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Update February 9, 2015

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

February 2015

As part of quarterly scheduled updates, the following changes have been made in eIRB2:

  • Section 1 - General Information:
    • Q3 (Is the PI a JHHS RN?) - This is a NEW question. Researchers will be prompted to answer this required question during their first Change in Research submission following the update. A “yes” will trigger pre-IRB review by the Johns Hopkins Health System’s Nursing department.
    • Q8 (Is this application using an outside IRB [e.g., CIRB]?) - This is a NEW question. Researchers will be prompted to answer this required question during their first Change in Research submission following the update.
    • Q9 (previously Q7) - This question has been revised. OLD: Is this a retrospective chart review only? NEW: Does this project ONLY involve retrospective review of charts and/or use of existing specimens?
    • Q10 (Is this a quality assurance/quality improvement project?) - This is a NEW question. Researchers will be prompted to answer this required question during their first Change in Research submission following the update.
  • Section 5 - Quality Assurance/Quality Improvement Project - This is a NEW section, triggered by a "yes" to 1 - General Information, Q10.
  • Section 6 - Protocol Information:
    • Q1 (Type of protocol) - "JHM-IRB eForm B" has been added as a type of protocol. Researchers should use the eForm B for retrospective review of charts and/or existing specimens ONLY studies (e.g., if you answer "yes" to 1 - General Information, Q9 (previously Q7). Please Note: if you were previously required to upload your protocol in Section 19 - Supplemental Study Documents, you will be required to upload your protocol into Section 6 - Protocol Information, Q2, and delete the protocol from the Supplemental Study Documents section.
    • Q2 (Check the option that best describes this protocol:) – This question has been removed from the application.
    • Q10 (previously Q11) - A new sub-question will be displayed based on your answer(s) to Q10.
  • Section 10 - Study Location, Q1 - Under "Non-Hopkins/Affiliates sites" --> "Is this an international site?”, we have added "County of Origin". This will allow us to run more accurate reports on where international research is being performed. Researchers may be prompted to answer this required question during their first Change in Research submission following the update.
  • Section 11 - Sample Size, Q8 and Q9 - These questions have been revised. Q8 now includes "as participants" in the inclusion criteria examples. Also, a “yes” will trigger pre-IRB review by the Johns Hopkins Health System’s Nursing department. Q9 now references the revised title of the nursing research form and includes the following statement: The IRB cannot approve your application until the signed form is uploaded.
  • Section 21 – Drugs, Q8 (Are any of the drugs, substances, or biologicals used in this study classified as Controlled Substances?) - This is a NEW question. Researchers will be prompted to answer this required question during their first Change in Research submission following the update. Other minor modifications have also been made.
  • Section 22 – Devices, Q5 (NSR or Exempt from IDE requirements) - Modifications have been made to the sub-questions. Researchers may be required to answer new/revised questions during their first Change in Research submission following the update.
  • Section 23 - Human Biological Samples:
    • Q2 (Will blood samples be collected…) has been removed from the application.  These questions do not trigger any additional fields, notifications, etc.
    • Q10 (previously Q11) - This question has been revised. OLD: If you are working with a JHH/JHBMC pathologist, enter pathologist's name: NEW: Provide the name of the Pathologist you are working with to obtain the specimens. In addition, a sub-question has been added requiring approval documentation from the aforementioned Pathologist.
  • Section 24 - IBC/RAC, Q3 (IBC Approval Letter) - Modifications have been made to fix a hide/show problem. This question should, and will now appear when Q2 is answered "Yes".
  • Section 26 - Imaging/Radiation – The branching logic that displays applicable imaging and radiation sections of the application (e.g., Radiation Exposure, Radionuclide Worksheet, External Radiation Exposure Worksheet) and triggers CRRC/RDRC review have been modified. Researchers may be required to complete additional sections of the application during their first Change in Research submission following the update.
  • Section 31 - Incidental Findings – The branching logic that displays the Incidental Findings section has been modified. Researchers may be required to complete this section during their first Change in Research submission following the update.
  • Change in Research, General Information, Q3 - This question has been revised. OLD: Summarize and explain reason(s) for all changes to this study.  Use the textbox or upload a document. NEW: Provide a summary, explanation and justification for all changes to this study.  Use the textbox or upload a document.
  • Continuing Review:
    • Section 3 - Problems, Events and Deviations, Q6 - A NEW question has been added allowing researchers to upload problem events that don’t require immediate reporting, sponsor-required adverse events that don’t meet the JHM IRB requirements for reporting, and/or and AE logs (i.e., RF3).
    • Section 4 - Study Population, Q4, 5 & 6 - NEW questions pertaining to pediatric re-consent have been added. Boilerplate language will also appear in the approval letter, triggered by answers to these questions. For additional information, refer to the help link located to the right of the question.
  • Protocol Event – Section 1 – General Information - Modifications include revisions to the red error message that appears if you answer "No" to all 5 questions and the addition of hyperlinks to reporting policy and RF forms; other text modifications.
  • Other Changes:
    • Administrative Functions – This NEW activity will allow researchers and IRB staff to update specific fields in the application outside of submitted a Change in Research. Fields include: updating study team member role (i.e., changing Jane Smith's role from research nurse to study coordinator); start/stop receiving all study related notifications; update clinical trials registration; update investigational drug data sheets (IRB P&T members only). We will continue to add to this list in future updates.
    • Lapsed state for CRs – A "Lapsed" state has been created for applications that expire while a Continuing Review is under IRB review.
    • Continuing Review approval letter – Additional language regarding clinical trials has been added to the Continuing review approval letter: "If the study is registered with Clinicaltrials.gov and is closed to recruitment and enrollment, the record must be updated within 30 days to reflect the study’s enrollment status.  See http://clinicaltrials.gov/ct2/manage-recs/how-edit for more information. Questions can be directed to register@clinicaltrials.gov."
    • REWards Notifications – Principal Investigators are required to complete REWards training within a year of their first eIRB application (see: http://www.hopkinscme.org/rewards.html). eIRB notifications will now be sent to remind Principal Investigators to complete the course prior to their individual deadlines.
    • Reviewer Notes Response Letters – Responses to IRB review concerns will now be available in a letter format on the application workspace (to the right of the IRB letter). In addition, new reviewer note categories (i.e., IRB Review Concerns - Review 1 [2…3…]; IRB Post Review) will be available in the "Reviewer Notes" tab, allowing IRB staff, IRB reviewers, and researchers to filter by the type of note they wish to view.
    • Planning Phase Further Study Actions (FSAs) and Approval Letter – Planning Phase applications will no longer allow for the creation of Further Study Actions. Other modifications have been made to the boilerplate approval letter language.
    • eIRB Notifications - Boilerplate language and outdated links to IRB guidance have been updated.
    • Retrospective Chart Review Only applications - Modifications have been made to the application for retrospective chart review only studies. Changes include (but are not limited to): General Information, Q9 (previously Q7): Does this project ONLY involve retrospective review of charts and/or use of existing specimens? Protocol Information, Q1: the new eForm B is the protocol template to be used if you answer to General Information, Q9 is "Yes"; Other modifications throughout the application and Continuing Review application.  Researchers may be required to complete additional sections/questions during their first Change in Research submission following the update.
    • Quality Assurance/Quality Improvement (QA/QI) projects - a NEW application workflow for has been created. The branching logic follows a workflow similar to Exempt and NHSR projects. QA/QI projects will receive a 3-year approval period. On the General Information section of the eIRB application, a new question (Q10) has been added. A "yes" to this question will trigger the appropriate sections of the application.
    • External IRB Application - A new workflow for external/outside IRB applications has been added. On the General Information section of the eIRB application, a new question (Q8) has been added. A "yes" to this question will trigger the appropriate sections of the application.