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 indicates 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.
Use the NIH RePORTER. You can search using keywords, or find similar applications funded by NIH and note the funding institute. The Matchmaker tab is particularly useful. You can enter your abstract and look for scientific matches. Finally, if you have submitted your proposed studies in an application to NIH before, and it was assigned any other institute, this decreases the likelihood that the research falls within the scientific mission of NIGMS.
The application will be returned without review by the institute.
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.
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.
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.
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.
For this PAR, eligibility is not related to academic rank.
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.
If you are an IDeA junior investigator 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.
You are eligible to apply if you have ESI status. If you receive a MIRA, the award 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 an NIGMS program director to be sure the proposed work falls within the mission of NIGMS.
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.
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.
Women and members of underrepresented groups who meet the other eligibility requirements are strongly encouraged to apply.
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.
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.
The NIH Common Fund DP2 Funding Opportunity Announcement states: "The NIH will not accept duplicate or highly overlapping applications under review at the same time.
No, NIH intramural research scientists are not eligible to apply. A MIRA application can include a collaboration with an intramural scientist, but no MIRA funds can be provided to the intramural laboratory. 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.
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.
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.
The maximum budget is $250,000 direct costs per year, excluding any subcontract indirect costs, for a total project period of 5 years.
No, the R35 forms package requires a detailed budget to be submitted for each year of requested support.
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.
July 1 is the earliest anticipated start date for ESI MIRA applications submitted for the October 3 deadline.
No. An inflationary escalation is any direct cost category should not be included, regardless of whether the annual total direct costs remain constant. If such increases are included in the submitted budget, the increases are removed from requested funds and result in decreases in the total awarded budgets of the years where they were included.
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.
NIGMS supports basic research that increases our understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. The specific areas of research that fall into this general mission can be found at the NIGMS overview page and on the web pages of the NIGMS scientific Divisions. In particular, note that NIGMS-supported research may utilize specific cells or organ systems if they serve as models for understanding general principles. Research whose overall goal is to gain knowledge about a specific organ or organ system or the pathophysiology, treatment, or cure of a specific disease or condition will, in most cases, be more appropriate for another NIH Institute or Center and thus will not be suitable for this Funding Opportunity Announcement.
NIGMS supports research in specific clinical areas that affect multiple organ systems: anesthesiology and peri-operative pain; sepsis; clinical pharmacology that is common to multiple drugs and treatments; trauma, burn injury, and wound healing (Division of Pharmacology, Physiology, and Biological Chemistry).
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.
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 his or her time on research, the investigator 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 is permitted. 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 or 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.
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 2018, the legislatively authorized maximum institutional base salary that can be requested or charged to an NIH research grant for 12 calendar months’ effort is $189,600, 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 $48,348, excluding fringe benefits (50 percent research effort x 51 percent MIRA effort requirement = 25.5 percent on the MIRA; 25.5 percent x $189,600 = $48,348). Assuming for example a 33 percent fringe benefit rate, this would correspond to a maximum of $64,303 annual direct costs.
In calendar months:6 calendar months (cm) research effort x 51% minimum MIRA effort requirement = 3.06 cm dedicated to MIRA3.06 cm/12 months = 25.5%$189,600 annual salary x 25.5% = $48,348 salary$48,348 x 33% = $15,955 fringe benefits $48,348 + $15,955 = $64,303 (total salary and fringe benefits)
Research areas supported by NIGMS are described on the NIGMS website:
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 or technology development). We strongly encourage applicants to discuss their planned proposal with NIGMS program staff well in advance of submission, since applications outside of the NIGMS mission will be returned to the applicant without review.
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 strongly encouraged. Such research can also be added after award of the MIRA, as change in scope, providing NIH written approval is obtained prior to initiating the studies.
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.
This process should be completed within a few weeks after the receipt date. Investigators whose applications are returned without review will be notified ASAP.
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.
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. As noted above, however, a program aimed almost exclusively on technology development may be more appropriately supported by other grant mechanisms.
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 collaborating PD/PI indicating why they cannot participate in collaborative research with the PD/PI without support from the MIRA.
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 written approval by NIGMS staff.
As indicated in the NIH glossary, Co-Investigators are defined as collaborators and are considered equivalent to senior/key personnel. The Co-Investigator designation does not affect the PI's roles and responsibilities as specified in the NIH Grants Policy Statement, does not imply that there are multiple PIs, and does not confer any advantages or responsibilities on the individual in question beyond those of a collaborator or senior key person. Applicants should therefore consider whether designation as collaborator or key personnel might be sufficient. Applicants should also keep in mind that the MIRA concept is based on the idea that NIGMS will provide support to individual investigators’ research programs. Collaborators will work together because of their mutual interest in a problem. 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 or request for salary support can be included. Please note, however, that as stated in the PAR, these arrangements are expected to be rare. If a consortium/contractual arrangement or salary for a collaborator must be included, the application must also include a letter from the collaborator indicating why they cannot participate in collaborative research with the PD/PI without support from the MIRA. If the justification provided is deemed insufficient by review or by NIGMS leadership, the requested funds may be removed prior to award.
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.
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.
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.
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.
These applications are explicitly allowed:
MIRA PIs are not prevented from submitting applications to other NIH Institutes.
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.
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.
You may discuss your ideas with the program contacts 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.
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.”
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]
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.
Yes. All MIRA applications must include a plan describing how key biological and/or chemical resources will be authenticated.
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.
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.
There is no change in the format/requirements for the Protection of Human Subjects section in the MIRA application. MIRA applicants should use the PHS Human Subjects and Clinical Trials Information form. Please note that study records should be entered for delayed start human subjects studies, i.e. a study that can be described at the time of application but will not begin at the time of award. The delayed onset human subjects study section only applies to studies for which definite plans for human subjects involvement cannot be described at the time of application.
Yes, both delayed start and delayed-onset human subjects research are permitted in MIRA awards. MIRA awardees should submit a prior approval request to their program director to add human subjects research to their MIRA. Prior approval requests should contain IRB approval of the human subjects study as well as a complete PHS Human Subjects and Clinical Trials Information form.
MIRA awardees can submit a prior approval request to their program director to add human subjects research to their MIRA or to initiate "delayed onset" studies. Prior approval requests should contain IRB approval of the human subjects study as well as a complete PHS Human Subjects and Clinical Trials Information form.
Appendix materials are limited to the same items as for other NIH grant mechanisms. Do not use the appendix to circumvent the page limits. See NOT-OD-11-080.
Letters of support should be included for all collaborators who will receive financial support from the MIRA and are listed as key personnel.
A.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.
The institutional letter of support must be included as an attachment to the PHS 398 Research Plan Form (Item 13 Letters of Support). See SF424 (version D) instruction guide [PDF, 7.25 MB] section G.400 pp G-146.
No late applications will be accepted.
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.
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 collaborating 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.
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.
For this PAR, in addition to the PI, biosketches of collaborators supported through a consortium, if applicable, are the only additional ones required. Because the focus of the MIRA application is the research program of the PI, the inclusion of other biosketches may distract reviewers from the contributions of the PI.
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.
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 application. These data can demonstrate that you have achieved independence and can generate results in your own laboratory. This is an important review criterion.
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.
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.
For this FOA, Drs. Kristine Willis, Peter Preusch, Pamela Marino, and Alison Cole will serve as the initial scientific points 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.
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.
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.
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 (OSR). 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.
Applications are due on October 3 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.
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.
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 may issue an aggregate roster listing all reviewers for applications to this FOA, rather than a separate roster for each individual panel.
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.
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.
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.
Yes. Appeals are allowed for PARs.
No, but if you are still eligible, you may submit a new application for a receipt date in the next fiscal year.
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).
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.
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.
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. As with all funding decisions, NIGMS also considers the breadth and diversity of the institute's research portfolio.
Investigators who contact NIGMS staff will be 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.
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.
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 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.
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 one week. If the PI declines the planned award, the institution should withdraw the application immediately. If the MIRA is declined, the PI has the option to pursue other mechanisms to obtain NIGMS funding, but NIGMS will not assume any obligations as a result of this decision.
Applicants will not be informed that they will NOT receive an award, because an award may be made at a later date. 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, 2018 (FY19) will be automatically withdrawn on March 31, 2020. 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.
No.
Yes. Automatic carry over authority will apply to MIRA. Standard NIH and NIGMS policies will apply.
MIRAs will be eligible for Research Supplements to Promote Diversity in Health-Related Research and may be eligible for certain 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.
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.
Standard NIH and NIGMS policies will apply.
NIGMS plans for MIRAs to be renewable through a competing 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.
Yes, MIRAs with modest budgets that have been very productive and score very well could receive budget increases. MIRA budgets will be set based on a number of factors. Scoring well on renewal will not by itself guarantee a budget increase.
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.
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.
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.
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.
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.
There are no changes to standard NIH policy on prior approval requirements. Prior approval is needed for the following:
You will need to notify your NIGMS program officer and grants management specialist of any significant changes to your animal research. Addition of animal studies and/or initiation of “delayed onset” studies requires NIGMS and NIH Office of Laboratory Welfare (NIH OLAW) administrative review prior to the start of these animal studies if you will be using funds from your 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.
MIRA awardees can submit a prior approval request in writing 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 the current MIRA funding opportunity announcement.
Your program director's name will be on your summary statement and in the NIH Commons.
MIRA grantees may apply for and receive research grants from other NIH institutes or centers or from other funding agencies. However, it is important to ensure the work supported by the MIRA is distinct from that supported by other sources or under review or funding consideration. A key test of scientific overlap is whether two grants would both be cited as having supported the same publication. If they would be, it is an indication that there may be scientific overlap between the two grants. NIGMS staff always evaluate the possibility of overlap with other active or pending grants prior to making an award. In addition, NIGMS staff look at the grants PIs cite on their papers at the time of each research performance progress report to check for possible scientific overlap between grants. They also evaluate the research the PI is currently conducting, and compare this to the work being supported by the PI’s other research support. If it is determined that scientific overlap exists, the MIRA grant may be adjusted or terminated.
Note that early-stage investigators may apply for an ESI MIRA and an overlapping NIGMS R01 simultaneously, but only one of the applications could be funded. Established investigators cannot have an NIGMS R01 and MIRA application in at the same time.
It is very important for PIs to accurately attribute grant support on their publications. The terms and conditions of all NIH awards, including MIRAs, state that all research publications supported in whole or in part by NIH must include a specific acknowledgment of NIH grant support, such as: "Research reported in this publication was supported by [name of the Institute(s), Center, or other NIH offices] of the National Institutes of Health under award number [specific NIH grant number(s) in this format: R01GM987654]." (If you have more than one grant, only cite the grant(s) that supported the research described in the article.)
In addition, prior to award of any NIH competing grant application, PIs are required to provide a complete list of all their active and pending other support and, in the subsequent annual progress reports, describe any changes in other support, including new funding received: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-114.html.
