All users of eIRB must have an account. Your name will not appear in the study team directory if you do not have an account. To set up an eIRB account:

• Hopkins-affiliated study team members: Use your JHED ID and JHED password to login to the eIRB system. Upon successful login, an eIRB account will automatically be created for you.
   
• Non-affiliated study team members: the PI's department JHED administrator must create an ADHOC JHED ID to allow the study team member access to eIRB and myLearning (if compliance training is required). 

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 [email protected] 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 can’t successfully login to JHED, contact JHED directly at [email protected] or call the JHED IT Support Center at 410-955-HELP (4357) for assistance in resetting your JHED password. If you can successfully login to JHEDbut not to eIRB and you have reset your JHED password, contact the eIRB Help Desk at [email protected].

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 [email protected]or call the JHED IT Support Center at 410-955-HELP (4357).
   
• Non Hopkins affiliated user: email the eIRB Help Desk at [email protected] for assistance.

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 comes from JHED and if your email address is missing/incorrect, that information feeds to eIRB. For assistance, contact JHED directly at [email protected] or call the JHED IT Support Center at 410-955-HELP (4357). 

The list you see in the Submit window is a list of errors in your application/FSA. 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/FSA screen.

Click on the blue icon beside each question for a link to regulations, forms, etc.

The SOM IRB will not approve adding non-Hopkins affiliated study team members who are not considered engaged in human subject research (defined as interacting with living individuals and/or accessing PHI/PII for research purposes). Non-Hopkins affiliates who will be engaged in human subject research with SOM PIs must enter into a Reliance Agreement with the institution. The PI should contact the IRB Reliance Manager at [email protected] to begin the process.

There is an institutional requirement for compliance training.  If compliance training dates are not appearing and certificates are not uploaded in this section, the application will be returned by IRB staff prior to IRB review.  You should not submit the application until all study team members have completed compliance training. JHM IRB Guidelines: Training Requirements for Human Subjects Research.

IRB compliance training is available via myLearning at http://training.jhu.edu/ComplianceTraining/.

MyLearning will track your course completion. Once you have completed your IRB compliance training, click on “My Learning History” on the left side navigation to obtain a copy of your course completion report. This data will automatically feed into the eIRB application. If this is your first eIRB application and/or the dates above are blank or incorrect, you must upload copies of IRB your compliance training certificates or a course completion report into the eIRB application.

Upon submission, the JHM IRB staff will enter the dates into your eIRB profile.

For assistance with compliance training requirements, contact the IRB Training Manager at [email protected] or the eIRB Help Desk at [email protected]. 

Email the eIRB Help Desk at [email protected] and we will add it to the list.

1. Login to eIRB at http://e-irb.jhmi.edu.
2. Select “My IRB Studies” from the left navigation bar.
3. Click the Researcher Prep tab.
4. Scroll down select the study name to open the new application or change in research workspace. If you received an email to agree to participate, simply click on the link provided. 
5. Select “Agree to Participate” from the Current Activities section on the left. 
6. Read the window and click OK.

Once an application has been submitted, no changes can be made by the investigator.  You will see a read-only version when viewing your study.  If revisions are required, the study will be returned to the investigator and appear under the “Action Required” tab.  Changes can be made at that time.  You will need to re-submit the application after you have saved your changes.

You need to create and submit a Change in Research application. On the left side of the application workspace underneath “Create Further Study Action”, click “Create…”  Select “Change in Research” from the options provided and click “Continue”. Complete the form including all of the changes you wish to make.

Remember that newly added study team members will need to agree to participate and that only the PI can submit the Change in Research application. You can track the status of your Change in Research application by clicking on the “In Process” tab on your eIRB homepage or under the Further Study Action tab on the main application workspace.

Open the application workspace for your approved study, and click the “Create…” activity located on the left navigation bar underneath “Create Further Study Action”.  FSAs look and function exactly like the application.  Once the FSA has been completed, the PI should click the Submit button the same way s/he submits the application.  Information, instructions, and tutorials may be found on the IRB website: http://www.hopkinsmedicine.org/institutional_review_board/training_requirements/eirb_training.html

You will need a change in research to change the PI.  Both the old and new PI will be able to submit the change. Please remember to also include revised documents (i.e., protocol, consent form, recruitment  and HIPAA forms) that may include the old PI’s name and contact information.

Once the application/FSA has been approved, select either the “Legacy Stamped Documents” tab (if your application was migrated from the archive eIRB to eIRB2) or the “Stamped Documents” tab on the application workspace. These documents will be listed in the approval letter.  Use these stamped documents with study participants. The IRB will upload the same approved documents without a logo directly into the application under their appropriate sections. The no logo documents are to be used when submitting changes in research. Only one version of each document should be visible. All documents that do not require an IRB stamp can be downloaded from the application.

IRB letters may be found in the “Review List” which is located on the application/FSA workspace. Select “View Letter” to open and review the IRB letter. 

The IRB tracked change version of the consent form may be downloaded from within the application.

IRB staff will add reviewer notes to the application sections of the eIRB application. Investigators will be required to make revisions to the application and/or provide a response/explanation in the text box provided.

A member of the study team must respond to each note prior to resubmission. After entering each response, click "OK" to save. If you need to edit your response, click on the “study team response” link provided and click "OK" to save your response. This does not submit the response. On the application workspace, click “Alert PI”, which sends an email the PI to remind them to submit the response.

Are you sure that you’ve submitted the application/FSA?  Applications, Further Study Actions, revisions, or responses cannot be processed by the IRB until the Principal Investigator clicks the “Submit” activity located under Current Activities on the left of the application/FSA workspace screen.

If the PI has submitted the response, check the status of your application by selecting “In Process” on   the Investigator Workspace and opening the application workspace. The last scheduled review date and  the application current status can be found on this workspace.

The word version of the approved consent forms may be downloaded from the consent question in the application.  The stamped consent forms are located on the Application Workspace under the “Stamped Documents” tab.

Continuing Reviews, Changes in Research, Emergency Use Requests and Termination/Post Termination Reports may be submitted at the same time.  More than one Change in Research application for the same study may not be submitted until the first has completed its review.  Problem Events may be submitted concurrently, even for the same study.

The eIRB system will not allow us to extend expiration dates for continuing reviews.  As you may recall, one of the findings that the government used to shut down the IRB in 2001 was a practice of allowing investigators to extend research beyond the limit of the approval, even in situations that seemed beyond their control.  Since then, the policy has been in place to terminate any study that had not been submitted for a renewal prior to the expiration date.  There is a place in your new application where you select that this is a resubmission of a previously approved study and enter the original study number.

The PI has 60 days to resubmit an application that has been returned before going to an IRB Committee for review.  You may seek a 60 day extension of this time limit by selecting “Request Extension – Pre IRB” under the Current Activities section of the application/FSA workspace.  You may also seek an extension for the submission of a response to IRB issues by selecting “Request Extension – Post IRB” under Current Activities on the application/FSA workspace.  You must submit this request in eIRB before the original requested due date.  We cannot accept responses beyond the deadline without a JHM IRB approved extension.

Only the Principal Investigator may withdraw an eIRB application or further study action.  Select PI Withdraw Study or Request Withdraw under Current Activities on the application/FSA workspace.  If you wish to pursue this application/FSA in the future, a new eIRB application/FSA must be created and resubmitted for IRB review.

A Termination Report should be submitted to the IRB when study activity is completed and access to study identifiers (if applicable) is no longer required for data analysis or manuscript writing.

You can find the original snapshot of your application under the History Log at the bottom of the page.  Remember that only PI and study team members listed in the original application will be able to access it.

As your eIRB application moves through the submission process, the application current status will change. Click Here to get a copy of the eIRB Application Workflow for New Applications.