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Human Subjects


Institutional Review Board (IRB)

The purpose of UCM's Institutional Review Board (IRB) is to ensure the protection of the rights and welfare of all human subjects that participate in research. Research conducted by faculty, staff, and students must be approved by the IRB, prior to research being conducted, as required by federal, state, and University regulations. The IRB reviews research applications and proposals involving human subjects to ensure the rights of the subjects are not violated and that the research conforms to the Code of Federal Regulations. The committee then approves, request revisions, or determines that the protocol does not fall under human subjects research. 

Researchers are required to complete the CITI Responsible Conduct of Research (RCR) training certification before a protocol will be approved.  Additional information is below.

When you have completed the study, please complete the Protocol Closeout Form. You may also request an amendment or renewal of your protocol through the website. It is required to document the number of subjects in your study and any adverse events the subjects experienced.  For instructions on completing and submitting applications, please view the Institutional Review Board 101 PowerPoint in the Forms and Resources page.

Points of Consideration Before Submitting a Protocol


Applications are submitted by the Principal Investigator (PI) to the Institutional Review Board through the submission form found in the application forms sectin under Human Subjects. 

Once you have completed the appropriate application,  combine the application as well as materials including surveys, consent, letters of permission and recruitment wording into one PDF document.  Then complete the information sheet under IRB Submission Form, attach the application and supporting documents, then submit. The application will be routed to the faculty advisor listed on the application. Once the advisor has approved, it will be routed to the IRB for the review. Reviewers' decisions generally take between two to four weeks.

Amendments and Renewals

Minor amendments are typically handled through a written request sent to the IRB by completing the Amendment form on the website. If there are no changes for a renewal, resubmission of old forms are needed in order to evaluate these against current regulations and policies. If amending and renewing, an amendment first and renewal second are suggested.  If you have questions concerning this process, please email

Informed Consent

A researcher must ensure that they have received consents form from participants. Guidance on what must be included, a sample form, and additional documents are available on the Forms and Resources page.

Waiver of Modification of Informed Consent

Researchers, in accordance with Federal regulations, may alter or waive the consent document, only under certain conditions. Waivers and/or alterations must be submitted with a full justification. Additional information is available in Forms and Resources.

CITI Training

OSPRI covers the cost for all faculty, staff, and students to complete as many CITI modules as are available. Researchers must complete the CITI Responsible Conduct of Research (RCR) training.

There are several RCR trainings that are discipline specific to choose from.  If the research is funded through a grant or contract, Principal Investigators must complete the RCR Administrator training and the Financial Conflict of Interest (FCOI) training modules. Each module’s certification is good for up to three years.

Additional information on how to register with CITI is available in the Forms & Resources page.  Please note, different modules are required for IACUC (animal research), and those are noted in the IACUC section of Forms & Resources.

IRB Application Forms

Students completing a hearing assessment

Determination of Research Form

This form will help to determine if a project will fall under the federal definition of research for human subjects.  At a minimum, all researchers presenting findings outside of the classroom must complete the DOR form and receive an approval letter from the IRB before starting their project. 

DOR Form

Students meeting to work on a project.

Exempt Application

This should be completed if research subjects will remain anonymous/confidential, there is no intervention, and minimal risk to subjects.

Exempt App

Students completing a medical assessment

Expedited or Full Review Application

Expedited Review is typically for research which has identifiable information, an intervention and minimal risk. A Full Review addresses research that is associated with greater than minimal risks or includes protected populations.

Expedited/Full App



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