Interpretation of Engagement of Institutions in Human Subjects Research Sample Clauses

Interpretation of Engagement of Institutions in Human Subjects Research. In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research. The following two sections apply these concepts. The scenarios in Section A describe the types of institutional involvement that generally would result in an institution being engaged in human subjects research. The scenarios in Section B include the types of institutional involvement that would result in an institution being not engaged in human subjects research, but these scenarios are not intended to be all-inclusive. There may be additional scenarios in which an institution would be not engaged in human subjects research. The determination of engagement depends on the specific facts of a research study and may be complex. In applying this guidance, it is important to note that at least one institution must be determined to be engaged in any non-exempt human subjects research project that is conducted or supported by HHS (45 CFR 46.101(a)). In the scenarios below, employees and agents are individuals acting on behalf of the institution, exercising institutional authority or responsibility, or performing institutionally designated activities.
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