eIRB News and Updates
eIRB Username Changes
On June 1, 2021, we began implementing the following changes to usernames in the eIRB system. The eIRB system will automatically populate “preferred name” from the JHED directory instead of “legal name.”
- If the “preferred name” section is left blank in JHED, there will be no change to the way your name appears in the eIRB system.
- For those who have a “preferred name” listed in JHED, this name will be displayed in the updated eIRB system. Any letters or documents approved prior to the update will not update with the preferred name.
- For those who do NOT want their “preferred name” listed in the eIRB system, you need to remove your preferred name from JHED using the instructions available at this link.
New Data Protection Attestation Incorporated into eIRB
A new Data Protection Attestation has been incorporated into the eIRB system to help streamline the paperwork associated with sharing limited data sets for research among JHU researchers. The Data Protection Attestation available here outlines expectations for the protection of patient data and serves as a data use agreement to enable the sharing of limited data sets among JHU researchers, (both those in and outside of the JHM covered entity). As of 8/26/2021, when study team members “agree to participate” for any study in eIRB and when a PI submits a new application or further study action, researchers agree to the terms of the Data Protection Attestation. This new change eliminates the need to upload a separate Use of Data Agreement when using data that represents 500 or more JHM patient records and eliminates the need to execute a separate DUA outside of the eIRB system for most transfers of a limited data set to JHU collaborators. APL researchers still require a Data Use Agreement in many circumstances. For more information, see the Data Protection Attestation Frequently Asked Questions.
eIRB is the system of record for studies that require Johns Hopkins to serve as the IRB of Record / Single IRB. Below you will find useful tutorials that can help guide PIs and study team members through the eIRB system as well as information on upcoming in-person eIRB training sessions.
If you have any questions after reviewing the tutorials below, please contact the eIRB Help Desk at 410-502-2092, or email [email protected] for further assistance.
If you have a specific question about the review of a protocol (e.g. timeline for review, questions about how to respond to issues raised by the Board, etc) contact a staff member for the Board assigned to review your protocol. A list of staff contact info is accessible here.
Request a Consult:
If you require a more comprehensive discussion (e.g. you need assistance in protocol planning), please request a consult by clicking on this link. A virtual meeting with an appropriate member of our staff will be will be scheduled using MS Teams.
- How to Get Started with the IRB process
- New Applications
- Change in Research
- Continuing Review
- Convert Studies to eIRB
- Emergency Use Request
- Protocol Event Reports
- Termination/Post Termination Reports
- Other Useful Tutorials (IND safety reports, Radiation Calculator, etc.)
- Agree To Participate Error and Fix
- How to Add a Study Team Member
- How to Download Certificates
- How to Enroll in Clinical Research Coordinator (CITI) Training
- How to Enroll in Initial IRB Compliance Training
- How to Enroll in Only GCP Training
- How to Enroll in Recertification Training
- Study Team Roles
- Study In Lapsed State
- IRB Training
- Video - Guide to Extending Approval for IRB Submissions
- Video - Uploading Documents to eIRB
- Video - Further Study Actions (FSAs) in eIRB
- Video - Guide on Accessing Approval or Acknowledgment Letter and Stamped Documents
Other useful information:
- eIRB FAQs
- System Requirements
- New Application Workflow
- Change in Research Workflow
- Continuing Review Workflow
- Emergency Use Workflow
- Progress Report Workflow
- Protocol Event Workflow
- Termination Report Workflow
eIRB training is very helpful and strongly encouraged in facilitating the use of the electronic application system (eIRB).
“eIRB 101: ”An Intro to SOM IRB and Submitting an Application" is a live online training session offered on the 3rd Friday of every month. Registration is required to attend an eIRB technical training class.
Registration for eIRB 101:
Registration for eIRB 101 Training is done through myLearning. Click here to register.
If you are unable to attend the eIRB 101 training session download the eIRB 101 presentation.