1. Does my project require IRB review?
The IRB is only charged with reviewing research that involves people as research participants. Your project needs to be reviewed if it meets the following criteria:
- Is it Research? Federal regulations define research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge...
- Does it involve human subjects? Federal regulations define human subjects as 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. Human participants include those who are actively involved in the research process (being interviewed, filling out surveys, etc.). They also include those who may not be in front of us: those who provided medical samples, left records of their activities through applying for marriage licenses, etc.
2. Can I begin human subject research before I receive IRB approval?
No. Research must be approved by the IRB before research can be conducted.
3. Who do I talk to if I'm not sure whether my project requires IRB review?
4. How do I submit my completed application?
5. What are the types of IRB review?
There are three types of IRB review: Exempt, Expedited and Full Board. The level of review depends on the risk to the human participants. The IRB makes the risk determination.
- Exempt - Studies that meet explicit criteria set forth by the federal regulations.
- Expedited - Studies that involve minimal risk and meet explicit criteria set forth in federal regulations.
- Full Board - Studies that do not meet criteria for Exempt or Expedited Review and are usually greater than minimal risk are reviewed by the Full Board. Examples are studies that involve vulnerable populations or questions of a sensitive nature.
6. Do students' academic research projects require IRB review?
If human subjects are involved, yes. Please note: student researchers are required to work with a faculty advisor (who serves as the Principal Investigator) for each research project.
7. What if I make any changes in my protocol, does the IRB have to review and approve it again?
Yes. Any changes to a protocol must be reviewed and approved by the IRB prior to the implementation of those changes. In many cases this can be done quickly. Highlight the changes on the application and send the application along with a Modification Request and any other applicable documents to the IRB Administrator: Josi dos Santos Santos (email@example.com, 702-992-2107), or email IRB@nsc.edu.
8. Does the IRB review studies once they have been approved?
Yes. The IRB is required by law to conduct continuing review of research at least annually. Requests for Continuing Review (Renewal) must be filed each year 30 days prior to the protocol expiration date.
9. Do I need IRB approval if my work will be conducted outside of the NSC campuses? Do I need IRB review if my study is already approved by another IRB?
Yes. To ensure that investigators comply with federal and NSC regulations, it is important that NSC, through the IRB, be aware of where and by whom such research is being done, even if it is done in a foreign country.
10. What happens if I conduct human subjects research without IRB approval?
You will be out of compliance with Federal requirements for human subject research. This can result in actions by the Federal government or NSC that will prevent you from conducting human subject research and could jeopardize the research reputation of NSC. In addition, many publications will not publish materials that have not received IRB approval.