What is an IRB?
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.
How do I know if my project needs IRB review?
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.
How do I submit my research for review by the IRB?
Download the application form from the IRB portal on MyPark. Fill out the form and send it as a document attachment in an e-mail to IRB Chair Brian Shawver at firstname.lastname@example.org . Include all necessary supporting documents (see “Forms” page for a list of required materials)
If I know my project meets the exempt regulations, do I still have to submit an application for IRB review?
Yes! Only the IRB can determine whether a proposal is eligible for exempt status. EXEMPT DOES NOT MEAN THAT IRB REVIEW IS NOT REQUIRED.
How long will it take for my proposal to be reviewed?
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.
NOTE: During spring, fall, and summer breaks, application processing time may be extended.
How will I know if my project is approved?
Investigators will receive e-mail notification of approval.
What do I do with the signed informed consent documents?
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.
Do I need to complete training on protections of human subjects before starting my work?
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.
What if I want to make a minor change in the study (add or remove a question from a survey, add a second focus group, or put an advertisement in the newspaper to recruit more participants) do I need to do anything?
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.
What if my funding changes?
Investigators are required to keep the IRB informed about any changes in funding.
Do I need to notify the IRB when my project is finished?
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.
I still have questions, who can help?
You can contact the IRB Chairperson, Brian Shawver
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