Institutional Review Board for Human Subject Research

Turnaround times can fluctuate throughout the year, and protocols are reviewed on a rolling basis in the order they are received. Studies involving greater complexity or higher levels of risk typically require additional review time. Please plan ahead to allow adequate time for the submission, review, and approval of your study. Contact our team at irb@tarleton.edu if there is a federal regulation timeline to meet.

Incomplete submissions or protocols lacking sufficient detail will be returned to the Principal Investigator (PI), which will delay the review and approval process. To help avoid delays, please ensure your study documents are complete and ready for review.

Announcement

Effective March 1, 2026, all IRB protocol submissions must be submitted through the Cayuse platform. 

Please note that IRBNet will be fully discontinued on May 1, 2026.

As part of our broader transition, all human subject research study submissions are now migrating to Cayuse, moving these activities out of legacy systems and into a single, integrated environment. This change strengthens the submission and review process by standardizing required information, improving communication between researchers and reviewers, and offering clearer visibility into each study’s progress from initial submission through final approval.

Below is the link to the Cayuse platform sign‑in, along with training documents and resources to help you get started and navigate the new system effectively.

If you have questions or need assistance, please write to us at irb@tarleton.edu

Accessing Cayuse:

• To access Cayuse, use – https://tarleton.app.cayuse.com/
• Sign in using your Tarleton‑issued username and password.
• Use the Tarleton Cayuse User Manual
• Tarleton IRB Cayuse Training Video
• Protocol Revision, how to respond to reviewer comments can be found here
• If you are a new researcher, consider watching a recent training video to help get you started. Researcher can gain access through the Cayuse Academy for enhance their knowledge.
• If you experience issues logging into Cayuse, please contact the IRB at irb@tarleton.edu and include your Email ID and Employee ID/Personnel Identifier
• For security and compliance reasons, all requests to add students to a Cayuse project must be submitted by the supervising faculty member using the subject line “Request to Add Students to Cayuse.” To streamline processing, please ensure the supervisor includes a complete list of all students who require access.
• If you are a new user, please allow up to three business days for your Cayuse account to be created.

Announcement

Please be advised that IRBNet will be discontinued on May 1st, 2026. As of March 1, 2026, all IRB protocol submissions have fully transitioned to Cayuse.

IRBNet is an online research compliance system used to manage the submission, review, and approval of human subject’s research protocols. It centralizes all study documents, forms, revisions, and communication, allowing investigators, IRB staff, and committee members to collaborate efficiently throughout the life of a project.

To access Cayuse, use – https://tarleton.app.cayuse.com/

Research projects that involve human subjects must be reviewed and approved by an Institutional Review Board (IRB). The IRB ensures that the rights, safety, and welfare of individuals participating in research are adequately protected. At Tarleton State University, the IRB is responsible for reviewing and overseeing all human subjects research conducted by TSU faculty, staff, and students.

A key first step for any investigator is determining whether a proposed project meets the federal definition of human subjects research. This determination guides whether IRB review is required and what level of review may apply.

Definitions

Research

• Research is defined as “a systematic investigation, including development, testing, and evaluation designed to develop or contribute to generalizable knowledge.” (45CFR46.102(l))
• “Generalizable knowledge” is information where the intended use of the research findings can be applied to populations or situations beyond that which was studied.
• The Belmont Report defines research as “an activity designed to test a hypothesis or answer a research question and permit conclusions to be drawn. Research is usually described in a formal protocol that sets forth an objective and a set of procedures to reach that objective.” (Belmont Report)

Human Subjects

Investigators are responsible for obtaining IRB approval before initiating any human subjects research that meets the federal definitions described above. The Office for Human Research Protections (OHRP) recommends that institutions ensure knowledgeable personnel—such as Research Integrity and Compliance (RIC) staff and IRB members—assist investigators in determining the appropriate status of their projects and confirming whether IRB review is required.

Investigators should err on the side of caution and submit a inquiry to the Office of Research Compliance. These determinations must be made by the Office of Research Compliance staff or the IRB Chair—not by individual investigators—to ensure consistency, accuracy, and adherence to regulatory standards.

Deadlines:

Material requiring full board review must be submitted on or before the first of the month to be reviewed at that month’s meeting. Tarleton State University IRB Full Board meetings are generally scheduled for the last week of the month, pending holidays and scheduling conflicts. Due to the Federal Quorum requirements, meeting dates and times are subject to change.

Plan Ahead

Investigators are strongly encouraged to submit materials well in advance of the deadline to allow sufficient time for questions or revisions prior to the scheduled board meeting. Submission deadlines apply only to protocols requiring Full Board Review. Deadlines do not apply to studies eligible for Exempt or Expedited review.

If you are unsure which review category your study may fall under, please contact irb@tarleton.edu. Review levels are ultimately determined at the discretion of the IRB reviewers, and it is often difficult to assign a category without a complete submission. Regulations also permit reviewers to elevate a study to a more rigorous review category when appropriate.

Review Categories

All TSU studies involving Human Subjects Research must receive IRB review and approval before any research activities begin. Definitions of “Human Subjects Research” can be found in 45 CFR 46.102.

Key points to remember:

• All approved studies must be closed after three years and resubmitted if continuation is desired.
• There are three categories of IRB review, listed from most to least rigorous:
  1. Full Board Review
  2. Expedited Review (available only when specific regulatory criteria are met)
  3. Exempt Review (available only when the study meets the exemption criteria)

In every case, IRB approval is required prior to initiating any human subjects research activities.

Claim for Exempt-Expedited- Limited Review 

Submission- Continuing Review 

IRB Adverse Event Report

Informed Consent Checklist

Informed Consent

Claim for Exempt, Expedited & Limited Review

Guidelines for a Cooperating Facilities Letter

Recruitment:

Research Participation (Sona)

SONA is a cloud-based participant pool management system. SONA is a resource for:

• Researchers to gain participation in their survey studies
• Researchers to gain sign-ups for their in-lab research studies
• Instructors to track participation in research studies as a requirement for courses or programs
• Students to participate in research studies

Questions?

Check out the SONA User Manual.

Login or Register Here

• Go to https://www.citiprogram.org
• Click “Register” (top right-hand corner of website)

• Under “Select Your Organization Affiliation” begin typing Tarleton State University.
• Click the checkbox “I AGREE to the Terms of Service and Privacy Policy for accessing CITI Program materials.”
• Click “Continue To Create Your CITI Program Username/Password”

Following are required IRB Training

1. Social and Behavioral Research (CITI – Basic or Refresher, as applicable) 
2. Responsible Conduct of Research (RCR) 

IRB Policies

15.99.01.T1 Use of Human Subjects in Research

15.99.01 Use of Human Subjects in Research

For Researchers

If you need assistance or additional information about IRB requirements, review processes, or submission guidance, please contact Office of Research Compliance at or irb@tarleton.edu Our team is available to help you navigate determinations, submissions, and compliance responsibilities.

For Research Participants

If you are currently participating in a research study, your first point of contact should be the research team conducting the study. They can answer questions about the study procedures, expectations, or your participation.

If you have questions about research in general, need information about your rights as a research participant, wish to report a concern or complaint, or are unable to reach the research team, you may contact the  Office at Research Compliance at 1225 N Hwy 281, Stephenville, TX 76401, Email: irb@tarleton.edu or Phone: 254-459-5563 or 254-576-6030