This release contains several improvements and resolves the following issues.
Common Rule
Effective January 21, 2019, with the implementation of the revised Common Rule (45CFR46), system changes made in 2018 to support the HRPP Flexibility Initiative now apply to all human subjects research, including those that are federally funded. These changes and other improvements are summarized in the eRRM version 4.3 release notes. Additional details and screenshots are provided in an Overview of Changes.
Consolidated IRB-Dearborn with IRB-HSBS
IRB-Dearborn was consolidated into IRB-HSBS as of January 1, 2019. Any Active or In-Progress applications that were under Dearborn IRB now fall under the review of HSBS IRB. A message regarding this change was posted to the study workspace.
New Ancillary Committee for Cellular Therapy
The following enhancements support the establishment of the new Cellular Therapy Ancillary Committee:
- A question was added to section 1-2 of the Human Subjects application. 1-2.10* Does the study involve administration of a cell therapy product? If answered “yes”, download the Cellular Therapies Scientific Review Committee Application, linked to in the help text, and upload the document with your answers to section 44.1.
- The study will be routed to the Cellular Therapy Ancillary Committee for review.
- An application or amendment workspace message near the subway map will indicate the status of the Cellular Therapy Committee's review.
For Cellular Therapy Ancillary Committee Members:
- A new workspace was created for the Cell Therapy role that lists applications or amendments that need to be reviewed, are in-progress, or have been completed.
- New activities are available on the Human Subjects application and Amendments to:
- Update Cell Therapy Staff Info
- Postpone Cell Therapy Review
- Complete Cell Therapy Review
- See the Cell Therapy Ancillary Committee step-by-step procedure for more details.
Human Subjects Application and/or Amendments (HUM, AME)
- Improvements were made to the communication of changes submitted for Ancillary Review.
- The question text and help text wording was updated on 1-1.2.8.1 regarding “Protected Health Information (PHI)“ protected by HIPPA.
- The Appointment selection on the Accept Role activity was fixed.
- The COI link on the Accept Role activity for Study Team Members was fixed.
- The ability to withdraw incomplete amendments was improved.
Repository Applications (REP)
Repository team members can now edit the Title of a Repository Application when completing an Amendment.
For IRB Staff and Reviewers
- With the establishment of the new Cellular Therapy Ancillary Committee, a new activity is available on Human Subjects applications and Amendments to Request Cell Therapy Review.
- The Generate Report activity in the Meeting Workspace now generates reports for Not Regulated Self Determined and Self Determined Exempt studies, similar to the report for Not Regulated studies.
- A new option, “Ceded study,“ was added to the list of CR Required Reasons.
- Changes were made to the application Termination Letters.
- With the changes to the Sponsor Information page and the Informed Consent types that were part of eRRM Release 4.3, the IRB Agendas needed adjustments to pull in the new data. Adjustments were made to the following IRB Agendas:
- Agenda by Reviewer
- Agenda by Submission Type
- IRB Staff Detailed Agenda