How to Submit
Submission to the Penn IRB requires regular utilization of this website in conjunction with using the Electronic IRB (eIRB) 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 eIRB.
General Submission Requirements
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For Greater Than Minimal Risk Research: All Greater Than Minimal Risk research must include a cover letter that has a complete list of documents being submitted for review as they should appear in your determination letter (document name, version #, date). The IRB will not add a document list to any determination letters for Minimal Risk or Exempt research unless specifically requested and provided by the study team.
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Supplemental Forms: Many forms such as the Continuing Review form, the Modification Form, the Closure Form, etc. used in the prior submission process have now been incorporated into Penn eIRB and therefore are not needed. Continuing Review submissions do have a new CR Supplemental Demographical Information Form. Please see the CR guidance for information. Certain forms have been updated and will still be required such as the Devices in Research form and the Drugs in Research form. Penn eIRB will prompt you to complete and upload those forms as needed.
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Paper Studies: All approved Paper Studies have been migrated into eIRB with basic information. Studies teams with paper protocols must complete the whole eIRB application. For more information see the Paper Protocol Guidance.
Initial 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 eIRB to facilitate IRB review and avoid your submission being returned for changes.
Initial Submissions
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).
Single IRB: Penn as the single IRB of Record
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.
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.
Ongoing Reviews
For studies that have already received IRB approval, the How to Submit pages contain guidance and requirements associated with these ongoing reviews.
Amendments
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.
NEW! Continuing Review and Amendments
The eIRB system allows for modifications to the protocol to be submitted concurrently with a Continuing Review (CR). If the Continuing Review requires convened board review, the modification will be reviewed with the CR at the convened board meeting. If the modification does not require convened board review, it is recommended that it is submitted separately from the CR.
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.