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Answers to Frequently Asked Questions About MIRA PAR-17-094

  1. Eligibility Information
  2. Award and Budget Information
  3. MIRA Program Description
  4. Application and Submission Information
  5. Review Information
  6. Post Review Issues
  7. Award Process
  8. Post Award Concerns
  9. Agency Contacts

I. Eligibility Information


Q. How can I determine if I am eligible to apply? Can you work through some examples?

A. This FOA targets investigators who have an R01-equivalent award (defined here as R01, R37, DP2 or SC1) that expires in the same or the next fiscal year (FY) as the planned submission (i.e., for submission in FY 2017, a project end date of October 1, 2016-September 30, 2018) which received funding in the prior FY (i.e., for submission of an application in FY 2017, an R01, R37 or SC1 grant must have received funding in FY 2016, a DP2 needs to have been initially awarded in 2012 or 2013). Other investigators are ineligible. The PI may have additional NIGMS and/or NIH awards, but may not have another award that requires 50 percent or more research effort (e.g., a Pioneer Award). See an overview of determining individual eligibility [PDF, 777KB] using NIH RePORTER.

  • Q. Does it include grants in no-cost extension status?

    A. An eligible award might be in a no-cost extension, but that is irrelevant to the determination of eligibility. An example in 2017 would be a PI of an R01 whose project end date was March 31, 2017. This grant would have received funding in FY 2016, and would make the PI eligible in FY 2017 to apply to the May 17, 2017, receipt date. If requested, this grant could be in its first no-cost extension on this submission date. The PI would also be eligible if this grant had expended all of its funds and terminated. Note that based on this grant, the PI would not be eligible to apply for the MIRA in FY 2018 as the R01 was not funded in 2017.

  • Q. If an investigator has two or more projects, do all of the projects have to meet the eligibility requirements?

    A. No, an investigator with only one eligible R01 equivalent in a given fiscal year is eligible to apply for the MIRA.

  • Q. Why are U01s excluded from eligibility consideration?

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

  • Q. Why are DP1 awards excluded from eligibility consideration?

    A. DP1 awards that would overlap in time with the MIRA render the investigator ineligible because the investigator’s research effort would exceed 100 percent.

  • Q. If I am a PI on a single multi-PI R01, am I eligible to apply?

    A. Yes, if the funding and project end dates meet the requirements; but see VII. Award Process Information. In addition, you should discuss the ramifications of the MIRA with your program officer and your collaborators on the multi-PI R01 before deciding whether a MIRA makes sense for your research program. Also, consider whether your portion of the multi-PI R01 is sufficient to sustain a substantial research program requiring 51 percent of your research effort.

  • Q. If I am a PI on a single PI R01 and a multi-PI R01, am I eligible to apply?

    A. Yes, but see VII. Award Process Information. In addition, you should discuss the ramifications of the MIRA with your program officer and your collaborators on the multi-PI R01(s) before deciding whether a MIRA makes sense for your research program.

  • Q. If I am a PI on two multi-PI R01s, am I eligible to apply?

    A. Yes, but see VII. Award Process Information. In addition, you should discuss the ramifications of the MIRA with your program officer and your collaborators on the multi-PI R01s before deciding whether a MIRA makes sense for your research program.

  • Q. If I am a PI on a P01 subproject, am I eligible to apply?

    A. If the subproject is your only GM award the answer is NO. If you are also a PI on an eligible R01-equivalent award, the answer is Yes, but see VII. Award Process Information. In addition, you should discuss the ramifications of the MIRA with your program officer and your collaborators on the P01 before deciding whether a MIRA makes sense for your research program.

Q. Are individuals at all stages of their careers eligible?

A. This FOA targets established investigators with an R01 equivalent award from NIGMS that needs to be renewed to maintain funding. The application could come from an investigator who would be submitting his or her first renewal or who is seeking future funding on the completion of a DP2 or SC1 award; alternatively, it could be submitted by an established PI with an extensive grant history. NIGMS has issued a separate FOA for early stage investigators.

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

A. 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.

Q. Are women and members of underrepresented groups encouraged to apply?

A. Women and members of underrepresented groups who meet the other eligibility requirements are strongly encouraged to apply.

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

A. 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.

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

A. Yes. Individuals may have support from other NIH components or from other sources. However, they must be able to commit 51 percent of their research effort to the MIRA. Also, note that the level of non-NIGMS support will be taken into account in determining the MIRA budget.

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

A. No. If a PI submits an application for an NIGMS R01 for February 5/March 5, 2017 receipt dates, he or she would not be able to submit a MIRA application on May 17, 2017. If the PI submits a MIRA application on May 17, 2017, then he or she would not be able to submit a continuation of his or her current R01 until after the summary statement for the MIRA is available. The application and eligibility dates in 2017 require a PI to choose between submitting an R01 continuation or applying for a MIRA.

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

A. 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.

Determination of MIRA funding levels will take into account the policy on NIGMS Funding for Investigators with Substantial Unrestricted Research Support. It is therefore expected that the budget for a MIRA for an investigator with substantial unrestricted research support will be close to that of an average-size NIGMS R01 award.

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

A. 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.

Q. Can I get a definitive determination of my eligibility prior to submitting an application to this FOA?

A. The determination of potential eligibility was designed to be unambiguous. By using the NIH RePORTER website and following this procedure [PDF, 777KB], the eligibility conferred by an R01-equivalent grant can be confirmed. However, the timing of other grant submissions to NIGMS could affect the eligibility, or receipt of new grants requiring 50 or more percent research effort would result in a loss of eligibility.


II. Award and Budget Information


Q. What is the anticipated success rate for this FOA?

A. NIGMS anticipates that the success rate will be approximately the same as that of established investigators’ success rates on renewing R01 grants.

Q. How many MIRAs does NIGMS expect to award in FY 2018?

A. The number of awards will depend on the number of meritorious applications received and available funds.

Q. How will the MIRA funding level be established?

A. For well-funded grantees (with annual direct costs from NIGMS grants averaging over $400K in over the previous 3-5 years), the annual direct costs for MIRAs for this FOA will generally be somewhat less than the recent funding history of the investigators who apply and are approved for conversion of their NIGMS support to a MIRA. The advantage to these PIs is the 5 years, rather than the standard 4 years of support on an R01, and the reduced administrative burden. Average budget reductions are expected to be approximately 12 percent relative to the applicants’ recent funding history, although each case is considered individually, and both larger and smaller decreases are possible. For PI’s whose annual direct cost support from NIGMS has been less than $250K, well-justified increases will be considered. The budget will be determined by NIGMS staff who will consider the PI’s recent NIGMS funding history, the study section recommendation, the National Advisory General Medical Sciences Council recommendation, NIGMS staff analysis of the needs and potential productivity of the program, the PI’s other support and the NIGMS budget available in FY 2018.

Q. What is the anticipated average award size for this FOA?

A. Because this FOA has expanded the MIRA program to include investigators with a single R01 equivalent award, the distribution of award sizes will differ from the previous two established PI MIRA FOAs (RFA-GM-16-002, RFA-GM-17-002) in which applicants were required to have two R01 awards or a single award equal to or greater than $400,000. The award size distribution will depend on the current funding levels of the eligible investigators who receive MIRAs and their budget requests, as well as the recommendations of study sections, the National Advisory General Medical Sciences Council and NIGMS staff.

Q. Can I request money for equipment in the budget?

A. 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.

Q. What is the maximum allowable budget?

A. Applications may request up to $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 current total 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.

Q. What are the anticipated start dates for MIRA?

A. April 1-June 1, 2018, is the anticipated start dates for MIRA applications submitted for the May 17, 2017, deadline. Applications submitted for the January 17, 2018, deadline are intended to be issued with start dates between January 1 and March 1 of 2019.

Q. Should I include year on year inflationary increases for salaries or supplies?

A. No. Annual increases in any direct cost category are not allowed. If increases are included in the submitted budget, the increases are removed from requested funds and result in decreases in the total budgets of the years where they were included.


III. MIRA Program Description


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

A. MIRA provides support for an investigator’s overall program of research. This approach makes MIRA fundamentally different from other funding opportunities offered by NIGMS, which provide support on a project-by-project basis. For the purposes of MIRA FOAs, a research program is defined as the collection of scientific projects in an investigator’s lab that are related to the mission of NIGMS. The anticipated advantages of this approach include increased stability of funding; enhanced ability to take on ambitious scientific projects and approach problems creatively; increased flexibility to follow important new research directions as opportunities arise; more widely distributed funding among investigators; increased efficiency and efficacy of NIGMS funding; increased productivity and improved chances for important breakthroughs; reduced time spent writing, reviewing and managing multiple research grants; and more time for the conduct of research and mentoring junior scientists in a more stable environment.

Q. What distinguishes MIRA from traditional NIH programs?

A. The three key differences are:

  1. The scope of the research supported by the MIRA, which encompasses the broad program of NIGMS-mission relevant research in the investigator’s laboratory, in contrast to a narrowly focused project(s).
  2. The flexibility that program-level support will provide 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 an approach to renewals that will avoid abrupt termination of laboratory support if the renewal is unsuccessful.

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

A. 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 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 of his or her time on research, he or she 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 their time on research, they 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 make 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.

Q. How much salary support can be requested?

A. 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 2017, the legislatively authorized maximum institutional base salary that can be requested or charged to an NIH research grant for 12 calendar months’ effort is $187,000, 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 $47,685, excluding fringe benefits (50 percent research effort x 51 percent MIRA effort requirement = 25.5 percent on the MIRA; 25.5 percent x $185,100 = $47,685). Assuming for example a 33 percent fringe benefit rate, this would correspond to a maximum of $63,421 annual direct costs.

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

A. 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. However, some types of research might be more suitably supported using a traditional R01 or other grant mechanism with more specific detail provided (e.g., clinical trials). See the NIH definition of a clinical trial at NOT-OD-15-015. NIGMS offers other mechanisms to support clinical trials.

Q. What about research focused primarily on HIV/AIDS?

A. NIGMS funds research on the structural biology of virus and host cell factors that are essential in the life cycle of HIV and related viruses. This work is within the mission of NIGMS, but is supported with dedicated funds appropriated through the Office of AIDS Research. For this reason, the MIRA grant mechanism with its implied freedom to explore other areas of research within the NIGMS mission may not be the most appropriate way to support HIV/AIDS research. Contact NIGMS staff before applying.

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

A. 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.

Q. Can a MIRA support clinical/translational research?

A. Yes. Clinical and translational research within the NIGMS mission may be supported through a MIRA. NIH-defined clinical trials cannot be part of any MIRA application or award and must be submitted to clinical trial-specific funding opportunity announcements. Pre-application discussion of clinical/translational research projects with a NIGMS program director is encouraged. Such research can also be added after award of the MIRA, as an expansion in scope, providing NIH approval is obtained prior to initiating the studies.

Q. Can I continue to work with my current collaborators?

A. Yes. NIGMS strongly endorses collaborative research. However, the MIRA concept is based on the idea that NIGMS will provide support to individual investigators’ research programs. Collaborators will work together because of their mutual interest in a problem, not through a subcontract. In cases where a collaborator’s efforts are well-justified, essential to the research program of the MIRA and cannot be supported by the collaborator, a consortium agreement can be included.

Q. Can I collaborate with an NIH intramural scientist?

A. 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.

Q. Can I work with foreign collaborators?

A. Yes. NIGMS supports international collaborative research efforts, and investigators are encouraged to pursue scientifically productive collaborations. In cases where a foreign collaborator’s efforts are well-justified, represent a unique scientific opportunity, are essential to the research program of the MIRA and cannot be supported by the foreign collaborator, a consortium agreement with a foreign institution can be included.

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

A. 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 changes with the NIGMS program director.

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

A. Changes in scope would include the addition, or a change in the approved use, of human subjects, vertebrate animals, select agents or human embryonic stem cells. These changes require prior approval by NIGMS before the work is initiated. However, such changes in scope can be approved with appropriate documentation. 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.

Q. Can a MIRA PI apply for other NIGMS R01, R15 or R21 grants?

A. 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 (Other Significant Contributor) but cannot receive any funds from the grant.

Q. Can a MIRA PI apply for other NIGMS P01 or Center grants?

A. The MIRA PI can participate in other NIGMS large-scale research grants as a Core Leader if the purpose of the Core is solely to provide a service. The MIRA PI can participate in Center and other large scale research applications as an Other Significant Contributor (i.e., collaborator), but cannot receive any funds from the grant.

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

A. These applications are explicitly allowed:

  • Grants supporting research resources;
  • Contracts;
  • Cooperative agreements if permitted by the specific FOA;
  • Grants supporting training, workforce development or diversity building;
  • Grants for clinical trials;
  • INBRE (P20), COBRE (P20/P30) or IDeA-CTRs (U54);
  • SBIR/STTR grants;
  • Conference grants;
  • Grants supported through NIGMS HIV/AIDS-related FOAs.

Research Supplements to Promote Diversity in Health-Related Research, and other 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.

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

A. Ask yourself how much time and effort it takes you to maintain the current NIGMS funding of your laboratory through multiple, separate grant applications. Decide whether a single NIGMS project, 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.

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

A. 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.


IV. Application and Submission Information


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

A. An investigator may be the PI on only one application for a MIRA in any one year. 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.

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

A. You may discuss your ideas with the program contact named in the FOA or with the program officer who administers your current NIGMS applications and awards.

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

A. 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.”

Q. What format should the application follow?

A. 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. 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. 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].

Q. Why is the research strategy section only six pages?

A. 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.

Q. Do I need to submit a plan for the authentication of key resources?

A. Yes. All MIRA applications must include a plan describing how key biological and/or chemical resources will be authenticated.

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

A. There is no change in the format/requirements for the Vertebrate Animals Section (VAS) of the MIRA application. MIRA applicants should follow current supplemental instructions on preparing the Vertebrate Animals section of the research plan. 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.

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

A. Yes. Clinical and translational research within the NIGMS mission may be supported through a MIRA. NIH-defined clinical trials cannot be part of any MIRA application and must be submitted to clinical trial-specific funding opportunity announcements. Pre-application discussion of clinical/translational research projects with an NIGMS program director is encouraged.

  • Q. How do I prepare the Protection of Human Subjects section?

    A. There is no change in the format/requirements for the Protection of Human Subjects section in the MIRA application. MIRA applicants should follow current supplemental instructions on preparing the human subjects section of the research plan. For delayed-onset human subjects research, as much detail as possible about the planned human subjects research activities or a description of why it is not possible to provide information on the human subjects research activities in the grant application should be included in the Protection of Human Subjects section of the MIRA application.

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

    A. MIRA awardees can submit a prior approval request to their program director to add human subjects research to their MIRA. Prior approval requests should contain a complete Protection of Human Subjects section as described in supplemental instructions on preparing the human subjects section of the research plan.

Q. What may I include in the appendix?

A. 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.

Q. Should I submit letters of support?

A. Letters of support should be included for all collaborators who will receive financial support from the MIRA and are listed as key personnel. The application must also include a letter from the institution's authorized organizational official indicating 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 research effort to MIRA activities.

Q. Where does the institutional letter of support go?

A.The institutional letter of support should be included as an attachment to the PHS 398 Research Plan Form (Item 13 Letters of Support). See SF424 (version D) instruction guide section G.400 pp G-151.

Q. What is the policy on acceptance of late applications?

A. No late applications will be accepted.

Q. Can I request money for equipment in the budget?

A. Yes. You may request money for equipment in the first year and in any subsequent years with appropriate justification. This is not intended as a mechanism to support the purchase of "big-ticket" items that may be covered under instrument-specific funding opportunities.

Q. Can I include a consortium contract for a collaborator?

A. Yes, but such requests must be extremely well-justified. NIGMS continues to encourage collaborative and interdisciplinary research when it is appropriate, and individual MIRA grantees are free to collaborate with one another or with other investigators using funds from their individual grants to support their parts of the team's research. A letter from the subcontract PI should be included, making his/her contributions to the program clear and detailing the reasons he or she cannot participate in collaborative research with the PI without support from MIRA.

Q. How will support of other senior/key personnel (co-PIs) be considered?

A. Senior/key personnel who are independent investigators can contribute effort toward MIRA. They may receive support from the award, but only if they do not also receive support from their own MIRA.

Q. What if they receive support from another NIGMS award that is not a MIRA?

A. In that case, they are encouraged to consider applying for a MIRA if they are eligible to do so. If two investigators who are collaborators apply for their own MIRAs at the same time, each may include the other collaborator as part of their budget request and NIGMS staff will take this into account when making funding decisions.

Q. Who, if anyone, in addition to the PI should be listed as "key personnel"?

A. For this PAR, key personnel should be limited to collaborators who will be supported by a consortium included in the MIRA application. Senior/key personnel must devote measurable effort to the project whether or not salaries or compensation are requested. "Zero percent" effort or "as needed" is not an acceptable level of involvement for those designated as senior/key personnel. Because the focus of the MIRA application is the research program of the principal investigator, the inclusion of many other senior key personnel and their biosketches may distract reviewers from the contributions of the PI.

Q. Whose biosketches should be included in the MIRA application?

A. For this PAR, in addition to the PI, biosketches of collaborators supported through a consortium are the only additional ones required.

Q. Can you provide examples of “contributions to the research community”?

A. The MIRA program wants to provide recognition during the review to PIs who have made significant contributions to a 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 model 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.

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

A. For this FOA, Dr. Vernon Anderson will serve as the initial scientific point of contact. For early stage investigators (ESIs), Dr. Kristine Willis will serve as the initial scientific point of contact. 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.

Q. Can I update my application?

A. The normal 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. See Post-Submission Materials Policy FAQ.

Q. Can I submit a video?

A. Per NIH notice NOT-OD-12-141, videos will be accepted by the scientific review officer (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.


V. Review Information


Q. How will responses to PAR-17-094 be reviewed?

A. For currently funded PIs (PAR-17-094), reviews will be 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.

Q. What is the timeline for application, review and award?

A. 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.

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

A. 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.

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

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

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

A. All applicants will receive a summary statement containing the reviewers' critiques, as well as a resume and summary of the discussion. Since all applications to PAR-17-094 are from previously successful PIs seeking continuation of NIGMS funding, the anticipation is that many, but not all, 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.

Q. How do the review criteria differ from those for a regular R01 research grant application?

A. 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.

Q. How will the study section arrive at a budget recommendation?

A. Reviewers will be asked to consider whether the budget is fully justified and reasonable in relation to the previous and proposed work in the PI’s lab. In answering this question, it is anticipated that reviewers will consider the past productivity of the investigator's laboratory in areas relevant to the NIGMS mission, given the resources at the laboratory's disposal, evidence of efficient use of funds in the past and likelihood of efficient use of funds in the future. The PI’s current level of support from NIGMS and other sources will be taken into consideration in these discussions. Reviewers will be asked to consider whether the level of NIGMS support of the laboratory should be increased, decreased or stay about the same. Reviewers will not be asked to recommend specific, changes to the detailed budget or budget amounts.

Q. Can I appeal the review of my MIRA application submitted to PAR-17-094?

A. Yes. Appeals are allowed for PARs.

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

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

Q. How does the NIGMS $750,000 policy apply to MIRA?

A. NIGMS has a long established policy that requires additional scrutiny of grant applications from investigators whose overall research support including an award for the pending application would exceed $750,000 in direct costs per year. See the NAGMS Council Guidelines for Funding Decisions. In keeping with this policy additional scrutiny will be given to MIRA applications from well-funded investigators.

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

A. The summary statements for MIRA applications will be made available to the National Advisory General Medical Sciences Council in the same way as are other applications.


VI. Post Review Issues


Q. When should I submit Just-in-Time information?

A. 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.

Q. How will MIRA funding decisions be made?

A. 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.

Q. How will investigators be informed about the process?

A. 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.

Q. What if I decline the MIRA after I am notified?

A. 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 2 weeks. If the PI declines the planned award, the institution should withdraw the application immediately. If the MIRA is declined, the PI has the option to pursue other mechanisms to obtain NIGMS funding, but NIGMS will not assume any obligations as a result of this decision.

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

A. 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.

Q. Will bridging funds be provided in the case of investigators who were unsuccessful in obtaining a MIRA application?

A. Each investigator’s situation will be carefully considered on a case-by-case basis. NIGMS will consider the end dates of recent and currently funded projects, review history of recent attempts to renew the relevant R01s, and the amounts of unobligated balances in reaching these decisions.


VII. Award Process

The initial budget determination is of the MIRA funding level, defined as the level of annual funding for the period of 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 corrections that are made to account for overlap with the PI’s current NIGMS grants along with the addition of the appropriate Facilities and Administrative Costs. The MIRA award level can vary with grant year and reflects the actual annual total costs in the Notice of Award.


Q. How will the requested budget be considered?

A. The requested budget will be reviewed and considered in light of previous NIGMS funding of the laboratory. Requested budgets substantially higher than the previous level of NIGMS grant support will receive particularly careful scrutiny. MIRA funding level recommendations will take into account specific circumstances, such as requests to support co-investigators and subcontractors, equipment, supplies, travel and other expenses. For well-funded PIs (>$400,000 in annual direct costs) a reduction of the requested budget may be anticipated (in FY 2016 these reductions averaged 12 percent). For PIs with modest funding (<$250,000 in direct costs) well-justified increases will be considered in establishing the MIRA funding level.

Q. What are the factors determining the MIRA funding level?

A. The MIRA funding level will be established by considering the requested budget; the study section and NIGMS advisory council recommendations; the history of NIGMS support and other grant support, pending applications and awards; the comments of reviewers in the summary statement; the overall NIGMS budget and MIRA program aggregate budget models; and ANY and ALL other information available to NIGMS staff. The MIRA funding level represents the best estimate of an appropriate level of total NIGMS support for the investigator’s laboratory over the next 5 years.

Q. How will future year commitments be decided?

A. The MIRA funding level will generally be maintained at the recommended annual direct costs level, subject to consideration of what the level of support should be after any modifications of the first year’s budget due to equipment requests and/or pro-rating of the overlap in time of the terminated R01-equivalent. The conclusion of on-going multiple PI and program project or center subprojects may also affect the award level in years 2-5. As indicated in the FOA, annual increases (i.e., inflation, increases due to promotions, COLA, etc.) should not have been included in the requested budgets. Furthermore, if one cost category increases while another cost category decreases while maintaining a constant total direct cost level, adjustments will be made to the award calculations to remove the requested cost category increase.

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

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

Q. I am a MIRA PI who is also a co-investigator on another NIGMS grant. How are those grants affected and how does that affect my MIRA funding?

A. If the MIRA application proposed to continue work on which he or she is currently a co-PI, 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 their award and that they are free to rebudget those funds in accordance with all relevant established policies. If after being awarded a MIRA, the investigator wishes to be listed as a co-investigator on another PI’s NIGMS grant application, this can be done and he/she may devote a specific level of effort to that project, but the MIRA investigator cannot request salary or other support 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 on which the MIRA PI can continue to receive funding. On NIGMS grants where the MIRA PI is a co-investigator and that grant is not listed on the MIRA Notice of Award, the MIRA PI cannot receive funds from that grant.

Q. How will existing administrative supplements to affected grants be handled?

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

Q. How will program project or center subprojects be affected?

A. NIGMS P01 and center grants where the MIRA PI is a PI or project leader (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 P01 or center grant award ends, the MIRA award level may or may not increase.

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

A. Non-affected grants include NIGMS grants that support research resources, cooperative agreements, grants that support training, workforce development or diversity building, clinical trials, SBIR/STTRs, conference grants and the portion of a center grant or a P01 that is strictly a core. Funds currently supporting these activities will not be included in the MIRA funding level.

Q. What about exceptions not covered above?

A. Each investigator’s situation will be researched in great detail and considered individually. Some types of awards, such as DP1, DP2, transformative R01 and other Common Fund awards managed by NIGMS are examples of grants requiring special consideration in setting the MIRA funding and the MIRA award levels.

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

A. 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).

Q. How much salary support can be charged against my MIRA?

A. 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. The legislatively authorized maximum institutional base salary that can be requested or charged to an NIH research grant for 12 calendar months effort is $185,100, excluding fringe benefits in FY 2016. Thus, for the example above (if the PI’s salary is at or higher than the legislatively authorized maximum), the 51 percent MIRA requirement of a total 50 percent research effort, corresponds to a maximum salary of $47,200, excluding fringe benefits (50 percent research effort x 51 percent MIRA effort requirement = 25.5 percent on the MIRA; 25.5 percent x $185,100 = $47,200). Assuming for example a 33 percent fringe benefit rate, this would correspond to a maximum of $62,776 annual direct costs.

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

A. 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.

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

A. 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 RFA will remain under consideration until the end of FY 2017 on September 30.


VIII. Post Award Concerns


Q. Will MIRAs be eligible for administrative supplements?

A. MIRAs will be eligible for Research Supplements to Promote Diversity in Health-Related Research and may be eligible for other types of administrative supplements, such as equipment supplements that may be offered by NIGMS through notices in the NIH Guide for Grants and Contracts. Equipment needs that can be anticipated in advance should be included in the MIRA budget request and will be considered in setting the MIRA funding level.

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

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

Q. How will the receipt of support from a MIRA affect the eligibility of co-PIs to receive other grants?

A. Senior/key personnel other than the PI may receive support from other awards, including other MIRA grants on which they are also not the PI. Independent investigators who receive any support from more than one NIGMS grant are encouraged to consider consolidating their support by applying for a MIRA application when they become eligible under future FOAs.

Q. Will no-cost extensions be permitted?

A. Standard NIH and NIGMS policies will apply.

Q. What will happen at the end of the 5-year MIRA grant project period?

A. NIGMS plans for MIRAs to be renewable through a competitive application and peer review. An FOA will be issued in time for applications to be received and awards to be made without a gap in funding.

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

A. 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 will alone not guarantee a budget increase.

Q. Can I convert my MIRA back to an R01?

A. Once a MIRA has been issued, that grant cannot be converted to an R01 award. The terms and conditions of the MIRA will continue through the end of the project period unless the institution chooses to relinquish the grant early. At the end of the project period, the investigator will have the option to apply for continuation of the MIRA or to apply for a new R01 or other forms of NIGMS support.

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

A. 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 relates any new program directions to the NIGMS research mission, discussion of how the work continues to be innovative and 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.

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

A. Changes in other support should 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 51 percent research effort precludes the application for other research grants that require 50+ percent research effort.

Q. Will a change of PI be allowed?

A. 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.

Q. 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?

A. Standard NIH and NIGMS policies will apply.

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

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

Q. Will a change of grantee institution be allowed?

A. Standard NIH and NIGMS policies will apply.

Q. What changes will require prior approval?

A. There are no changes to standard NIH policy on prior approval requirements. Prior approval is needed for the following:

  • A change in scope including but not limited to, a change from the approved used of vertebrate animals or involvement of human subjects, select agents or human embryonic stem cells. See following Q&A for more detail.
  • 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.

Q. 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?

A. 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 R35 award. 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 R35 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 R35 award 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.

Q. What approvals are required to add human subject studies to my MIRA project or to initiate “delayed onset” human subject studies?

A. 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 a complete Protection of Human Subjects section as described in supplemental instructions on preparing the human subjects section of the research plan.

Q. Who will be the program director for my MIRA?

A. 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.


IX. Agency Contacts

The agency contacts for the overall program, peer review and grants management are listed in the FOA. PIs may also find it useful to contact the program director who administers their current and other pending NIGMS grant applications and awards.

Program Contact
Vernon E. Anderson, Ph.D.
National Institute of General Medical Sciences
Tel: 301-594-0828
Email: NIGMS Est PI MIRA@mail.nih.gov

Peer Review Contact
Maqsood Wani, Ph.D.
Center for Scientific Review
Tel: 301-435-2270
Email: wanimaqs@csr.nih.gov

Grants Management Contact
Lisa Moeller
National Institute of General Medical Sciences
Tel: 301-594-3914
Email: moellerl@mail.nih.gov

This page last reviewed on July 18, 2017