eIRB+ Process Update: "Study Team Member" Only Modification

Dear Research Community,

As a requirement of conducting human subjects research, the Northwestern University IRB requires all individuals to complete human subjects protection training and to re-certify every 3 years. In an effort to improve compliance with training requirements, we are implementing a change to “study team member” only personnel changes that receive automatic approval upon submission.

Beginning October 30, 2019, modifications that only add or remove individuals designated as “study team member” will receive an error message upon submission if any individual on the “internal” study team member list has expired or absent training. To lift the error message, individuals lacking current training must either update their training or be removed from the study team member list.

This new process is only for “study team member” modifications and will not occur during the submission of any other IRB applications. For all other IRB applications, the IRB analyst will request applicable training update during their review, per usual. As a reminder, modifications to change the Principal Investigator (PI) or add a co-investigator (Co-I) must be reviewed by an IRB Analyst and do not receive automatic approval in eIRB+. Investigators (PI or Co-I) should never be designated as “study team member” in the eIRB+ application.

Additionally, the IRB Office completed an integration of eIRB+ and CITI Training information in June, which now automates the process for updating eIRB+ user profiles with the relevant human subjects protection training courses completed through CITI under the Northwestern affiliation within the last 3 years. Please allow 24 hours for any user’s profile to be updated with the current training information from CITI, including newly registered users and training re-certification for current users. Should you have any issues with training requirements, please email irbtraining@northwestern.edu for assistance.

Thank you,

Northwestern University IRB