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.
Before accessing the system, complete these steps to ensure you are eligible and ready to submit.
Before you begin, use the resources below to determine if your project meets the federal definitions of both “research” and “human subjects.”
All study team members must complete an online training course in the protection of human subjects through the CITI program. Principal Investigators are responsible for ensuring their team’s training is current.
Key requirements:
Renewal: Training must be renewed every 3 years.
GCP: “Good Clinical Practice” training is also required for clinical trials or FDA-regulated research.
Compliance: Individuals with expired CITI training are prohibited from conducting any human subjects research, including data analysis.
Resources:
Non-exempt, cooperative research with other institutions may require use of a single IRB (sIRB). This section explains the policies and steps for “relying on” an external IRB or having Penn State “serve as” the reviewing IRB. You can also reach out to your IRB Analyst for more information.
Certain studies are required by sponsors, such as NIH, to have a data management and sharing plan.
Before you can create a new study, you must prepare all your study documents. This involves downloading the correct templates, completing the protocol template, and gathering all supporting materials.
The protocol is the central piece of your IRB application. These resources provide the required templates and guidance on how to write a clear, complete, and ethical study plan.
In addition to your protocol, your submission will likely require other materials, such as consent documents, recruitment flyers, survey instruments, or site permission letters.
If conducting a clinical trial, the Principal Investigator is responsible for complying with ClinicalTrials.gov registration and reporting requirements.
Once your protocol is complete and you have assembled all the accompanying documents, you are ready to complete the online submission. This involves logging into CATS IRB, completing the online form, uploading your documents, and executing the final submission. Read carefully as you complete the online form: your submission is not finalized until you click the Submit button!
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).
This section explains what happens after you click "Submit." Learn how the IRB reviews your application, what the different review levels mean, and how to respond to IRB requests for clarification or modifications.
After you click “Submit,” your application begins a multi-step review process. An IRB Analyst will assign your study a review level, which determines the path it takes. These resources explain the potential paths, outcomes, and what to expect in terms of timing.
It is common for the IRB to request changes or clarifications before approving a study. This is a normal part of the collaborative review process. Use these guides to find reviewer comments and submit your response in the CATS IRB system.
Your responsibilities do not end at approval. Use these resources to modify your protocol, renew your study, or report issues.
If you need to change any aspect of your approved study—such as procedures, study team members, or documents—you must submit a Modification for IRB review and approval before implementing the change. Note: studies reviewed at the Exempt level are only required to submit modifications in certain circumstances; see the Investigator Manual for details.
Your study may require the completion of a Continuing review if it’s reviewed at the Expedited or Full Board level. The study approval letter will indicate whether periodic review is required, and you will receive notices from the system. NOTE: Studies determined to be Exempt do not have a Continuing Review requirement.
You must promptly report certain problems, events, or new information to the IRB. This is known as Reportable New Information (RNI) and is critical for ensuring participant safety and data integrity. Use these resources to understand what to report and how to submit it.
Studies may be selected for routine post-approval reviews (audits) to ensure compliance and provide study team educational support. These reviews can be proactive or for cause. Use the links below to learn how to prepare for a review and to understand the difference between “Routine” (not-for-cause) and “Directed” (for-cause) audits.
There are four milestones that must be met to close a study: the study must be closed to enrollment, study interventions with participants are complete, no identifiable information is being collected, and the analysis of identifiable information has concluded. Once these milestones are met, you must formally close your study with the IRB. Graduate student PIs should close their studies prior to graduation.
Refer to these guidelines if your study involves international research, student subjects, chart reviews, or other unique methods.
Browse polices, guidelines, and SOPs, or connect directly with an IRB analyst. You can also submit feedback on the Learning Path or report broken links.
Use this form to report broken links, typos, or outdated information. You can also make suggestions! Tell us what new checklists, job aids, or topics you would like to see added.
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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.