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.
Creating a New Study or Accessing a Draft Study
If you (or any collaborators) have not completed CITI, you will need to do so BEFORE you complete this submission.
If a section does not yet have a checkmark, you have an incomplete item somewhere in that section.
This might be you! Or it might be your faculty advisor, or even another student collaborator. Think carefully about your situation and "who is ultimately responsible for the conduct and oversight." If you are unsure who to enter, ask your faculty advisor.
Anyone who was already identified in Section 1 does NOT need to be added again here.
For past disapprovals, you will need to provide details and documentation.
Note that if a funding application is pending but not yet decided, you will mark Pending, but then you will also eventually need to send the IRB an update when that funding application is either received or rejected.
Note: Do NOT include explanatory background of the problem or literature in this field. Just state clearly and concisely the overall question or phenomenon you are studying and what you hope to learn about it.
Do not cut and paste full sections from your thesis or dissertation; this should be a very short summary. Cite only the 3-4 most crucial publications to support what you will be doing and why.
If the answer to this question is Yes, be prepared to provide additional details about what country or countries your data will come from and whether you have identified their equivalent of an IRB for approval of your research.
If your project will not be applied in ANY way that contributes to generalizable knowledge, then it may not qualify as "research" as defined by federal regulations, and you may not need IRB approval. You are encouraged to call the SHSU IRB office and ask for clarification or guidance.
If you are uncertain, speak with your advisor or the SHSU IRB for clarification. Answering yes here will trigger a more rigorous review of your proposal.
You should also answer NO if you will be observing participants, with or without interaction, in a PRIVATE place. Note that a "public school" is a "private place" for the purposes of this question.
If you will be sitting in a PUBLIC place like a park and watching people without interaction, you may need to choose YES here. You will likely not need to enter any more information about your project or receive IRB approval, if you are not actually interacting with human participants.
There are some exceptions to this, for example if you are conducting secondary research with identifiable private information or biospecimens whose collection was unrelated to this project. If your research falls under one of these exceptions, and you are truly NOT interacting with human participants, then choose NO here. You will then answer accordingly to the question 4 regarding secondary research, and you will need to complete an additional application section detailing the secondary data source and the original purpose for its collection.
If you are NOT conducting an online survey, or it is not online and anonymous, select No instead.
Note: For logical consistency, if you select Yes here, you also should have selected Yes above for "interaction or intervention."
If you answer Yes:
You will be asked further whether or not you consider this activity "benign" (brief, painless, not invasive or embarrassing). If you are unsure, definitely click on the question mark icon to read more details about benign interventions. Check with your faculty advisor if you find you still need clarification.
You will also be asked again whether your study involves deception, or being untruthful with participants.
Completing the Application Information Page and Application Sections 1 and 2
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