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Frequently Used Services
The Human Subjects Electronic Research Application (HS-ERA) is the IRB online submission system and e-application. Submission to the Penn IRB requires regular utilization of this website in conjunction with using HSERA.
How to Submit
This section describes the logistics and requirements for each type of IRB submission. Review instructions and associated guidance prior to creating your submission in HSERA.
Single IRB Requests to Rely
Click for guidance on how to ask Penn to rely on an external IRB or serve as the single IRB of Record (sIRB).
Treatment Use with an Investigational Agent
When a patient has a serious or life-threatening condition that is not addressed by current approved treatments, options may exist to use an investigational drug or device to treat. The use of an investigational product outside of a clinical trial for treatment of a patient is called “expanded access.” Click below for detailed submission guidance.
Frequently Asked Questions
Click below for FAQs about HSERA, IRB review & submission requirements, required CITI training, and more!
Click below for information about training required to conduct human subjects research at Penn as well as curated educational sessions offered by the Penn IRB to guide members of the research community with their submissions and the conduct of human subjects research.