HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Figures Only Full Text Full Text (PDF) Submit a response Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Cooper, J. A. Search for Related Content PubMed PubMed Citation Articles by Cooper, J. A.

Responsible Conduct of Radiology Research

Part III. Exemptions from Regulatory Requirements for Human Research¹

¹ From the Association for the Accreditation of Human Research Protection Programs, 915 15th St NW, Suite 900, Washington, DC 20005-2315 and the Department of Radiology, University of Pittsburgh Medical Center, Pittsburgh, Pa. Received October 8, 2003; revision requested January 5, 2004; revision received May 6; accepted June 14. Address correspondence to the author (e-mail: jcooper{at}aahrpp.org).

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.

© RSNA, 2005

This article has been cited by other articles:

				A. B. Wolbarst and W. R. Hendee The National Institute of Biomedical Imaging and Bioengineering and NIH Grant Process: An Overview Radiology, January 1, 2007; 242(1): 32 - 55. [Abstract] [Full Text] [PDF]

				J. A. Cooper Responsible Conduct of Radiology Research Part IV. The Boundary of Research and Practice Radiology, November 1, 2005; 237(2): 383 - 384. [Abstract] [Full Text] [PDF]