Release Notes Version 4.1

Released December 5, 2016

The following changes apply to the Human Subjects Application:

  • On the Update NCT Number Activity, updated link to Medical School's Office of Regulatory Affairs.
  • An issue causing the help text on section 25-2 to not display has been fixed.
  • References to are changing to
  • For Multi-site Research study applications, a warning message will display if an Amendment is initiated when a Continuing Review is in progress (or vice versa). Contact your IRB representative before proceeding.
  • To align with FDAs Expanded Access Program, "Emergency one-time use" (of drugs/biologics or devices) application types have been renamed to "Single-patient Expanded Access (Emergency or Non-Emergency)". Multi-patient Expanded Access (Emergency or Non-Emergency) continues to require the "standard" application type. Expanded Access applications involving drugs or biologics will now also route to the Research Pharmacy.

The following changes apply to IRB staff:

  • New determination letter templates were added for SCR and AME Umbrella Applications and Admin Approved AMEs.
  • Reviewer checklist items have been renumbered to reflect the Governance Application project global changes.
  • An issue preventing "Other Core Staff Owners" from copying to the staff reviewer checklists on IRBMED, Dearborn and Flint Amendments has been fixed.
  • For IRBMED Ceding Applications, AE/ORIO and Termination letter templates were added.
  • IRBMED Ceding Application Amendment letter templates were updated.
  • New approval letters for Multi-site Research Applications and their child submissions have been added to the Prepare Letter and Approve activities. Also, expanded access notifications were updated.

The following changes apply to PRC staff:

  • The template was updated for the PRC Expedited Approval letter.

The following changes apply to the IBC Application:

  • Text was added to Types of Potentially Hazardous Bio Materials section - "The selections you make on this page determine the sections of the application that you will need to complete. Please keep in mind that you hold only ONE application to cover ALL work you are conducting that requires IBC review and approval. As you make your selections, please review and consider the guidance provided by the Institutional Biosafety Committee."
  • Deleted question 4-2.2: Describe the inventory control system in place to account for toxin use and disposal. Renumbered subsequent questions.
  • Deleted question 6.1.1: Does your protocol with non-primary human cells include ALL of the following?
  • New options have been added to questions 6.1, 7, and 8, and a new description of homogenized materials question have been added to the Risk Mitigation - Lab Practices for BSL2 Work section.
  • View Differences now displays changes to Sections 6 and 6-1.
  • A new OSEH summary report is available for IBC Staff and OSEH inspectors.
  • Reviewers will no longer receive notifications after their "Approval" recommendation is submitted.

The following changes apply to the Repository Application:

  • Determination letters were updated to reflect current OHRP website links.