
Navigating the IRB review process can be challenging.
Below are some common questions and answers about IRB submission, review, and compliance:
What is the IRB?
The Institutional Review Board (IRB) works to protect the rights and welfare of human research subjects recruited to participate in research activities conducted within the institution with which it is affiliated. The mission of the NCWU IRB is to review, approve or deny research involving humans, with the intent to protect the rights and welfare of the research participants.
How do I know if I am conducting research with human subjects?
According to the Department of Health and Human Services, a human subject is defined as a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information. Need more help? The National Institutes of Health has a quick and easy decision tool to help you determine if your research meets the requirements of human subject research: https://grants.nih.gov/policy/humansubjects/hs-decision.htm
How do I select and prepare the correct IRB application?
Not sure if your study qualifies as human subjects research? Not sure if your study should be submitted for exempt, expedited, or full IRB review? No problem! Use this survey to guide you through the process.
What are my responsibilities after IRB approval?
The principal investigator(s) and research team must conduct the study in accordance with the NCWU IRB-approved protocol. The following activities require further submission to the IRB:
- Amendments:
- Any modifications (change in recruitment, change in procedures or tests used, changes to data collection timeline, etc.) to the study must be approved by the IRB prior to implementation. Amendments should be sent to the Chair of the IRB.
- Any modifications (change in recruitment, change in procedures or tests used, changes to data collection timeline, etc.) to the study must be approved by the IRB prior to implementation. Amendments should be sent to the Chair of the IRB.
- Reportable Events:
- Serious adverse events, unanticipated problems, protocol deviations and other events must be reported to the Chair of the IRB.
- Have more questions? Contact the Chair of the IRB: JKelly@ncwc.edu
Frequently used IRB documents: