Why is the system being upgraded?
eIRB was launched in 2004 and the last major upgrade was in 2009. eIRB currently includes data for over 5000 approved/active applications, 18,000+ total protocols (new and terminated) and 23,000+ PIs and study team members. The current architecture and vast amount of data being stored has led to increasing memory issues, slow processing speed, and our inability to take advantage of new features that are available for this product today. Unfortunately, these internal system problems have caused users to spend more time dealing with error messages and poor system performance. In January 2012, The Office of Human Subjects Research (OHSR) and the Office of Research Environment System (RES) began the arduous task of rebuilding the system with new architecture on the latest software platform available.
When will eIRB2 be launched?
TBD. Migration will occur over a weekend to minimize the impact on workflow.
Will all applications be transferred to eIRB2?
Initially, all approved applications without a pending IRB action (i.e., a Change in Research) will be transferred to eIRB2. New applications in the Researcher Prep state for less than 90 days will also be transferred. When pending actions are approved by the IRB, the application will automatically be transferred to eIRB2. Terminated and Expired applications will not be transferred to eIRB2. The current approved study application and all current stamped documents will be transferred. All other actions (changes in research, continuing reviews, and problem events) for approved applications will remain in a read-only format in eIRB.
What will happen to the applications and data not transferred to eIRB2?
The current eIRB system will be used to archive terminated and expired applications. Further Study Actions (changes in research, continuing reviews, and problem events) approved in eIRB will be archived there in a read-only format. These actions will not be transferred to eIRB2 but will remain available to PIs and study team members.
Are there major differences between eIRB and eIRB2?
There are three areas where you will notice significant differences:
- The recruitment and drugs/devices sections have been reworked to flow more smoothly.
- Protocol Events (referred to as Problem Events in eIRB) will have a different format. The first few questions of this section are designed to help researchers determine whether it is necessary to submit the event in question immediately or with the continuing review application. Also, instead of adding multiple protocol events to one report, each event will be submitted as a separate report.
- “Reviewer Notes” have replaced the “Respond to Issues” activity. The PI/study team will address IRB concerns within the application. Notes will appear in the relevant sections of the application, and the PI/study team will be required to respond to each note prior to re-submission.
How can I find out more about eIRB2?
To watch a recorded information session go to http://webcast.jhu.edu/Mediasite/Play/c928229f0e744c16ab9d4de7c30eb1f31d