eFAQs

1. Why couldn’t I login with my JHED ID and JHED password?
   
   All users of eIRB must be assigned an eIRB account.  To set up an account in eIRB, Hopkins affiliated study team members select JHED User Self Registration and non Hopkins affiliated study team members select Non JHED User Self Registration from the eIRB login screen at http://e-irb.jhmi.edu.
   
   
2. I have an eIRB account, but I can’t login.  Should I create a new account?
   
   Do not create a new eIRB account.  Do you have a JHED ID?
   
   No:  You are a Non Hopkins affiliated user (Non JHED user).  Contact the eIRB Help Desk at jhmeirb@jhmi.edu for assistance.
   
   Yes:  You are a Hopkins affiliated user (JHED user).  Contact information in eIRB is pulled from JHED.  Try to login to JHED at https://my.johnshopkins.edu/.  If you cannot successfully login to JHED,  contact JHED directly at jhed@jhmi.edu or call the JHED IT Support Center at 410-955-HELP(4357) for assistance in resetting your JHED password.  If you can succesfully login to JHED but not to eIRB, or if you reset your JHED password, contact the eIRB Help Desk at jhmeirb@jhmi.edu .
   
   
   
3. I can’t remember my password.  What do I do?
   
   The IRB does not have access to your password. 
   
   Hopkins affiliated user: to verify your JHED ID and reset your JHED password contact JHED directly at jhed@jhmi.edu or call the JHED IT Support Center at 410-955-HELP(4357). 
   
   Non Hopkins affiliated user: email the eIRB Help Desk at jhmeirb@jhmi.edu for assistance.
   
   
   
4. Why aren’t I receiving eIRB notifications?
   
   eIRB generates automatic emails at key points of the review process to notify users of new information or actions that need to be taken.  Contact information is pulled from JHED and your email address is not exposed in JHED.  Therefore automatic notifications cannot be sent to you when you are part of a study.   For assistance in exposing your email in JHED, contact JHED directly at JHED@jhmi.edu or call the JHED IT Support Center at 410-955-HELP(4357).
   
   Non Hopkins affiliated study team members who are not receiving eIRB email notifications should contact the eIRB Help Desk at jhmeirb@jhmi.edu.
   
   
   
5. What happens if new questions appear after I submitted my application?
   
   If your application is returned to you prior to approval you may need to answer all new questions required by your application.  If your application is already approved, you may need to answer new questions in your next Further Study Action.  eIRB will prompt you to answer any required new questions.
   
   
   
6. If changes are made to the application or Further Study Action after I have started, what will happen to the information I have already entered but haven’t submitted?
   
   Your data and documents will be retained by eIRB in the new application or Further Study Action format.  You will not lose your information.
   
   
   
7. I clicked Submit but it didn’t work.  All I got was some type of list.  What do I need to do to submit?
   
   The list you see in the Submit window is a list of errors in your application.  Each list item explains the error and provides a link to the screen where you can fix it.  This is the same list that appears when you click Hide/Show Errors on the Light blue Toolbar at the top and bottom of the application screen.
   
   
   
8. Where do I find a link to the forms and regulatory guidance?
   Click on the question mark icon   beside each question for a link to regulations, forms, etc.
   
   
   
9. Where do I find technologic help?
   
   Click on the information technology icon   beside each question for step by step technologic instructions.  Select How Do I? from the Left Navigation Bar on the eIRB Home Page at http://irb.jhmi.edu/eIRB/.
   
   
   
10. Where do I upload my cover letter?
    
    eIRB does not require a cover letter.  When submitting an application or Further Study Action, the Principal Investigator has the ability to upload a document or add comments in the Submit window.  This information will appear in the History Log.
    
    
    
11. How do I submit my annual renewal?
    
    Further Study Actions may be submitted for activities regarding currently approved studies.  These include problem/event reports, annual continuing reviews, amendments/changes in research, termination reports, and post-termination reports.
    
    
    
12. Should I download forms from the IRB website?
    
    No.  eIRB requires the use of specific forms.  Use the regulatory guidelines help link     located beside the question to download the forms you need.
    
    
    
13. My study team members are not listed in eIRB.  How do I add them?
    
    Not all faculty and staff are listed in eIRB.  To set up an account in eIRB, Hopkins affiliated study team members select JHED User Self Registration and non Hopkins affiliated study team members select  Non JHED User Self Registration from the eIRB login screen at http://e-irb.jhmi.edu.
    
    
    
14. The compliance training dates for some of my study team members are not displayed in eIRB.  How can I enter this information?
    
    There is an institutional requirement for compliance training which must be completed before IRB approval can be granted.  It is not necessary to send compliance training certificates in advance of an eIRB submission.  Upload copies of training certificates into question 2.0 on the eIRB application screen Study Team Compliance Training, and we will enter the dates into the eIRB system upon submission of the application.
    
    
    
15. Who is required to take CORE training?
    
    All principal investigators of active IRB protocols are required to complete the Course on Research Ethics (CORE) or its equivalent.  Individuals who were not active PIs as of October 1, 2006 have one year from the date of first submission to complete the CORE requirement.  Fellows must complete the CORE course before the end of their training period.
    
    If you can provide documentation that you have completed one of the research ethics courses listed below you will not need to coplete the CORE requirement:
    
    Research Ethics 550.860.01 (School of Public Health)
    Research Ethics and Integrity: US and International Issues 366.665.01 (School of Public Health)
    Science of Clinical Investigation: Ethical and Regulatory Issues in Clinical Research (Instructors Dr. Norm Fost and Dr. N. Franklin Adkinson)
    
    
16. My funding source is not listed.  How do I get it on the list?
    
    Just email the eIRB Help Desk at jhmeirb@jhmi.edu and we will add it to the list.
    
    
    
17. I finished my application.  What is the activity Request Study Team Participation that is listed under Current Activities?
    
    Completing the Request Study Team Participation activity automatically issues an email notification to all study team members.  This email contains a link to login to the application.  Study team members review the application and uploaded documents before agreeing to participate.  Each study team member is required to complete the Agree to Participate activty, the equivalent of an electronic signature.  After everyone has agreed, the Pirncipal Investigator may submit the application. 
    
    
    
18. I got this email telling me to agree to participate in a research study.  How do I do that?
    
    Login to eIRB http://e-irb.jhmi.edu select My IRB Studies from the Left Navigation Bar. Scroll down and open the Summary View for the study by selecting the study name on the right.  Select the Agree to Participate activity from the Current Activities section on the left.  Read the window and click OK.
    
    
    
19. I got this email telling me to agree to participate in a research study, but when I login to eIRB I get the eOPC workspace.  How do I get to eIRB?
    
    This technical problem occurs when you have an eOPC account before you have an eIRB account.  Just contact the eIRB Help Desk at jhmeirb@jhmi.edu and we will fix it for you.
    
    
    
20. What is the procedure for obtaining department approval?
    
    eIRB observes the department approval hierarchy consistent with University policy.  If department review is required, your department will electronically receive, review, and approve the application prior to IRB review.  The application will move out of the In Pre-IRB Review state once an outcome has been recorded.
    
    
    
21. How can I make changes to an application that has already been submitted?
    
    Once an application has been submitted, it is in the In IRB Process state and no changes can be made by the investigator.  You will see a read-only version when viewing your study.  Revisions can only be made at the request of the Department Reviewer or the IRB.  If revisions are required, the study will return to the investigator and appear under the PI Responsibility tab.  Changes can be made at that time.  You will need to re-submit the application after you have saved your changes.
    
    
    
22. How do I make changes to an application that has already been approved?
    
    Further Study Actions may be submitted for activities regarding currently approved studies.  These include problem/event reports, annual continuing reviews, amendments/changes in research, termination reports, and post-termination reports. 
    
    
    
23. What is the procedure for withdrawing my study or response from IRB review?
    
    Only the Principal Investigator may withdraw a study or response. 
    
    eIRB applications may be withdrawn by the Principal Investigator prior to submission by selecting Withdraw Study from the Current Activities section of the Summary View.  This willl delete the study from eIRB.  
    
    Once an application has been submitted, click Request Withdraw in the Current Activities section of the Summary View.  This allows you to request the withdrawal of an application through eIRB.  Completing this activity sends an email notification to the IRB office to consider the request.  You will receive an email confirming the withdrawal.  At this time the application will move to the Inactive Studies tab on the study team workspace of your home screen.  It will be read-only, giving you access to all of the information and uploaded documents.  The application cannot be reactivated.  If  you wish to pursue this study in the future a new eIRB application must be created and resubmitted for IRB review.
    
    
    
24. Where do I upload my response?
    
    The Response Document may be uploaded WITHIN the Submit activity window or Study Team Member Prepares Response activity window, AFTER all IRB required revisions to the application or Further Study Action have been completed.  DO NOT upload the Response Document into any application or Further Study Action question.
    
    
    
25. I completed the revisions and uploaded a response.  Why isn’t anyone processing it?
    
    Are you sure that you’ve submitted the application?  Applications, Further Study Actions, revisions, or responses cannot be processed by the IRB until the Principal Invistigator clicks the Submit link located under Current Activities on the left of the Summary View screen.
    
    
    

If you have any comments, questions or suggestions
you may contact the JHM eIRB at: