45 CFR Part 46

Studies on education often involve an intervention or interaction with human subjects either in person or through identifiable records, which brings such studies under the dominion of rules for protection of human participants in research, aka human subjects. At nearly all U.S. institutions under whose auspices educational research occurs, many studies involving human subjects must have their plans reviewed in advance by an institutional review board (IRB; often called “Committee for Human Research Protection” or the like). These entities are broadly governed by federal regulations that define ethical principles and procedures that researchers may be obliged to understand and follow.

The most widely cited regulation on human subjects research in the United States is referred to by the shorthand 45 CFR Part 46 (also 45CFR46), which ...