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Update April 28, 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 Applications

  • The eIRB system has been updated, where appropriate, to reflect the name change of "All Children's Hospital" to "Johns Hopkins All Children's Hospital".
  • External IRB Applications (triggered by Section 1 – General Information, Q8 = Yes) – A programming error requiring investigators to answer a hidden question in Section 15 (Written Consent) of applications has been resolved.
  • For Planning Phase Applications Only, you will now be permitted to submit Change in Research, Termination Report and Continuing Review Further Study Actions.
  • Section 9 – Sample Size - a programming update has been made to require a response to Q9 (Upload the Approval of Research Involving Nursing or Nursing Resources Form) if the previous question (Q8) = "Yes".
  • Section 22 – Devices - A programming error in Section 22 (Devices) allowed an application, that indicated the use of a device, to be submitted absent of any devices listed in Q3 - Q6. This validation error has been resolved.
  • Section 29 – Radionuclude Worksheet - The hide/show criteria that triggers Section 29 (Radionuclide Worksheet) has been changed.
  • Section 34 – SKCCC CRO - Requested changes to Section 34 (SKCCC CRO) of the eIRB application have been implemented.

IRB Workflow

  • High Risk Review – This concurrent ancillary review is required if Section 6 (Protocol Information), Q10 = anything other than “None of the above”. The high risk review has been converted to an internal, hard-stop pre-review (similar to IRB Compliance Team Review). Applications requiring high risk review will transition from "IRB Assignment" to "High Risk Review" for New Applications. This will require the high risk ancillary reviewer to review the application before it transitions on to IRB reviews. For Change in Research applications that require high risk review, the application will transition from "Researcher Prep" or "PI Response - xxxxx" to "RSS Review - Pre IRB" state (after any applicable pre-reviews [e.g., PRA Review, JHHS Nursing...]). IRB staff will include high risk review issues in their pre-review issues prior to returning an incomplete application to the study team.

Other Changes

  • “Submit IND Safety Reports” activity - Documents uploaded using the "Submit IND Safety Reports" activity were not appearing in the acknowledgement notification that is sent to the study team. This error has been resolved.
  • “eIRB Training” link on eIRB homepage - In February 2016, the processes for creating non-affiliated accounts (eIRB and myLearning access) were changed. Instructional text that referred to the old process has been updated.
  • Primary Affiliation/Department updates:
    • Updated “Endocrinology & Metabolism – Broadway” to reflect “Endocrinology, Diabetes, & Metabolism – Broadway”.
  • "Geisinger Health System PCORI-PaTH" has been added to the list of primary affiliations.