External (non-UM) Study Team Members

Institutional Review Boards have a role in assessing an investigator’s (or, a study team member’s) qualification in conducting the human subject research activities proposed in a protocol or an IRB application. IRBMED review and approval process includes evaluating study team members’ qualifications and appropriate U-M affiliation(s).  IRBMED oversight applies to the study team members affiliated with U-M in accordance with IRBMED jurisdiction (outlined in IRBMED Standard Operating Procedures). For study team members that are not affiliated with U-M, appropriate IRB oversight must be established prior to conducting any human subject research activities. IRBMED may choose to extend its oversight to study team members not otherwise affiliated with an institution having an IRB or whose institution is not otherwise a performance site in the research. This guidance outlines the current IRBMED process to identify these external study team members, document them in the IRB application, and work with IRBMED in establishing appropriate IRB oversight.

See also U-M Human Research Protection Program (HRPP) Operations Manual Part 5 (particularly, V. UNAFFILIATED INVESTIGATORS)

External Collaborators: The study team members who are not affiliated with  University of Michigan (U-M) but are conducting non-exempt research with human participants on behalf of the U-M.  Their institution or organization is not otherwise a performance site.

NOTE: Generally, Active Emeritus Faculty, Adjunct Faculty, Visiting Faculty, Visiting Scholars, Visiting Graduate Students, International Visiting Scholars and Volunteers vetted through Volunteer services count as affiliated with U-M during the term of their sponsorship/appointment. Contact your IRB (IRBMED or HSBS) for confirmation.

Section 01 of the IRB application (eResearch Regulatory Management) 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 Managing Engaged External Collaborators Guidance must be followed.

• U-M Human Research Protection Program
  • Operations Manual Part 5
  • Authorization Agreements Process
  • Single IRB-of-Record (sIRB) Process
• Documents on managing external collaborators from IRB Coordinated Services and Practices (CSP) unit
• OHRP regulations 45CFR46.109(a) and (d)).
• OHRP guidance “Engagement of Institutions in Human Subjects Research (2008)”
• FDA guidance “IRB Responsibilities for Reviewing the Qualifications of Investigators,…. (2013)”
• ITS eResearch Regulatory Management Training Resources and Reference Materials
  • “Adding a Study Team Member”
  • “Obtaining a Friends Account”