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Update February 11, 2016

If you have any questions, please contact the JHM eIRB at jhmeirb@jhmi.edu or 410-955-3008.

As part of scheduled updates, the following changes will be made in eIRB2:

New Application/Change in Research Application

  • There is a growing need to know the primary affiliation of not only PIs, but also study team members. This field (Section 1 – General Information, Q18, Sub Q3) will now be a required field for all study team members. As a result of this change, you will be prompted to answer this question in the first Change in Research submission following the update.
     
  • A user reported problems with updating/deleting documents in Section 5 - Quality Improvement Project (Q3). This has been resolved.

IRB Workflow

  • “Alert PI” in “Researcher Prep” state – All study team members will have access to the “Alert PI” activity for applications that are in the "Researcher Prep" state. This activity is used to alert the Principal Investigator when an application requires submission to the IRB. Previously, the "Alert PI" activity was only available for applications that were in a "PI Response" state.
     
  • Effective February 15, 2016, non-affiliated investigators needing eIRB access will be required to have a sponsored ADHOC JHED account. This process will be consistent with the current non-affiliate account creation process for myLearning access (As of January 1st, 2016, myLearning no longer issues guest accounts. Non-affiliated individuals required to complete training through the myLearning system will be required to obtain an ADHOC JHED ID from their PI’s department administrator. All JHED administrators were made aware of this change.) This will allow the investigator to access both eIRB and the myLearning compliance training site using the same account information.
     
  • Also, additional JHED information fields have been added to the eIRB person profile to assist IRB staff in determining whether the account is Hopkins-affiliated or non-Hopkins affiliated (as the compliance training requirements differ).

Ancillary IRB Reviews

  • The Medical Affairs (MA) reviewer has requested that she only be required to review applications involving JHH employees/records. The current trigger for MA review is Section 12 (Participant Information), Q6 = "JHH employees/records". The application has been modified to replace “JHH employees/records” with “Employees/Records” and two sub-checkboxes have been added: “JHH employees/records” and “Other” with a textbox. The MA review will only be triggered if "JHH employees/records" is selected.
     
  • The Sidney Kimmel Comprehensive Cancer Center Clinical Research Office (SKCCCCRO)-assigned J number has been added to the subject line of all SKCCCCRO eIRB-related notifications.
     
  • In the February 2015 eIRB update, we added an optional ancillary review for the CRN network affiliates (AAHSRI, GBMC, Reading, PRMC, INOVA). We were made aware that a PI chose GBMC as their primary affiliation in error, which resulted in a hard stop at “Department Review”, which should not be required for any of the CRN affiliate sites. If a PI selects a CRN affiliate site as their primary affiliation in error, a department review will not be required.
     
  • In comparing the Pathology Review workspace history log to other ancillary review history logs, we noticed that the "Description" column was blank and the "Author" column was missing. This has been resolved.
     
  • Applications that require JHHS Nursing Review were not appearing in the investigator "In Process" tab. This has been resolved.
     
  • An issue was discovered in relation to the Howard County General Hospital (HCGH) ancillary review. HCGH was selected as a study location, but the HGCH ancillary review failed to transition from "Open" to "Waiting Review". It transitioned to "Not Required". This has been resolved.
     
  • Issues were reported with template language and notification criteria related to All Children's Hospital (ACH) ancillary review. These issues have been resolved.
     
  • Ancillary reviewers will now be able to upload a document within their record outcome activity, when applicable. It will not be required.

Other Changes

  • In the August 2015 eIRB update, we updated permissions for the extension request activities that allow all study team members to request an extension to respond to IRB issues. Previously, only the Principal Investigator was permitted to submit an extension request. We've updated the title of the notification as well as the boilerplate language to remove the PI-only distinction.
     
  • A user reported that comments entered by the PI within a withdraw request were not displaying in the eIRB notification. This has been resolved.