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.

• 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”