Answers to Frequently Asked Questions About MIRA PAR-19-367

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
  • PI relinquishes other NIGMS support with some exceptions, e.g., resource, training, small business grants
  • Award levels somewhat lower than current support in return for increased award length, stability, flexibility, and reduced administrative burden
  • Plan for future renewals – lower application numbers, higher success rates, flexible funding levels

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 investigator, allowing her or him to pursue new research directions as opportunities arise. This flexibility is reflected in the form of the MIRA application, which shifts emphasis away from details of proposed experiments and toward the importance of the overall research questions; specific aims are eliminated, and the review process and review criteria emphasize the potential impact of the work over details of the approach.
  3. The possibility of NIGMS taking an approach to renewals that may avoid abrupt termination of laboratory support if the renewal is not fully successful.

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 is calculated differently than professional effort in that research effort does not include effort expended toward teaching, administration and/or clinical duties and needs to be converted to calendar months.

For example, if an investigator spends 50 ?percent of his or her time in the clinic and 50 percent on research, 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 his/her time on research, he/she must devote at least 12.75 percent effort to MIRA (25 percent research effort x 51 percent MIRA effort requirement = 12.75 percent effort to the MIRA). 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. Some institutions may require support on research grant funds to offset a shift in effort from teaching to research. Others may offer teaching or clinical load reductions as an incentive for research. If other duties to the institution will be correspondingly reduced if the MIRA and other pending applications are funded, that change in effort for research must be reflected in the calculation.

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 much salary support can be requested?

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. In FY 2019, the legislatively authorized maximum institutional base salary that can be requested or charged to an NIH research grant for 12 calendar months' effort is $192,300, excluding fringe benefits. Thus, if the PI's salary is at or higher than the legislative authorized maximum, the 51 percent MIRA requirement of a total 50 percent research effort, corresponds to a maximum salary of $49,037, excluding fringe benefits (50 percent research effort x 51 percent MIRA effort requirement = 25.5 percent on the MIRA; 25.5 percent x $192,300 = $49,037). Assuming for example a 33 percent fringe benefit rate, this would correspond to a maximum of $65,219 annual direct costs.

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.

What about research focused primarily on HIV/AIDS?

The HIV/AIDS structural biology program that used to be managed by NIGMS has transitioned to NIAID, so it cannot be part of an NIGMS-funded MIRA.

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 I name a co-investigator in my application?

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 collaborator or key personnel 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. Collaborators will work together because of their mutual interest in a problem. Funding for a collaborator can be requested only in rare cases.

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. 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 proposed changes with the appropriate NIGMS program director.

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 MIRA PI apply for other NIGMS R01, R15, or R21 grants?

On submission of a MIRA application, the PI cannot submit another research grant to NIGMS until the MIRA application has been reviewed and a summary statement issued. Upon receiving a MIRA, NIGMS will not fund an application for a research award where the MIRA PI is the PI or a multi-PI. The MIRA PI can participate in other NIGMS research applications as a collaborator (i.e., Other Significant Contributor) but cannot receive any funds from the grant.

Can a MIRA PI apply for an NIGMS P41 grant?

A MIRA PI can apply for an NIGMS Biomedical Technology Research Resource P41 grant.

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

These applicants are explicitly allowed:

  • Grants supporting research resources;
  • Contracts;
  • Grants supporting training, workforce development, or diversity building;
  • Grants solely for clinical trials;
  • INBRE (P20), COBRE (P20/P30) or IDeA-CTRs (U54);
  • SBIR/STTR grants;
  • Conference grants;

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 stability and reduced administrative burden. NIGMS expects that well-funded research groups supported by the established investigator MIRA FOA will be somewhat reduced in size relative to their recent scales.

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

How can I determine if I am eligible to apply?

This FOA targets investigators who are currently funded with at least one single-PI R01-equivalent award (defined here as R01, R35, R37, DP1, DP2, or SC1) from NIGMS.

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 original project expiration date of the qualifying award, regardless of the status and duration of a no-cost extension. For example, if the qualifying R01-equivalent award ends in fiscal year 2020 (October 1, 2019 to September 30, 2020), a MIRA application needs to be submitted before September 30, 2021.

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 early stage investigator (ESI) MIRAs.

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

A renewal MIRA application can be submitted at any time prior to the original project end date, but no later than the end of the second fiscal year following the original project period expiration date of the qualifying R35 award. For example, if the current MIRA expires in 2020 (October 1, 2019 to September 30, 2020), a renewal MIRA application needs to be submitted before September 30, 2022.

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?

Yes, a PD/PI may choose to submit a new or renewal MIRA application before the qualifying award is due for renewal. Successful MIRA applications will be funded in the fiscal year of Council review and may truncate the current project period of the qualifying award (a MIRA or R01-equivalent award).

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. NIGMS intends to ensure that the success rate for MIRA renewals will be higher than for R01 renewals.

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 RM1 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.

Why are U01s excluded from eligibility consideration?

Because U01s involve substantial NIH staff involvement. It is unclear how that involvement would be incorporated into 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?

Yes, although NIGMS has issued a separate FOA for ESIs and it is recommended that those with eligibility apply there.

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 who has received an R01-equivalent award from NIGMS.

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.

Are individuals who have support from sources other than NIGMS eligible to apply?

Yes. Individuals may have support from other NIH components or from other sources. However, they must be able to commit 51 percent of their total research effort to the MIRA. Research supported by non-NIGMS sources may not be included in the MIRA application, 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 $750,000 direct 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 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.

Can I obtain a second appointment at another domestic or foreign institution after I receive a MIRA?

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.

Do I have to request a no-cost extension of my qualifying award in order to maintain my eligibility for MIRA application?

The MIRA eligibility time window is determined by the original expiration date of the qualifying NIGMS award (a single-PI R01-equivalent award). It is a good idea to request a no-cost extension to keep the qualifying award active before the MIRA is funded.

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 to the Scientific /Research Contact listed at the end of this FOA. 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.

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."

What format should the application follow?

Follow the instructions in the SF424 R&R application guide as modified by the instructions in the FOA. 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 validation plans. Avoid duplicating material covered in other sections. For new applications, 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. For renewal applications, a progress report publication list with citation of grant support for each publication is recommended. Provide information on current and pending research support at the time of application in the format typically used for 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 [PDF, 62.5KB].

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 submit a plan for the authentication of key resources?

Yes. All MIRA applications must include a plan describing how key biological and/or chemical resources are identified and validated.

How do I handle the Vertebrate Animals Section? Do I need to address sex as a biological variable?

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 will need to mark "yes." You will need to 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.

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 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.

What may I include in the appendix?

Appendix materials are limited to the same items as for other NIH grant mechanisms. Do not use the appendix to circumvent the page limits. See NOT-OD-11-080.

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 his or her 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?

Letters of support should be included from a collaborator who will receive financial support from the MIRA, which is not anticipated in most cases.

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 are listed in the FOA. 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.

Can I update my application?

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.

Can I submit a video?

Per NIH notice NOT-OD-12-141, videos will be accepted by the SRO managing the review. Contact the SRO for instructions. The aggregate of your video submission files cannot exceed 2 minutes in length. The videos should be embedded as a single PDF and cannot exceed 25 MB in size and must be received by 30 days prior to the review meeting. See Interim Guidance for Videos Submitted as NIH Application Materials?.

Budget Information

How will the MIRA funding level be established?

For well-funded investigators (generally with more than $400,000 direct costs from NIGMS), an award 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 that NIGMS is unlikely in the future 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, his or her 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), he or she might expect an amount similar to or even higher than this level.

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 a detailed budget request in my MIRA application?

No, a detailed 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 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. As described above, MIRA budgets will be set based on a number of factors, and scoring well on renewal alone will not guarantee a budget increase.

What are the anticipated start dates for MIRA?

For the January 17, 2020 due date, award start dates will be between January 1 and March 1 of 2021. For the May 18, 2020 application due date, award start dates will be between April 1 and June 1, 2021.

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 by special emphasis panels organized by the Center for Scientific Review. The name and contact information for the scientific review official assigned to each application will be posted in the eRA Commons once the assignment has been made.

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 January of the following year. 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-19-367?

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

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 the annual direct costs that support research in the investigator's laboratory, as well as any pending applications. See the MIRA webpage for an example.

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.

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 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 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.

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?

These will be included in the MIRA funding level consideration and also in offsets taken to determine the MIRA award level in each year.

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 PIs 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.

How does effort on my other NIGMS grants affect my ability to meet the 51 percent research effort requirement on the MIRA?

The MIRA is meant to provide support for the PI's effort on NIGMS-related research. As a result, the effort on those NIGMS grants that are being phased out in order to start the MIRA are subsumed under the effort on the MIRA. For example, assume the following: The MIRA PI currently devotes research effort on several grants:

  • 1.8 calendar months on NIGMS R01 (effort to be subsumed under the MIRA)
  • 2.2 calendar months on NIGMS R01 (effort to be subsumed under the MIRA)
  • 3.0 calendar months on P01 from another institute in NIH
  • Total of 7.0 calendar months research effort

Since the 1.8 and 2.2 calendar months contributed to the NIGMS R01s will be subsumed into the MIRA, the PIs remaining research effort is the 3.0 calendar months on the P01 from another Institute in NIH. Therefore, the level of effort on the MIRA must be at least 51 percent of these 7 months of research effort (51 percent x 7 = 3.57 calendar months).

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

Will MIRAs be eligible for administrative supplements?

MIRAs will be eligible for certain types of administrative supplements. Please refer to the NIGMS Feedback Loop post on this topic for details.

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 original project end date.

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 his/her effort level on MIRA to less than 51 percent of his/her 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 in 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.

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 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 funding opportunity announcement.