The Institutional Review Board (IRB) is charged with ensuring that research involving human subjects is conducted in a manner that is in compliance with federal, state, and local regulations. Any human subject research conducted at TAMUK must be reviewed and approved prior to initiation.

What is the IRB?

An IRB is an appropriately constituted group that has been formally designated to review and monitor research involving human subjects. An IRB has the authority to approve, require modifications (to secure approval), or disapprove research. This group serves an important role in the protection of the rights and welfare of human research subjects.

To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

The Institutional Review Board (IRB) is charged with ensuring that research involving human subjects is conducted in a manner that is in compliance with federal, state, and local regulations. Any human subject research conducted at TAMUK must be reviewed and approved prior to initiation.

Research and human subjects are defined as follows:  

• Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
• Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
• Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
• Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions. 

Human Subjects

Federal regulations Title 45 Part 46.102 (e)(1) define  Human Subject as a living individual about whom an investigator (whether professional or student) conducting research

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimen.

The regulations further define:

Intervention (45 CFR 46.102(e)(2)) includes both physical procedures by which information or biospecimens are gathered (e.g. venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes

Interaction (45 CFR46.102(e)(3)) includes communication or interpersonal contact between investigator and subject.

Private information (45 CFR46.102(e)(4)) includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g. medical record)

Identifiable private information (45 CFR 46.102(e)(5)) is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

Identifiable biospecimen (45 CFR46.102(e)(6)) is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

Research Roles and Responsibilities

As a Texas A&M University-Kingsville investigator or research staff working on a human subjects study, you are expected to follow the federal, state, and university policies regarding the protection of human subjects.

Broadly, investigators and research staff are responsible for:

• Minimizing risk to subjects and protecting subject rights and welfare
• Securing IRB and other departmental or institutional regulatory approvals in advance of the research
• Obtaining and documenting informed consent
• Disclosing conflicts of interest
• Complying with sponsor-specific requirements as applicable (e.g., NIH, DoD, FDA requirements) Completing applicable training for the protection of human research subjects

Do I need to Submit an IRB Application?

The easiest way to determine if you need an IRB is for the PI on the projects (students cannot be PIs) to click the link below and fill in the online form so our office can review what is being done and get a determination.  This review may require time for us to send it to the IRB Chair to confirm an answer, so please account for this in your project planning stage.

Prior to completing the form below, review the flowchart provided here.

"Do I need an IRB" Online Form Questionnaire

Where do I submit my IRB application?

Texas A&M University-Kingsville has partnered with Cayuse to streamline Research Administration processes.

Research Compliance requires Investigators to submit new studies using this online platform, to take advantage of real-time progress tracking and an easier review and revision process.

The LIVE Cayuse Human Ethics can be accessed in three ways:

• Log into JNET->Campus Resources->Quick Links->Cayuse.
  • It will take you straight to your landing page.
• Navigate to our designated TAMUK Cayuse Webpage for FAQs, login link and more information.
• Go directly to app.cayuse.com
  • You will log in with your ku/ka/kf email account and Email user password, as if logging into Microsoft Office 365 products.
• Quick Start Guide

Training is available. Contact TAMUK IRB to activate your access to the training sandbox for you and/or anyone you’d like to train and to set up any 1:1 Zoom meetings to walk through the process.

TAMUK Key Information

Texas A&M University-Kingsville has an approved Federalwide Assurance (FWA) with the U.S. Department of Health & Human Services (HHS) and is also registered with the HHS Office for Human Research Protections (OHRP). The IRB review and approve research in accordance with Department of Health and Human Services (DHHS) regulations at  45 CFR 46, FDA regulations  21 CFR Parts 50 and 56, and International Conference on Harmonization (ICH) E6, Good Clinical Practice (GCP), as applicable.

The Institutional Review Board Organization (IORG) number is a unique number assigned by the Office for Human Research Protections (OHRP) to an institution or organization the first time they register an IRB. An IRB must be registered before it can be designated under an OHRP-approved FWA.

• IORG’s can register multiple IRBs under their institutional organization number.

Federal Wide Assurance number (FWA) is the documentation of an institution's commitment to comply with Federal regulations and maintain policies and procedures for the protection of human participants. An institution must have an FWA to receive Department of Health & Human Services (DHHS) support for research involving human subjects. This is the principal mechanism for compliance oversight by the  Office for Human Research Protections.

 

TAMUK: (IORG and FWA numbers)
IORG: IORG0001234  Expires: 04/11/2027	FWA #: FWA00001427 Expires: 10/28/2026

IRB Contact Information

Email:  tamuk.irb@tamuk.edu

Phone #1: 361-593-2677

Phone #2: 361-593-4764 

IRB Members

Lori Kupczynski, Ed.D.	Chair	Daniella Varela, Ed.D.	Scientist
Randolph Shane Creel, Ph.D.	Scientist	Cadi Lusk, M.L.S.	Non-Scientist
Maria Consuelo Donato Molina, Ph.D.	Scientist	Christine Radcliff, M.L.S.	Non-Scientist
Francisco Fernandez, Ph.D.	Scientist	David Rosse, B.S.	Non Affiliated / Non Scientist
Christopher Hearon, Ph.D., FACSM	Scientist	Ruth Chatelain-Jardon, Ph.D.	Alternate - Scientist
Hua Li, Ph.D.	Scientist	Kelly  Hall, Ph.D.	Alternate - Scientist
William McClendon, M.S.	Non-Scientist/Prisoner Representative	Desmond Millender, Ph.D.	Alternate - Scientist
Stephen Oller, Ph.D.	Scientist	Adriana Garza - Flores, M.A.	Alternate for Non-Scientist

Convened Meeting Dates

Upon Submission of  Exempt/Expedited IRB applications, expect a return  within 14 business days.

Note: The TAMUK IRB will not be reviewing any applications during the following times in Academic Year (AY) 2025:

December 14, 2024 - January 19, 2025

May 16, 2025-June 1, 2025

The TAMUK IRB has scheduled dates for Convened meetings of the Full Board on the second Tuesday of each month.  A quorum is required for the IRB to officially review and vote on protocol actions, so be aware the meeting dates may be shifted from the second Tuesday based on holidays, campus closures, and other events to allow members to attend.  Protocols are due the 1 ^st business day of the month in order to go to that month’s convened meeting.

2024 - 2025 Meeting dates:

• Tuesday, September 10, 2024 – 2PM
• Tuesday, October 8, 2024 – 2PM
• Tuesday, November 12, 2024 – 2PM
• Tuesday, December 10, 2024 – 2PM
• January – no meeting held due to semester break
• Tuesday, February 11, 2025 – 2PM
• Tuesday, March 11, 2025 – 2PM
• Tuesday, April 8, 2025 – 2PM
• Tuesday, May 13, 2025 – 2PM
• Tuesday, June 10, 2025 – 2PM
• Tuesday, July 8, 2025 – 2PM
• Tuesday, August 12, 2025 – 2PM

If you have a time-sensitive IRB Protocol due to class requirements, graduation plans, or grant submission, please call Research Compliance to verify what review path is right for your research. Not all studies require a Convened Meeting of the Full Board for review.  

What boilerplate statement do I need on my documents?

The boilerplate is a statement attached to all study documents the potential participants will read/review. This statement shows the documents were reviewed and/or approved by the TAMUK IRB for use in a research project.

The Texas A&M University-Kingsville Boilerplate Statement should be included on the bottom of all documents that human subjects will read, including informed consent, surveys, questionnaires, etc.

 

 

For  convened and  expedited protocols, the Texas A&M University-Kingsville Boilerplate Statement is:

 

 

For  exempt protocols, the Texas A&M University-Kingsville Boilerplate Statement is:

Consent and Assent for Human Subjects