An Institutional Review Board (IRB) is a committee within the University that reviews research proposals that use human subjects as participants in research. The Institutional Review Board reviews medically noninvasive proposals to determine if the research project follows the ethical principles for the protection of human subjects as required by federal and University regulations. The IRB has the authority to approve, disapprove, or require modifications of these projects.
All proposed research that involves the use of human subjects requires review and approval by the IRB prior to the initiation of the research. Human subjects research is research that meets both the definition of research and involves human subjects as defined in the federal regulations.
Research means a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
The definition of a human subject is “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
If you have questions about whether your study needs to be reviewed e-mail or call the IRB office.
Go to the online application form. Follow the direction on the page to fill out the form and submit it to the IRB; when you have submitted the form, you will be notified with an automatically generated e-mail. At that point, you simply wait for the IRB to make a determination on your application.
Yes! Only the IRB can determine whether a proposal is eligible for exempt status. EXEMPT DOES NOT MEAN THAT IRB REVIEW IS NOT REQUIRED.
It depends on the nature of the study and the level of risk to research participants. The times given below are averages for studies that are not given restrictions by the board or require additional information. Studies that are given restrictions or require additional information will take an additional amount of time depending on how fast these restrictions are met or additional information provided.
- Exempt Review – 5 to 10 working days.
- Expedited Review – two weeks.
- Full Board Review—this depends on the meeting times of the IRB, but is usually no longer than six weeks.
NOTE: During spring, fall, and summer breaks, application processing time may be extended.
Investigators will receive e-mail notification of approval.
The principal investigator is required by University and federal regulations to maintain records of all correspondence, relating to the use of human subjects in research. Copies of the application, research progress reports, notices of approval and signed Informed Consent Documents must be maintained in the investigator’s records. Copies of these research records must be retained for three years after the close of the study and are subject to inspection by federal authorities and the IRB.
Yes. Investigators and all other key personnel are required to complete the NIH Computer Based Training Course and provide a copy of the certification of completion to the IRB. This training must be completed by the investigators and necessary personnel every 2 years. Go to http://phrp.nihtraining.com/users/login.php to start the program. When finished, be sure to print out the certificate of completion.
All modifications to human subjects research must be reviewed and approved PRIOR TO IMPLEMENTATION. The investigator should request modifications by submitting a Research Progress Report Form to the IRB Chair.
Investigators are required to keep the IRB informed about any changes in funding.
Yes. When your project is completed you will need to submit a final report by completing the appropriate sections of the Research Progress Report Form.
You can contact the IRB Chairperson, Samuel Chamberlin