Definition of Human Participation
The IRB is responsible for regulating all research that involves human participants. As defined by federal regulations, a human participant is any individual who an investigator (professional or student) interacts, either directly or indirectly, in order to gain data or identifiable private information.
Direct interaction is defined as: directly talking to, manipulating, physically or verbally relating with, or in any way coming into contact with the individual in order to conduct a research protocol.
Indirect interaction is defined as: utilizing information about an individual without directly gaining that information from that person. For example, a principal investigator might use existing data about school enrollment for research purposes. Although the principal investigator is using the data, he or she is not directly consulting the participant to solicit the data.