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Update October 29, 2015

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:

eIRB New Application:

  • Section 1 – General Information, Q4 – A new departmental review has been created for “JHHS Pharmacy”. The application trigger for the departmental review is: Section 1 - General Information, Q4 = "Pharmacy - Broadway". Kenneth Shermock will be the department reviewer.
     
  • Section 1 – General Information, Q16­ – Revised question and added validation that only one answer should be selected):
    • Old: What is the current status of your study?
    • New: At the time of your resubmission or conversion, what is the current status of your study?
       
  • Changes to Quality Improvement Project Application Workflow – Application workflow changes have been made for Quality Improvement projects. Changes include:
    • Section 1 – General Information, Q7 - Replaced "Not Human Subjects Research (NHSR)" with "Not Human Subjects Research (NHSR)/Quality Improvement (QI)"
    • Section 1 – General Information, Q10 - Revised to remove reference to "Quality Assurance"
      •  if Q10 = Yes and Q7 is not "Not Human Subjects Research (NHSR)/Quality Improvement (QI)", the answer to Q10 will automatically update to reflect "Not Human Subjects Research (NHSR)/Quality Improvement (QI)" when the page is saved;
    • Sections 4 (Exempt/NHSR), 11 (Sample Size), 12 (Participant Information) and 23 (Human Biological Samples) are now hidden if Section 1 – General Information, Q10 = Yes.
    • Other minor language changes as required.
       
  • Section 15 – Written Consent, Q1 – In bullet #1, replaced "time allotted for obtaining consent" with "confirmation that as much time as necessary will be allowed for obtaining consent".
     
  • Section 15 – Written Consent, Q9 – This question was added in the August 2015 update, but did not require a response. Research who did not answer this question previously will be prompted to provide a response in their first Change in Research submission following the update.
     
  • Section 36 – Data Confidentiality, Q3 – Added new question: “Will PHI or other confidential information be stored on laptops or other mobile devices (such as mobile phones, tablets, netbooks, flash drives and other portable storage devices) for this study? If Q3 = Yes, investigators must check a box to confirm that all mobile devices will be encrypted as required under JH IT policies. This is a NEW question. Researchers will be prompted to answer this required question in the first Change in Research submission following the update.
     
  • Planning Phases applications are currently programmed to be Acknowledged. Going forward. Planning Phase applications will be Approved as opposed to Acknowledged. Justification: NIH requires IRB “approval” before releasing just-in-time funds, so an “acknowledgment” will not suffice.

Continuing Review Application:

  • Section 2- Renewal Summary, Q1 – Revised question:
    • Old: Provide a detailed progress report of the study during the last approval period, including (but not limited to): current activities, procedure changes, risks and data monitoring or analysis.
    • New: Provide a detailed progress report of the study during the last approval period, including (but not limited to): current activities, brief summary of significant changes in research, risks and data monitoring or analysis.
       
  • Section 2 – Renewal Summary, NEW Q9 – Added new question:
    • Is this a multi-center trial? If Yes, Upload any relevant multi-center trial reports:

Study Team ‘Current Activities’ on Application Workspaces:

  • “Admin Changes” – Biosafety registration number – this new addition to the current "Admin Changes" activity will allow investigators to update their biosafety registration number outside of submitting a Change in Research application (eIRB Application Section 23 – Human Biological Samples, Q7).

Other Changes:

  • Applications that are inactive (e.g., Withdrawn, Disapproved, Expired, and Terminated) will no longer appear in ancillary review workspaces.
     
  • Lapsed Studies and Changes in Research – Investigators will now be able to create and submit a Change in Research application if the current status of the application is “Lapsed”.