What is the Institutional Review Board (IRB)?
IRB is a committee of faculty who review proposals for human subjects research to ensure that studies are safe, ethical, and in compliance with relevant laws. At SHSU, the IRB is a division of the Office of Research and Sponsored Programs (ORSP).
What research must be approved by the IRB?
Most research involving living humans cannot begin until the IRB approves it. Depending on how high-risk or low-risk the research is, more or less detail may be required, and IRB review may be more in-depth or more expedited.
If our research only involves compiling existing data, or studying inanimate objects (like literature), then IRB approval is not required.
If our research involves living animals, then we will instead need approval from Institutional Animal Care and Use Committee (IACUC).
What steps should I complete before I request IRB review?
Before you request IRB review of a research study, you must complete CITI training with scores of 80% or greater in each module. If multiple people will collaborate on a research project, every one of them must complete CITI training. The ORSP Compliance website provides a link to the training and instructions for registering on the CITI site.
You should discuss your project with your faculty advisor before you begin your IRB application. You may also want to consult them along the way if you are not sure of the best way to answer a certain question. Be aware that IRB applications take time to review—this may be faster or slower depending on the complexity of the project and the risks involved, as well as how many other applications are waiting for review—so start your application as early as you can. ORSP provides some additional information about student-led and class projects and things to take into account concerning application timing.
You should have some general notes about your planned project before you begin, but it’s ok if you aren’t ready to complete every part of the application in one sitting. You can begin an IRB application, save it, and come back to it at a future time to add or edit information.
How do I submit my research for IRB review?
IRB review processes are done online in a special software program, Cayuse Human Ethics. To access Cayuse Human Ethics:
The tabbed pages of information below will offer detailed guidance through a student IRB application.
Once you are logged into Cayuse Human Ethics, you will see a Dashboard displaying any existing studies that you may have created or tasks you need to complete.
To begin a new application, click the blue "New Study" button at the upper right.
Enter a title for your study. This should be clear, descriptive, and recognizable to you; this does not need to be a "catchy" title like you might use for presentation or publication of a study.
For purposes of this example, I will be creating a sample application for a project on water pollution in Houston. I will call it "Measuring Pollutants in Houston Texas Water Samples."
When you are done entering a title, click the blue checkmark.
Now you should see a screen with your study title, an IRB application number, and a red "Unsubmitted" flag.
Click the blue "New Submission" button at the upper right, and choose the drop-down option for "Initial."
Now a blank application has been created.
Click the "Edit" button just below the red "Unsubmitted" flag.
Even though this walk-through will strive to provide clear instructions, it is strongly encouraged that you read all instructions on the opening page of your initial application. You will also see small question-mark icons throughout the application which will provide more guidance on specific questions--use them!
Click on the next tab in this box for steps to complete Section 1 of the application.
Section 1 focuses primarily on the PEOPLE involved in the project, plus a few basic details about the project funding and timeline.
Question 1A identifies the Primary Contact for the project. This will normally be you! Your information should appear by default.
Questions 1B and 1C identify the Principal Investigator (PI). This is the person who bears responsibility for the conduct of this research. This will often be you, but depending on your circumstances, it may be your faculty advisor. Ask your advisor if you aren't sure who qualifies as the PI. To enter a person, click the "Find People" button, type in a name, and click the magnifying glass button to search.
If several names appear, read them carefully and click on the correct one to select it. Then click Save.
If you, the student, is entered as the PI, you will see three more questions appear to document your faculty sponsor. Use the "Find People" button to find and select your sponsor's name, then indicate whether or not they have CITI training and how long you expect the project to take.
Questions 1D and 1E identify any other researchers--whether students, faculty, or staff, at or outside SHSU--who will be collaborating on this research project. Select or enter those individuals if applicable.
Question 1F asks whether this project has ever been reviewed and disapproved by IRB before. If this is a new project developed by you, the answer is no. If this is a project developed by your faculty advisor, you could ask them whether it's ever been proposed before, just to double-check.
Question 1G asks whether or not this project has funding. If you or your faculty advisor received a grant for this specific project, perhaps from EURECA or ORSP, then the answer may be yes. Boxes will appear depending on your selection so that you can specify the source of the grant.
Question 1H identifies your expected date to start collecting data. This should be at least two weeks in the future to allow time for IRB review.
You have reached the end of Section 1 -- celebrate! 🎉 Click the green SAVE button at the upper right. Assuming that you haven't skipped any questions to come back to later, you should now see a checkmark beside Section 1 in the application navigation menu.
When you are ready, click on the next tab to see steps for completing Section 2.
Section 2 digs into the purpose and procedure of the research.
Question 2A identifies the research question, hypothesis, or purpose. This is the overall question your study is trying to address. It reflects the phenomenon you are studying, and what you are attempting to learn about it. The IRB may not approve your study if they cannot see how your methods will address your question.
Question 2B seeks a brief summary of the background information and existing literature that is relevant to your project.
This should be limited to 250 words and then include no more than 3 or 4 citations that are the most important.
Question 2C asks whether the project may contribute to the body of scientific knowledge. If you expect that your results will in some way be presented, published, or shared, then the answer is YES.
Question 2D identifies whether you will deliberately collect data outside the United States.
Question 2E-1 asks about observation of living people. Many studies will enter a No answer to this question. However, if you will only observe people--and not interact--you can select Yes. If you select Yes, you will be further prompted to indicate whether observation will occur only in public spaces, such as airports and malls.
Question 2E-2 asks about intervention with living people. This may mean physical interaction, like taking blood samples, or simple verbal interaction, such as surveys and interviews. If you are completing this application, the answer will usually be Yes. You will then be asked to indicate whether or not you will ask people about their thoughts, feelings, opinions, or experiences.
Questions 2E-3 through 2E... TO BE CONTINUED! TUTORIAL UNDER CONSTRUCTION, CHECK BACK SOON...
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