Responsible conduct of radiology research: part II. Regulatory requirements for human research.

The purpose of this series of articles is to explain the ethical and legal basis for responsible conduct of radiology research and the rules that an investigator must follow. In this article (part two of the series), the regulatory requirements to conduct human research are explained. The Food and Drug Administration and Department of Health and Human Services research regulations require two main protections to be in place for the conduct of research involving humans: informed consent and prior review and approval by an institutional review board. Investigators conducting research should know the criteria for institutional review board approval and design their research to meet those criteria. When investigators do not design their research, they should actively work with the sponsor of the research to improve the design in terms of protection of study participants. Investigators should also know the information that must be disclosed when obtaining informed consent and incorporate those requirements into the informed consent process and the documentation of informed consent. Investigators should know about waiver of informed consent and consent documentation and when these situations might be appropriate for their research.