Avoid Common Revisions When Transitioning Protocols to IRBOnline

Details

Avoid Common Issues When Transitioning Protocols to IRBOnline

Avoid revisions by following instructions below:

  1. Provide information on the CURRENT status of the project.

    • For documentation purposes the application must include the full study protocol that was conducted or will be conducted by UIUC researchers.
    • Include information about the whole study, but make it clear at what stage you are. 
    • In #6.11 include a statement describing where in the procedures you are, For example: 
      • All interventions with participants are complete as of 11/2023, data analysis using identifiable data continues, or
      • All participants have been consented and we have completed the first study intervention with all participants, remaining procedures ongoing, or
      • Data Analysis only – includes video recordings of participants

     

  2. If Data Analysis Only

    • Is the data identifiable or de-identified? For De-identified, see below. 
    • Must provide information about the project and what the procedures were, the application must explain what did happen
    • Do not include the consent form in the Consent Form question #23.1, instead include any consent documents in Other Documents #23.7.  The consent form section is only for consent forms that will continue to be used. 

     

  3. De-identified Data is not the same as Coded Data

    • De-identified means all identifiers have been removed and the researchers have no access to the identifiers or a key or link between the data and the identifiers. 
    • Video Recordings and audio recordings of a participants’ face or voice are identifiable.

     

  4. If data has all been de-identified
  5. Make sure that a PI Departmental Approval Form is attached

 

Tip Sheet

Mapping Document (Map responses from old Protocol Form to New Study Application)

Transitioning to IRBOnline Resources

Posted Date

09-15-2024
Internal Announcement