Responsible conduct of radiology research. Part III. Exemptions from 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 needs to follow. In this article (part three of the series), the situations in which human research in radiology is exempt from regulatory requirements are explained. There are several situations in which an activity falls under the regulatory definition of research but is exempt from the research regulations. Investigators who conduct exempt research should know the regulatory criteria for the exemptions. In the case of research that is potentially exempt from the Department of Health and Human Services regulations, the institutional review board or an authority other than the investigator should make the determination of whether a proposed research activity is exempt from the regulations. For research exempt from Food and Drug Administration regulations, investigators should follow institutional guidance and seek input from the institutional review board or Food and Drug Administration for questionable cases.
Cooper
Jeffrey A
JA
Association for the Accreditation of Human Research Protection Programs, 915 15th St NW, Suite 900, Washington, DC 20005-2315, USA. jcooper@aahrpp.org
D028744:Ethics Committees, Research; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D011871:Radiology / Q000331:legislation & jurisprudence*; D014481:United States; D014483:United States Dept. of Health and Human Services; D014486:United States Food and Drug Administration