According to federal regulations if you are intervening or interacting with living humans at any point in your research you are conducting human research.
In order to comply with University policies and federal regulations all research involving human subjects must be reviewed by an Institutional review board.
All applicants, sponsoring faculty (Co Pi), key personnel must complete the Social and behavioral module in CITI unless otherwise informed by Research Integrity and Compliance. If NIH funded and a clinical research additional training may be required.
A user guide is available on our website for guidance at the following url: https://www.txstate.edu/research/orc/kuali-protocols/training-resources.html
- Click on "Submit or Edit an IRB Protocol" on the left hand side of this page. This will direct you to a new page and you can then click “Kuali Protocols Login”. You will be asked to enter your Texas State net ID and password. If you do not have a Texas State issued net ID or password contact Monica Gonzales at 512-245-2334 or via email at firstname.lastname@example.org.
- Complete the interactive application. The application is a live document meaning it can be updated at any time by Research Integrity and Compliance. It is recommended you complete the questions in the order they are displayed. Changing responses changes questions displayed therefore previous responses can be deleted. It is highly recommended you use Chrome as that is the most compatible browser. Kuali is not compatible with any mobile devices such as IPads or phones. Please note the Kuali IRB number at the top of the page. This is used to track your application. Research Integrity and Compliance reserves the right to abandon any applications that are “in progress” for more than 3 months to ensure you are using the most current application.
- Upload supporting documents if applicable. Templates are available for consent forms and email recruitment on our website at
- If a student you will be required to communicate directly with your faculty advisor to submit on your behalf. The Kuali system does not send notifications to the faculty advisors informing them it needs their approval. The submit button is available only to your faculty advisor and by them clicking the “submit” button they are confirming the application is ready for our review.
- When successfully submitted the status will change from “in progress” to “Submitted for review”
No, effective May 1, 2016 only one application will be used. The Kuali online application system will inform you about the type of review your research may qualify based on application responses. However, the IRB will determine if your application is a true exemption per federal regulations.
No, effective May 1, 2016 our new improved application incorporates questions that were originally asked in the synopsis.
You will need to contact the other institutions IRB to determine what they need from you. You will also need to submit to Texas State IRB for approval.
We welcome all types of research at our institution and would love for you to apply to our IRB. We would need you to find a current Texas State University faculty member to sponsor you and serve as a contact on our campus for any questions participants may have during the research. Once you have a sponsoring faculty apply using our online application system.
There is always consequences for your actions. Research Integrity and Compliance take noncompliance seriously. Consequences for not following University and federal regulations may include placing a hold on your research funds, asking you to stop research activity immediately and destroying all data collected, not to mention possible legal issues.
- Click on "Submit or Edit an IRB Protocol" on the left hand side
- Click on “Kuali Protocols Login”
- Login to the online system using your Texas State net ID and password
- Click on "Manage Protocols" on the left hand side of the screen
- Your student’s application should show up as well as other information based on the columns you choose to display. Click on your student’s application.
If you do not see your student’s application have your student check the access level assigned to you. Refer to our user guide https://www.txstate.edu/research/orc/kuali-protocols/training-resources.html
- If you agree the application is ready for review by the IRB acknowledge the “Investigator Certification” at the bottom of the application. Once certified click “Submit” at the right hand side. This will send the application to the IRB for review. If successfully submitted the status changes from “in progress” to “submitted for review”
Please note if you require revisions from your student prior to submission do not certify and submit. Once submitted your application is locked.
If you have technical issues please contact Kassaundra Nesbitt at 512-245-4524. All other questions contact Monica Gonzales at 512-245-2334.
All changes to a protocol should be reported to the IRB prior to implementation. This can be done by logging in to Kuali and submitting your amendment through the system. Please refer to our user guide for technical guidance. https://www.txstate.edu/research/orc/kuali-protocols/training-resources.html
Our current application is a live document and interactive. This means that the application can change at any time and based on how you respond to the questions presented not all questions will be applicable. Therefore, each application is tailored to the research project based on your responses.
The main questions that are consistent however are the following:
- Key Personnel
- Purpose of Study
- Previous Research
- Recruitment of Participants
- Informed Consent process
- Procedures • Confidentiality
- Location of Research Data
Documents to upload if applicable:
- CITI Training Completion certificates https://www.txstate.edu/research/orc/IRB-Resources/Training.html
- Consent forms
- Email recruitment
- Verbal scripts
- Classroom announcements
- Letter of support from collaborating organizations
- Project instruments (Surveys, Interview questionaires, Focus Group prompts, Devices, Technology)
The Texas State IRB has developed consent and recruitment templates that may be used by investigators to develop effective documents for IRB review. These templates can be found on the IRB website. https://www.txstate.edu/research/orc/IRB-Resources/templates
No, we currently do not have a template for a letter of support. The IRB requests a signed letter of support to be on the non Texas State University collaborators letter head, with printed signature, and title. The person signing the letter of support should be an official who has the authority to represent the organization. Examples include CEO’s, Executive Directors, Principals, ect.