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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).

View larger version (75K): [in a new window]   Figure 1. Categories of research exempt from DHHS regulations (6): 45 CFR 46.101.

View larger version (60K): [in a new window]   Figure 2. Categories of research exempt from the FDA requirement for IRB review (10): 21 CFR 56.104.

View larger version (53K): [in a new window]   Figure 3. Criteria for emergency use of a test article (10–13): 21 CFR 56.102 and 56.104.

View larger version (63K): [in a new window]   Figure 4. Criteria for waiver of consent with emergency use of a test article (15).

View larger version (57K): [in a new window]   Figure 5. Definition of a custom device.