Version 4.5.3

September 20, 2021

Human Subjects Application (HUM)

  • Several application changes have been made to support the U-M Children on Campus policy (Standard Practice Guide 601.34) including a new question to identify study team members who interact with study subjects (or supervise those that do), and a new question to identify if Exempt 1 studies include minors as research participants.

The new question to identify study team members who interact with study subjects (or supervise those that do) applies to the following application types: Interaction/intervention, Multi-site, and Non U-M IRB Review. For newly added study team members, the question will be asked as part of the "Accept Role" activity. For existing members, the question must be answered in the Study Team section of the application by a person with study edit rights.
(Note: Because PIs are responsible for all interactions, they are not presented with this question.)

Study Team Members that indicate interaction on studies that include minors (or supervise those that do) will receive a one-time system notification summarizing the training and background check requirements.

See the Children on Campus policy for more information.

  • The "Accept Role" and “Notify Study Team Members to Accept Role” activities are now hidden until an Application Type is selected in Section 1-1. Previously, they were available as soon as a study team member was added. This change facilitates display of the new interaction with subjects question that is only required on certain application types.
  • The "Cancer Epidemiology and Prevention Program" and the "Health Behaviors and Outcomes Program" options in question 1-6.4 have been combined into one new program type, "Cancer Control and Population Sciences Research Program". All applications that previously indicated one of the prior options have been converted to the new program type.

Participating Site Application

A problem preventing IRB Staff from having Edit rights to the SITE application has been fixed.

IBC Application

The IBC Application's "Finish" button at the end of the smartform has had its label changed to "Save & Exit" to more accurately describe its function.