INBRE Developmental Research/Pilot Projects Approval Guideline

To reduce administrative burden on INBRE recipients, developmental research projects and pilot projects that do not involve Human Subjects (HS) or Vertebrate Animals (VA) research will only require official notification to NIGMS with appropriate documentation at least 14 calendar days before the projects begin. Prior approval by NIGMS is no longer required to initiate these projects. INBRE developmental research projects and pilot projects that involve human subjects or vertebrate animals research will continue to require NIGMS prior approval before the projects can begin.

Although NIGMS prior approval is no longer required when HS or VA research are not involved, developmental research projects and pilot projects may not begin until the Authorized Organization Representative (AOR) has submitted all required documentation to NIGMS by emailing the Grants Management Specialist (GMS), Program Officer (PO) assigned to the parent award and the NIGMS Post Award Projects mailbox with the complete grant number in the subject line. Documentation must be submitted at least 14 calendar days prior to the anticipated start of developmental research projects and pilot projects.

Failure to submit the required documentation at least 14 calendar days prior to initiating the developmental research project or pilot project can result in non-compliance enforcement actions. The AOR will receive a confirmation from NIGMS that the required documentation was received. If the AOR is not contacted by NIGMS for additional information within 14 calendar days after submission, the developmental research project or pilot project may start. If the AOR is contacted by NIGMS for additional information, the project may not start until NIGMS receives the additional information.

Additionally, NIGMS is streamlining the required documentation and submission process for developmental research projects and pilot projects. The required documentation has been streamlined for awardees by providing a suggested format for an Addendum and Addendum Instructions [PDF]. If you choose to not complete the Addendum, all instructions listed in the “Post-Award Program Requirements for Research/Pilot Project Investigators” section of the active NOFO must be followed.

This change applies to Developmental Research Projects and Pilot Projects for all the INBRE NOFOs: PAR-23-100; PAR-20-102; PAR-18-262; and PAR-17-160.

Resources

NIGMS Developmental Research and Pilot Project Addendum
NIGMS Addendum Instructions [PDF]