical research.
  • Significant service to scientific professional societies, peer review panels, or journal editorial boards.

Who will be the scientific point of contact for my MIRA application?

The names and email addresses of the scientific contacts for distinct scientific areas. 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.

Budget Information

Can I request a budget increase to expand my research program when I convert my R01(s) to a MIRA?

A strategic goal of NIGMS is to fund as broad a portfolio of meritorious investigators as possible, giving them the resources they need to carry out important research. For this reason, and to improve overall returns on investments, NIGMS pays close attention to budget levels in all funding decisions, and gives large budget increases only in highly compelling cases. As stated in the FOA, most investigators should ask for budgets similar to what their overall NIGMS funding has averaged over the past three years. On average, investigators are likely to get ​higher budgets through MIRA than through NIGMS R01s.

Can I request a budget increase when I renew my MIRA?

Yes, you can. As reported in this FBL post, investigators have received budget increases when they renewed their MIRAs in the past. We anticipate similar budget increases for future MIRA renewals. As described on our funding policies page, multiple factors are considered when staff makes budget recommendations. Although there will be different budget scenarios and exceptions, as a guide, if your current MIRA budget is $250-275k or less, requesting a budget of $300k for your renewal would be reasonable.

How will the funding level for a new MIRA be established?

For well-funded investigators (generally with more than $400,000 direct costs from NIGMS), a new MIRA will likely be somewhat lower than the current/recent total budget in recognition of the stability, flexibility, decrease in administrative burden, and increased length of award that the MIRA provides. Investigators should keep in mind of NIGMS Policy that NIGMS is unlikely to award more than 2 R01s to a PI, so the MIRA is likely to be a better choice for most well-funded investigators.

In general, if an investigator's current total research support from NIGMS is between $250,000 and $400,000 in direct costs, the award may be about the same, reduced, or slightly increased.

If an investigator's current NIGMS research funding is more modest (less than $250,000),the MIRA will likely be funded at $250,000 unless the PI has significant other support.

MIRA budgets for New Investigators will generally be $250,000 in annual direct costs.

Because every situation is different, budget determinations are done with a great deal of consideration and on a case-by-case basis.

Can I request money for equipment in the budget?

Yes. You may request money for equipment in any year as long as there is appropriate justification. Note that this is not intended as a mechanism to acquire "big-ticket" items that may be covered under instrument-specific funding opportunities.

What is the maximum allowable budget?

Applications may request no more than $750,000 in direct costs per year for a period of 5 years. However, investigators are expected to request what is actually well-justified for their research program. In general, the request should be commensurate with the investigator's stable base of NIGMS research funding. Cost efficiency is one of the goals of the MIRA program and will be one of the considerations in review and funding decisions.

Should I include an itemized budget request in my MIRA application?

No, an itemized budget request is not required and will not be accepted. Instead, provide a total budget request for each budget period as instructed in the funding opportunity announcement.

Should I include a separate budget form if consortium/contractual costs are requested?

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.

What information should be included in the budget justification?

Justification for budget categories detailed below should be included in the budget justification. If none of the following budget items apply to your MIRA, state “not applicable” on the budget justification page so that a system error message will be avoided when submitting the application. Additional information beyond these categories should not be provided.

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.

Can I request Facilities and Administrative (F&A) Costs?

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.

Should I include year-on-year inflationary increase for salaries or supplies?

No. Annual increases in any direct cost category are not allowed. Except when equipment is requested, NIGMS expects the budget to remain constant for all years for the entire project period. If increases are included in the submitted total budget, the increases will be removed from requested funds and may result in decreases in the total budgets of the years where they were included.

If I submit a renewal application for my MIRA, is it possible to receive an increased budget?

Yes, MIRAs with modest budgets that have been very productive and score very well could receive budget increases. The most recent data on MIRA renewal success rate and MIRA budget.

What is the timeline for submission, review, and award?

For applications submitted for the January due date, the review will be in July and the award will generally start between December 1 of the same year and March 1 of the following year. For applications submitted for the May due date, the review will be in November and the award will generally start between April 1 and June 1 of the following year. Some applications may be funded toward the end of the fiscal year.

What happens to my multiple component GM awards when I receive a MIRA?

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.

The project period of my NIGMS award was ended early to start a MIRA. Will I be able to use my existing unobligated balance?

Yes. Grants on which a project period is ended early may initiate the first no cost extension, thereby remaining active and retaining the unobligated balance. Funds should continue to be expended on the aims of the active grants that are or will be in no cost extensions.

Review Information

How will MIRA applications be reviewed?

MIRA applications will be reviewed at the Center for Scientific Review. Below are the links to the current standing MIRA review panels.

https://public.csr.nih.gov/StudySections/DBIB/GGG/MRAA
https://public.csr.nih.gov/StudySections/DBIB/BCMB/MRAB
https://public.csr.nih.gov/StudySections/DBIB/CB/MRAC

In addition to the chartered MIRA study sections, Special Emphasis Panels can also be organized as needed.

What is the timeline for submission, review, and award?

Applications received for the January 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. Applications received in May will be reviewed in October/November for consideration by the National Advisory General Medical Sciences Council in January of the following year, with the earliest possible awards beginning in April.

Will the reviewers have expertise in the subject area of my application?

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. Thus, reviewers will be expected to bring a broad perspective rather than detailed expertise.

How can I find the roster for the study section that will review my application?

Rosters will be available 15 days before the study section meeting.

How will the review process for MIRA differ from that for R01 research grant applications?

All applicants will receive a summary statement containing the reviewers' critiques, as well as a resume and summary of the discussion. Since all MIRA applications are from previously successful PIs seeking continuation of NIGMS funding, the anticipation is that most of these MIRA applications will be discussed. Reviewers will be asked to provide a single overall impact score and will not provide individual criterion scores. 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. Reviewers will be asked for guidance on whether the budget should be increased, decreased, or stay essentially the same as the average level of NIGMS support over the previous several years. However, award levels will be based primarily on the parameters described in the Section IV, Budget Information.

How do the review criteria differ from those for an R01 research grant application?

The review criteria are the same, but the wording has been modified to emphasize the review of the investigator's overall NIGMS-relevant research program rather than a specific, narrowly focused project with highly tailored specific aims. Reviewers should emphasize MIRA-specific aspects of significance, investigator qualifications, innovation, approach, and environment.

Can I appeal the review of my MIRA application submitted to PAR-22-180?

Yes. Appeals are allowed for PARs.

If my application for MIRA is not funded, will I be able to prepare a resubmission?

No, but if you are eligible, you may submit a new application for a receipt date in the next fiscal year.

What will be Council's involvement in the second level peer review of MIRA applications?

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.

Post Review Issues

How is scientific overlap between a MIRA and my other grants or applications evaluated?

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.

When should I submit Just-in-Time information?

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 information provides a complete and accurate accounting of all awards that support research in the investigator's laboratory, as well as any pending applications.

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 their total research effort to MIRA activities.

How will MIRA funding decisions be made?

NIGMS staff will carefully consider the study section and advisory council recommendations, including the scores and language in the summary statement, Just-in-Time information and recent history of NIGMS, NIH and 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.

How will investigators be informed about the process?

Investigators who contact NIGMS staff will be provided feedback in the usual way on the 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.

What if I decline the MIRA after I am notified?

Once the PI is notified by program staff that NIGMS intends to fund a MIRA and the recommended funding level, the PI should reply by email with their 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 programs to obtain NIGMS funding, but NIGMS will not assume any obligations as a result of this decision.

When will I find out if I will not receive a MIRA?

Applicants will not be informed that they will NOT receive an award, because an award may be made at a later date. MIRA applications in response to this PAR will remain under consideration until the end of the fiscal year following the year of submission of the MIRA application.

Award Process Information

What is the principle for MIRA award level determination?

The initial budget determination is the level of annual funding for the MIRA. The MIRA funding level corresponds to the annual direct costs in the absence of other continued NIGMS funding. The MIRA award level reflects adjustments that are made to the MIRA funding level to account for overlap with the PI's current NIGMS grants along with the addition of the appropriate Facilities and Administrative Costs.

What is the anticipated success rate for this FOA?

NIGMS anticipates that the success rate will be the same as or higher than that of established investigators' success rates on renewing NIGMS R01 grants. The success rates for new and renewal MIRA applications for fiscal year 2021 are published in this NIGMS FBL post.

Will carryover of an unobligated balance from one budget period of the MIRA to another be permitted?

Yes. Automatic carry over authority will apply to MIRA. Standard NIH and NIGMS policies apply.

I am a MIRA PI who is also a co-investigator on someone else's NIGMS grant. How will that grant be affected and how does that affect my MIRA funding?

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 stipulate the existing NIGMS grants from which the MIRA PI can continue to receive funding. A MIRA PI who is a co-investigator cannot receive funds from NIGMS grants not specified on the MIRA Notice of Award.

How will existing administrative supplements to affected grants be handled?

Diversity supplements will be included in the MIRA funding level consideration and also in offsets taken to determine the MIRA award level in each year. Equipment supplements will be excluded from MIRA budget base calculations.

How will NIGMS multiple-PI R01s be affected?

NIGMS multiple-PI R01s where the MIRA PI is one of the PIs (whether contact PI or not) will continue through the end of the current project period. These funds will be considered in setting the MIRA funding level and an offset will be taken in the first year and each of the remaining years on a prorated basis. Depending on the funding recommendation, once the multi-PI R01 award ends, the MIRA award level may or may not increase.

The remaining multiple-PIs can submit a renewal application. The MIRA PI can continue to be listed as an unpaid collaborator in the renewal application, but the MIRA PI cannot request any salary or receive funds in any form from the renewal application. The MIRA PI’s support must be provided from the MIRA grant.

What kinds of grants will not be affected by the MIRA?

Non-affected grants include NIGMS grants that support research resources, training, workforce development or diversity building, clinical trials, SBIR/STTRs, conference grants, 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.

The project period of my NIGMS award was ended early to start a MIRA. Will I be able to use my existing unobligated balance?

Yes. Grants on which a project period is ended early may initiate the first no cost extension, thereby remaining active and retaining the unobligated balance. Funds should continue to be expended on the aims of the active grants that are or will be in no cost extensions.

Post Award Concerns

How should investigators attribute support from their MIRA on publications?

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: R01GM987654]."

(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.

Will MIRAs be eligible for administrative supplements?

MIRAs will be eligible for certain types of administrative supplements as described in the FOA (PAR 22-180).

Can I convert my MIRA back to an R01?

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 support. At the end of the MIRA, an R01 submission must have a requested start date that is after the project end date of the MIRA.

What, if anything, will be different about the annual reporting required for MIRA?

Annual reports will be required using the Research Performance Progress Report (RPPR). The FOA 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 describes any new program directions within the NIGMS research mission, discussion of how the work continues to be of high impact, and 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.

How will NIGMS manage overlap with other grants that may be awarded after MIRA?

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.

Can I adjust my effort on 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 their effort level on MIRA to less than 51 percent of their total research effort.

Will a change of PI be allowed?

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 doubtful 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.

What happens if the PI becomes unable to carry out the duties as PI or will be absent for more than 3 months at a time for any reason?

Standard NIH and NIGMS policies will apply.

How will NIGMS handle changes in senior/key personnel on a MIRA?

Senior/key personnel named in the Notice of Award may be replaced or eliminated from the budget with NIH written prior approval. Standard NIH and NIGMS policies apply. See NIH Grants Policy Statement regarding key personnel for full details.

Will a change of grantee institution be allowed?

Standard NIH and NIGMS policies will apply.

Who will be the program officer for my MIRA?

If you currently have grants administered by two or more different NIGMS program officials, the program director for your MIRA will be assigned by considering the scientific areas included in the MIRA application, NIGMS internal referral guidelines and discussion among NIGMS staff.

Regarding allowable exceptions to the restriction on obtaining other funding from NIGMS after a MIRA award is made, what is meant by “funding for clinical trials”?

This generally refers to a clinical activity that is not part of the MIRA investigator’s own research program, for example, serving as a site PI for a multi-site clinical trial. That is often a structured activity staffed by physicians, nurses, and personnel who are working in a professional care-giving capacity and not in a research role.

Can an NIH Director’s Transformative Research Award (tR01) be assigned to and awarded by NIGMS while I am funded with a MIRA?

No. A tR01 is assigned to a specific institute at NIH based on the scientific area of the proposed research. If your tR01 proposes research that falls within the scientific mission of NIGMS, it would be considered to overlap with your MIRA, even if the proposed work in the tR01 application is different from what was described in the MIRA application. A MIRA PD/PI is encouraged to contact their PO before submitting a tR01 application to NIH.

Prior Approval Issues

What changes will require NIH written prior approval?

Standard NIH and NIGMS policies will apply.

What approvals are required to add animal studies to my MIRA project, or when studies included as delayed onset in the application are to be initiated?

Prior approval is needed for the following:

  • A change in scope, including, but not limited to, a change from the approved use of vertebrate animals or involvement of human subjects, select agents or human embryonic stem cells
  • Additional no cost-extensions beyond a first no-cost extension or late notification of an initial no-cost extension
  • Change in status of the PI or senior/key personnel named in the Notice of Award
  • Change in grantee organization or organization status
  • Addition of a foreign component if not included in the original application, including a significant new foreign collaboration, requires NIGMS' prior approval; however, MIRA funds may be used to support a subcontract at a foreign institution only if the collaboration is essential to the PI's research program, represents a unique scientific opportunity and cannot be supported by the collaborator.

What approvals are required to add animal studies to my MIRA project, or when studies included as delayed onset in the application are to be initiated?

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 via their AOR to the assigned grants management specialist 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 funding opportunity announcement.

If my MIRA is in a No Cost Extension (NCE), do I still need to meet the minimum level of effort requirement on the MIRA of 51% total research effort?

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 emailed, it must provide evidence of the AOR's approval; a cc to the AOR is not acceptable.