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"Study Team Member" Personnel Changes

Dear Research Community,

In an effort to reduce burden on the research community and the IRB, we are changing how ‘study team member’ personnel changes are reviewed by the IRB Office.  Principal Investigators are still required to maintain the study team members list in the eIRB+ application and for ensuring that all study team members complete human subjects protection training every three years.

Beginning October 3, 2018, modifications that only add or delete an individual designated as ‘study team member’ will no longer require IRB review nor be issued an approval letter.  Upon submission, these modifications will automatically be moved to an approved state and an email notification will be sent via eIRB+.

Given the need to assess expertise and conducted conflict of interest review, modifications to add or delete Investigators (PI or Co-I) will still require IRB review and be issued an approval letter.  An Investigator is defined as: the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research, or proposed for such funding, which may include, for example, collaborators or consultants.  Investigators (PI or CO-I) should never be designated as ‘study team member’ in the eIRB+ application.

Thank you,

Northwestern University IRB Office