Thesis and dissertation research involving human subjects requires IRB review. Research investigations conducted by students as class or course projects generally do not require the approval of the IRB prior to execution.
Research projects conducted primarily for instructional purposes within the context of a formal class and not designed to contribute to generalizable knowledge do not require review by the IRB. In these cases, the class or course instructor oversees all projects conducted in conjunction with the class and is responsible for the professional and ethical implementation of these projects. If a student plans to use a class or course project to also fulfill thesis or dissertation requirements, then IRB approval prior to implementing the project and collecting any human subjects data is needed.
Before submitting an application for IRB review, students and Responsible Faculty are encouraged to review the Guidance: Examples of Activities that Do and Do Not Require UNC Charlotte IRB Review and Approval document
Does Your Student Project Need IRB Review?
Use the following definitions from the Code of Federal Regulations as guidelines to help you determine whether your student project needs to be reviewed by the Institutional Review Board.
Are human subjects involved in the study?
IRB Definition of "Human Subjects"
- A living individual about whom an investigator (faculty, staff or student) conducting research obtains:
(1) Data through intervention or interaction with the individual, OR
(2) Identifiable private information (e.g., school transcripts, health records).
Is this project considered research?
IRB Definition of "Research"
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
- Generalizable Knowledge
- Will the results of this project or research be made available to the public through publication or presentation as a posters, web site, thesis on file at the library, etc.?
Activities that meet this definition constitute research for purposes of University policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.
REMEMBER: If you want to publish it, you, as the investigator, may be required to prove that your work received IRB review AND approval.
NOTE: Retroactive review and approval is NOT possible.
Still Not Sure?
If it is unclear whether the work fits the definitions above, review the Guidance: Examples of Activities that Do and Do Not Require UNC Charlotte IRB Review and Approval document and contact the Office of Research Compliance.
IRB examination and approval has the advantage of assuring that the investigator has met federal regulations and University policy even if it is not entirely clear that they are wholly applicable. IRB review has the further advantage of providing the investigator with an experienced examination of the protocol that could prevent risk and/or embarrassment to subjects or the investigator.
What if another person is the Primary Investigator? You do not need separate IRB approval if you are doing work under the Primary Investigator’s direction where you are acting as co-PI or an employee (paid or not)—as long as the project already has IRB approval! If, however, you were not named as a co-PI or employee on the originally-approved protocol application, an amendment would need to be submitted to the Compliance Office for IRB Approval.
Make sure the IRB of record can provide you with a copy of their Certificate of Approval prior to involvement with subjects. If you are using data from the original project later for research, apply for approval of research consisting of secondary data analysis.