Initial Submission

All initial submissions of new human subjects’ research are required to be submitted to the IRB using the IRB’s electronic submission system, the Human Subjects Research Electronic Application (HSERA).

Is IRB Review Required?

Is IRB Review Required?

Only activities meeting the regulatory definitions of research with human subjects requires review by the IRB. Click for guidance on whether your project meets the requirements for submission.

Quality / Performance Improvement (QI/PI) Guidance

There is often confusion as to whether a Quality / Performance Improvement project may meet the criteria for human subjects’ research. While many QI/PI efforts do not require IRB review, some do. Click for guidance.

IRB Review for Federal or State Grants

Review this guidance if your proposal received an impact score through the Just-in-time (JIT) process and you need an Approval in Concept determination, or you need a Delayed Onset determination to conduct preliminary or conceptual work.

Initial Submission Guidance

Levels of IRB Review

There are three levels of IRB review: exempt, expedited, and convened. Institutional policy requires IRB review of all human subjects’ research that falls into an exempt or expedited review category. Human subjects’ research not falling into one of these categories requires convened board review. Click for detailed guidance on levels of IRB review.

Submission Completion Guidance

Ensuring a complete submission package is crucial to a smooth IRB review process. Click for guidance and tips on how to ensure that your submission package including criteria for IRB approval, document submission requirements, and more.

Other Penn Reviewing Entities

In addition to IRB review, submission to other Penn entities may be required to before your study can commence. The Human Research Protections Navigation Tool is designed to help researchers find out what other reviews may be needed.

2018 Common Rule

The Common Rule was updated in 2018 and the revisions were effective in January 2019. Click for detailed guidance on what has changed.

Specialized Guidance Topics

Click for focused topics like applicable state laws, exclusion of pregnant women, individuals with HIV, how to screen for suicide ideation, and community based research.

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