Welcome to the IRB Learning Path. This page is your step-by-step guide to the human subjects research process, from initial submission to study closure. Each section contains the specific resources you need for that stage of your project.
Use the resources below for a foundational overview of the Human Research Protection Program (HRPP) and the IRB’s role at Penn State.
Getting Started with the Human Research Protection Program (Video · 3m 23s)
A quick orientation on the HRPP office and the IRB’s role at Penn State.
Meeting schedules, committee rosters, fee schedules, and FWA/IORG compliance numbers.
IRB Basic Steps: Is it Human Subjects Research? (Webpage)
Determine if your project meets the federal definitions of “research” and “human subjects.
Student Submission Guide (Webpage)
Information specific to student/trainee investigators and their advisors.
Contact Your IRB Analyst (Webpage)
Still unsure? Schedule a meeting with your assigned Analyst (assigned by PI last name).
Log in and complete required training. CATS IRB accounts are created within 24–48 hours of completion.
Interactive tool to identify which courses are required for your role and study type.
Locating Completed IRB Training Records (Word Doc)
Step-by-step guide to verify training records of study team members in CATS IRB.
Key requirements: Training must be renewed every 3 years. GCP training is also required for clinical trials or FDA-regulated research. Individuals with expired CITI training are prohibited from conducting human subjects research, including data analysis.
Single IRBs and IRB Authorization Agreements (Webpage)
Policies and the 5-step “Request to Rely” and 4-step “Request to Serve” processes.
Understanding Single IRB Review (Video · 8m 05s)
Single IRB of Record for Multi-Site Studies (Video · 6m 32s)
The single most comprehensive guide to the entire IRB process. Use as your primary reference.
Who Can Serve as a Principal Investigator? (Webpage)
Scientific Review Requirements (Webpage)
Required for College of Medicine researchers conducting clinical trials or greater-than-minimal-risk studies.
Data Management and Human Subjects Research (Webpage)
Guidance for drafting a data management plan and using a data repository (required by sponsors such as NIH).
Penn State policy for how long to keep research records (e.g., 3+ years) and tips for confidential storage.
Live Session: Getting Started with the IRB (via Zoom)
Get a high-level overview of working with the IRB at Penn State, including the IRB structure and how to prepare and submit materials via CATS IRB.
Lacking Definite Plans (Word Document)
If you have a grant that requires an IRB letter before your human subjects research plans are finalized, you must complete this special “Lacking Definite Plans” submission. Use this step-by-step guide for submitting your grant application in CATS IRB to obtain a “lacking definite plans” letter for your funding agency.
CATS IRB Library of Protocol Templates (Link)
Access the official Penn State protocol templates. You must download and use the most current versions from this library.
Live Session: IRB Protocol Training (via Zoom)
This live session provides step-by-step guidance on how to write the content for your protocol. (Note: This class does not cover navigating the CATS system.)
For specific kinds of research, such as physical activity and chart reviews.
Job Aid for Researchers – Initial Industry-Sponsored Studies (Word Document)
All research requires consent; learn about the different types of consent, tips, and which templates to use.
Consent: Key Information (Webpage)
Guidelines for drafting the ‘Key Information’ section, detailing when it is mandatory and how to align with federal regulations.
Recruit Participants (Webpage)
Guidelines for preparing recruitment materials (flyers, scripts, emails) and information on using the StudyFinder tool.
Step 3: How to Submit (Webpage)
Refer to the “Components of an IRB Submission” section to verify that you have all required documents before you start your online submission.
Quality Assurance program (Webpage)
Provides support for investigators at University Park and the Commonwealth Campuses.
Research Quality Assurance (Webpage)
Assists investigators at the College of Medicine (requires Penn State login).
Access the system with your Penn State email address and password. College of Medicine and Penn State Health users: review the instructions for logging in to Penn State systems.
Create and Submit a Study to the IRB (Webpage with screenshots)
Step-by-step walkthrough of the entire submission process, from upload to hitting “Submit.”
Breakdown of the Submission Form sections, including Basic Information, Protocol uploads, Funding Sources, and Local Site Documents.
CATS IRB Researcher’s Navigation and Tips (Webpage)
Helpful tips for navigating CATS, including how to find templates, avoid common review delays, and respond to clarification requests.
Assign/Change Primary Contact or PI (Webpage)
How PIs can assign a team member to take action on their behalf (PI Proxy) or receive all study-related communications (Primary Contact).
Confirm Study was Submitted (Webpage)
How to visually verify that your study has successfully moved to “Pre-Review.”
Withdraw a Submission (Webpage)
Returns your study to “Pre-Submission” status. Use this to stop the review process so you can make edits and resubmit later.
Discard a Submission (Webpage)
Archives a study you no longer intend to pursue. Warning: This action cannot be undone. (Note: Do not use this to cancel a Modification).
Ancillary Review Guide (Webpage)
Your study may also require approval from other compliance offices (like IACUC for animals or COI). This guide explains this process and how it can affect your IRB approval timeline.
IRB Basic Step 4: After You Submit (Webpage)
Current timelines for initial review times and actionable tips to decrease your “time to approval.”
Respond to a Clarification Request (Video, 2m 54s)
Respond to Requests (Modifications or Clarifications) (Webpage)
Step-by-step (with screenshots) guide on how to navigate CATS to submit your revisions for both Clarification Requests and Modification Requests.
IRB requests for changes are a normal part of the collaborative review process, not a cause for concern.
Submit a Modification (Webpage)
Modifications to Study Team Members (Webpage)
A specific guide for making changes to your study team, such as adding/removing members or changing the Principal Investigator (PI).
Discard a Modification (Webpage)
Use this guide if you have started a modification in CATS but no longer wish to submit it. Warning: This action cannot be undone.
Change Contact Information (Webpage)
A guide for changing your contact information in the CATS system.
Create and Submit a Continuing Review (Webpage)
This step-by-step guide (with video) shows how to complete and submit your annual Continuing Review to prevent your study from lapsing.
Consult to learn more about your ongoing responsibilities.
Reportable New Information (Webpage)
Definitions of what must be reported (e.g., protocol deviations, confidentiality breaches) and how to submit the RNI form in CATS.
Research Quality Assurance – College of Medicine and Penn State Health (Webpage)
Post-IRB Approval Reviews – University Park & Commonwealth Campuses (Webpage)
Proactive Audits for Continued Training (PACTs) (Webpage)
An educational review for researchers newer to the IRB process. A PACT is a great way to get feedback on your procedures before you enroll participants.
Submit a Study Closure (Webpage)
A step-by-step guide on how to officially close your study in CATS IRB. Note: This action is completed using the “Continuing Review” form.
Checklist for Departing Researchers (Webpage)
See this checklist for guidance for researchers leaving the University.
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
When to Use Short Form Consent: Unexpected Limited English Proficiency
This is the comprehensive guide for all IRB policies and procedures.
IRB Policies and Guidelines (Webpage)
A central page linking to University and federal IRB policies.
Standard Operating Procedures (CATS Library)
A library of all official SOPs for the IRB.
HRPP Artificial Intelligence (AI) Resources (Webpage)
This webpage offers curated guidance and reference materials to assist researchers in navigating the responsible use of artificial intelligence (AI) in human subjects research.
Contact Your IRB Analyst (Webpage)
The best place to start for specific questions. Analysts are assigned by Principal Investigator (PI) last name, and you can schedule a meeting via Bookings.
Submit Website Feedback (Microsoft Form)
Use this form to report broken links, typos, or outdated information. You can also make suggestions for new checklists, job aids, or topics.
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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.