Step 2: Before You Submit

Revised standards for Human Subjects-Related Research Visits during COVID-19

Before conducting in-person research with participants, please read The Revised Standards for Human Subjects Research.  In-person research may require additional review by the University COVID Safety Committee; this is separate from the IRB's review.  Questions?  Contact

Learn more on COVID-19 and human subjects research here.

Required Training

Penn State requires initial and continuing (every 3 years) education through the Collaborative Institutional Training Initiative (CITI) in the protection of human research participants for individuals conducting or overseeing human subjects research. A Penn State access account is needed to access CITI trainings

All CITI training requirements for relevant study personnel must be complete before approval can be granted for any CATS IRB submission. 

In some instances, researchers may be required to complete additional CITI training. For example, NIH-funded investigators and staff involved in the conduct, oversight, or management of clinical trials must be trained in Good Clinical Practice (GCP). This decision-making tool helps researcher to identify the required training for various research roles and study types. See here for more detailed information and instructions on CITI. 

Centralized Application Tracking System (CATS) IRB

CATS IRB is the web-based application system that Penn State researchers use to complete submissions for the use of human participants in research. For those with a Penn State access account, completed CITI training automatically grants access CATS IRB within 1 to 2 business days. To access CATS IRB without CITI training, contact: 

Navigating CATS IRB

To login to CATS IRB go to If you are new to Penn State, please note that you will not be able to access to CATS IRB until you have your Penn State access account. If you have a study that you are interested in transferring to Penn State, contact

Online and in-person training on human subjects research and the CATS IRB submission process is available. It is suggested that first-time users attend a training. 

CATS IRB Library and Help Center 

The CATS IRB Library is a series of documents investigators will need to use or reference to create materials for submission to the IRB. For links to training and guides, refer to the Help Center. Acess the Library and Help Center from the Sidebar menu on the left side of the CATS IRB homepage, pictured below.

Picture of My Inbox page in CATS IRB

Important CATS IRB Help Center resources include:

Before you begin your submission to the IRB,  review the Investigator Manual, which outlines the responsibilities of investigators and includes important guidance on topics such as how to write a study protocol and document informed consent as well as crucial information regarding when IRB review and approval or determination is required and what information needs to be reported to the IRB post-approval. Additional guidelines from the IRB program and Penn State policies can be viewed on the Policies and Guidelines page.

What's Next?

Continue to Step 3 for information about the materials needed to complete an IRB submission.