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- Human Research Protection Program (HRPP) Home Page
- About the IRB
- CATS IRB
- Clinical Trials
- COVID-19: Human Subjects
- Expanded Access Submissions
- Find Your IRB Analyst
- HRPP Advisory Committees
- HRPP Quarterly Webinars
- Information for Participants
- IRB Basic Steps
- IRB Learning Path
- IRB Resources, Training, and Events
- IRB Policies and Guidelines
- Single IRBs and IRB Authorization Agreements
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IRB Resources, Training, and Events
For all Colleges and Locations
We have streamlined the training materials listed below into a new, easy-to-navigate format. Check out the IRB Learning Path to view these resources in a more organized way.
Required IRB Training in CITI
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.
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).
Optional Trainings
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.
CATS IRB Help Center Guides
- Investigator Manuals
- IRB Researcher’s 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 (information on how to use a system report to determine which IRB training courses they have completed)
CATS IRB and Submission Resources
Basics
- 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
- Short Form Consent
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
- Research Locations
Reviews
Ending a Submission
IRB Guidelines
- 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: Physical Activity and Exercise
- GUIDANCE: Chart Review
- GUIDANCE: Education Research
- GUIDANCE: Screening
- Data Management and Human Subjects Research
- ORP Guideline: Eligibility to Serve as a Principal Investigator
For Reviewers
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Office for Research Protections
Address
200 Innovation Blvd.
Suite 110
University Park, PA 16802
The Office for Research Protections (ORP) ensures that research at the University is conducted in accordance with federal, state, and local regulations and guidelines that protect human participants, animals, students, and personnel involved with research.