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Defining Human Subjects Research

Research is designed to test a hypothesis through the collection and analysis of data. The resulting conclusions are used to develop or contribute to generalizable knowledge. A hypothesis is a tentative assumption that is empirically tested. If the conclusions resulting from data analysis do not support the hypothesis, it must be rejected or modified. A research study is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.

 

The IRBs responsibility is to review research protocols that involve human subjects. A human subject is a living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual, or (2) identifying private information