INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN RESEARCH SUBJECTS
In accordance with federal and institutional regulations, any undertaking in which University faculty, staff, or students investigate and/or collect data on human subjects for research purposes must be reviewed by the Institutional Review Board (IRB). It is the responsibility of each investigator to seek review of any study involving human subjects prior to initiation of the project.
Purpose and Mission
The IRB is a University committee composed of faculty members who are appointed by the institution and a community representative. The IRB is responsible for reviewing all research activities involving human subjects regardless of the source of funding.
The mission of the IRB is to promote and safeguard research activity that involves human subjects within the academic community. A list of current IRB members is available here.
Required Procedures for Submitting Research Protocols for IRB Review
- Meet the federally mandated educational requirement by completing the online Protecting Human Research Participants tutorial. At the end of the tutorial, a Certificate of Completion will be issued.
This certificate must be attached to the application at the time of submission for the principal investigator and all other key personnel. If the Principal Investigator is a student, the faculty advisor must also complete the tutorial and attach a copy of his or her certificate. IRB proposals are not reviewed until all required certificates have been submitted.
- Classify the research project as an exempt, expedited, or full review study. The resources below may also assist in appropriately classifying the research.
- Complete the appropriate application materials and write the research protocol narrative and other appropriate materials.
- Submit the application and supplementary information, including the Protecting Human Research Participants tutorial certificate of completion, to Sponsored Programs, Jones 414/Coates CPO 20.
- There is no deadline for exempt or expedited review applications; they are reviewed on an ongoing basis. Investigators can typically expect to receive notification of approval in approximately two weeks from the submission date. Approval times may be extended during the summer months and other times when faculty are away from campus.
- Applications submitted for full review must be received by Sponsored Programs according to the deadlines established each academic year. Applications submitted after the deadline will be scheduled for review at the next meeting. If full review applications are received during the summer months, a meeting will be scheduled for their review as soon as possible and typically within two weeks of receipt of the application.
Reporting Requirements and Forms
- Form A: Continuing Review - Research protocols that have been approved by the IRB through either expedited or full review procedures are subject to annual review by the IRB if the project extends for more than one year. A completed and signed Form A must be submitted to the IRB prior to the anniversary date of the protocol’s approval for each year the study is active, up to a maximum of three years from the original approval date. If the project is to continue beyond three years from the original approval date, the investigator is required to complete and submit for IRB review a new research protocol using the University’s current application forms. To request approval to extend the project beyond the original approval period, Form B is required.
- Form B: Request to Extend Project - Research protocols that have been approved by the IRB through either expedited or full review procedures are approved only for the period indicated on the approval notification. Form B is used to request approval to extend the project beyond the original date and must be submitted in advance of the project’s expiration date. Form B may be used to extend the project up to a maximum of three years from the original approval date. If the project is to continue beyond three years from the original approval date, the investigator is required to complete and submit for IRB review a new research protocol using the University’s current application forms.
- Form C: Protocol Revision Form - Research protocols that have been approved by the IRB must have prior approval for any deviation from the original approved protocol. Form C is used to request approval to implement changes to a previously approved protocol.
- Form D: Final Report - The final report must be filed with the IRB within 30 days of the project’s expiration date. If the project is not anticipated to be completed by the expiration, investigators may request an extension for up to three years from the original approval date. Once the final report has been filed, the protocol will be officially closed, and no further action may take place until a new protocol has been submitted for review and approved by the IRB as a new study.
Resources
Contact Information
IRB Chair: Dr. Myra Beth Bundy, 622-1003
IRB Administration: Gus Benson or Tiffany Hamblin, 622-3636
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