CAYUSE IRB

These instructions are intended for principal investigators. If you are not a principal

investigator, some changes may be necessary.

The purpose of the UT Tyler IRB is to review research proposals that involve human beings before the research is initiated to ensure ethically-conducted research for the protection of human subjects. Proposals are reviewed based on the ethical principles outlined in the Belmont Report: beneficence, justice and respect for persons. The principles are reflected as standards of practice in the Code of Federal Regulations established by the Department of Health and Human Resources, Title 45.

Institutional Review Board (IRB)

Institutional Review Board (IRB)

• It is the policy of The University of Texas at Tyler (UT Tyler) that all research conducted by any UT Tyler faculty member, staff member, or student using human subjects must have prior approval from a UT Tyler Institutional Review Board (IRB) before the research is initiated.

• This review is conducted according to federal rules and regulations set forth by the Department of Health and Human Services (DHHS) “45 CFR 46”. These regulations are enforced by the Office of Human Research and Protections (OHRP).

Institutional Review

Only RESEARCH involving HUMAN SUBJECTS must be reviewed by the IRB.

• Research is a systematic investigation designed to test hypotheses, evaluate programs, draw conclusions, or contribute to generalizable knowledge.

• Human subjects in research are living individuals about whom investigators (professionals or students) conducting research obtain (1) data through intervention or interaction with individuals, or (2) identifiable private information.

IRB 2020 Committee MembersDavid Pearson, Ph. D., Chair Pharmacy

Carla Reichard, Ph.D., Assistant Director, ORS

Christopher Thomas, Ph.D., Education

Danice Greer, Ph.D., Nursing

Danita Alfred, Ph.D., Nursing

David Strong, Ph.D., Literature & Languages

Dennis Combs, Ph.D., Psychology

Emily Scheinfeld, Ph.D., College of Arts & Sciences

Fredericka Brown, Ph.D., Mechanical Engineering

Lauren Kirby, Ph.D., Psychology

Leonard Brown, Ph.D., Computer Science

Janet Gehring, Ph. D., College of Nursing & Health Sciences

Neil Dong, Ph.D., College of Nursing & Health Sciences

Phillip Dancy, Ph.D. (External Member)

Richard Helfers, Ph.D., College of Arts and Sciences

Chris Frydenlund, Environmental Health and Safety (Ex-Officio)

Check out our Website!

Find these resources for help:

• Office of Human Research Protection Information• Training Modules: Protection of Human Subjects in Research• IRB Handbook• Resources for IRB Members• IRB Forms• Resources for Researchers

https://www.uttyler.edu/research/compliance/irb/

CAYUSE-IRBWhat is it?

CAYUSE IRB is an online system for submitting IRB protocols.

How will users log-on?

Existing users will be sent an email with their UT Tyler username and a link for resetting their password. The link for logging in can be found on the UT Tyler CAYUSE IRB webpage.

Important Note: New users will need to have their account created by the Office of Research and Scholarship. Visit https://www.uttyler.edu/research/compliance/irb/cayuse-irb.php for instructions.

How are we notified when something needs to be done or the study proceeds through the system?

You will receive notifications generated automatically by Cayuse IRB and they will be sent to the PI, the primary contact, and each member of the research team listed under Find People at EACH stage of the review process.

Training Requirement

• All research team members (including principal investigators, research assistants, major advisors, and staff) are required to successfully complete an IRB (human subjects) training course. A current certification (less than 3 years old) must be submitted with all levels (exempt, expedited, and full reviews) of new IRB applications and with any request for extension.

• The UT Tyler IRB accepts human subjects training certificates from the Collaborative Institutional Training Initiative (CITI). More information on UT Tyler’s requirements can be found here: https://www.uttyler.edu/research/compliance/irb/training/

• The human subjects training should not be confused with the Responsible Conduct of Research (RCR) training which is a Graduate School requirement.

Before starting your IRB Application, please have the following documents prepared• Supplemental documents in individual document files:

• informed consent form(s)• authorization(s)• recruitment document(s)• Questionnaire(s)

• Files can be in various formats (PDFs, docx).• All copies of CITI training certificates for all researchers interacting with subjects

and/or handling identifiable data.

Important Note: You do not have to finish the IRB protocol in one sitting. All information is saved and can be edited before submission.

Have the Following Prepared:

New CAYUSE Account Creation

To access Cayuse, a user must have a Cayuse account. Accounts have been created for all UT Tyler principal investigators who have active protocols from after September 1, 2017. In order to add a UT Tyler research team member to your study, they must also have a Cayuse account. If an account needs to be established, click here and fill out the short form. The Office of Research and Scholarship staff will then create an account in Cayuse for you. Please note that there will be a delay of up to a few business days.

Logging into CAYUSE

Click Here.

Log in using your UT Tyler Account Info

Logging into CAYUSE

If you have trouble logging in, try these steps:• Clear your browser CACHE (instructions for clearing

cache http://webhelp.evisions.com/HelpFiles/SP/en/Content/Browser%20Support%20-%20Research%20Suite.htm?Highlight=browser)

• Allow cookies from https://uttyler.cayuse424.com/• Enable Java

Firefox Settings

At the top left of your Firefox window, click the Firefox button and select Options.Alternatively, if you do not see a Firefox button, click the “hamburger icon” and click Options.

Pop-up Blocker• Click Content on left menu.• Make sure that Block pop-up windows is unchecked.• Alternatively, if you wish to allow pop-ups only for Cayuse 424 while blocking pop-ups on other sites, click

Exceptions and enter your institution’s Cayuse 424 URL as it appears in the address bar. Then, click Allow.

Enabling Cookies• Click Privacy on left menu.• If Remember History is selected, cookies are already being accepted and no further changes are required. If

Never remember history is selected, select Remember history or Use custom settings for history. • If you wish to use custom settings, you can either check the option to Accept cookies from sites to Accept

cookies for all websites, or uncheck it and use the Exceptions button to allow cookies only for Cayuse 424.• If creating an exception, enter your institution’s Cayuse 424 URL as it appears in your browser, then select

Allow.

CAYUSE Dashboard

You can keep track of your applications and where they are in the review process by looking at these sections on your Dashboard.

CAYUSE Dashboard

IRB members should select Researcher for the role if they are submitting a protocol. The star indicates the default role, and this can be changed at any time.

Creating a New Study

Click Here.

Adding a Title

Type Here.

Click on the check mark when you are satisfied with your title.

Editing a Title

Hover your cursor over the title bar, and click on the pencil to edit. Once you are finished editing, click on the check mark to save.

Creating a New Submission

Click Here and then click “Initial”.

Starting your Application

Click here to start your IRB application.

Application Form

Each section will be marked with a green check mark once it is complete. You cannot submit until each section has a green check mark beside it. However, you can complete the sections in any order.

The red * means you must answer the question. You cannot submit until it is answered.

Person Finder

On some parts of the application, you will see buttons like this.

Person Finder

The FIND PEOPLE buttons will take you to a screen like this where you can search for users with an existing CAYUSE account.

Once you have your name selected. Click save.

If your PI, Co-PI, Faculty Advisor, or Research Assistant(s) are not found, they will need to submit a CAYUSE account creation form to the ORS.

Attachments

This is what you will use to attach the required documents.

Clicking on it will bring up a screen like this. Click on the + button, and attach the links or files you would like. Then click apply.

You may attach more than one link/document.

Throughout the application, you will see several buttons like this.

Completing your Submission

When you see green check marks on each section, the “Complete Submission” button will appear at the bottom. *Please note that you should only click on this button after all PIs, Co-PIs, and/or the faculty advisor has looked over the application. Once you click on this, your application will be ‘locked’ to editing unless the IRB reviewer requires changes.

Confirm & Certify Once you click on “Complete Submission”, you will have to confirm the routing of your submission.

Then, you must Certify your submission.

*You will need to Certify each time you submit revisions, amendments, and renewals.

Confirm AgainConfirm one last time. This will send your application to any listed PI(s), Co-PI(s), and/or faculty advisor(s) for reviewing and certification. Once everyone has certified, the application will be sent to the IRB office to begin the review process.

What Next?

• Receipt notification email – Your application has been received by the IRB office. The IRB Analyst will pre-review (check that all necessary items are included) and will route your submission for review.

• More Information Requested (if necessary) – You will receive an email notifying you that we need more information before we can approve it. Comments will be in your application; not in the letter. You will make revisions to your application and resubmit. Everyone who certified the first submission must re-certify.

• Exemption Notification (if appropriate) – the study involved little-to-no risks and we don’t need additional information, so you’re good to move forward.

• Approval Letter (when appropriate) – you provided all of the information we need and/or revised the application packet so that everything fits within the regulations so you’re ready to move forward

Need Help?

Please contact the Office of Research and Scholarship if you have any questions about using CAYUSE.

Research@uttyler.edu(903)565-5858

Additionally, you can visit the Cayuse Help Center for answers to many questions. You will need to first create an account.

For any questions about the IRB process, contact David Pearson, the IRB chair.Dpearson@uttyler.edu

(903)566-6109