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Answers to Frequently Asked Questions about MIRA PAR-17-190

  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

I. Eligibility Information


Q. Am I eligible to apply?

A. NIH defines early stage investigators as new PIs who are still within 10 years of having received their Ph.D. degree or completing medical residency (or the equivalent) and have not yet received R01-equivalent grant support (i.e., R01, R37, DP1, DP2, U01 or SC1 grant awards). Your eRA Commons account will indicate your ESI status and provides links to request exemptions and extensions. For PAR-GM-17-190 the only requirements for eligibility are that your ESI status = Yes in the eRA Commons and that you have an independent research appointment at an eligible organization.

Q. Can I apply for extension of my ESI status?

A.Yes. Extensions of ESI status are granted for a number of reasons, including family care responsibilities, extended periods of clinical training, extended periods of additional (non-degree) research training, disability or illness, active duty military service, federal loan clinical service requirements, and natural or other disasters. See New and Early Stage Investigator Policies.

Q. Why were the eligibility criteria changed after the original pilot (RFA-GM-16-003)?

A. The MIRA program remains an experiment and we are testing ideas to see if they work. Limiting eligibility to ESIs only will provide greater comparability with respect to the experience level of the applicants than was possible with RFA-GM-16-003.

Q. Are postdoctoral fellows and career development awardees eligible to apply?

A.If your institution defines your position as one that permits you to submit an NIH grant application as an independent principal investigator of a research project grant, then you may apply. If you are not in an independent position, as is true for most postdoctoral fellows, then you may not apply.

Q. What about K99/R00 awardees?

A. K99 awardees who have not yet transitioned to an independent position may not apply. R00 awardees who have transitioned to an independent position may apply.

Q. What about other K awardees?

A. If your K award is from another NIH institute (e.g., NHBLI, NINDS, NIDDK, NICHD), then there is a good chance that your area of interest is most closely aligned with the mission of that institute, rather than NIGMS. However, check with program staff of both NIGMS and the other institute for guidance.

Q. What if I have recently been, or expect to be, promoted to an associate professor?

A. For this PAR, eligibility is not related to academic rank.

Q. What if I currently hold a SCORE award?

A. If you currently hold a SCORE SC1 award (not applicable to SC2, SC3), then you are NOT eligible for this PAR. NIGMS considers the SC1 to be a substantial form of support equivalent to an R01, so that you are no longer considered a new PI. See the SCORE Answers to Frequently Asked Questions.

If you currently hold an SC2 or SC3 award and are otherwise eligible for this PAR, you may apply. If you are successful in receiving a MIRA, the SCORE award would be terminated or phased out.

Q. What if I currently have support from an IDeA COBRE award?

A. If you are one of the IDeA junior investigators and are otherwise eligible for this PAR, you may apply. The PI of an NIGMS IDeA grant is expected to be an established scientist and would not be eligible for this PAR. If the junior investigator’s support on the IDeA includes NIGMS-specific aims, the NIGMS-related support will be terminated prior to the start of the MIRA. The award level of the IDeA grant is not reduced. However, the IDeA PI is informed what portion of the funds (all or partial) can no longer be made available to the junior investigator who will receive the MIRA.

Q. What if I currently hold an AREA R15 grant?

A. You are eligible to apply. If you receive a MIRA, the early years may be adjusted to account for funds that you have already received for the AREA grant. This adjustment will apply to AREA grants that were awarded by NIGMS. However, if the PI has previously been supported by another institute of the NIH, the PI should be sure to check with a program director that their proposed work does fall within the mission of NIGMS.

Q. Do I need to have prior NIGMS support?

A. No, you do not. You may have received support from other institutes previously (e.g., through R03 or R21 awards), but if you are otherwise eligible and the proposed work is within the mission of the NIGMS, you may apply. However, the fact that your previous work was supported by another part of NIH may be an indication that the work really is of interest to one of the other institutes.

Q. May two or more ESI 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. For this PAR, multiple PI applications are not allowed. While team science is an important component of the biomedical landscape, this MIRA PAR is focused on supporting the individual laboratories of newly independent investigators.

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. Will revised MIRA grant applications be accepted?

A. Revised applications may not be submitted in response to PAR-GM-17-190. You may submit a NEW application on the same general topic as the one you submitted for RFA-GM-17-004 if you are still considered an ESI. The new application should make no reference to the previous application or its review. However, you may wish to change the application to address concerns raised during the previous review.

Q. Can I submit a MIRA and an R01 application at the same time?

A. Yes. The PAR specifically states: “It is anticipated that the MIRA review will be highly competitive; therefore, a PD/PI may submit an R01 application and a MIRA application in parallel.  Should both applications be selected for funding, the PD/PI will be required to relinquish one of the awards.”  This means that ESI PIs may submit an R01 to either the June 5 or October 5 deadline in addition to submitting a MIRA on October 3.  Please note that this is a change from previous versions of the ESI MIRA FOA, which did not allow dual submission.

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 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.


II. Award and Budget Information


Q. How many MIRA applications from early stage investigators will be funded?

A. The number of awards made will depend on the number of meritorious applications received and on available funds. NIGMS expects to fund approximately as many early stage investigators through all its grant mechanism as it has in recent fiscal years.

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

A. This is yet to be determined because it will be a function of the number of applications received. However, it is anticipated that the success rate will be similar to that for early stage investigator applications for R01 grant support in past years.

Q. What is the maximum budget I can request?

A. The maximum budget is $250,000 direct costs per year, excluding any subcontract indirect costs, for a total project period of 5 years.

Q. Can I submit a modular budget?

A. No, the R35 forms package requires a detailed budget to be submitted for each year of requested support.

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 anticipated start date for MIRA?

A. July 1 is the earliest anticipated start date for ESI MIRA applications submitted for the October 3 deadline.

Q. Should I include annual inflationary increases for salaries or other direct costs?

A. No. Annual increases in any direct cost category are not allowed, regardless of whether the annual total direct costs remain constant. 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 the program of research in the investigator’s laboratory that falls within the mission of NIGMS. A MIRA PI must devote at least 51 percent of his or her 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. 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 or more research effort. 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 calendar months of effort and percent of annual salary recovered from the grant as long as the salary charged is not in excess of the level of effort expended. The legislatively authorized maximum institutional base salary that can be requested or charged to an NIH research grant for 12 calendar months’ effort is published annually. Thus, if the PI’s salary is at or higher than the legislative authorized maximum for FY2017 ($187,000) and they have a total research effort of six calendar months, 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.

In calendar months:
6 calendar months (cm) research effort x 51% minimum MIRA effort requirement = 3.06 cm dedicated to MIRA
3.06 cm/12 months = 25.5%
$187,000 annual salary x 25.5% = $47,685 salary
$487,685 x 33% = $15,736 fringe benefits
$487,685 + $15,736 = $63,421 (total salary and fringe benefits)

Q. What scientific areas of research fall within the NIGMS mission and are appropriate for support through MIRA?

A. Research areas supported by NIGMS are described on the NIGMS website:

About NIGMS
Overview
Contacts by Research Area
Funding Opportunities Search

However, some types of research might be more suitably supported using a traditional R01 or other grant mechanism that require more detailed descriptions of the work (e.g., clinical studies). We strongly encourage applicants to discuss their planned proposal with NIGMS program staff substantially in advance of submission, since applications outside of the NIGMS mission will be returned to the applicant without review.

 

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. A 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. Who makes the final decision about whether a MIRA application is responsive and within the NIGMS mission, and when?

A. This decision is made by NIGMS program officials, division directors and NIGMS leadership. A preliminary determination may be made by contacting NIGMS staff. However, a final decision will only be made based on the submitted application itself.

Q. When will I know whether my application was accepted or rejected based on responsiveness to the NIGMS mission and how will that decision be made?

A. This process should be completed within a few weeks after the receipt date. Investigators whose applications are returned without review will be notified ASAP.

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 program 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 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. Please note, however, that as stated in the PAR, applications involving a consortium/contractual arrangement are expected to be rare. If a consortium/contractual arrangement must be included, the application must also include a letter from the subcontract PD/PI indicating why they cannot participate in collaborative research with the PD/PI without support from the MIRA.

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. Please note, however, that as stated in the PAR, applications involving a consortium/contractual arrangement are expected to be rare. If a consortium/contractual arrangement must be included, the application must also include a letter from the subcontract PD/PI indicating why they cannot participate in collaborative research with the PD/PI without support from the MIRA. Please also note that foreign collaborations added after review require approval by NIGMS staff.

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

A. This must be considered on a case-by-case basis and requires the application of reasonable judgment by both the investigator and NIGMS staff. The extension of studies on a problem from one organism to another would be reasonable. Insights gained from studying one biological problem that extend the project into another within the mission of NIGMS would also be reasonable. When in doubt, you should discuss changes with the NIGMS program director.

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

A. Any research in the PI’s lab that falls within the NIGMS mission and does not introduce changes related to substantive grants policy issues would be considered within scope. Changing research direction within scope, i.e., within the NIGMS mission, does not require prior approval by NIGMS. Briefly, the NIGMS mission is to support basic research that increases understanding of biological processes. As a general rule, research into the biological processes underlying a specific disease state (by and large excluding studies on sepsis; anesthesia; inflammation and innate immunity; wound healing; or trauma, burn, and peri-operative injury, all of which are supported by NIGMS) or research seeking to develop novel therapeutics or medical devices is most appropriately supported by the relevant categorical institute. If you are unsure whether or not your new research direction is within the NIGMS mission, contact your NIGMS program director.

A MIRA may change in scope for reasons related to grants policy or for scientific reasons. Policy-related changes in scope would include the addition, or a change in the approved use, of human subjects, vertebrate animals, select agents or human embryonic stem cells. These changes require prior approval by NIGMS before the work is initiated. However, such changes in scope can be approved with appropriate documentation. On the other hand, work that migrates away from the NIGMS mission and into the mission of another NIH institute or center would be considered scientifically out of scope and NIGMS program staff will communicate with the PI to determine the best course of action.  The budget of MIRA grants that are determined to be out of scope scientifically may be reduced in non-competing years, or the award may be terminated.

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

A. 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 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. 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 in NIH-funded biomedical research.


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 manages the portfolio of NIGMS applications and awards closest to your research. Portfolio descriptions can be found on the NIGMS website: Contacts by Research Area.

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 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-152.

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. 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, if applicable, included in the MIRA application. Senior/key personnel must devote measurable effort to the project whether or not salaries or compensation are requested. "Zero percent" effort or "as needed" is not an acceptable level of involvement for those designated as senior/key personnel. Because the focus of a MIRA application is the research program of the principal investigator, the inclusion of many other senior key personnel and their biosketches may distract reviewers from the contributions of the PI.

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, if applicable, are the only additional ones required.

Q. Does a MIRA application need to be exceptionally innovative (i.e., like a DP2)?

A. NIGMS hopes that the MIRA mechanism will enhance investigators' ability to conduct ambitious and creative research; however, there is no special emphasis on conducting exceptionally risky or out-of-the-box studies. The Institute wants to support investigators who are working to answer important and interesting questions about biological systems that have relevance to human health.

Q. Do I need to have preliminary results?

A. The MIRA application is very short and this may preclude the presentation of extensive preliminary results. Reviewers will be asked to bear this in mind, as well as the career stage of the ESI applicants for this PAR. Nonetheless, if you can provide a few compelling examples of preliminary data that support your application, it could strengthen your proposal. These data can demonstrate that you have achieved independence and can generate results in your own laboratory. This is an important review criterion.

Q. DHow important is independence?

A. The reviewers will be asked to identify investigators with the potential to establish independent research programs that will make unique contributions to the investigator's area of science. Use the biosketch to emphasize your personal contributions to any publications resulting from work with former mentors. Evidence of independence may include preliminary data obtained since establishing an independent laboratory and publications separate from previous mentors. The resources and environment section of the application should address laboratory space and equipment available to the investigator. A letter from a department chair or dean should attest to the commitment of the institution to the development of the PI, any specific commitments and plans for mentoring of the PI.

Q. My application image in the Commons does not show that I am an Early Stage Investigator on the face page, but I am. Is this an error? Whom should I contact to get this corrected?

A. No correction is needed. This is an artifact of the NIH record system that assigns ESI eligibility to individual applications. The R35 mechanism is so new that the NIH record system has not yet been programmed to assign the necessary flag to the grant application. The eligibility of the principal investigator as an Early Stage Investigator is maintained under a separate data field. This is the field that will be used to check the eligibility of the PI and accept an application in response to this PAR.

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

A. For this FOA, 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. Note that Dr. Vernon Anderson will serve as the initial scientific point of contact for the separate MIRA FOA for established investigators (EstIs).

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 applications to PAR-17-190 be reviewed?

A. Responses to this PAR will be reviewed by special emphasis panels (ad hoc study sections) that cover broad areas of science and review only applications submitted in response to this PAR. These panels will be organized by the NIGMS Office of Scientific Review. The reviews will use the review criteria specified in the PAR which emphasize the potential of the applicant and de-emphasize details of the experimental approach. No individual criterion scores will be assigned, only an overall impact score. Depending on the number of applications, it may be necessary to invoke a process whereby only the upper half of the applications are discussed.

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

A. Applications are due on October 3rd and will be reviewed in February/March for consideration by the National Advisory General Medical Sciences Council in May, with an earliest possible award date of July 1.

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

A. Yes. The Office of 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. Draft rosters will be available 30 days before the study section meeting; note that these draft rosters may not be final and are therefore subject to change. OSR further reserves the option to issue an aggregate roster listing all reviewers for applications to this FOA, as opposed to issuing a separate roster for each individual panel.

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. 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.

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 proposed work. In answering this question, it is anticipated that reviewers will consider the resources at the laboratory's disposal, and likelihood of efficient use of funds in the future. Reviewers will not be asked to recommend specific changes to the detailed budget or budget amounts.

Q. Can I appeal the review of my MIRA application submitted to PAR-17-190?

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 would exceed $750,000 in direct costs per year, inclusive of any award that might be made on the pending application. See the NAGMS Council Guidelines for Funding Decisions. In keeping with this policy additional scrutiny will be given to MIRA applications from well-funded investigators. It is expected that a majority of applicants to the ESI MIRA program will have less than $750,000 per year in support (direct costs).

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 Other Support 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 and the Just-in-Time information and recent history of other grant support, in making recommendations about whether to fund a grant and at what level.

Q. How will investigators be informed about the process?

A. Investigators who contact NIGMS staff will be given feedback in the usual way on their reviews and their prospects for receiving a MIRA. As always, NIGMS staff cannot make any definite statements until the plan to make an award is approved at an appropriate level. The Notice of Award is the only official notice of a government commitment to fund a MIRA.

Q. What if I received good scores on both a DP2 application and a MIRA application and both are considered for funding?

A. Since both the DP2 and the ESI MIRA PAR are limited to ESI eligible investigators and both are considered to be R01 equivalent awards, you cannot receive both awards, regardless of whether or not they are both assigned to NIGMS.

Q. What if I received good scores on an R01 assigned to a different institute of NIH and am offered both the R01 and the MIRA?

A. If you receive an R01 award before the MIRA has been reviewed, the MIRA application will be inactivated and will not be reviewed. If the R01 award is received after the review, but before the MIRA is awarded, the MIRA will be inactivated and no award will be made. If both applications are considered for award at very nearly the same time, then NIGMS staff will make a case by case decision about whether to fund the MIRA, or to require withdrawal of the pending R01 application before an award is made.

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 approximate recommended funding level of the offered award, 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. In general, all NIH applications remain active until the automatic withdrawal date of March 31 of the fiscal year after submission. For example, grants submitted on October 3, 2017 (FY18) will be automatically withdrawn on March 31, 2019. In practice, it is expected that under this FOA, all awards will have been made by the end of the fiscal year in which the application was submitted.

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

A. NIGMS policy is to consider bridging funds only for projects that have received prior NIGMS support. Bridging funds will therefore not be an option for applications submitted under this FOA.


VII. Award Process


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 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. 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 (September 30) in which they are submitted.


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 supported key personnel 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. The PI of a MIRA will not be awarded other support from NIGMS, nor may a MIRA PI receive funds from the grants of another NIGMS investigator.

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. Scoring well alone on renewal will 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 and defines the relationship of any new other support to the activities supported by MIRA. These reporting requirements are more specific for MIRA than for an R01 research project grant. See PAR-17-190: Item 3. Reporting under Section VI. Award Administration Information for more information.

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 unlikely that NIGMS would approve a permanent change of PI. A temporary change may be allowed with prior approval under circumstances such as sabbatical leave, medical condition, disability or personal or family situations such as child or eldercare needs.

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. Refer to senior/key personnel named in the NoA and see Section 8.1.2.6 Changes in status of the PD/PI in the NIH Grants Policy Statement for full details.

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.

This page last reviewed on June 28, 2017