Effective March 16, 2020, the standard Urgent Amendment process is being temporarily suspended until further notice. Urgent amendments should follow the procedures outlined in the guidance below.
1. Urgent Modifications made to Eliminate Apparent Immediate Hazards to Subjects
If a study team determines it is necessary to make protocol modifications to eliminate apparent immediate hazards to subjects, these modifications can be made without prior IRBMED approval but must be reported to the IRBMED within 5 calendar days via the ORIO reporting mechanism. NOTE: Additional reports to FDA may be needed if the U-M PI is also IND/IDE holder. Contact MICHR MIAP at email@example.com for assistance.
In the ORIO title, indicate “COVID Protocol change without IRBMED approval” along with any other indicators related to change. For additional information and instructions on submitting these modifications, CLICK HERE for IRBMED Guidance.
NOTE: The pause initiated by the U-M Office of Research (UMOR) does not need to be reported to IRBMED via an eR submission (AME, ORIO, or SCR).
2. Time-sensitive Modifications Not Impacting Subject Safety
If there is no apparent immediate hazard to subjects but the intended change is time-sensitive (changes to lab criteria to enroll a subject, changes to the study team, timing of study visit, changing from in-person visits to telephone visits, etc.), researchers must obtain IRB approval before any changes in the study procedures can be implemented. Consider the strategies below for these situations. These protocol changes must not impact the risk level to the subjects and thus must be considered minimal risk.
a. Standard eResearch Amendment using “COVID Time-Sensitive” or “COVID Urgent” in the amendment title. Use this method for time-sensitive minor modifications when no other amendment is in process.
b. NEW COVID-19 PROCESS – eResearch ORIO using the AE/ORIO application for minor modifications that are time sensitive if an unrelated amendment is in progress. Indicate “COVID time-sensitive change” in the ORIO title and select “Protocol Deviation” as the sub-type. Modifications must be minor and qualify for expedited review according to regulatory criteria.
For additional information and Examples of urgent modifications NOT eligible for approval via the eResearch ORIO process, CLICK HERE for IRBMED Guidance.
Questions? Contact firstname.lastname@example.org.