UI faculty, staff, students and trainees may submit a Human Subjects Research Determination (HSRD) form through HawkIRB to receive formal IRB documentation of whether or not IRB approval is required. This determination is a courtesy to the researcher and is not a regulatory requirement. 

You may submit an HSRD form without completing the human subjects protection training in the CITI Program. However, if IRB approval is required, the Principal Investigator and all research team members must complete human subjects protection training prior to submission of the New Project form.  

Whoever submits the HSRD form from their HawkIRB inbox is considered the ‘Principal Investigator’ of the project. The determination memo will be addressed to them. If IRB approval is required, the New Project form will be started in their HawkIRB inbox. If a HawkIRB Delegate prepares an HSRD form on behalf of a Principal Investigator, they must start the form in the PI’s inbox. 

To submit an HSRD form,

  • Log into HawkIRB

  • Select "Human Subjects Research Determination" under the gold bar to initiate the HSRD form

    • Select the appropriate IRB of record

    • Provide complete responses to all questions (four short sections)

    • Submit the HSRD to the HSO/IRB for review

The IRB Chair and/or their designee will determine if their Human Subjects Research Determination request meets the definition of human subjects research and requires IRB approval.  

  • If IRB approval is NOT required, HawkIRB will issue a memo stating that the project does not require IRB review or approval. 
  • If IRB approval is REQUIRED, the HawkIRB application will initiate a DRAFT New Project form on your behalf based on the responses provided in the HSRD request form. It is the Investigator's responsibility to complete and submit this DRAFT New Project form to initiate the IRB review process. Research cannot begin until IRB approval is granted. 

More information can also be found in the UI Investigator’s Guide/IRB Standard Operating Procedures (Section I, Part 12.E)