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?
Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subjects or the subject’s environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
Is this project considered research?
means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this 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. Excluded from the definition of Research are:
- Most scholarly and journalistic activities that focus directly on the specific individuals about whom the information is collected (e.g. oral history, journalism, biography, literary criticism, legal research, and historical scholarship).
- Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
- Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
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 Protections and Integrity.
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 research assistant (paid or not)—as long as the project already has IRB approval. If, however, you were not named as a co-PI or research assistant on the originally-approved protocol application, you need to be added to the protocol via a personnel modification. Make sure the IRB of record can provide you with a copy of the
ir Certificate of Approval prior to involvement with subjects.