All study team members must complete an online training course in the protection of human subjects through the CITI program. Researchers choose between the biomedical training and the social science training. Either fulfills the human subjects requirement. Penn State requires initial and continuing (every 3 years) education in the protection of human research participants for individuals involved in the conduct or oversight of human participant research.

Researchers working on a clinical trial or FDA-regulated research must also complete Good Clinical Practice (GCP) training. Choose between the drugs/device (U.S. FDA focused) GCP training and the social/behavioral research GCP training. Select the course most appropriate to your research, but please note that researchers conducting protocols involving a drug or device must choose the FDA option if affiliated with Penn State University (not Hershey) in CITI.

For new studies and study modifications, CITI training must be complete for all study team members before it can be approved. It is the principal investigator’s responsibility to ensure all study team members listed on the IRB submission have current Human Subjects Research training, and Good Clinical Practice training when applicable, in order to continue working on the study. Individuals with expired CITI training are prohibited from conducting any human subjects research, including data analysis.

See the instructions on how to register in a course and navigate the CITI system or go directly to CITI to complete required training (be sure to choose the correct log-in location).  

• Investigator Manual
• Multi or Collaborative Site Information
• CATS IRB Navigation Tips
• Recruit Participants
• Research Records
• IRB Basic Steps
• The Revised Common Rule 
• Scientific Review Requirements
• Lacking Definite Plans
• Data Management and Human Subjects Research

New Study

• IRB Submission Form
• Create and Submit a Study
• Ancillary Review Guide
• Student Submission Guide
• Consent
• Consent: Key Information Section

Modifications, Clarifications, and Reportable New Info

• Submit a Modification
• Modifications to Study Team Members
• Assign/Change Primary Contact or PI Proxy
• Change Contact Information
• Respond to Requests
• Discard a Modification
• Reportable New Information

Reviews

• Continuing Review

Ending a Submission

• Withdraw a Submission
• Discard a Submission
• Submit a Study Closure

Optional Zoom trainings are intended to help researchers prepare to submit their studies to the IRB.  We also offer more in-depth training on specific topics, such as CATS IRB submission and completing the protocol.  Please note: If a training offers SARI credit, it will be noted in the training description in the sign-up form.  Please see Events below for available options.  Trainings are applicable to researchers across the University, including Penn State Health and the College of Medicine.

• Single IRB Review
• IRB Introductory Video
• IRB Submission Basics
• IRB Protocol Training (VoiceThread option, self-paced)
• IRB Protocol Training (video option)
• Institutional Engagement in Human Subject Research
• RNI: What Needs to Reported and When (2022)

• IRB Researcher's Guide
• IRB Multi-Site Study Guide
• Job Aid for Researchers - External IRB Submissions
• Job Aid for Researchers - Request to Serve (R2S) IRB Submissions
• Job Aid for Researchers - Initial Industry-Sponsored Studies
• CATS IRB Training Look-up Instructions
  A report is available that allows users in the system to look up other users in order to determine which IRB training courses they have completed. Includes instructions, special notes and troubleshooting tips.

• IRB Guideline I – Parental Consent and Child Assent 
• IRB Guideline II – International Research Involving Human Participants 
• IRB Guideline V – Research Using Penn State Students as Participants 
• IRB Guideline X – Guidelines for Computer- and Internet-Based Research Involving Human Participants 
• GUIDANCE: Photographs, Video and Audio Recordings
• GUIDANCE: Chart Review
• Data Management and Human Subjects Research
• ORP Guideline: Eligibility to Serve as a Principal Investigator