System changes for this release effective May 11, include updates to Human Subjects Applications (HUM), Amendments (AME), Adverse Event/Other Reportable Information Occurrence (AE/ORIO, ADV) reports, scheduled Continuing Reviews (SCR), and Institutional Biosafety Committee Applications (IBCA) in support of several compliance and regulatory initiatives.
Visit eResearch Enhancements: IRB Application Updated to Enhance Research Oversight and Safety for additional information about the new HUM questions.
HUM, AME, CR, and ADV Changes
Human Subject Applications & Amendments
Added new questions to Section 01-2 Standard Study Information to determine:
If software or devices used in the study will require review by Michigan Medicine Information Assurance.
If the study includes research conducted in embargoed countries.
That the study meets the requirements of DOJ bulk sensitive data regulations.
Moved the embargoed country question from the self-determined submission activity to the application smartform.
Added a new question to the Study Team table in Section 01 to identify if someone is affiliated with an external institution or organization.
Updated the COI questions for both internal and external affiliates. U-M affiliate questions (D1 and D2) have been reworded; non-UM affiliate questions (friend accounts) have been condensed from four to three Financial questions.
Added new location questions to Section 03 U-M Study Functions, as an additional evaluation by Environment, Health & Safety (EHS) may be required.
Updated the definition of Normal Healthy Subjects and help text in Question 9-1.1.
Added a new question to Section 15 Drug and Section 16 Devices to determine if healthy subjects are involved in the testing of drugs or devices.
Adverse Event/Other Reportable Information Occurrence
Updated question/answer branching logic, which will increase the number of studies that need to complete Section 01-5. RDRC/SHUR Adverse Events or ORIOs when submitting an ADV/ORIO.
Continuing Reviews
Added a new Continuing Review (CR) view when studies are being terminated to confirm the Study Team’s plans for the disposition of data and/or biospecimens.
IBCA Changes for DURC-PEPP Policy
Numerous changes were made to the IBC Application in support of the new federal policy for oversight regarding Dual-Use Research of Concern and Pathogens with Enhanced Pandemic Potential (DURC-PEPP). The policy is effective May 6, 2025 and applies to all federally funded research.
Enabled DURC-PEPP Category 1 and DURC-PEPP Category 2 designations that involve categorizing all research pertaining to Infectious Agents and Biological Toxins, their respective risk groups, and certain types of manipulations.
Added new questions to capture the appropriate DURC-PEPP categorizations of Gene/Vector constructs and Infectious Agents to several locations throughout the application.
Updated the list of Agents and Toxins based on adjusted categorizations.
Revised the original “Dual Use Research of Concern” smartform page with new DURC-PEPP pages.
The new pages have two sets of questions: one set of 9 questions for DURC-PEPP Category 1 research, and one set of 4 questions for DURC-PEPP Category 2 research.
If the application meets the criteria for Category 1 research, then both the Category 1 and Category 2 question sets will be required.
If the application only meets the criteria for Category 2 research, then only the Category 2 question set will be required.
If the application does not meet the criteria for either DURC-PEPP category, then the DURC-PEPP section/page(s) will not be displayed.
Added a new workspace warning message to indicate if the research is subject to DURC-PEPP policy.
Added DURC-PEPP answers to the In-Progress Application Summary, Approved Application Summary, and to the EHS Summary Report.
Other IBC Application Updates
Removed the "HHS and USDA Select Agents and Toxins" question from the Types of Potentially Hazardous Biological Materials page.
Removed "Non-Recombinant" text wherever it pertains to biological toxins, as it only applies to infectious agents.
For IRB Staff and Committee Members
Added the "FDA" indicator value from the Reviewer Checklist to display on the IRB tab (below the 2018 Common Rule message) on the Study workspace.
Updated Reviewer Checklist items for Section 15 Drug and Section 16 Devices to determine if healthy subjects are involved in the testing of drugs or devices.
Updated Umbrella approval letter templates for study applications (HUM), amendments (AME) and continuing reviews (CR) with requested changes from IRBMED.