IRB Grant Review No Longer Required – 2018 Common Rule

The requirement for the IRB to review the entire grant/funding application for consistency with the IRB application has been removed.
  • The investigator DOES NOT need to submit a copy of the grant that is supporting the conduct of the research with the myIRB application
    • The myIRB application will no longer ask for an attachment for the grant or funding application
    • A reviewer may still request to see a portion of the grant if they have questions during the review process
  • The investigator DOES need to list grant(s) or other funding mechanisms as sources of support in the myProject application, Section 2
    • PI is responsible for listing only funding sources that describe research consistent with that described in the myIRB application. Confirm that the following are consistent:
      • Demographics and number of subjects to be recruited or information or biospecimen descriptions
      • Specific aims or objectives of the research
      • Sources of information or biospecimens
      • Research procedures
      • Analyses 

 

 

 

 

 

    • PI Assurance Document has been updated to include the following attestation:
      “The specific aims and description of research in this IRB application are consistent with those described in each of the sources of support listed as providing financial and/or material resources to conduct this study. If a source of support describes more than one research study, activities or aims not specifically described in this application, or a broad research program, I will consult with the Washington University Human Research Protection Office as to whether separate IRB applications are required for human subjects approval of these activities.”
    • OSRS will continue to verify that the grant/funding is listed in the approved myIRB application.