External (non-UM) Study Team Members

Section 01 of the IRB (eResearch Regulatory Management) application is designed to capture information regarding the study team members. The non-UM study team members are usually identified in various ways (please see the Table below):

1. A study team member is listed with a Friend Account
2. A study team member is pre-identified with “Other” as the study team role
3. A study team member is not a student and has no Appointment Department selected
4. The U-M study team self-identified an individual as an external collaborator

 Generally, the human subject research activities performed by an external study team member are overseen by the institution they are affiliated with.  

• If the external study team member’s human subject research activity is already covered by another IRB, there is no need to list them in the UM IRB application. Instead, the site may need to be listed in Section 03-1 of the eResearch application as a participating site. Note that this type of scenario (where the external site is engaged) may trigger Single IRB (sIRB) requirements. Contact IRBMED for guidance on sIRB requirements.
• If the external study team member’s human subject research activity is NOT covered by another IRB and the U-M study team would like IRBMED to consider providing IRB oversight, the “IRBMED External Collaborators Checklist” must be completed. This document obtains additional information regarding the external collaborator and the research activities.

External study team members can be added to the eResearch application at the time of a new study application (HUM) or by creating an amendment.

• In Section 01, add the external study team member in the role “Other”
• In Section 05 Study Team Expertise, add a heading “EXTERNAL STUDY TEAM MEMBERS” and then add a brief note regarding the research activities conducted by each non-UM member.
• In Section 44, upload the completed “IRBMED External Collaborators Checklist”

Using the completed engagement checklist, IRBMED regulatory staff works with the study team in assessing and ensuring that any necessary authorization agreements are established. IRBMED staff will notify the study team of the outcome in eResearch.

• External study team member conducts only “not-engaged” human subject research activities: IRB oversight is generally not required. 
• External study team member “engaged” in human subject research activities and IRBMED is willing to provide IRB oversight: An “Individual Investigator Agreement” is generally required (depending on the status of the collaborator’s affiliation with an FWA holding institution) to assure that the external collaborators understand their human subject research obligations. Generally, the final IRB approval letter will be issued after the agreement is fully executed (signed by all parties). The external collaborator may not perform any study-related functions until the eResearch submission is finalized and the agreement is fully executed.
• External study team member “engaged” in human subject research activities and IRBMED is NOT willing to oversee their activities: the study team will be given guidance for any follow-up actions.