When do you need to submit IRB and IACUC applications?

Refer to the guidance below, and also check with the funding agency for their specific requirements.

NIH Projects

New/Competitive Renewal/Re-submission

What

For New / Competitive Renewal / Re-submission projects, the Just-in-Time policy allows applicants and signing officials to submit the IRB/IACUC application at a later date in the application process – after the peer review and as the application is being considered for funding. The application must be in the fundable scoring range to be considered.

For Delayed On-Set studies where human subject or animal activities are scheduled to begin after a period of funded protocol development, include a memo in your InfoEd application explaining the timeline.

When

  • Applicants will see a JIT link appear on the eRA Commons’ Status screen soon after the review scores are posted. However, applicants should only submit JIT information when it is specifically requested by the grantor agency.
  • IRB/IACUC applications should be submitted as soon as the JIT request is received

How

Questions

For JIT related questions, contact your Departmental Assigned GCO Specialist.

Resources

Transfers/Non-Competitive/No-Cost Extension

What

Transfer / Non-Competitive / No-Cost Extension projects require IRB/IACUC applications. Submitting a compliance waiver for these projects is not an option.

When

If the project yearly start and end dates are the same as the GCO/InfoEd submission, then submit IRB/IACUC prior to the InfoEd submission.

If the IRB/IACUC yearly start and end dates are different from the GCO/InfoEd yearly submission dates, then submit IRB/IACUC approximately 8 weeks prior to the IRB/IACUC expiration date. Be sure to check whether your IRB/IACUC project approval expires annual or triennially.

Failure to submit the compliance application will result in delays of review of the InfoEd application at the GCO.

How

Reference

Non-NIH Projects

Other Peer Reviewed New/Competitive Renewal/Re-submission

What

For New / Competitive Renewal / Re-submission projects IRB/IACUC applications do not need to be submitted before or at the same time as the research proposal to the external funding agency. However, investigators should plan to leave sufficient time to obtain the required compliance approvals before a funding decision is made. External funding agencies may deny funding if appropriate approvals have not been obtained at the time of the award announcement.

If you choose not to submit the IRB/IACUC application with your proposal, then you must attach a signed compliance waiver in the Internal Documents tab of the InfoEd application.

For delayed on-set studies where human subject or animal activities are scheduled to begin after a period of funded protocol development, include a memo explaining the timeline rather than the waiver with InfoEd application.

If you are applying to another funding agency that has a two-step review process that allows for a “just in time” review by the ISMMS compliance committees at a later date, you do not need to submit a compliance application or a waiver. Check with the funding agency for their specific requirements.

When

Submit IRB/IACUC application or waiver before or during the InfoEd GCO application.

How

  • InfoEd Requirements (if opting not to submit IRB/IACUC application(s))
    • Attach a signed compliance waiver to the Internal Documents of the InfoEd application.
    • Attach a timeline memo for delayed onset studies to the Internal Documents of the InfoEd application.
  • IRB Submission
  • IACUC Submission

Resources

GCO Application Submission Checklist

New ISMMS Sponsored/Unfunded

What

ISMMS Sponsored/Unfunded projects require IRB/IACUC applications as appropriate. Submitting a compliance waiver for these projects is not an option.

When

Submit the IRB/IACUC application prior to the InfoEd GCO submission. Failure to submit the compliance application will result in delays of review of the InfoEd application at the GCO.

How

Reference

New Industry Sponsored

What

Industry Sponsored Projects are projects in which Mount Sinai is receiving funding from a for profit entity such as a pharmaceutical, biotechnology or medical device companies. These projects require IRB/IACUC applications. Submitting a compliance waiver for these projects is not an option.

Exception – unless it is a competitive, peer reviewed application. If so, Industry projects act like the “Other Peer Reviewed” in the dropdown above.

When

Submit the IRB/IACUC application prior to the InfoEd GCO submission. Failure to submit the compliance application will result in delays of review of the InfoEd application at the GCO.

How

Reference

Transfers/Non-Competitive/No-Cost Extension

Check with the IRB/IACUC whether you are submitting every year or every three years to these offices.

References

Research 411 Portal

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