Grant Submission Process

 

IRB Approval of the grant proposal is only required if the grant is from a federal agency that DOES NOT follow the Common Rule (45CFR46) or the grant is funded by the FDA.

The Agencies that DO follow the Common Rule are listed below:

  • Agency for International Development
  • Consumer Product Safety Commission
  • Department of Agriculture
  • Department of Commerce
  • Department of Defense
  • Department of Education
  • Department of Energy
  • Department of Health and Human Services (DHHS; includes the NIH)
  • Department of Homeland Security
  • Department of Housing and Urban Development
  • Department of Labor
  • Department of Transportation
  • Department of Veterans Affairs
  • Environmental Protection Agency
  • National Aeronautics and Space Administration
  • National Science Foundation
  • Social Security Administration

FOR THOSE GRANTS REQUIRING IRB APPROVAL
NOTE: this is a rare occurrence (e.g. grant from Department of Justice)

  1. If your grant/proposal includes human subject research, click here for the content which is to be included in the Human Subjects section of the grant application.
  2. When the grant is written, submit the grant application to your Grants Office.
  3. IRB-HSR certification is not needed prior to this submission.
  4. Simply write "Pending" next to IRB-HSR Approval Date.
  5. When you are notified that your application is in the "fundable range" you should submit the following to the IRB-HSR via email to irbhsr@virginia.edu:
    1. One PDF of the full grant/proposal application (excluding appendices)
    2. One electronic copy of the Grant Information Form.
    3. If the grant is being submitted by UVA
  6. The IRB will provide administrative certification of the grant submission. Submission to the IRB may be done at any time and does not need to meet full board submission deadlines.
  7. A Human Subject Protection Training Certificate will be provided by OSP or the School of Medicine Office of Grants and Contracts

JUST IN TIME REQUIREMENTS

If an agency, that does follow the 2018 Common Rule (e.g. NIH or agency listed above), requires documentation from the IRB during the Just in Time process and prior to IRB approval of the study protocol, take the following steps:

  1. Complete the Just in Time Grant Information Form and submit it to the IRB-HSR. The IRB-HSR will provide documentation to the study team that they may then submit to the sponsor.

How do I close a Grant with the IRB?

Submit a Grant Closure Form by emailing the completed form to IRB-HSR@virginia.edu. This should be submitted when all work on the grant is completed.