The following sections from the Answers to Frequently Asked Questions About MIRA RFA-GM-17-002 are also relevant to the MIRA for new and early stage investigators. Check for most recent additions on 10/31/2016.
I. Funding Opportunity Description
IV. Application and Submission Information
VI. Award Administration Information (Including Funding Restrictions in Section IV.2 of the FOA)
A. NIH defines new investigators as those who have not yet received R01-equivalent grant support (i.e., R01, R37, DP1, DP2, U01 or SC1 grant awards). NIH defines early stage investigators as new PIs who are still within 10 years of having received their Ph.D. degree. Your eRA Commons account will indicate your ESI status and provides links to request exemptions and extensions.
For RFA-GM-17-004 the only requirement for eligibility is ESI status = Yes.
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.
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.
A. If your institution defines your position as being 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, such as most postdoctoral fellows, then you may not apply.
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.
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 another institute, rather than NIGMS. However, check with staff of both NIGMS and the other institute for guidance.
A. For this RFA, eligibility is not related in any way to academic rank.
A. If you currently hold a SCORE SC1 award (not applicable to SC2, SC3), then you are NOT eligible for this RFA. 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 RFA, you may apply. If you are successful in receiving a MIRA, the SCORE award would be terminated or phased out.
A. If you are one of the IDeA junior investigators and are otherwise eligible for this RFA, you may apply. The PI of an NIGMS IDeA award is expected to be an established scientist and would not be eligible for this RFA.
If the junior investigator’s support on the IDeA award 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.
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 award. 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 that their proposed work does fall within the mission of NIGMS.
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.
A. No. The MIRA concept is to support research in the laboratory of a single PI. There may be occasions where scientists are so closely connected that it is impossible to separate the research of the one from the other., but for this RFA, multiple PI applications are not allowed. While team science is an important component of the biomedical landscape, this MIRA RFA is focused on supporting the individual laboratories of newly independent investigators.
A. According to the RFA, all research to be supported must fall within the mission of NIGMS. Information on this point is available on the NIGMS website:
Another approach may be to look up related research in the NIH RePORTER to see which NIH components support that area. If it is not NIGMS, it is likely that it is not within the NIGMS mission.
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 can only be made based on the submitted application itself.
A. The timeline is:
A. Revised applications may not be submitted in response to RFA-GM-17-004. However, you may submit a NEW application on the same general topic as the one you submitted for RFA-GM-16-003 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.
A. No. The RFA specifically states: “Because MIRA is designed to provide support for the NIGMS mission-related research in the laboratory, a MIRA application is deemed to have overlap with any other pending applications from the PD/PI assigned to NIGMS. Therefore, NIGMS will not accept a MIRA application on November 4, 2016, from an investigator who is the PD/PI of another NIGMS application submitted for the January 2017, May 2017 or October 2017 Council rounds, except as mentioned under Section I. Conversely, NIGMS will not accept any other applications for these Council rounds from an investigator who submits a MIRA application, except as described under Section I.” These council dates correspond to the June/July 2016, October/November 2016, and February/March 2017 receipt dates and any ESI or AIDS-related extensions of those receipt dates.
A. A DP2 application is not assigned to any institute of the NIH until after its review. Therefore, the DP2 that is within the mission areas of NIGMS does not automatically overlap with a MIRA. If you submitted a DP2 application on September 9, you may or may not be permitted to submit an application for the MIRA program on November 4, 2016. Both are being reviewed by CSR, and CSR’s Receipt and Referral Office is responsible for screening applications for potential scientific overlap. If CSR is willing to accept the application for review, NIGMS is willing to accept the application for potential funding.
A. NIH policy states an applicant should not submit an overlapping application until after the summary statement of the preceding application is received. See NOT-OD-09-100.
An article on the NIH Extramural Nexus blog addresses the withdrawal of an application before receiving the summary statement:
“If a new application is withdrawn after a review outcome (i.e., score, ND, or NR) is available, but before the summary statement is released, then the opportunity to submit a resubmission is lost since the resubmission has to respond to the issues in the summary statement. Also note that under this scenario you may not submit a duplicate application as a new submission.”
Whether a MIRA application is a duplicate of the previous R01 application is a determination that will be made by CSR’s Receipt and Referral Office.
A. Responses to this RFA will be reviewed by special emphasis panels (ad hoc study sections) that cover broad areas of science and review only applications in response to this RFA. These panels will be organized by the CSR. The reviews will use the review criteria specified in the RFA 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.
A. The RFA anticipates funding up to 70 awards; however, the number of awards made will depend on the number of meritorious applications received, and could be greater than 70 if MIRA applications significantly outnumber R01 applications from early stage investigators. NIGMS expects to fund approximately as many early stage investigators as it has in recent fiscal years.
A. This is to be yet to be determined because it is a function of the number of applications. 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.
A. The maximum budget is $250,000 direct costs per year, excluding any subcontract indirect costs, for a total project period of 5 years.
A. Yes. Clinical and translational research in the mission of the NIGMS may be supported through a MIRA. Since a MIRA is intended to support NIGMS-relevant work in the laboratory, it may evolve over time and move from basic research into more clinical and translational areas. Such work may include delayed onset of studies involving the addition of human subjects and vertebrate animals research and thus, would be a change of scope requiring prior approval by NIH before the studies begin. In other cases, work involving human subjects and vertebrate animals may warrant more detailed descriptions and review than can be accommodated by the MIRA format. Clinical trials, for example, are not well suited to this mechanism.
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.
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 RFA. 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.
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.
A. No correction is needed. This is an artifact of the NIH record system that distinguishes applications as being eligible for ESI consideration. 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 RFA.
A. NIGMS staff are responsible for determining whether an application is responsive to an RFA. The scientific appropriateness of the application will be considered by at least three NIGMS staff members, including the most relevant program director, before being accepted or rejected. This process should be completed within a few weeks after the receipt date. Investigators whose applications are returned without review will be notified ASAP.
A. All applications received in response to this RFA we be initially referred to the CB IRG because the CB IRG chief is overseeing CSR’s review of all applications. The reviews will be conducted by Special Emphasis Panels organized by CSR once the scientific areas are determined. At that time, the entries in the Commons will be changed to reflect the study section and SRO responsible for organizing the review of your application. Applications will not be referred to any of the regularly constituted CSR study sections, so there is no need to contact anyone about your preferred study section assignment. If you submitted a cover letter requesting a particular study section, that information is known to CSR and may be useful to them in identifying appropriate expertise, but your request for a particular study section cannot be honored.
A. Since both the DP2 and the MIRA for ESI RFA 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 are offered both, you must choose one or the other.
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.
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3/19/2018 3:17 PM
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