Avoid Common Revisions When Transitioning Protocols to IRBOnline
Details
Avoid Common Issues When Transitioning Protocols to IRBOnline
Avoid revisions by following instructions below:
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
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.
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.
- If data has all been de-identified
- If only de-identified data analysis remains, this means the researchers have no access to identifiable data, the study can be closed and does not need to be transitioned.
- Can I just close the study?
- Criteria for closing a study
- If only de-identified data analysis remains, this means the researchers have no access to identifiable data, the study can be closed and does not need to be transitioned.
- Make sure that a PI Departmental Approval Form is attached
- Specialized Faculty and Staff require a PI Departmental Approval form signed and attached in #23.7
- PI Eligibility criteria
- PI Departmental Approval Form
Mapping Document (Map responses from old Protocol Form to New Study Application)
Transitioning to IRBOnline Resources
Posted Date
09-15-2024Internal Announcement