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Office of Research and Innovation
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IRB Application Process

Protocol Application Process- Getting Started With a New or Existing Protocol

Welcome to the IRB Guidance page

This page is designed to help researchers navigate the Institutional Review Board (IRB) process for research involving human participants. Whether you're a student, faculty member, staff researcher or external collaborator, understanding your responsibilities is key to conducting ethical and complaint research.

Step 0: Does your study require IRB review?

Take the IRB Determination Survey
If your project does require IRB review, follow the 5 steps to IRB Success outlined below.

IRB Approval Process

4 Post-Review(IRB Analyst) 3 IRB Member(s)Review 2 Pre-Review(IRB Analyst) Initial ProtocolSubmission 1 return to PI for revisions

Pre-Review Stage

IRB Review Stage

Expedited Review

  • 1-2 IRB reviewers
  • No more than minimal risk to participants
  • Duration 2-3 weeks after Pre-Review
  • OHRP categories 

Full-Board Review

  • Convened IRB board reviewers
  • More than minimal risk to participants
  • Duration months after Pre-Review

Exempt Determination

  • IRB analyst or 1 IRB member reviewer
  • Less than minimal risk to participants
  • Duration 1-2 weeks after Pre-Review
  • OHRP Categories 

5 Steps to IRB Success

Please note that holidays and the summer break may result in extended review timelines due to limited reviewer availability. We appreciate your understanding and encourage you to plan ahead when submitting time‑sensitive studies.

 

STEP 1: Complete CITI training
Please see our Human Subjects Research CITI training page to determine what trainings you need to complete before engaging in human subjects research.

STEP 2: Request authentication

If this is your first time submitting an IRB protocol in Cayuse please email the following information (listed below) to irb-office@cpp.edu to be added into the system, additionally send a screenshot of your error message ( when attempting to log in https://cpp.cayuse424.com error message will read "We're sorry. This account has been disabled on the Cayuse424 system"):

  • Highest degree attained (Ph.D., MS, MA, BS, BA, associates, high school, etc., as appropriate)
  • First and last name
  • Bronco ID (the nine-digit number, which will eventually be used to link with CITI training data)
  • Bronco email (e.g., billybronco@cpp.edu)
  • Status (faculty, staff, student, unaffiliated, etc., as appropriate)
  • CPP College and Department
Authentication request are processed within 48-72 hours after emailing our office.

STEP 3: Train yourself to use Cayuse IRB

STEP 4: To submit an IRB protocol

Enter the Cayuse IRB site using your Bronco Credentials (from #2 above) and start a "new study".

  • For the Cayuse IRB site to start or continue with an existing protocol, use the Cayuse IRB site.

STEP 5: IRB protocol upkeep

To revise, modify, renew, report an adverse event, or close your IRB protocol, follow as below:

submissions navigation

Revise: Submitted protocols are commonly returned to PIs with IRB comments; refer to the presentation on navigating revisions (PPT).
Modification: After IRB approval, any changes to the approved protocol require submission of a Modification. Please review this presentation to learn how to submit a modification in Cayuse IRB.
Renew: PIs are notified as a protocol approaches expiration. To renew approval for another year, a Renewal Submission must be submitted prior to the expiration date.
Adverse Event (Incident): Research does not always go as planned, and adverse events or unanticipated problems may occur. Adverse events must be reported to the IRB within 48 hours through the Cayuse system.
Closure: A Closure Submission is required when data collection for the study is complete.

Review key regulatory definitions: research, human subject, interaction, intervention, identifiable private information, identifiable biospecimens, minimal risk, and other regulatory definitions.

FAQs

Research and recruitment may begin only after the IRB has reviewed and approved the protocol and issued an approval letter.

 

In accordance with federal regulations, most IRB approvals issued under the revised Common Rule do not expire and continuing review is generally not required unless specified by the IRB. Approval remains in effect as long as the study is ongoing, compliant, and no changes are made without IRB approval. Investigators must still submit modifications, report problems, and close the study when all research activities are complete.

 

Protocols with an expiration date may be approved for a period of up to one year before renewal is required. Approved protocols must be renewed one to two months prior to expiration if ongoing interaction with research participants is anticipated. Choose the renewal option within Cayuse IRB. 

Visit the IRB's Resources page for CPP’s informed consent form templates, and refer to the U.S. Health and Human Services Informed Consent Form Checklist for additional guidance.

 

Should there be any changes to your research plan as described in the approved protocol, you will need to submit a modification.

Examples of changes include, but are not limited to:

  • A change of study design, methodology, or recruitment methods
  • Changes to any data collection documents, including surveys and questionnaires
  • Changes to consent documents
  • Changes to the population proposed in the approved protocol
  • Changes in funding
  • Addition/Deletion of investigators (PIs), co-PIs, and research assistants
  • Change of Project Title
  • Addition/Deletion of research performance sites 

At any time prior to the expiration date, the principal investigator (PI) may request closure of the protocol if research activities including data collection has stopped and only analysis of the data are taking place. The PI may close the study, by submitting a " + new submission"  within Cayuse IRB and choose the closure option as seen below. 

No. Once a protocol's approval has expired, all human subjects research activities must stop immediately in accordance with federal regulations. This means you may no longer recruit participants, obtain consent, interact with participants, or collect data. However, you may continue analyzing data that was collected before the expiration date, since participant involvement has ended.

If your protocol has expired, it cannot be renewed. To continue conducting human subjects research, you must submit a new IRB protocol, which will be assigned a new protocol number and undergo full IRB review. All required study documents must be resubmitted with the new application.

As a courtesy, the Cayuse IRB system sends renewal reminders before a protocol's expiration date. Investigators are responsible for submitting renewal materials before expiration if they wish to continue their research without interruption. If you have questions about your options, please contact the IRB Office.

Please contact the IRB office to informed them of the completion of your project involving interaction with human subjects. You may also want to contact the funder of your study and provide them an update of the study as some funders need to be informed. If you wish to close the study then you can use the " + new submission" button and choose the closure , where you may also add a summary of the withdrawal/closure.

Per federal regulation, it is the PI's responsibility to report adverse events of any kind to the IRB. Reporting adverse events promptly will enable the IRB and university research community to respond appropriately, to help the researchers continue their work, and to protect human subjects in research investigations from avoidable harms. 

To submit an adverse event report through Cayuse.  Use the "+ new submission" button and choose the option "Incident". 

Please refer to Adverse Event Reporting Page for more details.

research-compliance/IRB/adverse-event_new#Adverse Event Reporting Page

Yes. All human subjects research must be submitted to the Cal Poly Pomona IRB for review before any research activities begin, even if you believe the study qualifies for an exemption. Only the IRB can make an official exemption determination.

If you are collaborating with another institution and the lead investigator submits a protocol to their institution's IRB, you must still submit a protocol to the Cal Poly Pomona IRB to ensure compliance with university requirements.

Requirements for multi-institutional research depend on the nature of the collaboration and whether an IRB reliance agreement is needed. Please contact the IRB Office at IRB-Office@cpp.edu for guidance on the requirements applicable to your study and to determine whether a Cal Poly Pomona IRB submission and/or a reliance agreement is required.

You can test the consent form by inserting only the text of the document into a readability calculator, like Hemingway App (https://www.hemingwayapp.com)