The IRB must review all projects that meet the definition of research that involve human subjects prior to any data collection. The IRB Chair reviews the protocol submission to determine the appropriate level of review, which is largely determined by the level of risk to subjects associated with the project.
Learn more about what is and is not research involving human subjects here.
There are 3 levels of IRB Review:
The IRB must determine the following for each new submission:
- The proposed research design is scientifically sound and will not unnecessarily expose subjects to risk
- Risks to subjects are minimized and reasonable in relation to expected benefits
- Subject selection is fair and appropriate related to the study purpose
- Additional safeguards required for subjects likely to be vulnerable to coercion or undue influence
- Informed consent is obtained from research subjects or their legally authorized representative(s)
- Subject privacy and confidentiality of research data are appropriate
Learn more about the IRB approval criteria here.