Is IRB review required?
What projects must be reviewed by the IRB?
Following the federal regulations, the LUC IRB must review all research involving human persons or their data conducted by Lakeside personnel. This type of research is known as human subjects research. However, not all academic work meets the federal definition of human subjects research.
To understand if your project needs review, you need to be able to answer two questions - Is it research? And, does it involve human subjects?
According to the federal regulations, research is a "systematic investigation designed to develop or contribute to generalizable knowledge."
If your project meets that definition, then next you need to consider whether it involves human subjects. Does your project include interactions with living persons? Or, does it involve identifiable data or biospecimens from living persons? If so, it probably involves human subjects data.
The federal government has provided a flow chart to help you answer these two questions, and determine if your project requires IRB review.
Some human subjects research is considered exempt under the federal regulations. Despite the name, exempt research is not exempt from IRB oversight, only certain regulatory requirements. You will still need to submit an application to the IRB so that the IRB can confirm exempt status. See here for more information.
What projects do not require IRB Review?
There are some common activities conducted by LUC personnel that do not meet the definition of human subjects research. These types of projects are not intended to produce generalizable knowledge and therefore do not need to be reviewed by the IRB. See the discussion below to help determine if your project falls into one of these categories.
Determination of Not Human Subjects Research Status
For projects that do not need IRB review, occasionally a funding agency may require an official letter stating that your project has been determined to be Not Human Subjects Research. If your funding agency asks for such a letter please fill out the Not Human Subjects Research Determination Form and submit it to ORS.
What projects must be reviewed by the IRB?
Following the federal regulations, the LUC IRB must review all research involving human persons or their data conducted by Lakeside personnel. This type of research is known as human subjects research. However, not all academic work meets the federal definition of human subjects research.
To understand if your project needs review, you need to be able to answer two questions - Is it research? And, does it involve human subjects?
According to the federal regulations, research is a "systematic investigation designed to develop or contribute to generalizable knowledge."
If your project meets that definition, then next you need to consider whether it involves human subjects. Does your project include interactions with living persons? Or, does it involve identifiable data or biospecimens from living persons? If so, it probably involves human subjects data.
The federal government has provided a flow chart to help you answer these two questions, and determine if your project requires IRB review.
Some human subjects research is considered exempt under the federal regulations. Despite the name, exempt research is not exempt from IRB oversight, only certain regulatory requirements. You will still need to submit an application to the IRB so that the IRB can confirm exempt status. See here for more information.
What projects do not require IRB Review?
There are some common activities conducted by LUC personnel that do not meet the definition of human subjects research. These types of projects are not intended to produce generalizable knowledge and therefore do not need to be reviewed by the IRB. See the discussion below to help determine if your project falls into one of these categories.
Determination of Not Human Subjects Research Status
For projects that do not need IRB review, occasionally a funding agency may require an official letter stating that your project has been determined to be Not Human Subjects Research. If your funding agency asks for such a letter please fill out the Not Human Subjects Research Determination Form and submit it to ORS.