Frequently Asked Questions (FAQ)

In addition to the questions below, the Investigators Manual (in CATS-IRB Library, General Tab) provides an extensive list of answers to questions about the requirements for conducting research at Penn State.

Does the IRB need to look at this project?

The institution relies on the IRB to make this assessment due to the complexity of the rules. Call the Human Subjects Protection Office (HSPO) at 717-531-5687 to consult with an IRB analyst. The OHRP Human Subject Protections Decision Charts may help you prepare for questions that will need to be addressed to make this determination.

What is the definition of Human Research?

See the IRB SOP HRP-001 Definitions, available in the CATS IRB Library under Standard Operating Procedures, which defines Human Research and provides other definitions followed by the human research protection program.

What is the schedule for submissions to the IRB?

Incoming submissions to the IRB are addressed in the order received. New research submissions undergo pre-review for completeness and, once ready for IRB review, are assigned to a reviewer or the next available meeting agenda, as applicable. Other submissions are reviewed in the order received, unless the submission involves an urgent issue that may affect participant safety. See the IRB Schedule for the meeting dates.

Are there fees for regulatory compliance review?

A regulatory compliance fee is accessed to support the activities of the Human Subjects Protection Office, the Office of Research Affairs, the Clinical Trials Office and other research support functions. The fee is based on the type of IRB Review required (e.g. convened committee or noncommittee review, continuing review, amendment, etc.). For more information, call Michele Stanton in the Clinical Trials Office at 717-531-3779.