Step 2: Before You Submit

Effective March 15, 2020: Revised standards for Human Subjects-Related Research Visits during COVID-19

In the context of rapidly evolving circumstances regarding COVID-19, and the University’s focus on social distancing and the health and well-being of the community, the Office of the Senior Vice President for Research, in consultation with Vice Dean for Research and Graduate Studies in the College of Medicine, has issued these revised standards related to human subjects-related research visits.  In summary, research visits should be performed remotely (e.g., by phone or Zoom) whenever possible.  Studies involving face-to-face interaction with participants with no direct drug or device therapeutic benefit are to be postponed until further notice. See the Penn State COVID-19 webpage for University updates.

The IRB program is operating remotely but at full capacity. 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. 

Contact the Human Subjects Protection Office to learn about additional training requirements at the College of Medicine.

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: 

  • (Penn State locations with the exception of College of Medicine and Penn State Health)
  • (the College of Medicine and Penn State Health)

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. Contact the Human Subjects Protection Office to learn about additional trainings provided at the College of Medicine and Penn State Health.

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.