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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.

Classroom Projects

Students often conduct projects involving human subjects as part of their learning experience. Since these projects are for experience and not designed to produce generalizable knowledge they are not reviewed through the IRB.

However, these projects must be completed with utmost regard for University policies, ethical standards, and the welfare of human participants. Because students may have limited experience and knowledge with regard to such matters, it is essential that instructors take responsibility for educating students about the ethical conduct of classroom activities and ensuring that both ethical guidelines and University policy are followed.

When classroom projects are for educational purposes only and present no risk to participants, faculty may submit a Faculty Assurance Form for Classroom Projects.

Some student projects will still require IRB review. These include:

  • Projects that may be presented in a forum outside the university or may be submitted for publication
  • Projects that are individually supervised such as an honors thesis, masters thesis, or dissertation projects
  • Projects that select individuals from a federally-designated vulnerable group such as prisoners, and children
  • Projects that propose to investigate opinions, behaviors, and/or experiences about sensitive physical or mental health-related information such as sexually-transmitted diseases, depression, or eating disorders, or studies about sexual behavior, sexual abuses, or illegal behavior

Oral History Projects

If an oral history project is seeking to produce generalizable knowledge then IRB review will be required, but many projects may be seeking to document local, specific, and non-generalizable knowledge. In those cases, IRB review is not required. If you're not sure, please contact ORS staff to help determine if IRB review is required, as the IRB cannot review research proposals retrospectively.

Program Evaluation

This can be known by many names: Program Evaluation, Quality Assurance, Internal Assessment. Whatever the title, these are systematic attempts to evaluate or develop an internal procedure or process. This may require interventions or interactions with human subjects, but if the data collected is not intended to produce generalizable knowledge, then it does not require IRB review. Program evaluation may be considered research when there is a hypothesis or question being answered and the information being collected is designed to contribute to generalizable knowledge (i.e. beyond the context of the specific institution(s) conducting the evaluation.

In some cases, the researcher may be unsure if they will eventually use the data for research. In those cases, it is a good idea to go through the IRB review process since the IRB cannot review retrospectively.

If it's not clear if IRB review is required, please contact ORS staff and we'll help you figure out the best path.

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.