eIRB-2

The Johns Hopkins University School of Medicine's (SOM) eIRB system was launched to its research community in 2005 in order to improve the protection of human subjects participating in research at JHU, and to address the ever-growing regulatory issues that the previous paper-based system could not handle efficiently. The SOM eIRB was one of the first of its kind, running on a web-based "customizable workflow" platform developed in collaboration with Huron/Click, Inc. The system and its intended use caught on fast and today the Huron/Click eIRB software platform is used by over 70 institutions and entities across the world. Implementing such an innovative system at the SOM was a remarkable accomplishment and has protected our human subjects successfully and provides a valuable tool to researchers and regulatory staff across the university. Being on the forefront of such a new software platform has also created some threatening problems that we are encountering today.

Over the past year the eIRB (or "eIRB-1" for purposes of this document) has become increasingly unstable; this is due in large part to the antiquated data architecture and increasing database size. These two core problems can also be attributed to memory issues, slow processing speed, complex, costly and time consuming software updates, and our inability to take advantage of various technologies that are available in the product today. Unfortunately, the internal system affects eventually trickle down to the users of the system who are forced to spend a great deal of time trying to work through the system but are met with nagging error messages and sluggish performance when trying to complete, what appear to be, very simple tasks. The current strategy used to address improvements to the data architecture, archiving unwanted data, and user experience in the current eIRB has been insufficient in our ability to make any marked improvements to the core problems mentioned above.

In order to alleviate the instability and improve eIRB's overall performance, The Office of Human Subjects Research (OHSR) and the Office of Research Environment System (RES) are in the process of proposing a new project to completely build eIRB from the ground up. The "new" eIRB (or "eIRB-2" for purposes of this document) will be designed using data architecture best practices and will be built on the latest Huron/Click software platform. This fresh approach will allow SOM to take advantage of the many new and exciting features we have not been able to implement thus far. Moreover, the new data architecture will allow us avoid encountering the same problems we are experiencing now with the original implementation including our ability to archive data that we longer need to access in the live system.

This project is in the very early stages and must still be approved both conceptually and fiscally. Over the next several months, OHSR and RES staff will be working together to plan the move to eIRB-2, which is tentatively scheduled to go live in early 2013. In the mean time, it is important that eIRB-1 is not changed or revised in any way so that RES can analyze, document, and design the new system. Great care with be taken to ensure that the move to eIRB-2 will have a limited affect on the current users of the system.