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HLSC 6500: Research Methods and Design

IRB Information

Research projects involving human subjects require review and approval by the UNT Institutional Review Board (IRB). The IRB is responsible for assuring that the rights and welfare of human subjects in research are adequately protected. The UNT IRB is responsible for reviewing and overseeing human subjects research conducted by UNT faculty, staff, or students.

Before they begin collecting data, investigators should first consider whether their research project fits the federal definition of human subjects research. It is advised that the "Investigator must err on the side of caution and submit a “Proposed Human Subjects Research Assessment” form to determine if a study meets the federal definition of human subjects research and requires IRB approval. This process ensures that the requirement of obtaining IRB review and approval for applicable projects is satisfied as required by federal regulations. These decisions should be made by Research Integrity and Compliance staff and not individual investigators."

More details can be found on the UNT Research integrity and Compliance (RIC) Office's "Determination for Research on Human Subjects" page

Time should be allotted within the research project timeline for submitting your IRB protocol and waiting for approval. The current review timeline is posted in a message in the Cayuse system and will depend on the volume of submissions received by the IRB office, but in general it's best to allot at least one month for the process of submitting your protocol and waiting for approval. 

IRB approval for student researchers

The RIC page for student researchers includes guidance for students navigating the IRB process. In most cases, a student researcher will need to have a faculty member serve as Principle Investigator (PI) on their research project, although a student researcher can create their protocol in the Cayuse system. 

Human subject research training requirement

Proof of completion of the CITI Human Subject Research training class is required for all researchers. Find more information about how to complete the required training on the RIC Training and Education page

Cayuse submission guide

The Cayuse IRB Initial Submission Guide contains helpful information to guide you through the process of creating an IRB protocol in Cayuse.

Informed consent form templates

The RIC provides informed consent form templates and prescribed recruitment language for various audiences/situations. Use these forms so that your informed consent and recruitment communication language will match that expected by the IRB.

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