Answers to Questions Cover the Following Topics:
The three key differences are:
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 The pending applications must be withdrawn before the MIRA will be issued.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
A MIRA PI can apply for an NIGMS Biomedical Technology Research Resource P41 grant.
These applications are explicitly allowed:
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 NOFOs in the NIH Guide.
MIRA PIs are not prevented from submitting applications to other NIH Institutes.
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 NOFO will be somewhat reduced in size relative to their recent scales.
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.
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.
This NOFO 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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
No, an investigator needs only one eligible R01-equivalent award in a given fiscal year to be eligible to apply for the MIRA.
Because U01s involve substantial NIH staff involvement. It is unclear how that involvement would be incorporated into MIRA.
No. Eligibility is restricted to PDs/PIs with at least one NIGMS single-PI R01-equivalent award.
Yes, although NIGMS has issued a separate NOFO for ESIs and it is recommended that those with eligibility apply there.
No. This NOFO 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.
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.
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 $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.
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.
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.
No. An investigator can only have one MIRA, which should be submitted by the institution where he or she primarily conducts his or her research program. Under rare circumstances, a subcontract might be permitted to support a part of the research program that is based at a different institution.
A PD/PI is expected to commit at least 51% of his/her total research effort to MIRA as originally reviewed and approved. Significant change of research environment will be evaluated by NIGMS staff on a case-by-case basis, and may lead to a reduction of budget level, reduction in duration of support, or termination of the MIRA award.
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.
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 NOFO. Your request will be determined by NIGMS staff on a case by case basis.
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.
You may discuss your ideas with the program officer who administers your current NIGMS applications and awards.
Specific aims are not allowed because a goal of MIRA is to move the scientific enterprise away from a focus on narrowly defined research projects with detailed specific aims and to refocus attention on the larger picture and potential overall impact of the research. If your institution's system for submitting a grant application gives you a warning and will not allow you to skip the specific aims page, enter the following text in the appropriate place: "Per the NOFO instructions, no specific aims are to be submitted."
Follow the instructions in the SF424 R&R application guide as modified by the instructions in the NOFO. In brief, this means that the scientific content of the application will rely mainly on the abstract, public health relevance statement, facilities and other resources page, biosketch and the six-page research strategy, plus details on the involvement of human subjects and vertebrate animals as necessary. Applications must also provide data/resource sharing and key resource 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.
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.
Yes. All MIRA applications must include a plan describing how key biological and/or chemical resources are identified and validated.
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.
Yes. Clinical and translational research within the NIGMS mission may be supported through a MIRA. Clinical research must be completely within the context of the NIGMS clinical areas (anesthesiology, clinical pharmacology, sepsis, injury and critical illness). Mechanistic clinical trials are permitted in MIRA when the mechanistic study is an essential part of the research program. Clinical research that involves recruitment of human subjects at more than one site or the substantial financial support of multiple collaborators and subcontractors is not allowed, because these fixed commitments are not consistent with the highly flexible nature of the MIRA program. Clinical trials that are designed to test safety and efficacy of interventions (Phase I, Phase II, Phase III) for the purpose of future clinical treatment and/or regulatory approval are not permitted in MIRA. Pre-application discussion of clinical/translational research projects with an NIGMS program director is encouraged.
There is no change in the format/requirements for the Protection of Human Subjects section in the MIRA application. MIRA applicants should use the PHS Human Subjects and Clinical Trials Information form. Please note that study records should be entered for delayed start human subjects studies, i.e. a study that can be described at the time of application but will not begin at the time of award. The delayed onset human subjects study section only applies to studies for which definite plans for human subjects involvement cannot be described at the time of application.
Yes, both delayed start and delayed-onset human subjects research are permitted in MIRA awards. MIRA awardees should submit a prior approval request to their program director to add human subjects research to their MIRA. Prior approval requests should contain IRB approval of the human subjects study as well as a complete PHS Human Subjects and Clinical Trials Information form.
MIRA awardees can submit a prior approval request to their program director to add human subjects research to their MIRA or to initiate "delayed onset" studies. Prior approval requests should contain IRB approval of the human subjects study as well as a complete PHS Human Subjects and Clinical Trials Information form.
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.
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.
Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
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.
Letters of support should be included from a collaborator who will receive financial support from the MIRA, which is not anticipated in most cases.
The MIRA program wants to provide recognition during the review to PIs who have made significant contributions to the research community. These contributions are not limited to, but are exemplified by, the following examples:
The names and email addresses of the scientific contacts are listed in the NOFO. Once applications are received, they will be referred to the most relevant program official based on internal NIGMS referral procedures and guidelines. The program official assigned to your application should be visible to you in the eRA Commons by the time the application is reviewed, and the name and contact information for the program official should appear at the top of the summary statement.
The NIH policy on post-submission of grant application materials is applicable. Updates related to administrative changes and publication of articles up to 30 days before the study section meeting may be submitted to the study section SRO (scientific review officer). See Post-Submission Materials Policy FAQ.
Per NIH notice NOT-OD-12-141, videos will be accepted by the SRO managing the review. Contact the SRO for instructions. The 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.
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.
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.
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.
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 notice of funding opportunity.
Yes, F&A costs should be applied as you normally would for an NIH research grant and requested in the application as per the instructions in the SF424 R&R application guide.
No. 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.
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.
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.
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.
MIRA applications will be reviewed by chartered MIRA study sections at the Center for Scientific Review. Below are the links to the current 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
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.
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.
Rosters will be available 15 days before the study section meeting.
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.
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.
Yes. Appeals are allowed for PARs.
No, but if you are eligible, you may submit a new application for a receipt date in the next fiscal year.
The summary statements for MIRA applications will be made available to the National Advisory General Medical Sciences Council in the same way as for other applications.
MIRA grantees may apply for and receive research grants from other NIH institutes or centers or from other funding agencies. However, it is important to ensure the work supported by the MIRA is distinct from that supported by other sources or under review or funding consideration. A key test of scientific overlap is whether two grants would both be cited as having supported the same publication. If they would be, it is an indication that there may be scientific overlap between the two grants. NIGMS staff always evaluate the possibility of overlap with other active or pending grants prior to making an award. In addition, NIGMS staff look at the grants PIs cite on their papers at the time of each research performance progress report to check for possible scientific overlap between grants. They also evaluate the research the PI is currently conducting, and compare this to the work being supported by the PI’s other research support. If it is determined that scientific overlap exists, the MIRA grant may be adjusted or terminated.
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.
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.
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.
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.
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.
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.
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.
Yes. Automatic carry over authority will apply to MIRA. Standard NIH and NIGMS policies apply.
If the MIRA application proposed to continue work on an NIGMS grant for which he or she is currently a co-investigator, the applicant's effort will be subsumed into the MIRA. When the MIRA is funded, NIGMS will inform the PI of the other grant that the MIRA PI can no longer receive funding as a co-investigator on the grant and that the PI may rebudget those funds in accordance with all relevant established policies. If after being awarded a MIRA, the MIRA PI wishes to be listed as an unpaid collaborator on another PI's NIGMS grant application, this is permitted, but the MIRA PI cannot request salary or receive funds in any form from another NIGMS award.
With acceptance of the MIRA, the special terms and conditions on the MIRA Notice of Award 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.
These will be included in the MIRA funding level consideration and also in offsets taken to determine the MIRA award level in each year.
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.
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 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:
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).
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.
MIRAs will be eligible for certain types of administrative supplements. Please refer to the NIGMS Feedback Loop post on this topic for details.
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.
Annual reports will be required using the Research Performance Progress Report (RPPR). The NOFO includes some additional instructions consistent with the broader goals of the research program supported by MIRA and the absence of detailed specific aims. Additional information is requested that 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.
Changes in other support must be reported in the RPPR. The relationship between other support and work supported by MIRA should be explained. NIGMS will assess whether there is sufficient scientific and budgetary overlap to warrant adjustment of the MIRA.
The requirement for at least 51 percent of total research effort must be met for the entire project period of MIRA. A PD/PI will not be permitted to reduce his/her effort level on MIRA to less than 51 percent of his/her total research effort.
Formally, the MIRA is awarded to the institution in support of a project, not to an individual person. The institution has the right to request prior approval by NIH for the replacement of the PI. However, given the very intimate association of the ideas, expertise and record of productivity of the specific investigator with the program of research described in the research plan of the MIRA application and the scientific merit of the application as determined during peer review, it is 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.
Standard NIH and NIGMS policies will apply.
Senior/key personnel named in the Notice of Award may be replaced or eliminated from the budget with NIH written prior approval. Standard NIH and NIGMS policies apply. See NIH Grants Policy Statement in key personnel for full details.
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.
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.
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 his/her PO before submitting a tR01 application to NIH.
Prior approval is needed for the following:
You will need to notify your NIGMS program officer and grants management specialist of any significant changes to your animal research. Addition of animal studies and/or initiation of "delayed onset" studies requires NIGMS and NIH Office of Laboratory Welfare (NIH OLAW) administrative review prior to the start of these animal studies if you will be using funds from your MIRA. Approval from your IACUC for any new animal studies that will be carried out or for any significant changes to your approved animal studies is also necessary. You will need to provide an updated VAS section and NIH OLAW will need to provide their written approval that you may proceed with your animal studies using your NIGMS MIRA funds including for the purchase of any animals. For details, please see NIH Notice NOT-OD-14-126.
If you conduct research involving animals on your MIRA without your IACUC approval, NIH may reduce the amount of your award or request return of funds, and you may not use any animal data obtained during this time for any activity related to the grant award.
MIRA awardees can submit a prior approval request in writing to their program officer to add human subjects research to their MIRA or to initiate "delayed onset" studies. Prior approval requests should contain a complete Protection of Human Subjects section as described in the current MIRA notice of funding opportunity.
The requirement of MIRA 51% total research effort applies for the duration of the MIRA, even during a no-cost extension. However, for exceptional circumstances, written prior approval for the reduction in PI/PD effort below the MIRA 51% total research effort can be requested. The recipient is reminded that active awards must have a measurable level of effort. Written prior approval requests should be submitted at least 30 days before the effective date of the change. If the request is e-mailed, it must provide evidence of the AOR's approval; a cc to the AOR is not acceptable.
