The study teams may encounter situations where the intended change is one-time, impacts only one or two subjects, and is not a study-wide change. For these situations, submit an ORIO, which IRBMED will consider and approve as an Amendment submission. As applicable and feasible, the sponsors and/or coordinating centers should be contacted for their concurrence. The study team should carefully evaluate whether the intended change is a one-time or a permanent study-wide change before using this ORIO process.
Example(s) of scenarios where this process may be permitted:
Example(s) of scenarios where this process will NOT be accepted:
- Changes to the study procedures that will impact all or most of the subjects
- Adding a study team member as this requires assessments only available within the Amendment process
- Adding a vulnerable population (such as children or cognitively impaired adults) and/or additional research arms where the changes must be made via an Amendment to complete the required information in eResearch.
For studies where UM PI holds the IND or IDE, the study teams will need to work with MIAP to ensure that necessary IND Amendments and IDE supplements will be submitted to FDA. Please contact your MIAP lead before submitting the ORIO to IRBMED to ensure that all FDA regulatory requirements can be met by using this route of review.
When submitting the ORIO:
Labeling: When creating the ORIO, update the ORIO title to indicate “Time-Sensitive Change” or “Urgent Change” (or as appropriate to reflect the situation) along with any other indicators. This will ensure that the submission is screened and triaged appropriately.
- Select the “Protocol Deviation” sub-type in eResearch ORIO 1-2.1
Include adequate details in the ORIO submission to minimize the back and forth between IRBMED and the study team. For example:
Indicate why the ORIO is being submitted instead of an Amendment.
State how the proposed changes will impact the current study procedures and participant risk level, and clarify whether or not the study materials (informed consent document or other) will be updated. If updated, upload them within the ORIO submission.
If the informed consent document needs to be updated:
- Use the most recent document from eResearch Section 10-1 to make changes
Add a note in the consent document footer (right-hand side) to indicate that this is a one-time urgent change and include the ADV submission ID for tracking purposes. Note: IRBMED will not be able to include its approval stamp in the header.
- Evaluate, and indicate whether or not subjects will be consented or re-consented.
- As applicable, state or clarify whether the sponsor and/or the coordinating center has been contacted about the proposed changes.
Also, upload any additional supporting documentation (such as sponsor approval or other similar documentation)
Once submitted, the ORIO will be reviewed by IRBMED staff to ensure that the proposed changes are in compliance with this guidance. The submission will then be assigned for either expedited (if the changes meet the regulatory definition of “minor”) or full board review (if the changes are substantial and/or may impact subject safety).
NOTE: If IRBMED notes that a study team is submitting frequent one-time/urgent ORIOs for an individual IRB application, IRBMED may require a protocol amendment to permanently address inclusion/exclusion criteria or protocol procedures that are not addressing current/recurrent circumstances.