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In This Section Texas Health Research & Education Institute
Institutional Review Board

Frequently Asked Questions

What is an IRB?
The Institutional Review Board (IRB) is a committee established under federal regulations that reviews human subject research to assure that the rights and welfare of human subjects are adequately protected. It oversees institutional compliance with all federal, state, and local regulations; in addition to Texas Health Resources policies.

What kinds of research studies require IRB approval?
All research involving human subjects or their identified protected health information must be submitted to the IRB for review. A human subject is an individual from whom an investigator conducting research obtains data through intervention or interaction, or identifiable private information. Click here to learn more.

How do I determine if my project requires IRB approval?
You should submit your project to the IRB if it involves human subjects or their identifiable data. Click here to view a tool designed to assist in determining if IRB approval is needed. If you have questions please contact the IRB office.

What is the process for IRB approval?
Click here to view our full board process.
Click here to view our expedited process.

What is FDA Research?
FDA research is research funded by the U.S. Food and Drug Administration. Click here to learn more.

How do I request an eIRB Account?
Click here to learn how to obtain an eIRB account

How do I create a new study in eIRB?
Click here to learn how to create and submit a new study in eIRB.

How do create and submit a continuing review?
Click here to learn how to create and submit a continuing review in eIRB.

How do I close my study?
To close studies use the continuing review application. Click here to learn
how to close your study?

How do I report an adverse event?
Click here to learn how to submit an adverse event through the eIRB system.

How do I make changes to approved research?
Any changes made to research that is already approved requires an amendment. Click here to learn how to submit an amendment.

What kinds of changes to my research require an amendment?
These types of changes require an amendment to be submitted to the IRB. Do not implement the change until you receive an approval letter from the IRB.

Examples of changes to a study include but are not limited to:

  • Changes to the protocol

  • Changes to the consent form

  • Changes to surveys/ questionnaires

  • Changes to recruiting materials

  • Addition or removal of a stipend

  • Changes in study personnel

  • Updated investigator's brochure

  • Changes in conflict of interest

  • Changes to the sample size

  • Addition or deletion of sites

  • Changes to inclusion/ exclusion criteria

  • Revision to data and safety monitoring plan

  • Requesting additional funding

  • Other changes as determined by the IRB

How do I find my study?
Click here to learn how to locate your study in eIRB.

How do I submit a conflict of interest disclosure?
Click here to learn how to submit a COI disclosure.

How do I submit an invoice?
Click here to learn how to submit an invoice.

Can my study be expedited?
Expedited review is a type of IRB review for studies that a) pose no more than a minimal risk to subjects, and b) meet at least one expedited review category. The study will be reviewed by one voting board member instead of the full board. Click here to view the expedited categories.

Is my study exempt from IRB review?
For your study to be exempt from review it must fit into one of the exempt categories. Click here to view the requirements for exemption.

What are Substantive Conditions (or Modifications)?
Click here to view definition.

Return to IRB Home Page

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