Human Subjects Electronic Research Application (HS-ERA)

The Human Subjects Electronic Research Application (HS-ERA) is a secure, web-based application that allows the creation, submission, electronic routing, and approval of Human Subject Protocols to the Institutional Review Boards (IRB), including the ability to submit Continuing Reviews, Unanticipated Problems, and Modifications to an existing Human Subjects Protocol created within the HS-ERA system. Also included is the ability to report Unanticipated Problems for protocols that were submitted on paper. HS-ERA includes electronic notifications to internal review entities and the ability for the IRB member to review protocols.

HS-ERA can be used by members of the research community involved in Human Subjects Protocol creation, submission, routing, or approval, including members of the Institutional Review Boards (IRB), the Office of Human Research (OHR), and ITMAT's Clinical and Translational Research Center (CTRC).

In addition, the following other internal review entities with appropriate access may also use this application to view a protocol:

• OEHRS (all radiation exposure questions)
• IDS (only when appropriate)
• Gene Transfer
• CACTIS (CT only)
• CAMRIS (MRI only)
• Investigational agent or device in the OR
• CTSRMC (cancer patients)
• COI (Conflict of Interest)
• Specimen Processing by Pathology
• Analysis of Biological Fluids
• Research Involves Apheresis or Cell Collection
• CTRC
• ORS