IRB Approval Process
- The researcher identifies a research project.
- If the researcher is a student, coordination and approval are needed from faculty sponsor(s) to begin the project and throughout the life of the project. Students cannot be the sole principal investigator on an IRB proposal.
- Undergraduate Projects
- Undergraduate projects classified as coursework do not require official IRB approval; rather the student must work with a faculty advisor to monitor the project to ensure IRB compliance throughout the life of the project.
- Graduate Projects
- As part of the thesis/dissertation process, Graduate Studies requires IRB when research involving human subjects is conducted.
IRB Approval is required prior to data collection
- The completed application form is signed by the principal investigator and advisor/instructor (if applicable) and submitted to the Office of Sponsored Programs as a FULL completed proposal. A full proposal includes:
- IRB Training Completed
- Completed IRB Application
- Copies of Data Collection Instruments (surveys or questionnaires)
- Copies of Consent Form(s)
- Copies of Written Support (letters of support from cooperating institutions)
- Copies of Debriefing Statement (if applicable)
All parts of an application packet must be submitted simultaneously. Incomplete application packets will be returned without review to the PI/Advisor.
- The IRB application is either routed through two members of the IRB for Exempt/Expedited Review or to the committee for a Full Review during a regularly scheduled meeting.
- A formal letter of approval, conditional approval or disapproval is sent by IRB to the principal investigator. In the case of suggested minor modifications, the principal investigator may be asked to revise the application and resubmit for review. If the proposal is disapproved, the researcher may make modifications and resubmit the application.
- Researchers with Expedited or Full Reviews must complete and submit a Continuing Review/Final Report Form at the end of the project or annually, whichever occurs first.
Post IRB Approval Process
Upon IRB approval, the following process applies.
- Follow formal consent process with potential participants
- Researchers are responsible, by law, for retaining signed consent forms for three years
- Collect Data
- Researcher is responsible to report any project variances or incidents to the IRB immediately
- Variances or incidents must be reported via the Continued Review Form
- Continuing Review (annually) or Final Report back to IRB (Expedited and Full Reviews ONLY)