Compliance refers to investigators’ obligation to abide by federal, state, and local requirements when seeking approval to conduct research with human subjects and when conducting research. Investigators are accountable to ensure that all applicable laws and regulations are adhered to, so that participants and the institution are protected from harm. Failure to comply with the terms and conditions of an approved protocol can result in the suspension of the investigator’s research and possibly the suspension of all human subjects research at the investigator’s institution.

Federal regulations require that federally funded research involving human subjects undergo a review for ethical propriety by an institutional review board (IRB). Most institutions where research is conducted require that all human subjects research be reviewed by an IRB, whether or not ...

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