Step 1: Submit PI Transfer/Departure/Change of Status Form

There are two version of the PI Transfer/Departure/Change of Status Form, submit the correct form for the funding situation. Submit the appropriate form(s) a minimum of 90 days prior to the PI’s departure.

External Funding

Internal or No Funding

Submit a form for each HawkIRB application

Submit only one form

The form(s) are initiated by the PI or their department to provide broad notification to UI entities that need to know about the departure and that assist with the transition process. This includes; the Division of Sponsored Program (DSP), Grant Accounting Office (GAO), Human Subject Office (HSO), Institutional Review Board (IRB), Office of Animal Research (OAR), Institutional Animal Care and Use Committee (IACUC), and Environmental Health and Safety (EHS).

Step 2: Notify the IRB and ClinicalTrials.gov

As soon as the PI knows their departure date, they should notify the IRB and make necessary changes to their active projects in HawkIRB and if appropriate, notify ClinicalTrails.gov. 

Submit the appropriate form to the IRB. Either:  

  • Modification Form 
    • To change the PI (if the study is not complete and research activity will continue at the UI under a new PI)
    • To request IRB approval if the PI will take research data/samples to a new institution or plans to have continued access after departure.   
  • Project Close Form 
    • If the research will no longer be conducted at the UI
    • Departing researchers should not close projects unless they have completed all the following: 
      • Protocol-indicated research activities, including interaction with subjects and collection of data or specimens 
      • Collection of data about subjects even when no subject contact is necessary 
      • ‘Cleaning’ of data 
      • Analysis of identified or coded data for research purposes or during the publication process 
      • Any other research use of data that involves access to identified or coded data or specimens collected during the conduct of research 

  • The project will close as soon as the form is submitted

  • Once submitted, the research team may no longer collect data about any of the subjects in the study, contact the subjects for research purposes, or work with identified data/samples 

  • If you will be collecting follow-up data the project should remain open, even if new subjects are not being enrolled

Step 3: If applicable, update ClinicalTrails.gov

Scenario

Action

Study activities will continue at the UIUpdate the study’s associated with ClinicalTrials.gov record to reflect the PI change
Study is complete and results are not requiredClose the record
Study is complete and applicable regulations require results to be reportedSubmit the results
Study is ongoing and will continue at the PI’s new institutionNotify the PRS administrator to initiate a transfer of the active record

 

Step 4: If applicable, update Delegates:

Once a PI has left the UI, they will no longer have access to the HawkIRB system and are considered “deactivated” when their UI appointment ends. This status depends on their UI employment (HR) or enrollment (registrar) records. If the PI has HawkIRB delegates, the delegates can complete project closure forms and modification forms, but only for the projects to which they have delegate access rights.