Department of Health
and Human Services (HHS)
and Human Services (HHS)
January 8, 2021
PAR-19-367 - Maximizing Investigators' Research Award (R35 - Clinical Trial Optional)
National Institute of General Medical Sciences (NIGMS)
The purpose of this Notice is to clarify NIGMS implementation of scientific overlap processes for applicants and awardees to the Maximizing Investigators' Research Award (MIRA) program for established investigators.
Part 2. Section 1. Funding Opportunity Description
The FOA currently reads:
Because the MIRA is intended to support a significant and ambitious program of research, the PD/PI is required to devote at least 51% of his/her total research effort to this award. See Section III.1 Eligible Individuals for more information about this requirement.
Investigators receiving a MIRA will be required to relinquish other NIGMS research grants, except for award mechanisms mentioned below. Investigators who receive support from NIGMS research grants of other investigators as collaborators and subcontractors on R01s will no longer be permitted to receive funds from those sources. Investigators who receive funds as project leaders on NIGMS multi-component grants (i.e., P01, P50 or RM1) will have their MIRA award level adjusted to remove any overlap between their MIRA and their multi-component grant. The MIRA Principal Investigator will be required to relinquish funding from the multi-component grant at the end of its competitive segment. 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 MIRA to support their contributions to the team's research. Investigators with K awards from another NIH institute may receive an NIGMS MIRA but will be required to adjust their person-months effort on those awards to be smaller than the person-months effort committed to MIRA. NIGMS will establish an orderly process to MIRA funding when reductions in other commitments are required. Details of how these changes may be accomplished are covered in Frequently Asked Questions on the MIRA web page.
The budget of a MIRA will be determined by NIGMS staff, based upon the funding history of the PD/PI, the recommendations of the initial review group and the National Advisory General Medical Sciences Council, and the expected productivity and impact of the program of research. NIGMS' Special Council Review policy for applications that result in over $750,000 total annual direct costs from all sources of research support being awarded to a PD/PI will apply to MIRAs. Although well-funded grantees (having more than $400,000 in direct costs from NIGMS research grants) applying for new EI MIRAs will generally receive budgets about 12% lower than their previous average NIGMS research funding levels (as determined by NIGMS staff), the Institute does not intend to use a similar blanket policy when setting budgets for MIRA renewals. Instead, the funding levels for each MIRA renewal will be independently determined based on a variety of considerations, including the results of peer review, the PD's/PI’s other support and commitments, and the Institute’s scientific priorities and available budget. Overall, we expect most budgets for MIRA renewals to be similar to what they were in the previous funding period, although some grants will have increased or decreased budgets based on the factors described above.
A researcher funded by a MIRA will not subsequently be awarded any other sources of NIGMS funding, with the following exceptions:
NIGMS will not accept applications from MIRA grantees for awards not on the above list that would begin prior to the end date of the MIRA.
Supplements to MIRAs: MIRAs will be eligible for Research Supplements to Promote Diversity in Health-Related Research, for Research Supplement to Promote Re-Entry into Biomedical and Behavioral Research Careers, and for Administrative Supplements for Equipment Purchases. Other supplements offered by NIGMS may also be made available to MIRA grantees, depending on the intention and constraints of the particular supplement program.
Renewals: Because of the Institute's commitment to the MIRA program and the fact that there will be fewer applications as a result of the consolidation of separate research projects, NIGMS anticipates a higher success rate for R35 renewal applications than is the case for R01s. If an application for renewal of the MIRA is unsuccessful, the grant will terminate at the end of its approved project period. Although a Resubmission will not be accepted, a PD/PI may submit a new MIRA application in the next two fiscal years after the original project period expiration date. PDs/PIs may alternatively choose to submit a new R01 grant application to resume support of their laboratory through individual project funding.
See Section VIII. Other Information for award authorities and regulations.
The FOA is modified to read (changes shown in italics)
Because the MIRA is intended to support a significant and ambitious program of research, the PD/PI is required to devote at least 51% of his/her total research effort to this award. See Section III.1 Eligible Individuals for more information about this requirement.
Also, because a MIRA is designed to provide support for a laboratory's research relevant to the mission of NIGMS, it is deemed to have overlap with most other research grant applications assigned to NIGMS for funding or management.
Overlap During Peer Review
A PD/PI may not have a MIRA application and another research grant application (e.g., R01, R15, R21) within NIGMS’ mission pending review* at the same time, with the following exceptions:
Resolving Overlap with Other NIGMS Research Grants During the Award Process
Investigators receiving a MIRA will be required to relinquish funding from other NIGMS research grants, including the following scenarios:
Investigators who receive support from NIGMS research grants of other investigators as collaborators and subcontractors on R01s will no longer be permitted to receive funds from those sources.
Investigators who receive research funds as project leaders or multiple PD/PIs on NIGMS multi-component and complex (e.g., Collaborative Program Grant for Multidisciplinary Teams (RM1)) grants will have their MIRA award level adjusted to remove any overlap between their MIRA and their multi-component or complex grant. The MIRA PD/PI will be required to relinquish funding from the multi-component or complex grant at the end of its competitive segment. 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 MIRA to support their contributions to the team's research.
Investigators with K awards from NIGMS will be required to relinquish the K award prior to the start date of the MIRA. Investigators with K awards from another NIH institute may receive an NIGMS MIRA but will be required to adjust their person-months effort on those awards to be smaller than the person-months effort committed to MIRA.
NIGMS will establish an orderly process to MIRA funding when reductions in other commitments are required. Details of how these changes may be accomplished are covered in Frequently Asked Questions on the MIRA web page.
The budget of a MIRA will be determined by NIGMS staff, based upon the funding history of the PD/PI, the recommendations of the initial review group and the National Advisory General Medical Sciences Council, and the expected productivity and impact of the program of research. NIGMS' Special Council Review policy for applications that result in over $750,000 total annual direct costs from all sources of research support being awarded to a PD/PI will apply to MIRAs. Although well-funded grantees (having more than $400,000 in direct costs from NIGMS research grants) applying for new EI MIRAs will generally receive budgets about 12% lower than their previous average NIGMS research funding levels (as determined by NIGMS staff), the Institute does not intend to use a similar blanket policy when setting budgets for MIRA renewals. Instead, the funding levels for each MIRA renewal will be independently determined based on a variety of considerations, including the results of peer review, the PD's/PI’s other support and commitments, and the Institute’s scientific priorities and available budget. Overall, we expect most budgets for MIRA renewals to be similar to what they were in the previous funding period, although some grants will have increased or decreased budgets based on the factors described above.
Applying for Subsequent Awards after Receiving a MIRA
NIGMS will not accept applications from MIRA grantees for awards that would begin prior to the end date of the MIRA, with the exceptions listed above.
Additionally, NIGMS will not accept assignment of an NIH Director’s Transformative Research Award (TRA) R01 or NIH Director’s Pioneer Award (DP1) application if the PD/PI has a MIRA. By virtue of assignment to NIGMS, the proposed research falls within the mission of NIGMS and would overlap with the MIRA.
Notes:
*Applications are defined as ‘pending review’ until a summary statement is issued.
** MIRA applicants and recipients can participate as a PD/PI on a Collaborative Program Grant for Multidisciplinary Teams (RM1) as part of the 51% effort required by the MIRA but may not receive additional funds from this RM1.
*** For the Biomedical Technology Development and Dissemination (BTDD) grants, the PD/PI must maintain 51% research effort toward their MIRA, and 3 person months' effort toward the BTDD. The BTDD award can only provide support in a MIRA PD/PI's laboratory for late-stage technology development and dissemination efforts.
Supplements to MIRAs: MIRAs will be eligible for Research Supplements to Promote Diversity in Health-Related Research, for Research Supplement to Promote Re-Entry into Biomedical and Behavioral Research Careers, and for Administrative Supplements for Equipment Purchases. Other supplements offered by NIGMS may also be made available to MIRA grantees, depending on the intention and constraints of the particular supplement program.
Renewals: Because of the Institute's commitment to the MIRA program and the fact that there will be fewer applications as a result of the consolidation of separate research projects, NIGMS anticipates a higher success rate for R35 renewal applications than is the case for R01s. If an application for renewal of the MIRA is unsuccessful, the grant will terminate at the end of its approved project period. Although a Resubmission will not be accepted, a PD/PI may submit a new MIRA application in the next two fiscal years after the original project period expiration date. PDs/PIs may alternatively choose to submit a new R01 grant application to resume support of their laboratory through individual project funding.
See Section VIII. Other Information for award authorities and regulations.
All other aspects of this FOA remain the same.
Zhongzhen Nie, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: MIRA2019RESEARCH@NIGMS.NIH.GOV