Biomedical Research

Biomedical Research Homepage

Biomedical Research Homepage

Biomedical research is a broad area of science seeking to prevent and treat diseases that cause illness and death. Biomedical research ranges from research on human specimens and medical record data to clinical trials. This section of the website contains curated IRB related content for biomedical researchers.

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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.



Click below to review our library of general and biomedical research guidance.


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