How to Submit
Submission to the Penn IRB requires regular utilization of this website in conjunction with using the Human Subjects Research Electronic Application (HSERA) system. This section describes the logistics and requirements for each type of IRB submission. Below select the type of application you need to submit and review the instructions prior to creating your submission in HSERA.
Types of IRB Submissions
The How to Submit pages contain guidance, instructions, and requirements for each type of IRB submission. Review these pages prior to creating your submission in HSERA to facilitate IRB review and avoid your submission being returned for changes.
Initial Submission
Initiating new research? Unsure if IRB review is required? Click here for guidance and instructions for new projects.
Treatment Use with an Investigational Agent
Click for guidance and instructions on submitting a Treatment Use request to the IRB and FDA to treat a patient with an investigational drug or device outside of a clinical trial.
Humanitarian Use Devices
Click for IRB submission guidance on submitting a request to treat a patient who has an Orphan Disease with a Humanitarian Use Device (HUD).
Ongoing Reviews
Modifications
Click for guidance and instructions on amending or modifying approved research. No changes may be made to an approved research plan without obtaining the IRB’s approval, unless there is a need to eliminate an immediate hazard facing the subject.
Continuing Review
Some research requires annual continuing review and some does not. Click for guidance on when continuing review is required as well as instructions and guidance on renewing your approved research for another year.
Deviations
A deviation is an unintentional action that departs from the IRB approved research protocol, regulations, or institutional policy, and is identified retrospectively (after the event occurred). Click for instructions and guidance on how to submit a deviation.
Exception Requests
An exception request is a prospective, one time, intentional action or process that departs from the IRB approved study protocol. Click for instructions and guidance on how to submit a prospective deviation from the research protocol.
Reportable Events
A reportable event is an adverse event or incident that has the potential to be classified by the IRB as an unanticipated problem posing risks to participants or others. Click for instructions and guidance on how to submit these events to the IRB.
Closure
Click for instructions and guidance on how to formally close a research study with the IRB.
Single IRB
It is now common practice for multi-site research studies to seek ethical review and approval of the proposed research by a single IRB.
Penn as a Relying Site
If you’re looking for information on how to ask Penn to rely on an external IRB, please click below for How to Request a Reliance Agreement.
Request for Penn to Serve as sIRB
Guidance is provided on when Penn is willing to serve as the single IRB of Record (sIRB), how to make an sIRB request, associated fees, creating consent templates for relying sites, and more.