System changes for this release include updates and enhancements to Human Subjects Applications (HUM), Amendments (AME), Adverse Event/Other Reportable Information Occurrence (AE/ORIO, ADV) reports, scheduled Continuing Reviews (SCR), and IBC Applications (IBCA).
HUM, AME, ADV, or CR changes
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A Principal Investigators' ability to Self-Determine certain Exempt or Not Regulated studies was temporarily removed with the March 29, 2020 system release. This ability will be re-enabled and referred to as “System-Generated Determination”.
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To improve the review and update of Study Team Members (upon Amendment or Continuing Review) the following changes were made:
- text changes to HUM Question 1.3 Study Team Members
- text changes on the SCR and AME Cover Sheets
- added a new view to the SCR smartform to more clearly display the HUM's list of approved study team members.
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Secondary Use applications will require Study Teams to answer a new question related to the study’s risk level in Section 5 Research Design, Question 5.9
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Updated questions for Exemption Categories 1, 2, and 3 to improve Exempt Determination eligibility
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Updated descriptions for the Not Regulated Categories
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Simplified the questions related to Human Gene Transfer (Section 7-2 and 7-3 Special Considerations, Section 23 Gene Transfer), reviewed by the Institutional Biosafety Ancillary Committee
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Updated the question set related to Ionizing Radiation, reviewed by the Radiation Safety Ancillary Committees (RDRC and SHUR)
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When radiopharmaceuticals are administered as part of a study (indicated in HUM Question 7-2.3.1 or 7-3.10.1), creation of an Adverse Event/ORIO will include Section 1-5 RDRC/SHUR Adverse Events or ORIOs on the report.
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Moved the PEERRS training requirement information from the text of Question 1.4 to the Help Text and updated this help text
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Removed the COVID-19 related questions from HUMs, Amendment Cover Sheets, and Adverse Events
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Removed outdated answer choices from the Amendment Cover Sheet Question 1.6: Why is this amendment being requested?
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Revised Question 4.1 text in Continuing Reviews
For Committee Reviewers
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To improve clarity of a study's FDA regulated status:
- A question on the Reviewer Checklist was updated to include more details to help determine when a study is FDA regulated
- Secondary Use applications will include a Reviewer Checklist item to evaluate if a study is FDA Regulated when device use is indicated in Section 1-1.2 Scope of Secondary Use Research Question 5
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Resolved an issue where the PI’s Appointing Department was missing on Ancillary Committee Review email notifications
For IRB Staff
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The activities for selecting Full Board or Expedited Reviewers will display only active Committee Members.
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To improve visibility of CV upload/edit dates, the Last Modified Date of the CV document stack will be displayed as part of a Study Team Member's record. (Note: this is the document stack modification date and does not indicate if changes were made within a document.)
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Updated language in the following letter templates:
- Renewal Reminder Notification Templates for 30, 60, and 90 day reminders
- Project Hold and Project Suspend notification letters
- HIPAA notification for Exempt and Not Regulated Determined letters
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Added two new approval letter templates for ADV
IBCA changes
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Added a new vector host selection choice of "E. coli non-K-12 strain" to IBCA Questions 3.1.1, 3.2.1, 3.3.1, 3.4.1, and 3.5.1
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Removed the COVID related question from the IBC application