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Responsible Conduct of Radiology Research

Part II. 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 December 23; revision received April 21, 2004; accepted June 14. Address correspondence to the author (e-mail: jcooper{at}aahrpp.org).

View larger version (37K): [in a new window]   Figure 1. Criteria for IRB approval of research (4,5): 45 CFR 46.111 and 21 CFR 56.111.

View larger version (78K): [in a new window]   Figure 2. Basic elements of informed consent (8,9): 45 CFR 46.116(a) and 21 CFR 50.25(a).

View larger version (47K): [in a new window]   Figure 3. Additional elements of informed consent (8,9): 45 CFR 46.116(b) and 21 CFR 50.25(b).

View larger version (54K): [in a new window]   Figure 4. Criteria for waiver of informed consent (8): CFR 46.116(b).

View larger version (41K): [in a new window]   Figure 5. Situations in radiology research where a waiver of informed consent might be considered appropriate.