Office of Research and Innovation

Research Compliance

Institutional Review Board (IRB)


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 subject are defined as follows:

Research:

a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. (Code of Federal Regulations Title 45 Part 46.102 (d))

Human subject:

a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information. (Code of Federal Regulations Title 45 Part 46.102 (f)) 

Do I need an IRB Protocol?

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.  

"Do I need an IRB" Online Form Questionnaire

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

The Cayuse Human Ethics module is LIVE!

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

Please take part in our Soft Launch of the software, and try it for your new IRB submission. 

The LIVE Cayuse Human Ethics can be accessed in two ways:
  • Log into JNET -> Campus Resources -> Quick Links  -> Cayuse. 
    • It will take you straight to your landing page.
    • You will log in with your ku/ka/kf email account and your email user password, as if logging into Microsoft Office 365 products.

Training is available.  Contact Angela 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.

We are excited to be moving forward with this new method of managing the submission, review, and tracking of studies.

The templates below for consent, assent, and data use will still be used, but updates are coming to them, soon.


The PDF for NEW IRB applications will be phased out over the Spring 2024 semester, but will be accepted until Commencement. Renewals and Amendment/Modifications will accept the PDF forms until a given study is within Cayuse and then the online processes will be used going forward.


The soon-to-be decommissioned Research Compliance PDF forms here are dynamic  PDFs, and don't behave quite the same as other PDFs.  Please right-click on the link to save these files to your computer, open your PDF software application, and in the application, go to File->Open, and navigate to where the form is saved, and select it.  If you just double-click on it, your computer will likely give you an error message like this one:


PDF Error


There is nothing wrong with your computer.  It just thinks this form is a webpage.  Following the instructions above will help it function properly.

If you have difficulty with these forms or need additional assistance, please call 391-593-2677 or email researchcompliance@tamuk.edu to set up an appointment so we can help.


TAMUK Faculty and Staff can serve as PIs on IRB protocols.  

Students at all levels, undergraduate, graduate, and Ph.D. candidate require a Supervising Faculty Mentor to oversee and assist with the preparation of their IRB protocols.  This faculty mentor signs off on the protocol as acceptable and certifies they will be the responsible party to the student as needed with the research design and proper execution of the protocol.   

IRB has (3) review paths.  Your final approval time is contingent on the promptness of returned revisions.

  • Exempt review
    • This does not mean an IRB is not needed, it means you are required to do one but the project qualifies as minimal risk and can be reviewed by a single reviewer via email communication
    • Examples - emailed surveys where no identifying data will be requested, analysis of preexisting de-identified data.
  • Expedited
    • This still is considered a minimal risk project, but requires 2 reviewers and documentation of consent (signed consent forms), and can be reviewed via email communication.  Note: The TAMU System does not allow digital signatures for documentation of consent.
    • Examples - studies where a pre-and-post test will be administered, to see if subjects gain knowledge following a class or presentation; any low-risk study that will make use of video, audio, or any other biometric type of identification.
  • Full Board
    • The TAMUK IRB reviews anything over minimal risk, projects that involve minors, vulnerable populations, at the Full Board level.  These protocols must be reviewed at a convened meeting, where a quorum of IRB members can discuss the risks and benefits of the study, and determine if it can be approved as is, if it can be approved with minor modifications, or if it needs to be tabled for later review after heavy revision, and finally, if the study simply cannot be approved.
    • Examples - studies collecting data from minors, ages 0-17; studies that ask potentially incriminating or potentially stressful questions, involved deception, extreme human performance studies, studies using the collection of biological samples from humans (these will also require a companion IBC protocol)

The TAMUK IRB holds convened meetings on the second Tuesday of each month during the Fall and Spring semesters, and as needed during the Summer Sessions.  Quorum is required for the IRB to officially review and vote on protocol actions, so be aware the meeting dates may change based on holidays, campus closures, and over events to allow members to attend. 

If you have a time-sensitive IRB Protocol due to class requirements, graduation plans, or grant submission, please call Research Compliance to verify review paths and meeting dates and times.

Exempt IRBs do not require documentation of consent.  The subjects still need to have a consent document presented to them, with all the required information, but no signature is needed. 
This is one reason we work to keep online surveys at the Exempt review level - since no signature is needed, the problematic logistics of meeting to obtain it can be avoided.  
 
Digital signatures are not accepted at this time by the A&M System for Documentation of Consent regarding IRB subjects unless we can meet the validation requirements.  
 
These requirements mean adherence to FDA level rules for digital signatures, and include some cumbersome practices, like entering a password to sign for each clause in a consent template.  As far as we know, the A&M system does not have any of those add-ons for any of our software packages.  After a conversation with the Chief Research Compliance Officer (CRCO) at System, as well as the representative for DocuSign, we were told it is not something we can do as far as Documentation of Consent for Human Subjects Research.
 
We can accept digital or scanned signatures for internal forms, for IRB (and other protocol) submissions, but for a participant in research, we cannot accept their signature on an Informed Consent document.
 
Expedited and Full Board reviews usually DO require documentation of consent:
 
In these instances, the PI can request a waiver for documentation of consent if the reviewers both agree it meets the criteria in 45 CFR 46 (below).

(1) An IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following:

(i) That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;

(ii) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or

(iii) If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

(2) In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.

Every individual working on a study is required to be listed within the study and have certification of the required training before they can perform any study tasks.  They cannot interact with the subjects or the data until their placement in the study is approved.

Also, some projects might require companion protocols to be reviewed by the IACUC or IBC committees.  These protocols require additional CITI courses and may require additional supplemental training.  Research Compliance can assist in making sure you know your training requirements.

Ensuring CITI Program Training will link to Cayuse

  1. In a web browser, navigate to: www.citiprogram.org
  2. In the upper right corner of the screen, Log In
  3. check your contact info to be sure your email is your @tamuk.edu email in the format listed below:
  • first.last@tamuk.edu
  • first.last@students.tamuk.edu

You may use a personal email as your secondary address for account recovery, but your @tamuk.edu email address is used to link your CITI training to Cayuse.

Please see this PDF for more guidance on training and how CITI training can be linked to Cayuse.

*NOTE: TrainTraq and any other certifications will not automatically link to Cayuse. Please save documentation of TrainTraq via a transcript or official confirmation of training completion to submit within Cayuse as part of your file uploads. 

 

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