In addition to IRB review, your project may also require review by one of the committees below. Research is usually described in a formal protocol that sets forth an objective and a set of procedures to reach that objective. Thus, a key aspect of research is that there be a systematic design in advance, generally utilizing a scientific approach or protocol, for the defined purpose of contributing to generalizable knowledge. However, some of these activities may include or constitute research in circumstances where there is clear advance interest to contribute to generalizable knowledge with a scientific protocol. Intervention includes physical procedures and manipulations of the subject or the subject's environment for research purposes.
Interaction includes communication between the investigator and the subject.
The IRB will make this determination. Also, studies based on data collected for non-research purposes may not constitute human subjects research unless individual identity is readily identifiable. In summary, any research involving human subjects must be reviewed and approved by the IRB before you begin. This Medical IRB, officially named The Committee on the Protection of the Rights of Human Subjects, is responsible for reviewing all research involving human subjects at the UNC-CH Schools of Medicine or Pharmacy, or involving the staff or patients of UNC Hospitals. If this describes your situation, you may go directly to the main submission page by clicking here .