Human Subjects - Institutional Review Board (IRB) - University of the 2026

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  1. Click ‘Get Form’ to open it in the editor.
  2. Begin by reviewing the general instructions provided at Xavier.edu/irb. This will help you understand the requirements for human subjects research.
  3. Complete the Determining Whether Proposed Activity is Human Research form, ensuring all sections are filled accurately.
  4. Fill out the application submission form, including your name, department, and contact information. Don’t forget to provide your electronic signature at the end.
  5. Attach necessary documents such as Informed Consent forms, research instruments, and any letters of permission from study sites.
  6. If applicable, include completed HIPAA forms and training certificates for all project personnel.
  7. Once all fields are completed and documents attached, submit your application through our platform. For student submissions, ensure it goes to your Faculty Advisor first.

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Federal regulations require that research projects involving human subjects be reviewed by an IRB. The IRB must approve or determine the project to be exempt prior to the start of any research activities.
A study protocol must meet specific criteria to be approved by the IRB. First, the protocol must have a clear scientific purpose. Second, the protocol must be designed to minimize the risks to participants. Third, the protocol must include procedures for protecting the confidentiality of participant information.
There are three types of IRB review outlined in the federal regulations: Exempt Status, Expedited and Full Board review. The UI IRB reviews HawkIRB applications at the lowest level of regulatory oversight allowed by the Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46).
The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.

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