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Update August 27, 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, Q8 – Revised question: Old: Is this application using an external IRB (e.g., CIRB) as the IRB of record?;  New: Has the JHM IRB entered a reliance agreement requiring the use an external IRB as the IRB of record for your research proposal (e.g., CIRB or NIH-funded study mandating use of a central IRB)? See help link for additional information.
  • Section 1 – General Information, Q15 – This question appears for resubmissions of expired, withdrawn, terminated and disapproved applications; however, the instructions ask for a progress report. For disapproval resubmissions, the investigator is required to include a response to the disapproval. The question has been revised to accommodate disapproval resubmissions.
  • Section 7 – Clinical Trials Information, Q7 – Added new question: “Who is the Responsible Party?” This is a NEW question. Researchers will be prompted to answer this required question in the first Change in Research submission following the update, if applicable.
  • Section 9 – Support Information, Q5 and Q6 – Modified existing questions (the revisions should not alter any previous answers to these questions.)
    • Q5 (Old): Will Johns Hopkins receive funds through a sub-contract?
      Q5 (New): Will Johns Hopkins receive funds through a sub-contract or sub-award?
    • Q6 (Old): Name the principal grantee and his/her institution/organization:
    • Q6 (New): Name the institution/entity through which you will directly receive funds:
  • Section 9 - Support Information, Q11 – Added a new question to assist the IRB in determining whether an approved application requires a Continuing Review annually or every three years. This new policy will not go into effect until Spring 2016.
  • Section 11 – Sample Size, Q8 – Added 'JHHS' distinction (Will you need JHHS nursing staff…)
  • Section 11 – Sample Size, Q9 – Removed language (…with the required nursing signatures.)
  • Section 12 – Participant Information, Q8­ – Removed “Whiting School of Engineering” and “Krieger School of Arts' and Sciences” and replaced with "Homewood"; created an FYI notification to IRB Homewood Director that will be triggered if "Homewood" is checked as a recruitment source.
  • Section 13 – Recruitment Information - Validation requirements and language modifications:
    • Q1 – If "No intervention/interaction with participants" is checked, none of the other checkboxes can be checked/
    • Q1 – Checkbox 4 –  added "…specifically for research purposes"
    • Q’s 3-6, Q8 and Q9 – these questions now require a response. Researchers will be prompted to answer questions in the first Change in Research submission following the update if previously unanswered.
    • Q8 – Checkbox 2 – remove the parenthetical language (including EPR, department databases, patient registry logs, etc.)
    • Q8 – Parenthetical text change:  Old: (i.e., 2000-2010); New: (i.e., January 2000 - December 2010)
  • Section 15 - Written Consent, Q9­ – Added a new question to address the new physician consent policy. This new question will assist IRB compliance monitors in confirming signatures on informed consent forms that require physician consent as per the new policy: New: Does the institutional policy on physician consent require that a physician-investigator or mid-level provider obtain informed consent for this research? If “Yes”, Provide the names of the physicians or mid-level providers in the study team who will do so:
  • Section 26 - Imaging Radiation, Q7 – A hide/show error with instructions that should only be shown if Q7 = Yes has been resolved.
  • ­Section 34 – SKCCC CRO, Q9 - Added parenthetical language. Old: Will a Weinberg pharmacy budget be developed? New: Will a Weinberg pharmacy budget be developed? (If 'yes', you are agreeing to be billed for pharmacy fees).
  • Application Workspace­ – The “Date Submitted:” field on the application workspace has not consistently displayed the initial submission date. New Applications submitted after this eIRB2 update will display the initial submission date on the application workspace.

Continuing Review Application:

  • Section 1 – Renewal Summary, Q1­ – Added additional language, requiring the investigator to provide more detailed information.
  • Section 2 - Renewal Summary – Hide/show errors have been fixed.
  • Section 2 - Renewal Summary, Q8­ – Added new question to assist the IRB in determining whether an approved application requires a Continuing Review annually or every three years. This new policy will not go into effect until Spring 2016.
  • Section 3 - Problems, Events and Deviation – Hide/show errors have been fixed.
  • Section 3 - Problems, Events and Deviations, Q6­ – Replaced "immediate" with "prompt" for consistency with IRB guidelines and policies.
  • Section 4 - Study Population – Hide/show errors have been fixed.

IRB Letters:

  • Fixed glitch on approval letters that include DoD language.
  • Minor changes in the acknowledged with administrative changes letters.
  • Minor change in pregnancy language in approval letters.
  • Modifications made to boilerplate header. Current Header/Revised Header:
    • PI Name/Principal Investigator
    • Study #/Number
    • Study Name/Title
    • Committee/IRB Committee

Study Team ‘Current Activities’ on Application Workspaces:

  • Admin Changes Activity – Detailed instructions have been added to assist study team members in using this activity as designed.
  • Request Extension – Pre IRB and Request Extension – Post IRB - All study team will now be permitted to request an extension to respond to IRB issues. Previously, only the Principal Investigator was permitted to submit an extension request.
  • Request Extension – Pre IRB – A confirmation email will be sent to study team members when a pre-IRB review extension is granted.

Other Changes:

  • A handful of applications did not transition to an "Expired" state when appropriate. The applications either remained in the "Approved" state or transitioned to "Lapsed" without the presence of a Continuing Review. This has been resolved.
  • Emergency Use Applications will be automatically routed to IRB Compliance Team Review after initial submission.
  • New Expedited Applications will be automatically routed to IRB Compliance Team Review after initial submission.
  • We’ve added an activity to allow the Office of Policy Coordination to flag an application that requires submission of a Change in Research as a result of updated conflict of interest information on a study team member. Study team members will be required to submit the Change in Research within 60 days of receiving the notification. Reminder notifications will be sent to study team members. If the required Change in Research is not submitted within 60 days, the IRB Director of Operations will be notified. IRB staff will unflag an application once the required Change in Research application has been submitted.
  • We’ve added an activity to allow IRB Compliance Monitors to flag an application that requires submission of a Further Study Action as a result of a monitoring visit. Study team members will be required to submit the Further Study Action within 60 days of receiving the notification. Reminder notifications will be sent to study team members. If the required Further Study Action is not submitted within 60 days, the IRB Director of Operations will be notified. IRB staff will unflag an application once the required Further Study Action has been submitted.
  • The IRB Compliance Monitors will be notified (upon IRB approval) if an application required a High Risk ancillary review prior to approval (Section 6 - Protocol Information, Q10).
  • A notification will be sent to the study team when applications are disapproved. This notification has been missing since the launch of eIRB2.
  • The “Create FSA” option was not recognizing Change in Research applications in the 'Acknowledged' state as being complete, causing an inability to submit Change in Research applications. This has been resolved.
  • The Conflict of Interest ancillary review was being triggered for Change in Research applications when not applicable. This has been resolved.