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Will I use IRAP for new submissions that rely on an external IRB like WIRB or the NCI CIRB?
Yes, you will submit these documents to the OIRB via IRAP. Instead of e-mailing documents to the OIRB through the
wirb@uab.edu orsingleIRB@uab.edu e-mail addresses, you will create a new submission and upload the documents referenced on the Institution Review Form. -
Will IRAP replace WIRB’s Connexus?
No, IRAP will not replace Connexus. Documents required by WIRB for their review must still be uploaded directly to Connexus. Documents required by the OIRB that were previously sent via e-mail to
wirb@uab.edu will instead be submitted via IRAP following the instructions in the IRAP My Human Subjects Investigator Handbook. -
Can an investigator name more than one delegate?
Yes, the investigator can name more than one delegate.
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If a group of coordinators help an investigator but are assigned to different projects, will all coordinators get the e-mails for all projects?
Delegates are module-specific, not project-specific. So all delegates for an investigator will be copied on all correspondence from the system. Some units have decided to have their coordinators set up e-mail rules to manage communications from IRAP.
- Example: Coordinator A and coordinator B both help Dr. Investigator with her projects, but coordinator A is responsible for projects 1, 2, and 3, while coordinator B is responsible for projects 4, 5, and 6.
- Dr. Investigator names both coordinator A and coordinator B as her delegates. Coordinator A doesn’t need a rule for projects 1, 2, and 3, so those e-mails still come to the inbox. However, coordinator A sets up a rule in their e-mail client to move e-mails for projects 4, 5, and 6 to a specific folder.
- Coordinator B doesn’t need a rule for projects 4, 5, and 6, so those e-mails still come to the inbox. However, coordinator B sets up a rule in their e-mail client to move e-mails for projects 1, 2, and 3 to a specific folder.
All communications from the My Human Subjects module include the IRB Project Number (IPN) in the subject line, so rules can be based on the IPN.
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For continuing reviews, which documents do I need to submit and do these have to be scanned individually?
Scan the Investigator's Progress Report (IPR) with the materials referenced in the IPR (Problem Summary Sheet, annual reports, DSMB reports, etc.) in one document named ipr.YYMMDD. Then scan the other required materials (previoulsy approved (stamped) consent forms, previously reviewed amendments, previous IPRs, Human Subjects Protocol, etc.) in one document named renewalpkt.YYMMDD. If the continuing review of your study should result in one or more newly stamped consent forms, scan those as separate documents with the appropriate naming conventions. Since IRAP will apply the approval stamp with the new dates to the consent form(s) within the system, these need to be separately uploaded documents.