Clarification of Scientific Overlap Concerns in PAR-20-117 "Maximizing Investigators’ Research Award (MIRA) for Early Stage Investigators (R35 - Clinical Trial Optional)"
Notice Number:
NOT-GM-21-002

Key Dates

Release Date:

January 11, 2021

Related Announcements

PAR-20-117 - Maximizing Investigators’ Research Award (MIRA) for Early Stage Investigators (R35 - Clinical Trial Optional)

Issued by

National Institute of General Medical Sciences (NIGMS)

Purpose

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 early stage 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.

 A researcher funded by a MIRA will not subsequently be awarded any other sources of NIGMS funding, with the following exceptions:

  • Grants supporting resources for the research community (e.g., P30, R24);
  • Biomedical Technology Development and Dissemination program RM1 grants;
  • Contracts;
  • Grants supporting training, workforce development, or diversity building;
  • Funding for clinical trials;
  • INBRE (P20), COBRE (P20/P30), or IDeA-CTRs (U54);
  • SBIR/STTR grants;
  • Conference grants.

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: ESI MIRA awardees will be eligible to renew their MIRAs through MIRA FOAs not limited to ESIs, e.g., through reissuances of PAR-19-367, which also provides NIGMS-funded investigators the opportunity to apply to the MIRA mechanism.

Resubmissions: Investigators who applied in response to RFA-GM-16-003, RFA-GM-17-004, or PAR-17-190 are welcome to apply provided they are still eligible (retain their ESI status), but the application must be written as a New submission without reference to the previous application or review or an Introduction to Application.

Prior Consultation with IC staff

NIGMS strongly encourages potential applicants to contact Scientific/Research Staff at least 6 weeks prior to submission for advice on the suitability of the proposed research for NIGMS. Applications that are determined to be outside of the NIGMS mission will not be accepted for review.

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., R15, R21) within NIGMS’ mission pending review* at the same time, with the following exceptions:

  • NIH Research Project Grant Program (R01)
  • Grants supporting resources for the research community
  • Collaborative Program Grant for Multidisciplinary Teams (RM1) grants**
  • Biomedical Technology Development and Dissemination (RM1) grants***
  • Contracts
  • Grants supporting training, workforce development, or diversity building
  • Grants supporting multi-site clinical research, both clinical trials and observational studies, with costs for patient recruitment, protocol-related expenses, and/or community resource activities (e.g., specimen banking, dissemination)
  • INBRE (P20), COBRE (P20/P30), or IDeA-CTRs (U54)
  • SBIR/STTR grants
  • Conference grants

Applicants who receive funding as the PD/PI of an R01, RM1, SC1, DP1, DP2, or any other type of disqualifying award, including certain ones listed above, prior to issuance of the ESI-MIRA become ineligible to receive the award.  Refer to NIH's Early Stage Investigator policies  for information about what impacts ESI status.

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 R01 research grants of other investigators as collaborators and subcontractors will no longer be permitted to receive funds from those sources.
  • Investigators who receive research funds as project leaders or personnel 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.

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 in the "Overlap During Peer Review" section except for R01. NIGMS will not accept an R01 application with a project start date before the end date of the MIRA.

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 recipients can participate as a PD/PI on a Collaborative Program Grant for Multidisciplinary Teams (RM1) awarded after the ESI MIRA 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 awarded after the ESI MIRA award. 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: ESI MIRA awardees will be eligible to renew their MIRAs through MIRA FOAs not limited to ESIs, e.g., through reissuances of PAR-19-367, which also provides NIGMS-funded investigators the opportunity to apply to the MIRA mechanism.

Resubmissions: Investigators who applied in response to RFA-GM-16-003, RFA-GM-17-004, or PAR-17-190 are welcome to apply provided they are still eligible (retain their ESI status), but the application must be written as a New submission without reference to the previous application or review or an Introduction to Application.

Prior Consultation with IC staff

NIGMS strongly encourages potential applicants to contact Scientific/Research Staff at least 6 weeks prior to submission for advice on the suitability of the proposed research for NIGMS. Applications that are determined to be outside of the NIGMS mission will not be accepted for review.

See Section VIII. Other Information for award authorities and regulations.

All other aspects of this FOA remain the same.

Inquiries

Please direct all inquiries to:

Sailaja Koduri, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: sailaja.koduri@nih.gov


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